IRB Forms and Documents


IRB Resources:

Read it before completing an IRB Form

IRB Forms

Form A  

Research Approval Application 

Form B

Research Modification Form

Form C

Application and Certification of Readiness to Conduct Student Class Projects

Form D

Certification of Completion of Student Class Project

Adverse Events Report Form

Consent Form Sample

IRB Documents:

IRB FAQs and Forms:

What is an Institutional Review Board (IRB)?»

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRB uses a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

Who are the members of IRB?»

The FDA regulations [21 CFR 56.107(a)] require that, as part of being qualified as an IRB, the IRB must have "... diversity of members, including consideration of race, gender, cultural backgrounds and sensitivity to such issues as community attitudes ....The IRB regulations [21 CFR 56.107(e)] prohibit any member from participating in the IRB's initial or continuing review of any study in which the member has a conflicting interest, except to provide information requested by the IRB. In accordance with IRB regulations [21 CFR 56.108(c) and 21 CFR 56.107(a)], IRB must include one or more members not affiliated with the institution.

No ad hoc substitutes for the IRB members are accepted by the FDA. Only formally appointed and listed in the membership roster may substitute, provided that the IRB's written procedures describe the appointment and function of alternate members. However, an absent member may participate by video- or phone conference. Such members may vote and be counted as part of the quorum. 

21 CFR 56.107(c) requires at least one member of the IRB to have primary concerns in the scientific area and at least one to have primary concerns in the non-scientific area, including physicians and Ph.D. level physical or biological scientists. When an IRB encounters studies involving science beyond the expertise of the members, the IRB may use a consultant to assist in the review, as provided by 21 CFR 56.107(f). 

Is my project considered research?»

All of the following activities may be considered research:

Pilot studies (research development)
Interview procedures
Experimental interventions
Medical chart reviews
Case studies (involving more than three individuals or a regulated investigational drug or device)
Analysis of identifiable, existing data.

What is expedited review?

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB.

The IRB regulations [21 CFR 56.110] permit an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk. A list of categories 

The IRB may also use the expedited review procedure to review minor changes in previously approved research during the period covered by the original approval. Under an expedited review procedure, review of research may be carried out by the IRB chairperson or by one or more experienced members of the IRB designated by the chairperson. The reviewer(s) may exercise all the authorities of the IRB, except disapproval. Research may only be disapproved following review by the full committee. The IRB is required to adopt a method of keeping all members advised of research studies that have been approved by expedited review.

[See Conditions for IRB Use of Expedited Review - Federal Register: November 9, 1998 (Volume 63, Number 216), Notices]

Do I need to report changes to my reasearch that apeared after IRB approval?

Yes. Procedural requirements [21 CFR 56.108(a)(3)] requires ensuring "prompt reporting to the IRB of changes in a research activity." To report the changes, submit the IRB Form B to

Do I need to report completion of my research?

Yes. Procedural requirements [21 CFR 56.108(a)(3)] requires ensuring "prompt reporting to the IRB of changes in a research activity." The completion of the study is a change in activity and should be reported to the IRB. Although subjects will no longer be "at risk" under the study, a final report/notice allows IRB to close its files and use provided information in the evaluation and approval of related studies.

To report your research completion, submit the IRB Form B to