Two Levels of Review: a) Departmental; b) IRB
Form A -- (Department Certification) -- Every year, prior to August 30, all departments submit Form A to the Grants Office.
For those departments in which there is no ongoing or anticipated research with human subjects, Form A requires only a check to that effect and the signature of the chair.
For those departments in which there is ongoing or anticipated research with human subjects, Form A requires the chair to designate one or more departmental faculty members as Departmental Reviewer (the chair can, of course, assume this role her/himself). If the departmental reviewer is also the principal investigator of the research, another departmental reviewer should be designated for that particular review.
Forms B 1-4 -- (All Other Research -- Self-Reported Status checklist: Exempt, Expedited, Full).
If Exempt or Expedited, checklist (Form B-1), research proposal, and associated documentation are submitted to the departmental reviewer.
If the departmental reviewer accepts the researcher’s Self Report of Status (exempt, expedited or full), she/he signs off on Form B-1.
If the departmental reviewer does not accept the researcher’s Self Report, she/he consults with the researcher and agreement on the status of the project is reached. If agreement cannot be reached, materials are forwarded to the IRB chair for review of status. The researcher, departmental reviewer, and the IRB chair must come to agreement on status before the project can proceed.
For exempt research, Forms B-1 and B-2 associated materials are then forwarded to the Grants Office. There is no further review.
For research requiring expedited review, the departmental reviewer forwards Forms B-1, B-3 and associated materials to the IRB chair, who sends them to an IRB committee member for review. (Expedited reviews are distributed to IRB members in approximately equal numbers over the course of the year.)
If the IRB member has no concerns, she/he performs the expedited review and signs off on the proposal on Form B-3 and forwards Forms B-1 and B-3 to the Grants Office. There is no further review.
If the IRB member has concerns, she/he communicates with the IRB chair and through the chair with the researcher. When agreement has been reached, there is no further review.
If agreement cannot be reached, the proposal comes to the full IRB committee. When the review is completed Forms B-1 and B-3 are forwarded by the IRB chair to the Grants Office.
If full IRB review is required, Forms B-1 and B-4, the research proposal, and associated documentation are forwarded to the IRB for Committee deliberation. When a decision is made all materials are forwarded by the IRB chair to the Grants Office.
The consent form must include:
A statement that the study involves research, a readily understood explanation of the purpose(s) of the research and the expected duration of the subject’s participation, a simple description of the procedures to be followed, identification of any procedures which are experimental, and if deception will be involved. If deception is involved, there should be an indication that the research cannot be fully described at this time, but that at the conclusion of the subject’s participation an explanation will be provided.
A description of any reasonably foreseeable risks or discomforts to the subject. These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
A description of any benefits to the subject or to others which may reasonably be expected from the research (if no direct benefit, this should be stated).
A statement concerning costs or compensation to the subject, if any.
An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject. Phone numbers should be provided.
Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained.
A statement that participation is voluntary, that refusal to participate will involve no penalty of loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
Updated February 29, 2008