Process For Review of Research Involving Human Participants
From SUNY Brockport Institutional Review Board

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.

Risk/benefit - to approve research the IRB will determine that the following requirements are satisfied:

a. Risks to participants are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk.

b. Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of knowledge that may reasonably be expected to result from the research. The IRB will examine study design or scientific merit of a proposed study only within the context of its risk/benefit analysis. Research participants should expect to participate in studies with sound research design.
Equitable selection of participants and recruitment - selection criteria will consider all populations that might potentially benefit from the research. The IRB ensures that the recruitment of participants is equitable and free from coercion.
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
Research design - project is scientifically sound. Is the hypothesis clear? Is the study design appropriate to prove the hypothesis? Will the research contribute to general knowledge? Is there consistency between the purpose of
the study, the variables identified, the hypothesis, purpose stated in informed consent, and instruments selected for data collection?

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?

continuing your project after 12 months
modifications you need to make to the project after your have received approval
investigator's responsibilities
maintaining records
composition of the Institutional Review Board
how to report problems that occur during research
research conducted without IRB approval
oral history/ethnographic research projects
Internet research
paying of participants
research conducted in other countries
deception used in research
secondary analysis of existing data
taping of participants
collaborative research
prisoners participating in research
suspension or termination of IRB approval for research project?
Additional information on each topic can be found in the appendix at the end of the full IRB guidelines. (This is the shortened version).

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.

Go to web site - http://www.citiprogram.org
You don't have to register in advance and can immediately access the course 24 hours a day.
Decide which user group you belong to based upon the following information:
a) Group 1 - undergraduate students completing a class project need to complete only modules 1-5 in the social and behavioral tract.
b) Group 2 - everyone else (faculty, staff, graduate students, and undergraduate students completing theses or independent studies) must complete modules 1-6 in the social and behavioral tract and also the following modules if applicable to your research (#7 research with prisoners, #8 research with children, #9 research in public elementary and secondary schools, #10 international research or #11 Internet research). You must take the brief quizzes at the end of each module and get a score of 75% on the collective modules to pass. If you don't pass the first time you can take the quiz after the module over again.
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 for each category can be obtained from the website.

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.

Packets for each category (with all the necessary forms for that category) can 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.

For complete IRB guidelines including packets for each category and the appendix refer to the 80 page full version of the IRB guidelines at the website.