Institutional Review Board for Human Participants

Social and Behavioral Studies Application Form

• Form
• Instructions

For all studies involving surveys, oral histories, focus groups, interviews, questionnaires, psychological experiments and secondary data analysis.

Medical and Clinical Studies

• Form
• Instructions

For studies involving the testing of drugs and devices, nutritional supplements, dietary manipulations, epidemiology, clinical and medical procedures, health services research and the use of human tissues, cell lines, or genetic material.

• Form
• Guidance

For research and teaching activities that may be eligible for exemption from IRB review.

Research as Class Instruction and Training Programs

• Form & Instructions

* Note: If you are directing one student, in independent study and the student will be constructing research using human participants, the student must complete the appropriate form above for either Social/Behavioral Research or Medical/Clinical Research.

(Guidance)

Consent Form

Sample Consent Form

Parental Permission Form

Sample Parental Permission Form

Assent Form

Sample Child Assent Form (for children approx. age 7-10)

Performance Agreement and Release

• Form

For studies involving photographing and/or recording participants for future use in any presentations or publication (including theses, dissertations,web sites, or future teaching or training programs)

Certificates of Confidentiality

• Link

Several federal agencies have the authority to grant Certificates of Confidentiality for studies collecting information that, if disclosed could have adverse legal consequences for participants. These certificates are available for all studies regardless of whether or not they are being supported by federal funds.

(Available for all studies, not just NIH funded studies)

Social/Behavioral Studies

• Form
• Instructions

Progress of approved research must be reported, in the manner prescribed by the IRB, on the basis of risks to participants, no less than once a year.

Medical/Clinical Studies

• Form
• Instructions

(Guidance)

When should you submit an amendment for your study?

Amendment Form

• Form & Instructions

Must be completed prior to initiating any changes/additions to a previously-approved study (including study protocols, study design, informed consent procedures, or principal investigator team) Proposed changes cannot be initiated without IRB review and approval (except when necessary to eliminate apparent immediate hazards to a participant's health or safety).

Unexpected Event Form

• Form & Instructions

Must be completed to report unexpected event(s) that occur during the course of a research project.

Project Closure

• Form & Instructions

Submit the IRB Project Closure Form upon final completion of the research project (either concluded or cancelled research).

*Note: Projects that involve long term follow-up of participants must remain open, even if enrollment of new participants has ended.