INSTITUTIONAL REVIEW BOARD (HUMAN SUBJECTS)

Policy: USG Ethics Handbook, Section 802.20 http://www.usg.edu/compliance/ethics/

http://info.gcsu.edu/intranet/rgs/GGrants/Compliance/ComIRBCheck.dwt

All faculty contemplating research involving human subjects must request and receive approval for their research from the Institutional Review Board. This requirement includes any research endeavor which is (a) funded by Georgia College or through Georgia College channels, (b) conducted by faculty, staff, students or employees of Georgia College who are acting in connection with their responsibilities or relationships to Georgia College or who intend to invoke the name of Georgia College in any report of the activity, (c) involve the records of Georgia College, or (d) use Georgia College faculty, staff, students or employees to identify and/or contact clients, patients or students to serve as subjects. Research for purposes of the Institutional Review Board is defined as any process that seeks to secure information from humans or about humans that differs in any way from customary medical or other professional practice. The process need not be interactive.

The procedures for submitting proposals for review are as follows:

It is essential that the proposal be submitted in sufficient time to allow for proper institutional review prior to initiation of research or submission of proposals to granting organizations.

1. Research conducted by students for a class project (not including thesis) should have approval initiated at the Department Level. If the student project is approved by faculty member and department chair, one copy of the proposal and appropriate cover form (entitled "Student Form") should be forwarded to the chair of the Institutional Review Board. If additional copies of the proposal are needed for review by members of the Institutional Review Board, the department chair will be notified. At that time, if deemed necessary, three members of the Institutional Review Board will review the proposal and the following will apply:

2 Approved = Approved
1 Approved - 1 Not Approved = Reviewed by the full Institutional Review Board
2 Not Approved = Not Approved

Those not approved will be documented with justification. Students may appeal to the full Institutional Review Board. The chair of the Institutional Review Board will notify the appropriate faculty member.

2. For all other research (including thesis work), one copy of the proposal and appropriate cover form should be forwarded to the Office of the Chair of the Institutional Review Board a minimum of ten (10) days before approval is required. (In extenuating circumstances, a shorter time frame may be possible). If a full review is required, additional copies will be requested. These additional copies of the proposal will be distributed to the members of the Institutional Review Board and a meeting scheduled. The faculty member responsible for the research must attend the meeting, present the proposal, and answer any questions. The Institutional Review Board will meet to approve/approve with conditions/not approve the proposal. After being reviewed by the Institutional Review Board and signed by the Institutional Review Board Chair, the proposal will be forwarded to the Dean of the Graduate College and Research Services who will notify the chair of the Institutional Review Board, who in turn, will notify the appropriate faculty member.

3. Approval Details. You should be familiar with the Georgia College "Assurance of Compliance..." which is available in the office of the Dean of the Graduate College and Research Services. Review of the proposal will be based on criteria as outlined in the Code of Federal Regulations 45 CFR 46 (Protection of Human Subjects).

You will be given a yellow form to follow in preparing your research outlined entitled "Information Required for Approval of Research with Human Participants". This questionnaire will identify sensitive areas which must be addressed prior to the initiation of research or application for support for research involving human participants. An explanation of specific items on the form follows:

The description of the research should include brief comments on (a) the problem to be examined, methods to be used in gathering data, and the nature of data to be gathered, as well as (b) the characteristics (age range, location, number, sex, etc.) of the participants to be contacted. Data- gathering instruments must be submitted for review if they are new or non-standard tests or questionnaires; if they have not been completed, examples of the types of questions to be asked must be listed and the instrument submitted after it has been completed. Also, if any incentives, compensations, and/or follow-up techniques will be used in efforts to obtain data from participants, clearly indicate their nature and the processes involved. If live participants are to be recruited through advertisements, a draft of the advertisement must be submitted for review.
Identify procedures which may involve discomfort, stress, or risk. Explain them and indicate alternative procedures which may be used, if any; note the legal and/or ethical concerns involved, list safety precautions being taken, and provide justification for procedures involving risk or discomfort. If either physical or emotional risks are involved, participants must be advised as to the availability and limits of treatment for sustained injuries.
Research involving human participants must not be carried out unless the benefit to the participant AND the importance of the objective substantially outweigh the inherent risk to the participant.
Consent forms must be signed in duplicate by the investigator and the participant or parent(s) or guardian(s). The investigator will retain one copy and give one copy to the participant.
Sample forms for documenting consent are available in the Office of The Dean of the Graduate College. These forms are not intended for all populations; however, they contain all of the elements which are normally required for use of human participants in research. Different consent forms may be used, but they should include at least the information indicated on the sample form.
Informed consent means the knowing consent to an individual or his/her parent(s) or guardian(s) so situated as to be able to exercise free choice without undue inducement or any element of force, fraud, deceit, duress, or other forms of constraint or coercion.
If deception is employed in your study, describe how participants will be deceived, explain the necessity of deception, and describe debriefing procedures, including the timing and information to be presented to participants. The Institutional Review Board recommends a written debriefing for studies involving deception. Specify any other agency or institution which is involved. Cooperating institutions must also approve the research; evidence of their approval should be submitted in written form for review.
If written consent is not obtained, full documentation of the reasons must be submitted for approval and must include assurance that risk to the participant is minimal.
In research with minors or other vulnerable populations, informed consent is especially necessary and in most cases must be obtained from parent(s) or legal guardian(s). An understandable explanation of the recent procedures should also be given to the minors or other vulnerable participants for whom consent has been obtained, and they should be given the chance to volunteer to participate in the proposed activity. This is called "assent." Their wishes determine their participation.
Where possible participants should be allowed to remain anonymous; otherwise, appropriate confidentiality of data must be maintained. Please describe in detail plans for maintaining confidentiality. Indicate who will have access to such data, and on what basis. If audio or video tapes are used, list the anticipated date they will be erased. If survey instruments are to be used, list anticipated date identifier will be removed from the completed instruments. Provide justification if identifying information will be retained on the instruments and indicate measures to be used to protect the confidentiality of information provided by participants.
Participants must be assured that their data will remain confidential in any research, but if individually identifiable data relate to illegal activities by identifiable persons, no guarantee can be given if disclosure of the data should be required by law. When anonymous questionnaires are involved but written informed consent must be obtained, the consent form can be signed and returned separately. This procedure avoids any possibility of linking names to the data.

RESEARCH REVIEW BOARDS

ANIMAL WELFARE COMMITTEE