Guide
for
Review of Research
Involving
Human Participants
IRB
Guidelines and Forms
Http://www.brockport.edu/etc/forms/grant/guidelines.html
Revised Summer 2006
Page #
| A. | Purpose Statement of SUNY Brockport IRB | 4 | ||||
| B. | Guide for Review of Research Involving Human Participants
1. Frequently asked questions 2. How do I submit my proposal for review? Six steps are involved3. Project Categories 1, 2, 3
|
5 8 9
|
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| C. | Appendix: | 71 | ||||
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Contact Persons
2006-2007
IRB Office at 585-395-2779; e-mail: irboffic@brockport.edu
Colleen Donaldson, IRB Administrator at 585-395-5118; e-mail: cdonalds@brockport.edu
Jan Gillespie, IRB Chair, at e-mail: jgillesp@brockport.edu
Marsha Moss, IRB secretary, at 585-395-2524; e-mail: mmoss@brockport.edu
PURPOSE STATEMENT
OF THE
INSTITUTIONAL REVIEW BOARD
SUNY BROCKPORT
Draft from 8/05
The Institutional Review Board (IRB) of SUNY College at Brockport exists to:
Introduction - The purpose of these guidelines is to assist faculty, student,
and staff researchers planning to conduct research involving human participants
to submit your proposal for review to the Institutional Review Board. This is
a collaborative process intended to result in research procedures which accomplish
your research objectives while protecting the rights and welfare of the participants.
The IRB tries to be as flexible as possible and reviews each project as a separate
case. The IRB sees its role as primarily educational and facilitating, and encourages
consultation at all stages of the research process.
1. Frequently Asked Questions
What is human participants research?
Human participants research" is defined as a systematic investigation designed to develop or contribute to general knowledge, which involves the collection of data from or about living human beings. (Federal regulations definition - 45 CFR 46.102). If the knowledge is to be
a) generalizable and extrapolated beyond the specific study, and it b) involves a systematic design, then it is research. This includes the use of data by agencies, practitioners, or students to modify existing programs, interventions, educational groups, etc. The results do not have to be published to be generalizable. Student research involving human participants outside their own classroom is included in this category if it meets the above criteria.Why must it be reviewed by the IRB?
Federal and state laws require this protection. Therefore, it is College policy to ensure that the rights and welfare of human participants are adequately protected in research conducted under its auspices.Who must submit material for review?
Any faculty, staff, student or external person who wants to conduct human participant research under the auspices of the College or on the grounds of the College must have prior approval of the College's IRB. Research conducted for course evaluation, institutional research, or ongoing college processes does not need to be reviewed. If research results in dissemination of information in external publications or presentations, then the research must receive prior approval. If no dissemination is planned at the time the data is gathered, but the possibility of future dissemination exists, the researcher should submit the project for approval before beginning research.How is it submitted?
The guidelines and forms you need are in this document which covers the range of topics related to submission of research proposals to the IRB. Specifically, there are packets for Category 1, 2, and 3 proposal preparation. Forms are submitted to the IRB Administrator, Academic Affairs, 6th Floor Allen Administration Building.When does it have to be submitted?
Proposals may be submitted at any time. Depending upon the level of your review category and the time of the year, proposals are generally approved within two weeks after a complete application is submitted. But depending upon the proposal and the speed with any revisions are made and submitted to the IRB it can take up to one month.Please note that Category I and II proposals submitted by December 1st of the fall semester can be reviewed before the semester break and campus shut-down. Category III proposals submitted by Thanksgiving can be reviewed at Category III meetings before the semester break. Proposals submitted beginning January 3rd will receive responses during the week preceding the start of the spring semester and the first week of classes.
If you are submitting a grant proposal to an external funding source that involves human participant research please call the Grants Development Director immediately at (585) 395-5118 (if you haven't already).
The IRB cannot give its approval or disapproval of human participants research projects already conducted. All research involving human subjects must be reviewed and approved prior to conducting the research. Refer to the attached appendix "research conducted without IRB approval."
Who reviews my application?
The College has authorized the Institutional Review Board (IRB) to review and approve human participant research. The IRB is a campus-wide committee made up of faculty members from several different departments, and at least one person from the community. Staff support is provided by the IRB Administrator through the Grants Development Office. There are three different levels of review by the IRB depending upon the activities you are conducting.
How will my application be reviewed?
The review process focuses on the procedures affecting the rights and welfare
of human participants including issues of risks to participants, informed consent,
voluntary participation, equitable selection of participants, and maintaining
confidentiality. These are based upon federal regulations.
Informed consent process - informed consent must be sought
from each prospective
participant or the participant's legally authorized representative. Their
participation
must be voluntary.
Privacy and confidentiality - the IRB will determine that
adequate provisions have
been taken to protect the privacy of participants and for ensuring confidentiality
of an
individual's participation as well as confidentiality of study data.
Special populations - when some or all of the participants
are likely to be vulnerable to
coercion or undue influence (such as children, prisoners, pregnant women,
persons who
are physically or mentally disabled, or economically or educationally disadvantaged
persons), additional safeguards must be included in the study to protect
the rights and
welfare of these participants.
The proposal checklist for evaluating IRB proposals is attached to each of
the packets for category 1, 2, 3 proposals to assist you in being sure that
you have addressed all of these points.
Where can I get assistance?
Contact the IRB Administrator, at (585) 395-2779 or irboffic@brockport.edu.
Questions about?
2. How Do I Submit My Proposal for Review?
SIX STEPS are involved.
STEP 1 - Training Requirement as of 9/01 required of all persons
submitting proposals
To be in compliance with federal regulations all persons (faculty, staff,
students) submitting a proposal to the Institutional Review Board must complete
a three-hour, online, modular training course on the protection of human
subjects in research.
Each module can be printed out if you desire.
- After you have completed the requirements above (depending on if you register in Group 1 or 2) you can print out a course transcript. This will be emailed to you and to the IRB Administrator who will keep a record of your participation on file. We will not be sending you a separate certificate of completion. This transcript is your record of completion and will be available for you to access online for two years.
- Questions can be addressed to the IRB Administrator at irboffic@brockport.edu or 585-395-2779.
STEP 2 - Determine the appropriate category for your research project - Category 1, 2 or 3 based upon guidelines that follow. If you have any questions call (585) 395-2779 or send an email to irboffic@brockport.edu.
STEP 3 - Provide the information requested in the packet for that category. Packets are attached for all categories or you can go to the website listed on the cover page and download just the guidelines for that category.STEP 4 - Fill in the cover sheet in each packet, have it signed as indicated, and place it as the first page of your proposal. The process will go faster if you submit a final version of your complete package free of spelling and grammar errors.
STEP 5 - Make the appropriate number of copies for whatever category fits your proposal and submit to IRB Administrator, Grants Development Office, 6th Floor Allen Administration Building. Refer to the checklist for your category in each packet to make sure you have all the necessary forms.
STEP 6 - your proposal will be reviewed initially by the IRB Chair, then depending upon the category it falls under, the application will be sent to additional reviewers or require a full meeting of the IRB. The IRB Administrator will contact you with any revisions that will need to be made as the proposal is reviewed. The entire process can take 1-4 weeks depending upon the level of review, the time of year, and your response time to any revisions. When the proposal is approved you will be notified immediately by phone or email and this will be followed with a formal approval letter. Your research proposal is approved for up to 12 months.
Category I and II proposals submitted by December 1st of the fall semester can be reviewed before the semester break and campus shut-down. Category III programs submitted by Thanksgiving can be reviewed at Category III meetings before the semester break. Proposals submitted beginning January 3rd will receive responses during the week preceding the start of the spring semester and the first week of classes.
3. Project Categories
Review the following guidelines to determine which of the three categories your proposal falls in. The method for review of your proposal depends upon the category. The Categories are 1 (exempt review), 2 (expedited), and 3 (requires full review by the IRB Board). You the researcher, and if appropriate your faculty advisor, makes the initial determination of the proposal's review category. The IRB makes the final decision. The IRB may require full review of any research submitted under either of the first two categories, or of any research previously approved under expedited review (if you seek approval beyond the initial 12 month approval period). The researcher can always request a higher level of review than that required if so desired.
The review categories are:
Category 1 (Exempt Review) - your proposal fits this category if the research presents no possible risk to subjects 18 years of age and older and is one of the following activities:
- anonymous, mailed survey on innocuous topics
- anonymous, non-interactive non-participating observation of public behavior
- secondary analysis of existing data (see definition in attached appendix).
Category 2 (Expedited Review) - your proposal fits this category if the research presents
no more than minimal risk to subjects and is one of the following activities:
- research on educational curricula, records, or teaching methods involving normal educational practices
- research involving the use of educational tests if information taken from these
sources is recorded in such a manner that subjects cannot be identified- research on individual or group behavior of normal adults where there is no
psychological intervention, physiological intervention or deception- interviews and non-mailed surveys on non-sensitive topics
- minor changes in previously approved research (see appendix)
- continuations of approval for previously approved no-risk research with no
more than minor changes in procedures (see appendix).- research conducted on the Internet on non-sensitive topics (see appendix).
Category 3 (Full Review) - your proposal fits this category if the research has the
potential for harming participants, violates their rights, or requires special protections for
participants. Such research includes activities such as:
- research which might put participants at risk
- research involving psychological or physiological intervention
- non-curricular, interactive research in schools
- interviews or surveys on sensitive topics (e.g. sexual activity, alcohol or
drug use, illegal behavior)- " research on special populations (e.g. prisoners, people with mental health issues or developmental delays) whether or not the research is covered by another assurance (see appendix)
- research involving deception (see appendix)
- research to be conducted on the Internet on sensitive topics (see appendix)
- international research, including class projects conducted in another country. International research requires additional approval from an IRB (or similar body) in that country and a copy of the translation of the informed consent document and any survey or interview questions (see appendix). Please contact the IRB Administrator at (585) 395-2779 for assistance prior to submitting your proposal.
Procedures for each category are described in the attached packets (along with examples of the types of proposals included in each category). Packets for each category can also be obtained separately from our web site at http://www.brockport.edu/etc/forms/grant/guidelnes.html.
If you have any questions regarding the appropriate category for your proposal contact the IRB Administrator for assistance at 585-395-2779 or irboffic@brockport.edu.4. Class Projects
Instructors who assign student projects that involve systematically obtaining information
from human participants may or may not need IRB review and approval depending on the purpose of the assignment. If the purpose of the assignment is to obtain information from a human being to improve one's own professional practice or to develop clinical skills and not to obtain data for purposes of generalizing, this does not fall under the definition of human participants research (e.g. single system design to test if a behavior management technique was effective in changing a student's behavior). However, it must be clear that the data obtained will not be used for any other purposes and would be destroyed after the assignment is complete. Students should still follow sound ethical principles in conducting their research, including procedures to maintain confidentiality and informed consent from each participant.If there is any possibility that the data collected would be used in the future for other purposes such as a conference presentation, publication, etc. then IRB approval must be sought from the outset.
Class projects that do require IRB approval may be reviewed as one proposal at the direction of the faculty instructor if the entire class is using the same procedure. But, if the entire class is not using the same procedure, each student or group of students using a different procedure must submit the required information. All members of the class and the faculty advisor must also complete the required online training program. A sample category 2 class project proposal can be found in the packet of guidelines for category 2 proposals.
5. Informed Consent Process and Forms
Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the participant and/or their legally authorized representative. In the case of minors (17 years of age or younger), the parent or legal guardian must give consent, as well as the minor. A copy of the consent form shall be given to the person signing the form, and the original signed form must be maintained in a place designated in your project description. Sample consent forms are also included with Category 1, 2, and 3 proposal packets.
Please remember that informed consent is fully informed consent. It is a process, not just a piece of paper. A participant must know all information regarding the study that would be relevant to their decision in order to make an informed decision to participate.
Please note that the final form that you use must first be approved by the Institutional Review Board before it can legally be administered and the IRB must by law retain in its records a sample copy of that form. The approved consent form will be date stamped and sent with your approval letter. It is the copy you should use for your research project.
Conditions of Approval:
Approval by the IRB applies only to the procedures submitted in the proposal. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of human participants. The investigator must also report to the IRB any problems that arise in connection with the use of human subjects.IRB approval is only valid for the period specified in the proposal up to one year. If a project continues beyond the specified completion date or beyond one year, the investigator must request a continuation of approval from the IRB (see appendix).
Next step - completing the appropriate packet for your project.
The following pages contain guidelines for category 1, 2, 3 proposals with samples to complete the information. If you have already determined the category that your proposal falls in based on the criteria under area #3 Project Categories earlier in these guidelines you can skip to the relevant section in these guidelines or go to the website at http://www.brockport.edu/etc/forms/grant/guidelines.html and download the packet just for that category.
CATEGORY I PACKET
Category 1 (Exempt Review) - your proposal fits this category if the research presents no possible risk to subjects 18 years of age and older and is one of the following activities:
- anonymous, mailed survey on innocuous topics
- anonymous, non-interactive non-participating observation of public behavior
- secondary analysis of existing data (see definition in attached appendix).
Informed consent - This research is exempt from the requirements of informed consent. The researcher, however, is still responsible for protecting the rights, such as privacy and welfare of the subjects. You must include (and attach a copy) of a cover letter or directions read prior to completing the survey that contains all of the standard elements of informed consent (see sample consent form in packet). A statement must be included on the cover letter or in the directions that states "returning the completed survey indicates consent to participate."
Directions to submit a Category 1 proposal:
This information must be typed, and should be carefully checked for spelling
and grammar. Please number paragraphs according to the number of the item
appropriate for your project. If an item is not applicable please put NA (for
not applicable).
Category 1 proposals should include in this order ( See specific items
below)
A. A completed and signed cover sheet with all required signatures.
B. Typed answers to questions 1-8 below.
C. Attach a copy of the survey form and written cover letter/directions (as
appropriate).
D. Submit one copy to IRB Administrator, Grants Development Office, 6th Floor,
Allen Administration Building.
A. Attach a completed and signed cover sheet with required signatures.
SUNY BROCKPORT INSTITUTIONAL REVIEW BOARD
Human Participant Research Review Form
Proposal #
(# will be inserted by IRB)
Please follow these steps to submit your application.
1) Use these two pages as the first pages of your application.
2) If a Category 1 review send just the original, if a Category 2 send the original
and one copy, if a Category 3 review send the original and eight copies (if
faculty member/graduate student); only three copies and an original if an undergraduate
student.
3) Deliver or mail to IRB Administrator, Grants Development Office, 6th Floor
Allen, SUNY Brockport, 350 New Campus Drive, Brockport, N.Y. 14420. (585) 395-2779,
irboffice@brockport.edu; fax number is (585) 395-2006.
Please type or neatly print.
1. Investigator(s) name(s) ______________________________________
Department _______________________________________________
Phone Number ________________________________
(where you can be reached during the day - so we can call with questions)
E-mail address: ______________________________________________
Local mailing address: _________________________________________
2. Project Title: ________________________________________________________
_____________________________________________________________________
3. College Status (for each investigator):
Faculty/Staff _________________________________
Undergraduate Student _________________________
Graduate Student _____________________________
4. If the principal investigator is a student, list name, department, and
local telephone
number of faculty supervisor. Please note that the Faculty/Staff Supervisor
must
indicate knowledge and approval of this proposal by signing this form.
Faculty /Staff Supervisor's name: ___________________________________________
Department and phone number: _____________________________________________
5. Check appropriate category of research project (complete after reviewing
guidelines):
Category 1 (Exempt Review) ____; Category 2 (Expedited Review) ___________
Category 3 (Full Review) _______________
6. The Principal Investigator must sign this form. (If the P.I. is a
student, their
faculty/staff supervisor must also sign this form).
I certify that: 1) the information provided for this project is accurate;
2) no other
procedures will be used in this project; 3) any modifications in this project
will be
submitted for IRB approval prior to use; 4) I have successfully completed the
required
online IRB training program.
____________________________________________________________________
| A. Signature of Investigator | Date |
B. Faculty/Staff Supervisor: 1) I certify that this project is
under my direct
supervision and that I am responsible for insuring that all provisions of approval
are complied with by the principal investigator. 2) I have successfully completed
the required online IRB training program. 3) My signature indicates I have reviewed
this proposal and agree it is in final form and ready to be submitted to the
IRB.
______________________________________________ ______________________
| Signature of Faculty/Staff Supervisor | Date |
8/06
B. Items 1-8
This information must be typed, and should be carefully checked for spelling
and grammar. Please number paragraphs according to the number of the item
appropriate for your project. If an item is not applicable please put NA (for
not applicable).
A sample completed project description can be found later in this packet.
C. Submit a copy of the survey form for your research if appropriate.
D. Submit one copy of the packet to IRB Administrator, Grants Development Office, 6th Floor of Allen.
Category 1 proposals are reviewed by the IRB Chair and if they do fit this
category a response will be given to you within 5 business days after submission
of the proposal.
You will receive a phone call or email from the IRB Administrator or Secretary
informing you that the proposal is approved or any revisions that may be needed
prior to final approval. Final approval is given initially by phone or email
and then followed by a formal letter within 5 business days. Maximum approval
period is for 12 months.
Sample Forms for Category I Proposals Follow. Please modify them as appropriate for your project.
Sample Cover Letter for Participants
Sample Letter for Institutional Consent
Sample Category I Proposal
Check list for IRB proposal review.
__________________________________________________________________________
Sample Cover Letter for Participants (for anonymous mailed or distributed
surveys)
(When submitting your form please delete information that is not relevant to
your
project).
Dear _________________
________________________is conducting a study on __________________which involves
a survey of X# of questions that will take approximately X amount of time to
complete. The answers to this survey are important because_______________ and
will be used to inform
__________________about___________________________. You are being asked to participate
in this study and your answers to the attached survey signify your consent to
participate. Please do not write your name on the survey. There will be no way
in which you will be connected to this survey, and results will be reported
in aggregate form only. You do not have to answer any questions that you do
not want to answer, and you may stop participating in the survey at any time.
It is hoped that approximately X# of people will participate in the study. The
results will be used to_______________________.
Thank you for your participation in the survey. You may return the completed
survey by
(include one relevant to your project - placing in drop box, using the
enclosed stamped and addressed envelope, etc). If you have any questions regarding
this study you may contact:
Name of Primary Investigator(s)
Department
SUNY Brockport
Phone number
Email
Sample Letter for Institutional Consent
Have institution print the consent on its letterhead and sign
To: Institutional Review Board
SUNY Brockport
I have read and approve the research study entitled, "________________________"
By _______________________________ [name(s) of primary researcher(s)] and give
consent for the study to be conducted at or through _________________________(name
of institution).
The institution may add any other appropriate requirements it wishes to emphasize
( such as so long as information regarding the study is shared with staff of
the agency after the completion of the study, so long as parental permission
is obtained, etc. )
___________________________________ _______________________________
| Signature Title at Institution |
Date |
Sample Project Description for Category 1 Proposal
PROJECT INFORMATION
Items 1-8 (Required to be completed by all projects)
There are no research assistants.
A Scholarly Incentive Grant, awarded by the Scholarly Incentive Award Committee to Drs. Scott and Smith for $500 will be the primary funding source for this project. To be funded will include such items as postage, letterhead, envelopes, and statistician fees.
This research project will begin upon IRB approval and will end by December 1, 2005.
The following are attached: (a) cover letter to respondents, (b) a copy of the survey instrument, and (c) the "Project Information" form.
Please note that the principal investigators have each passed the online training, course which should be in your files.
IRB Proposal Checklist (used by IRB reviewers to evaluate each proposal)
Project Description:
Item #1 _____State purpose of the research - how the proposed study is beneficial to new knowledge/why is the research important?
_____ purpose needs to be restated in the informed consent for potential participants to know the potential value of the research study.
Item #2 _____ the number of participants should be consistent in all parts of the proposal and in the informed consent, cover letters, etc.
Item# 3 _____ Methods for data collection should be consistent throughout the
proposal and the informed
consent regarding questionnaire/survey, interview, audiotaping, videotaping,
observations, use of materials already required for classroom work, etc.
Item #4 Research Instruments:
_____cite sources on each page of instruments if not self-designed
_____explain who designed questionnaire
When using published or unpublished evaluation or measurement tools, surveys,
etc. the source should always be cited on each page of the tool in addition
to citing the source in the proposal. Permission forms to use tools should be
attached to the proposal whenever it is required to obtain such permission.
Institutional Permission:
________ preferable that the permission be on agency letterhead and signed by
an employee who has authority to give permission. (Permission is needed from
an organization, business, school, etc. to recruit participants from its membership,
conduct surveys on its premise, etc.). The investigator can compose the letter
and ask organizations to copy it onto letterhead and then sign and submit it.
Informed Consent Forms:
_______check for consistency between the proposal and consent form for number of participants, forms of data collection, protection of the identity of the participants as well as organizations from which recruited.
______ indicate affiliated with SUNY Brockport and include the Department
______ state risks are not anticipated or that time spent or fatigue can be a minor risk
______ if participants will have face to face interviews or be audio or videotaped, then signed consent forms are needed
______ include the names and phone numbers of both the principal investigator(
s) and the faculty member
If children are part of the research, then both parent consents and child assents
should be developed
______ include statement of " I am 18 years or older. . ." for all adult consents.
Overall
______ proofread and correct proposal, informed consent, and/or questionnaire
_____ check for consistency between the proposal, hypothesis, informed consent,
and data collection instrument.
CATEGORY II PACKET
Category 2 (Expedited Review) - your proposal fits this category if the research presents no more than minimal risk to subjects and is one of the following activities:
Research conducted in schools, agencies or businesses -
All research conducted in schools requires written permission on letterhead
from the school superintendent or principal. Research conducted in a business
or other organization also requires written permission of the director of that
organization. This must be attached to your proposal when it is submitted. (Signed
faxes on letterhead are acceptable).
Informed consent - research under this category does not, in most
cases, require written documentation of informed consent, but oral consent
is required. The proposal should include written information to assist participants
in making an informed decision. If minors are involved (under the age of
18 years) in the research then written permission of their parent or guardian
is required for their participation. Written consent is also required for interviews
and for audio or videotaping.
The researcher must detail for the reviewers that legally effective informed consent (examples follow) is:
Category 2 proposals should include in this order: ( See items below):
A. A completed and signed cover sheet with all required signatures.
B. Typed answers to questions 1-12. Sample completed project description is attached.
C. Attach a copy of your informed consent statement. If your research involves minors please attach two informed consent forms - one for their parent/guardian to sign and a second one for the minor to sign (depending upon age, it may just be read to them).
D. If research is to be conducted in a school, then please attach a letter of written permission from the school superintendent or principal. If the research is to be conducted in a business or other organization, please attach a letter of permission from the director of the organization. Sample completed consent forms are attached.
E. Attach any interview or survey questions used and indicate their source.
F. Submit two copies (including the original) to IRB Administrator, Grants Development Office, 6th Floor Allen Administration Building.Directions for completing a Category 2 proposal:
A. Attach a completed and signed cover sheet with required signatures.
SUNY BROCKPORT INSTITUTIONAL REVIEW BOARD
Human Participant Research Review Form
Proposal #
(# will be inserted by IRB)
Please follow these steps to submit your application.
1) Use these two pages as the first pages of your application.
2) If a Category 1 review send just the original, if a Category 2 send the original and one copy, if a Category 3 review send the original and eight copies (if faculty member/graduate student); only three copies and an original if an undergraduate student.
3) Deliver or mail to IRB Administrator, Grants Development Office, 6th Floor Allen, SUNY Brockport, 350 New Campus Drive, Brockport, N.Y. 14420. (585) 395-2779, irboffice@brockport.edu; fax number is (585) 395-2006.Please type or neatly print.
1. Investigator(s) name(s) ______________________________________Department _______________________________________________
Phone Number ________________________________
(where you can be reached during the day - so we can call with questions)E-mail address: ______________________________________________
Local mailing address: _________________________________________
2. Project Title: ________________________________________________________
_____________________________________________________________________3. College Status (for each investigator):
Faculty/Staff _________________________________
Undergraduate Student _________________________
Graduate Student _____________________________4. If the principal investigator is a student, list name, department, and local telephone
number of faculty supervisor. Please note that the Faculty/Staff Supervisor must
indicate knowledge and approval of this proposal by signing this form.
Faculty /Staff Supervisor's name: ___________________________________________
Department and phone number: _____________________________________________5. Check appropriate category of research project (complete after reviewing guidelines):
Category 1 (Exempt Review) ____; Category 2 (Expedited Review) ___________
Category 3 (Full Review) _______________
6. The Principal Investigator must sign this form. (If the P.I. is a student, their
faculty/staff supervisor must also sign this form).I certify that: 1) the information provided for this project is accurate; 2) no other
procedures will be used in this project; 3) any modifications in this project will be
submitted for IRB approval prior to use; 4) I have successfully completed the required
online IRB training program.
____________________________________________________________________
A. Signature of Investigator Date B. Faculty/Staff Supervisor: 1) I certify that this project is under my direct
supervision and that I am responsible for insuring that all provisions of approval are complied with by the principal investigator. 2) I have successfully completed the required online IRB training program. 3) My signature indicates I have reviewed this proposal and agree it is in final form and ready to be submitted to the IRB.
______________________________________________ ______________________
Signature of Faculty/Staff Supervisor Date 8/06
Project Description Questions to be answered. A sample completed project description follows.
B. Provide typed answers to items 1-12 below.
This information must be typed, and should be carefully checked for spelling and
grammar. Please number paragraphs according to the number of the item appropriate for your project. If an item is not applicable please put NA (for not applicable).
- Provide a brief project description. Describe: a) The objectives, methods and procedures of the project. b) The purpose of the research - include why it is significant and how it contributes to general knowledge. c) The emphasis should be on the human subject involvement in the project. Discussion of theoretical or statistical aspects of the project should be avoided. d) If a questionnaire, and/or testing instrument is to be used describe how it will be administered, by whom, and its source. If the survey is copyrighted, note when permission to use was given and indicate this at the bottom of page one of the survey form. e) If interviews are to be conducted, describe the nature of the interview and how responses will be recorded by written notes, audio or videotape, etc. (see appendix).
- Number of and the relevant characteristics of subjects.
- Describe how subjects will be selected for participation in this project and any fees, extra
credit, or other items they will receive for participation if appropriate.
- Status and qualifications of research assistants, if any. They must also complete appropriate IRB online training.
- Source of funding for project, if any.
- Expected starting and completion dates for project. (Note that project cannot begin until
approval has been received from IRB. Projects are given approval for a maximum of one year; if they continue past that point they must again receive IRB approval).
- Attach copies of all questionnaires, testing instruments, or interview protocols, and any
cover letters or instructions to participants.
- Attach a copy of your transcript of completion for the online training course. If you do not
have it, indicate that you completed it and records will be verified by the IRB Administrator.
- Specify steps to be taken to guard the confidentiality of participant's responses. Indicate
what personal identifying indicators will be kept on subjects (if any). Specify procedures for storage and ultimate disposal of personal information. This would normally mean keeping information in a locked file cabinet and shredding information at the end of the research project.
- Attach an informed consent document that includes the basic elements of
informed consent. ( See below for Sample Informed Consent)
- If the participants are to be drawn from an institution or organization (e.g. hospital,
social service agency, prison, school, etc.) that has the responsibility for the participants, then a copy of that assurance or, if not available, documentation of permission from the institution must be submitted to the IRB before final approval can be given.
- If the subjects will come into contact with any mechanical, electrical, electronic or other
equipment, Form 101, must be completed in order for the safety of the equipment to be
checked. See appendix.C. Attach a copy of your informed consent statement whether it will be signed by subjects or just read to them. If research involves minors, two informed consent forms should be attached - 1) one that provides for written permission of parent or legal guardian for a minor to participate and 2) a separate one that is addressed to minors. The form addressed to minors should be in language understandable to their age level. The form may be read aloud to a child and when appropriate the child should be given a copy to read along with.
Sample forms follow.D. If research is to be conducted in a school, institution or at a business the researcher must also attach a written letter of permission on the agency's letterhead from the school superintendent or principal, or the director of a business or organization where the research will be conducted. Sample letter follows.
E. Attach copy of any interview or survey questions used and indicate their source. The IRB cannot review your project without this information.
F. Submit 2 copies (one copy in addition to the original-- two copies and the original if minors are involved) to the IRB Administrator, Grants Development Office, 6th Floor Allen Administration Building. Be sure to submit a final version to the IRB that has been carefully reviewed for spelling and grammatical errors. Doing so will expedite the review process.
Category 2 proposals are reviewed by the IRB Chair and if the proposal is found to meet this category of review the proposal is then mailed to one additional member of the IRB Board for their review and approval. However, if the proposal involves minors it will be reviewed by two members of the IRB, in addition to the Chair. The approval time is dependent upon the time of year, the completeness of your proposal, and how quickly you respond to any revisions requested by the IRB Administrator. The average time is within 2 weeks of submission.
You will receive a phone call or email from the IRB Administrator or Secretary informing you that the project is approved or any revisions that may be needed prior to final approval. Final approval is given initially by phone or email and then followed by a formal letter within 5 business days. Maximum approval period is for 12 months.
Attachments for Category 2 Proposals on following pages:
B. Informed Consent Directions
C. Sample of General Informed Consent
D. Sample of Parental Consent
E. Sample of Minor Consent
F. Sample Letter for Institutional Consent
G. Sample IRB Category 2 Proposal
H. IRB Proposal Review Checklist
I. See IRB Appendix for Forms 101, 202, 303, and 404 as needed.B. Informed Consent Directions
Category II research projects do not need to obtain signatures on informed consents
unless 1) minors are involved or 2) audio or videotaping of interviews are involved. If minors are involved you must provide two separate consent forms. One for parent/guardians and one for minors (17 years of age and younger). The minors' forms should be in a language understandable to their age level.Proposals are approved more quickly if researchers use the attached sample informed
consent forms and modify them to fit your project. The following elements must be included:
A. Statement that the study involves research and why it is being conducted.
B. Explanation of the purpose of the research and the expected duration of the participant's involvement (e.g. how long will it take to complete the survey and number of questions).
C. Description of the procedures to be followed, and identification of any procedures that are experimental.
D. Description of any benefits to the participant's or to others which may reasonably be expected from the research.
E. Description of any reasonably foreseeable risks and discomforts to the participant.
F. Statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained, stored for how long, how destroyed.
G. For research involving more than minimal risk, an explanation as to whether any medical treatment is available if injury occurs; or counseling available for questions that might be sensitive, and if so, what they consist of, or where further information may be obtained.
H. Name and phone number of whom to contact for answers to pertinent questionabout the participant's rights, and whom to contact in the event of a research-related injury to the participant.
I. Statement that participation is voluntary, and refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.
J. Statement that participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
K. Name of institution should be fully spelled out (ex.Greater Rochester Collaborative
Masters in Social Work Program through SUNY Brockport and Nazareth College).
Whether presented orally or in writing, to the participants' the IRB must be provided a written description of these elements of informed consent to be presented to them. If the research cannot practically be completed without this requirement being waived or altered, please say so here, and include a debriefing procedure.
If minors are involved - in addition to parental consent adequate provisions must be made
for soliciting the assent of the children capable of providing their agreement. According to
federal regulations, assent means .."a child's affirmative agreement to participate in research.
Mere failure to object, absent affirmative agreement, should not be construed as assent."
Procedures for obtaining assent of children must be appropriate to their age level, maturity,
and psychological state. The essential information given to the child must include a
description of the procedures and clear indication that their participation is voluntary. If the research is being conducted in schools, it must be clearly stated that this research is not part of the child's regular school program, not being conducted by the school, and that participation will not affect the child's grade.In cases where there is inconsistency between the consent of the parent and the agreement of the child, the following rule will be followed: A "no" from the child overrides a "yes" from the parent, but a "yes" from the child does not override a "no" from the parent.
Non-participation in a research project being conducted as part of a class or group (whether or not minors are involved), must detail alternatives for those in the class not participating in the research. For example, if extra credit is being offered for participation then the researcher must detail how those not participating have an alternative method of obtaining extra credit. This is to minimize coercion to participate. Another example would be if an investigator is conducting research in a classroom where they will be observing, interviewing and taping the class. Please explain what procedures will be followed for those children in the class whose parents have not given permission, or where the child does not agree to participate in the research.
Following pages have examples of three informed consent forms for different participants to use as models.
C. SAMPLE OF GENERAL INFORMED CONSENT FORM
(not involving minors).
This can be modified to fit the needs of your project. Note that it contains the required elements of informed consent.STATEMENT OF INFORMED CONSENT
The purpose of this research project is to examine some of the ways adults, 65 and older, take care of their health. Four areas will be studied including exercise, diet, taking medications, and seeking medical care. This research project is also being conducted in order for me to complete my masters thesis for the Department of ___________ at the State University of New York College at Brockport.
In order to participate in this study, your informed consent is required. You are being asked to make a decision whether or not to participate in the project. If you want to participate in the project, and agree with the statements below, (INSERT EITHER OF THESE TWO OPTIONS - a) "please sign your name in the space provided at the end"; b) "your completion of the survey and/or interview signifies your consent" (if signature is not required - most Category 2 proposals). You may change your mind at any time and leave the study without penalty, even after the study has begun.
I understand that:
I am 18 years of age or older. I have read and understand the above statements. All my questions about my participation in this study have been answered to my satisfaction. I agree to participate in the study realizing I may withdraw without penalty at any time during the survey process. Returning the survey (and/or completing interview if appropriate) indicates my consent to participate.
- My participation is voluntary and I have the right to refuse to answer any questions.
- My confidentiality is guaranteed. My name will not be written on the survey. There will be no way to connect me to my written survey. If any publication results from this research, I would not be identified by name.
- There will be no anticipated personal risks or benefits because of my participation in this project.
- My participation involves reading a written survey of X# of questions and answering those questions in writing. It is estimated that it will take X# of minutes to complete the survey.
- Approximately X # people will take part in this study. The results will be used for the completion of a masters thesis by the primary researcher.
- Data will be kept in a locked filing cabinet by the investigator. Data and consent forms will be destroyed by shredding when the research has been accepted and approved.
If you have any questions you may contact:
Primary researcher Faculty Advisor Name Name Phone Number Department and phone number Note: Signatures and the date are required for any category 2 proposal involving minors. Add a line with a place for signature and the date.
Additional information will be applicable for some projects.
If one of the following applies to your proposal please add this to the consent form above the section regarding whom to contact for information.
- Payment for participation - include the amount of payment and procedures to be paid. Please note that participants must be paid even if they don't complete the study. If you are paying participants more than $600 annually please contact the IRB Administrator for specific language that must be included in your consent form. Also see attached appendix.
- Taping (audio and video) - if you are audio/video taping you have two options:
a) If you require participants to consent to the taping in order to participate, you should clearly state this in the consent form in the study description section.
b) If it is acceptable for participants to refuse taping and still participate, you should include a separate section for taping information at the end of the consent form with a separate signature line for consent to the taping.
All participants completing interviews must sign a consent form.
- Referrals - if the study has the potential to arouse questions and concerns in participants
( i.e. regarding their substance use, etc., include an agency and phone number list for
participants to contact if they feel the need to do so (ex. College Counseling Center, local
agencies, etc.).
- Studies conducted in classrooms/school settings - you must include on the consent form
a statement that participation in the research will not affect participants' grades or class
standings.
- Research conducted on the Internet - should include the following statement on the consent form:
"This project has been approved by the SUNY College at Brockport's Institutional Review Board. Approval of this project only signifies that the procedures adequately protect the rights and welfare of the participants. Please note that absolute confidentiality cannot be guaranteed due to the limited protections of Internet access."D. Sample of Parental Consent Form
The form should be modified for your proposal. Two forms must be submitted to the IRB for approval if the proposal involves minors. One form for parent/guardian and one for minors. They both must be written in language understandable to the educational level of the parent and child.
STATEMENT OF INFORMED CONSENT FOR PARENTS
This form describes a research study being conducted with students about their understanding of and attitudes about the American voting process. This purpose of this research is to understand the perceptions of young people regarding participation in voting because they are the future citizens of this nation. The person conducting the research is a (insert one option - faculty member, staff or student) at SUNY College at Brockport. If you agree to have your child participate in this study, s/he will be asked to complete a questionnaire about her/his knowledge of the voting process and her/his attitudes about voting.
The possible benefit from being in this study could be that information will be learned that would allow teachers to better prepare young people to become informed voters.
Your child's participation in this study is completely voluntary. Being in it or refusing to be in it, will not affect your child's grades or class standing. S/he is free to change her/his mind or stop being in the study at any time.
I understand that:
- My child's participation is voluntary and s/he has the right to refuse to answer any
questions. S/he will have a chance to discuss any questions s/he has about the study with
the researcher after completing the questionnaire.
- My child's confidentiality is guaranteed. Her/his name will not be written on the survey.
There will be no way to connect my child to the written survey. If any publication results
from this research, s/he would not be identified by name. Results will be given
anonymously and in group form only, so that neither the participants nor their schools can
be identified.
- There will be no anticipated personal risks or benefits because of participation in this project.
- My child's participation involves reading a written survey of X# of questions and answering those questions in writing. It is estimated that it will take X# of minutes to complete the survey.
- Approximately X # people will take part in this study. The results will be used for the completion of a research project by the primary researcher.
- Data and consent forms will be kept separately in a locked filing cabinet by the
investigator and will be destroyed by shredding when the research has been completed.You are being asked whether or not you will permit your child to participate in this study. If you wish to give permission to participate, and you agree with the statement below, please sign in the space provided. Remember, you may change your mind at any point and withdraw from the study. Your child can refuse to participate even if you have given permission for her/him to participate.
I understand the information provided in this form and agree to allow my child to participate as a participant in this project. I am 18 years of age or older. I have read and understand the above statements. All my questions about my child's participation in this study have been answered to my satisfaction.
If you have any questions you may contact:
Primary researcher Faculty Advisor Name Name Phone Number Department and phone number ___________________________________________ ______________________
Signature of Parent /Date
Child's name _____________________________________
E. Sample of an Informed Consent Form for research involving minors.
The form should be modified for your proposal. Two forms must be submitted to the IRB for approval if the proposal involves minors. One form for parent/guardian and one for minors. They both must be written in language understandable to the educational level of the parent and child.
STATEMENT OF INFORMED CONSENT FOR MINORS
This form describes a research study being conducted with students about their understanding of and attitudes about the American voting process. This purpose of this research is to understand the perceptions of young people regarding participation in voting because they are the future citizens of this nation. The person conducting the research is a (insert one option - faculty member, staff or student) at SUNY College at Brockport. If you agree to participate in this study, you will be asked to complete a questionnaire about your knowledge of the voting process and your attitudes about voting.
The possible benefit from being in this study could be that information will be learned that would allow teachers to better prepare young people to become informed voters.
Your participation in this study is completely voluntary. Being in it or refusing to be in it, will not affect your grades or class standing. You are free to change your mind or stop being in the study at any time.
I understand that:
- My participation is voluntary and I have the right to refuse to answer any
questions. I will have a chance to discuss any questions I have about the study with
the researcher after completing the questionnaire.- My confidentiality is guaranteed. My name will not be written on the survey.
There will be no way to connect me to the written survey. If any publication results
from this research, I would not be identified by name. Results will be given anonymously
and in group form only, so that neither the participants nor their schools can be
identified.- There will be no anticipated personal risks or benefits because of participation in this
project.- My participation involves reading a written survey of X# of questions and answering those questions in writing. It is estimated that it will take X# of minutes to complete the survey.
- Approximately X # people will take part in this study. The results will be used for the completion of a research project by the primary researcher.
- Data and consent forms will be kept separately in a locked filing cabinet by the
investigator and will be destroyed by shredding when the research has been completed
You are being asked whether or not you want to participate in this study. If you wish to participate, and you agree with the statement below, please sign in the space provided. Remember, you may change your mind at any point and withdraw from the study. You can refuse to participate even if your parent/guardian gives permission for you to participate.
If you have any questions you may contact:
Primary researcher Faculty Advisor Name Name Phone Number Department and phone number I understand the information provided in this form and agree to participate in this project.
___________________________________________ ______________________
Signature of participant /Date______________________________
Birth date of participant
_________________________________________ ________________________
Signature of a witness 18 years of age or older /Date
F. Sample Letter for Institutional Consent
Have institution print the consent on its letterhead and sign
To: Institutional Review Board
SUNY BrockportI have read and approve the research study entitled, "________________________"
By _______________________________ [name(s) of primary researcher(s)] and give consent for the study to be conducted at or through _________________________(name of institution).
The institution may add any other appropriate requirements, such as so long as information regarding the study is shared with staff of the agency after the completion of the study, so long as parental permission is obtained, etc.___________________________________ _______________________________
Signature/ Date
Title of person signing (representing the authority to give institutional permission)
G. Sample Category 2 Proposal For a Class Project (sample for non-class project follow this segment).
1) Project description:
This project is being conducted as part of a class project for Course 355 (Organizational
Communication). It involves an examination of the communication behavior within actual
organizations. Specifically, through interviews, students (individually or in teams) will
investigate a number of aspects of organizational communication, including the flow of
information throughout organizations, relationships between employees, the recruitment and
socialization of employees, and the way management and employees communication with each
other.This project has been organized differently this semester. Rather than having each student
submitting an individual IRB proposal, I am submitting this one proposal on behalf of all of
the students in Course 355 (both section 01 and 02). To make this possible, I am standardizing the research questions (attached to this proposal) that will be asked, as well as the statement of informed consent (I will create a template with space for students to add their names and contact information).This design means that I will be responsible for verifying: 1) that my students have completed
online training and 2) that my students have obtained written permission from an appropriate person in each organization. Before my students may begin this project (receive any course credit for the assignment), they must submit their IRB completion certificate as well as written
permission from the organization signed by an appropriate person (the template that I am giving
students for this letter is attached to this proposal).
Finally, along with submitting all research materials (interview notes etc.) at the end of the
project, I also am requiring students to submit a signed consent form for every person that they
interviewed. The ability to even receive a final grade on the project is contingent on the
submission of all these materials.2) Number of participants and relevant characteristics:
Approximately 30 students in both section of the course will each be expected to interview
about 10-12 participants, so the total number of participants will be around 300-360 people.
Participants will be selected based on their membership in a relevant organization.3) Selection Process (how participants will be selected):
Each student is expected to obtain a sample that represents the various departments/levels of the
given organization.4) Status of Research Assistants (background/qualifications):
Given that I am the principal investigator submitting this proposal, my students essentially are
acting as research assistants for this project. In addition to the students' online training, I
devoted an entire course session outlining the project, discussing the nature of the research,
going over the interview questions, and discussing important procedures. In addition, I begin
each class session allowing students to ask any course-related questions, so as additional issues
arise, I am in a position to address them.5) Source of Funding:
There is no funding for this project6) Start/Completion date:
The project will start as soon as it gains IRB approval. Research will be completed by the end of
the Fall 2006 semester.7) Attach copies of all questionnaires, testing instruments, or interview protocols, and any cover letters or instructions to participants. Please see the attached materials
8) IRB training certificate is attached.
9) Anonymity/Confidentiality (how you will protect participants so they are not identified with
their responses):
The names of participants will not be recorded. Instead, each person's position within the
company will be recorded. If any researchers know the participants, the researchers will not
identify any participant with their responses. Therefore, the final report and presentation to the
class will include references to position (for example: "senior manager," "middle manager,"
"member of the marketing department," etc.). There are no plans to share any information with
the organization being studied. However, if information is requested, only general conclusions,
and not any identifying information, will be shared with them. The names of organizations will
not be used in the questionnaire or written summaries. Organizations will be referred to by
type.Upon completion of the project, all information gained through interviews, including the
statements of informed consent, will be given to Professor Harrington, who will keep it locked
in his office, until it is destroyed at some point after the semester has ended.Prof. Harrington will keep all of the organization permission letters so that they may be
provided to the IRB Administrator upon request.10) Consent form
A consent form with all of the required information is attached to this document.11) N/A
12) N/A
Interview Guide
The following is the interview guide that all students will use for this project. This list may include additional relevant follow-up questions.
- What are a few words you would use to describe the atmosphere in your department? In the entire organization? What makes you choose those descriptions?
- On a scale of 1-10 (10 being great), how would you describe the quality of communication with your immediate supervisor? What are some of the key reasons behind your evaluation?
- How did working here compare to what you were told it would be like when applying?
- What kinds of training and orientation activities did you experience when you arrived here? How well did they help you become part of the organization?
- How well are you kept informed of changes taking place in the organization? Please elaborate.
- Please consider the questions in reference to interactions with people in each of the departments your department interacts with in some way (you can have participants indicate on a 1-10 scale):
- Do people in this department have the same work goals as you?
- How much do people in this department know about your job?
- How much respect do you get from the people in this department?
- How often do you communicate in this department?
- Do the people in this department communication with you in a timely way (before it's too late!)?
- When there is a problem, are people in this department more focused on solving it or figuuring out whose fault it was?
Remember - it's important to have respondents answer these questions in reference to relevant departments around them, not just one: doing one question at a time for all departments; so, for #1, "do people in ___ dept. have same goals? How about the ___ dept? the ___ dept? … "and so on for each question.
Thank you very much for your time!
Statement of Informed Consent (for a Class Project)
The purpose of this research is to study communication within an actual organization. It is being conducted to fulfill requirements for a course in organizations at SUNY College at Brockport. This research is being conducted by interviewing various members of your organization who are willing to participate. Our goal is to examine organizational communication, including the flow of information throughout organizations, relationships between employees, the recruitment and socialization of employees, and the way management and employees communicate with each other.
In order to participate in this study, your informed consent is required. You are being asked to make a decision whether or not to participate in the project. If you want to participate in the project, and agree with the statements below, please sign below. You may change your mind at any time and leave the study without penalty, even after the study has begun.
I understand that:
- My participation is voluntary and I have the right to refuse to answer any questions.
- My confidentiality and my organization's confidentiality are guaranteed. There will be no way to connect my responses to me or to my organization.
- There will be no anticipated personal risks or benefits because of my participation in this project.
- My participation involves an interview of about 10 questions that will take 20-40 minutes.
- Approximately 10-12 people from my organization will take part in this study. The results will be used for the completion of a class project in Course 355 (Organizational Communication) at SUNY Brockport.
- Data will be kept in a locked filing cabinet in the investigator's office. Data and consent forms will be destroyed by shredding at the end of the Fall 2006 semester.
I am 18 years of age or older. I have read and understand the above statements. All my questions about my participation in this study have been answered to my satisfaction. I agree to participate in the study realizing I may withdraw without penalty at any time during the survey process. Completion of my interview indicates my consent to participate.
If you have any question you may contact:
Faculty Advisor Faculty Member Name Department of _______ , SUNY Brockport
Email address
PhoneStudent Researcher(s): (include name and email address of all group members) Signature of Consent: _____________________________________ Date: __________________
NOTE TO STUDENT: PLEASE HAVE YOUR ORGANIZATIONAL REPRESENTATIVE DETACH THE BOTTOM OF THIS PAGE AND COPY ONTO THE ORGANIZATION'S LETTERHEAD BEFORE SIGNING IT:
H. Sample Organizational Letter of Approval (on the organization's letterhead)By signing below I am giving my permission for (insert student name(s)) ______________________to approach employees of (insert the name of the organization here) to be interviewed as part of their Organizational Communication course project at SUNY Brockport. They may interview any employee who is willing to participate. In understand that neither the employees' names nor the organization's name will be used in the research project.
________________________________________________
Name of Organization's Director (please print)________________________________________________
Signature_____________________
Date
Sample Category 2 Proposal for Individual Research
1) Project description:
This project is an initial investigation into the ways in which teachers frame classroom messages as well as the goals that these framing devices are intended to meet. There is an interesting reason to pursue research in this area. Presumably, all teachers have to deliver bad news or bad grades to students, or make decisions that inevitably will not be satisfactory to at least some students. This project is being conducted under the premise that teachers vary in their ability to communicate these messages to students, and that differences in the ways teachers frame their messages would account for meaningful variance in a number of important instructional outcomes, including students' affect for the teacher, perceptions of the teacher's credibility, perceptions of fairness, actual learning, and teacher evaluations.
However, before I can consider the above hypotheses, there is a more immediate problem that I'm aiming to address with the project I'm proposing here. Because framing is such a powerful and salient concept, a number of different research programs have investigated framing from a number of different perspectives (Hallahan, 1999). The downside of this is that the literature
on framing is fragmented and lacks coherence. Furthermore, not all approaches to framing may be relevant in the instructional context. The proposed project addresses this problem by exploring the different ways in which instructors frame messages in the classroom. Specifically, I will ask participants to describe a recent example of when they intentionally framed something they said to students, as well as the goal they were trying to achieve by framing the message as they did. My analysis of the responses will involve the development of categories of framing and outcome goals.This study will provide the foundation for a research program in which I could systematically manipulate the different types of framing and examine the types of outcomes I mentioned above.
2) Number of participants and relevant characteristics:
I will contact full- and part-time instructors at SUNY College at Brockport (approximately 500 participants) by email. Faculty of any level of experience or seniority who are teaching at least one course this semester will be invited to participate.
3) Selection Process (how participants will be selected):
All faculty at SUNY College at Brockport will be contacted via email and directed to ANGEL to complete the survey. I have attached an email from Christopher Price, the director of CELT, in which he give me permission to use CELT's mailing list for this project.
4) Status of Research Assistants (background/qualifications):
There are no research assistants for this project. After data collection, individuals unfamiliar with this study will categorize the responses, but these individuals will see nothing more than individual statements (they will not see a complete questionnaire).
5) Source of Funding:
There is no funding for this project.6) Start - Completion dates:
The project will start a few weeks into the fall semester. Data will be collected by the end of the Fall 2006 semester.
7) Attach copies of all questionnaires, testing instruments, or interview protocols, and any cover letters or instructions to participants.Please see the following attached materials:
- Message to faculty asking them to participate
- Statement of Informed Consent
- The Survey I plan to use
- Email from Christopher Price in which he gives me permission to use the CELT
ANGEL mailing list for this project.8) Attach a copy of your certificate of completion for the online training course. If you don't have it indicate that you completed it and records will be verified by the IRB Administrator.
I've completed it.9) Anonymity/Confidentiality (how you will protect participants so they are not identified with their responses):
On ANGEL it is possible to administer a survey in which the respondents are not identified (their name is not linked to their submission). I have used this approach before and will use it for this study. Furthermore, I am not seeking demographic information that would allow me to identify instructors.10) Consent form
A consent form with all of the required information has been attached to this document.
11) N/A
12) N/A
IRB Proposal Checklist (used by IRB reviewers to evaluate each proposal)
Project Description:Item #1 _____State purpose of the research -
how the proposed study is beneficial to new knowledge/why is the research important?_____ purpose need to be restated in the informed consent for potential
participants to know the potential value of the research study.Item #2 _____ the number of participants should be consistent in all parts of the
proposal and in the informed consent, cover letters, etc.Item# 3 _____ Methods for data collection should be consistent throughout the proposal and the informed
consent regarding questionnaire/survey, interview, audiotaping, videotaping, observations, use of
materials already required for classroom work, etc.
Item #4 Research Instruments:
_____cite sources on each page of instruments if not self-designed
_____explain who designed questionnaire
When using published or unpublished evaluation or measurement tools, surveys, etc. the source
should always be cited on each page of the tool in addition to citing the source in the proposal.
Permission forms to use tools should be attached to the proposal whenever it is required to obtain
such permission.Institutional Permission:
________ preferable that the permission be on agency letterhead and signed by an employee who has
authority to give permission. (Permission is needed from an organization, business, school, etc.
to recruit participants from its membership, conduct surveys on its premise, etc.). The
investigator can compose the letter and ask organizations to copy it onto letterhead and then
sign and submit it.Informed Consent Forms:
_______check for consistency between the proposal and consent form for number of participants, forms of
data collection, protection of the identity of the participants as well as organizations from which
recruited.______ indicate affiliated with SUNY Brockport and include the Department
______ state risks are not anticipated or that time spent or fatigue can be a minor risk
______ if participants will have face to face interviews or be audio or videotaped, then signed consent
forms are needed______ include the names and phone numbers of both the principal investigator( s) and the faculty
member. If children are part of the research, then both parent consents and child assents should
be developed
______ include statement of " I am 18 years or older. . ." for all adult consents.Overall
______ proofread and correct proposal, informed consent, and/or questionnaire
_____ check for consistency between the proposal, hypothesis, informed consent, and data collection
instrument.
CATEGORY III PACKET
Category 3 (Full Review) - your proposal fits this category if the research has the potential for harming participants, violates their rights, or requires special protections for participants. Such research includes activities such as:
- research which might put participants at risk
- research involving psychological or physiological intervention
- non-curricular, interactive research in schools
- interviews or surveys on sensitive topics (e.g. sexual activity, alcohol or
drug use, illegal behavior)- research on special populations (e.g. prisoners, and the mentally
incompetent) whether or not the research is covered by another assurance (see appendix)- research involving deception (see appendix)
- research to be conducted on the Internet on sensitive topics (see appendix)
- international research, including class projects conducted in another country. International research requires additional approval from an IRB (or similar body) in that country and a copy of the translation of the informed consent document and any survey or interview questions (see appendix). Please contact the IRB Administrator at (585) 395-2779 for assistance prior to submitting your proposal.
Research conducted in schools, agencies or businesses -
All research conducted in schools requires written permission on letterhead from the school superintendent or principal. Research conducted in a business or other organization also requires written permission of the director of that organization. This must be attached to your proposal when it is submitted. (Signed faxes on letterhead are acceptable).
Informed consent - research under this category requires written documentation of informed consent. The proposal should include written information to assist participants in making an informed decision. If minors are involved (under the age of 18 years) in the research, then written permission of their parent or guardian is required for their participation.The researcher must detail for the IRB reviewers that legally effective informed consent (examples follow) is:
- obtained from the participant or their legally authorized representative for minors or those adults who cannot themselves give informed consent;
- be in language understandable to the participant or their representative (in some cases this may involve an interpreter). If the research will be conducted with non-English speaking participants then a copy of the informed consent document(s), survey and/or interview questions must be provided in English and the foreign language to the IRB
- be obtained under circumstances that offer the participant or their representative sufficient opportunity to consider whether the participant should or should not participate;
not include language through which the participant or their representative is asked to
waive or appear to waive any of the participant's legal rights, or release or appears to
release the research investigator, the sponsor, the institution, or its agents from liability
for negligence.Deception research will only be approved if it meets certain conditions (e.g. debriefing).
Category 3 proposals should include in this order:
A. A completed and signed cover sheet with all required signatures.
B. Typed answers to questions 1-16. (Sample follows).
C. Attach a copy of your informed consent statement. If your research involves minors please attach two informed consent forms - one for their parent/guardian to sign and a second one for the minor to sign (depending upon age, it may just be read to them.)
D. If research is to be conducted in a school then please attach a letter of permission from the school superintendent or principal. If the research is to be conducted in a business or other organization please attach a letter of permission from the director of the organization.
E. Attach a copy of any interview or survey questions used and indicate their source.
F. Attach copies of responses to forms 101- 404 (only if applicable. See appendix.)
G. Attach a note to the original proposal only with which of the meeting dates of the IRB posted on the website you (and your faculty supervisor if you are a student) would be available to meet with the IRB Board within the two weeks following submission of your proposal. Or contact Marsha Moss at mmoss@brockport or 585-395-2779 for scheduled committee meetings dates/times.
H. If a faculty member or graduate student submit 8 copies and the original to IRB Administrator, Grants Development Office, 6th floor Allen Administration Building. (585) 395-2779.
If an undergraduate student submit 3 copies and the original to the address above.
Directions for completing a Category III proposal:
A. Attach a completed and signed cover sheet (see next page) with all required signatures.SUNY BROCKPORT INSTITUTIONAL REVIEW BOARD
Human Participant Research Review Form
Proposal #
(# will be inserted by IRB)
Please follow these steps to submit your application.
- Use these two pages as the first pages of your application.
- If a Category 1 review send just the original, if a Category 2 send the original and one copy, if a Category 3 review send the original and eight copies if a faculty member of graduate student; 3 copies and the original if an undergraduate student.
- Deliver or mail to IRB Administrator, Grants Development Office, 6th Floor Allen, SUNY Brockport, 350 New Campus Drive, Brockport, N.Y. 14420. (585) 395-2779, irboffice@brockport.edu ; fax number is (585) 395-2006.
Please type or neatly print.
1. Investigator(s) name(s) ______________________________________Department _______________________________________________
Phone Number ________________________________
(where you can be reached during the day - so we can call with questions)E-mail address: ______________________________________________
Local mailing address: _________________________________________
2. Project Title: ________________________________________________________
_____________________________________________________________________3. College Status (for each investigator):
Faculty/Staff _________________________________
Undergraduate Student _________________________
Graduate Student _____________________________4. If the principal investigator is a student, list name, department, and local telephone number of faculty supervisor. Please note that the Faculty/Staff Supervisor must indicate knowledge and approval of this proposal by signing this form.
Faculty /Staff Supervisor's name: ___________________________________________
Department and phone number: _____________________________________________5. Check appropriate category of research project (complete after reviewing guidelines):
Category 1 (Exempt Review) ____; Category 2 (Expedited Review) ___________
Category 3 (Full Review) _______________6. The Principal Investigator must sign this form. (If the P.I. is a student, their
faculty/staff supervisor must also sign this form).I certify that: 1) the information provided for this project is accurate; 2) no other
procedures will be used in this project; 3) any modifications in this project will be
submitted for IRB approval prior to use; 4) I have successfully completed the required
online IRB training program.____________________________________________________________________
A. Signature of Investigator Date
D. Faculty/Staff Supervisor: 1) I certify that this project is under my direct
supervision and that I am responsible for insuring that all provisions of approval are complied with by the principal investigator. 2) I have successfully completed the required online IRB training program. 3) My signature indicates I have reviewed this proposal and agree it is in final form and ready to be submitted to the IRB.
______________________________________________ ______________________
Signature of Faculty/Staff Supervisor Date
C Siguature of Department Head or Designee Date ____________________________________________________________________
8/06
B. Project Description (sample completed project description follows)
Provide typed answers to items 1-16 (See below)
This information must be typed, and should be carefully checked for spelling and grammar. Please number paragraphs according to the number of the item appropriate for your project. If an item is not applicable please put NA (for not applicable).
- Provide a brief project description. Describe: a) The objectives, methods and procedures of the project. b) The purpose of the research - include why it is significant and how it contributes to general knowledge. c) The emphasis should be on the human subject involvement in the project. Discussion of theoretical or statistical aspects of the project should be avoided. d) If a questionnaire, and/or testing instrument is to be used describe how it will be administered, by whom, and indicate its source. If the survey is copyrighted, note when permission to use was given and indicate this at the bottom of page one of the survey form. e) If interviews are to be conducted, describe the nature of the interview and how responses will be recorded by written notes, audio or videotaping, etc. (see appendix).
- Number of and the relevant characteristics of subjects.
- Describe how subjects will be selected for participation in this project and any fees, extra
credit, or other items they will receive for participation if appropriate.
- Status and qualifications of research assistants, if any. They must also complete
appropriate IRB online training.
- Source of funding for project, if any.
- Expected starting and completion dates for project. (Note that project cannot begin until
approval has been received from IRB. Projects are given approval for a maximum of one
year; if they continue past that point they must again receive IRB approval).
- Attach copies of all questionnaires, testing instruments, or interview protocols, and any cover letters or instructions to participants.
- Attach a copy of your transcript of completion for the online training course. If you
do not have it indicate that you completed it and records will be verified by the IRB
Administrator.
- Specify steps to be taken to guard the confidentiality of participant's responses. Indicate what personal identifying indicators will be kept on subjects (if any). Specify procedures for
storage and ultimate disposal of personal information. This would normally mean keeping
information in a locked file cabinet and shredding information at the end of the research
project.
- Attach an informed consent document that includes the basic elements of informed consent
(See attachments below).
- If the participants are to be drawn from an institution or organization ( e.g. hospital, social
service agency, prison, school business etc.) that has the responsibility for the participants,
then a copy of that assurance, or if not available, documentation of permission from the
institution must be submitted to the IRB before final approval can be given.
- Attach copy of any interview or survey questions and their sources.
- Specify any special populations (e.g. minors, prisoners, or people with mental health issues
or developmental delays) involved in this project and describe the procedures for obtaining
the appropriate consent (see appendix).
- If the participant(s) will be exposed to any psychological intervention such as deception,
contrived social situations, manipulation of their attitudes, opinions, or self esteem,
psychotherapeutic procedures, or other psychological influences, complete Form 202. See
appendix.
- If there will be any treatments upon the body of the participant(s) by mechanical,
electronic, chemical, biological, or any other means complete Form 303. See appendix.
Note: Form 101 should also be completed if any sensory monitoring device(s) will be
employed (e.g. electroencephalograph).
- If the participants in the project may be exposed to the possibility of injury,
including physical, psychological or social injury, complete Form 404. See appendix
- Attach copies of responses to forms 101-401 only if required (see appendix).
- Be sure to submit a final version to the IRB that has been carefully reviewed for spelling and grammatical errors. Doing so will expedite the review process.
Where to submit and how many copies:
a) Faculty and graduate students: Make 8 copies of the proposal in addition to the original
b) Students: Make 3 copies of the proposal in addition to the original
c) Submit to the IRB Administrator, Office of Academic Affairs, 6th Floor Allen
Administration Bldg.
d) Also check the time of the scheduled meetings of the IRB on the IRB website or contact Marsha Moss at mmoss@brockport or irboffic@brockport.edu for times of scheduled meetings of the IRB for the semester. Please tell us in a note attached to your proposal which of tthe meeting times you and your faculty mentor (if available) can meet with the IRB. This is not required but it makes the process go faster if you are there to answer any questions the IRB may have about your proposal.
Review process:Category 3 proposals are reviewed by the IRB Chair initially and if the proposal is found to meet this category of review a meeting of the full IRB Board with the researcher (and faculty supervisor if a student research project) will be scheduled. We make every effort to have the meeting within one-two weeks after receiving your proposal. The Board is provided with copies of your proposal for review prior to the meeting. The approval time is dependent upon the time of year, the completeness of your proposal, and how quickly you respond to any revisions requested by the IRB Administrator. The average time is within 2-3 weeks of submission unless your proposal is submitted just prior to or during school breaks then it may take several weeks. At the conclusion of the IRB Board meeting you will be told what revisions are needed for final approval (if any). Final approval is given initially by phone or email and then followed by a formal letter within 5 business days. Maximum approval period is for 12 months from the date of the IRB meeting.
Attachments for Category 3 Proposals
A. Cover/signature pages
B. Informed Consent Directions
C. Sample of General Informed Consent
D. Sample of Parental Consent
E. Sample of Minor Consent
F. Sample Letter for Institutional Consent
G. Sample Category III Proposal
H. IRB Proposal Review Checklist
I. See IRB Appendix for Forms 101, 202, 303, and 404 (if applicable)
B. Informed Consent Directions
For all Category 3 proposals, signatures are required at the bottom for participants. If minors are involved you must provide two separate consent forms: 1) One for parent/guardians and 2) one for minors (17 years of age and younger). The minors form should be in a language understandable to their age level.Proposals are approved more quickly if researchers use the attached sample informed
consent forms and modify them to fit your project. The following elements must be
included:
A. Statement that the study involves research and why it is being conducted.
B. Explanation of the purpose of the research and the expected duration of the participant's involvement (e.g. how long will it take to complete the survey and number of questions).
C. Description of the procedures to be followed, and identification of any procedures
that are experimental.
D. Description of any benefits to the participant's or to others which may reasonably be
expected from the research.
E. Description of any reasonably foreseeable risks and discomforts to the participant.
F. Statement describing the extent, if any, to which confidentiality of records
identifying the participant will be maintained, stored for how long, how destroyed.
G. For research involving more than minimal risk, an explanation as to whether any
medical treatment is available if injury occurs; or counseling available for questions that might be sensitive, and if so, what they consist of, or where further information may be obtained.
H. Name and phone number of whom to contact for answers to pertinent question
about the participant's rights, and whom to contact in the event of a research-related injury to the participant.
I. Statement that participation is voluntary, and refusal to participate will involve no
penalty or loss of benefits to which the participant is otherwise entitled.
J. Statement that participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
K. Name of institution should be fully spelled out (ex. Greater Rochester Collaborative
Masters in Social Work Program through SUNY Brockport and Nazareth College).
Whether presented orally or in writing, to the participants' the IRB must be provided a written description of these elements of informed consent to be presented to them. If the research cannot practically be completed without this requirement being waived or altered, please say so here, and include a debriefing procedure.
If minors are involved - in addition to parental consent adequate provisions must be made for soliciting the assent of the children capable of providing their agreement. According to federal regulations, assent means .."a child's affirmative agreement to participate in research. Mere failure to object, absent affirmative agreement, should not be construed as assent. Procedures for obtaining assent of children must be appropriate to their age level, maturity, and psychological state. The essential information given to the child must include a description of the procedures and clear indication that their participation is voluntary. If the research is being conducted in schools, it must be clearly stated that this research is not part of the child's regular school program, not being conducted by the school, and that participation will not affect the child's grade.In cases where there is inconsistency between the consent of the parent and the agreement of the child, the following rule will be followed: A "no" from the child overrides a "yes" from the parent, but a "yes" from the child does not override a "no" from the parent.
Non-participation in a research project being conducted as part of a class or group (whether or not minors are involved), must detail alternatives for those in the class not participating in the research. For example, if extra credit is being offered for participation then the researcher must detail how those not participating have an alternative method of obtaining extra credit. This is to minimize coercion to participate. Another example would be if an investigator is conducting research in a classroom where they will be observing, interviewing and taping the class. Please explain what procedures will be followed for those children in the class whose parents have not given permission, or where the child does not agree to participate in the research.
9. If the participants are to be drawn from an institution or organization (e.g. hospital, social service agency, prison, school, etc.) that has the responsibility for the participant's, then a copy of that assurance or if not available, documentation of permission from the institution must be submitted to the Board before final approval can be given.
10. If the subjects will come into contact with any mechanical, electrical, electronic or other
equipment, Form 101, must be completed in order for the safety of the equipment to be
checked. See appendix.Three sample informed consent forms follow.
Please note the following additional items that should be included in any consent form if applicable to your project.If one of the following applies to your proposal please add this to the consent form above the section regarding whom to contact for information.
6. Payment for participation - include the amoun