IRB Form Instructions
The Institutional Review Board (IRB) is conducting a review of all of the forms and guidance information for proposals to conduct research with human participants. The forms on this page are the most current versions to be used for all projects. As new forms are developed they will be made available on this page along with improved guidance information. Together the new forms and guidelines will make the process of proposing, processing and approving research projects simpler.
Supplements to Applications
Note: If the proposed modification changes any associated IRB documents (e.g., the Questionnaire A Application, the informed consent document(s), study information sheet etc.), the investigator must submit an updated version of each document for IRB review. Submit two (2) versions of the revised documents:
- One clean copy of each revised document (changes not highlighted), and
- One highlighted copy of each revised document (all changes highlighted).
Request for Non-Human Subject Determination
This form should be used to request a non-human subject research determination. The form presents clear criteria along with a series of yes/no questions to facilitate rapid determination of whether or not a proposed project meets the federal definitions for human subject research. All requests must include sufficient detail of the activity to allow such a determination.
The IRB will conduct a continuing review of all non-exempt ongoing research at intervals that are appropriate to the level of risk for each research protocol, but not less than once per year. Continuing review must occur as long as the research remains active for long-term follow-up of participants, even when the research is permanently closed to the enrollment of new participants and all participants have completed all research-related interventions. Continuing review of research must occur even when the remaining research activities are limited to the analysis of private identifiable information.
- the initial application updated with any approved changes;
- the current consent document(s); and
- the Continuation Review Application, including total number of subjects enrolled and/or withdrawals along with an explanation for each.
Continuation Review Application (.doc) (updated)
Consent Form Templates
Research that involves a human being as a subject in research requires legally effective informed consent of the subject or the subject’s legally authorized representative. In some circumstances a waiver of consent may be approved by the IRB. The IRB will evaluate both the consent process and the procedures for documenting informed consent to ensure that adequate informed consent is obtained from participants.
Report of Unanticipated Problems
- Harm is anything that has a negative effect on the welfare of subjects during the course of research; the nature of the harm may be social, behavioral, psychological, physical, economical, legal, and reputational.