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.

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 participant 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.
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 or testing instruments, and any cover letters or instructions to participants. Sample cover letter can be found on following pages.
Attach a copy of your transcript 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.

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)

The objective of this study is to determine employment practices, policies, and procedures of National
Intramural Recreational Sports Association (NIRSA) colleges and universities throughout North America. The above topic and entire procedure is completely innocuous in nature and will not result in harmful effects in any way to any party. The process under which the instrument was developed was a collaborative effort on the part of the four researchers Dr. Bill Scott, Dr. Bob Smith, Mr. Steve Hughes and Mr. Scott Jockey. The content of the instrument was based on the current existing literature of the area being studied (employment practices, policies, and procedures followed by NIRSA colleges and universities throughout North America) and input from the researchers, as experts in the area being studied. The subjects (campus recreation directors) will be mailed the survey along with directions that will provide them with the information to self-administer the survey. Upon completion, the subjects will return the survey in a self-addressed, stamped envelope (allowing for the preservation of subject anonymity) provided by the principal investigator (Dr. Bob Smith). It will be stated to all subjects in the cover letter that they are under no obligation to participate in this research study and may exercise that option by not completing and/or not returning the survey.
The subjects will be NIRSA members who are campus recreation directors of two and four-year institutions of higher education in North America. All subjects will be at least 18 years of age. The total number of subjects receiving a survey will be 682.
Subjects will be/were selected based on the fact that they are the campus recreation director at their institution of higher education (both two and four-year institutions) and have an active NIRSA membership.
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.