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Institutional Review Board

Guide 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
  2. 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:

    1. generalizable and extrapolated beyond the specific study
    2. 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. Failure to follow the required guidelines will result in additional delays. Please check your proposal carefully prior to submission.

    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.

    1. Risk/benefit - to approve research the IRB will determine that the following requirements are satisfied:
      1. Risks to participants are minimized by using procedures that are consistent with sound research design and which do not unnecessarily expose participants to risk.
      2. 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. (Read more)
    2. 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.
    3. Informed consent process - informed consent must be sought from each prospective participant or the participant's legally authorized representative. Their participation must be voluntary.
    4. 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.
    5. 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.
    6. 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?

Guide for Review of Research Involving Human Participants

Questions? Please call Kim Remley at (585) 395-2523 or kremley@brockport.edu