Policy
IRB Documentation
The IRB prepares and maintains adequate documentation of IRB activities, including the following
- Copies of all research proposals reviewed, approved sample consent documents, and continuing reports submitted by investigators.
- Detailed records of IRB meetings, showing
- Members present (any consultants/guests/others shown separately).
- Results of discussions on debated issues and record of IRB decisions.
- Record of voting (showing votes for, against and abstentions).
- Records of continuing review activities, updated consent documents and summaries of ongoing project activities. Consent documents show IRB approval and date of approval expiration.
- Copies of all correspondence between IRB and the investigators from irb@midmich.edu.
- Any statements of significant new findings (unanticipated risks or adverse reactions) provided to subjects.
- Adverse reactions reports and documentation that the IRB reviews such reports.
- Emergency use reports.
- General project information provided to subjects (e.g., fact sheets, brochures).
These documents and records shall be retained for at least three years after completion of the research, and the records shall be accessible for inspection and copying by authorized representatives of the Department of Health and Human Services, the Food and Drug Administration, the Department of Veterans Affairs, and other federal regulatory agencies, at reasonable times and in a reasonable manner. In addition, the IRB maintains a permanent record of the list of current IRB members, written procedures for the IRB, and self-assessments.
All forms submitted or retained as evidence of informed consent must be preserved by the investigator for three years; six years if the study accesses protected health information and is covered under Health Insurance Portability Accountability Act (HIPAA) policy. Once the timeframe is complete, the documents should be destroyed. Should the PI leave Mid, signed consent forms are to be transferred to the IRB Chair to be secured within Institutional Research.
Project/Investigator Documentation
The IRB requires certain documentation regarding research projects and from investigators, including the following
- Professional qualifications to do the research (including a description of necessary support services and facilities).
- Appropriate Mid protocol review form including protocol summary.
- Complete study protocol which includes
- Title of the study and summary of the research to be conducted
- Purpose of the study (including the expected benefits obtained by doing the study and how risks are reasonable in relation to expected benefits)
- Sponsor of the study
- Subject inclusion/exclusion criteria (including scientific and ethical reasons for excluding subjects who might otherwise benefit from the research)
- Justification for use of any special/vulnerable subject populations (such as children [under age 18], prisoners, or handicapped, economically/educationally disadvantaged, or mentally disabled persons)
- Study design (including, as needed, a discussion of the appropriateness of research methods)
- Description of procedures to be performed
- Provisions for managing adverse reactions
- Circumstances surrounding consent procedure, including setting, subject autonomy concerns, language difficulties, vulnerable populations
- Procedures for documentation of informed consent, including any procedures for obtaining assent from minors (‘minor’ is defined in Michigan as an individual under the age of 18), using legally authorized representatives (see XII.B.&C.), witnesses, translators and document storage
- Remuneration to subjects for their participation
- Any compensation for injured research subjects
- Provisions for protection of subjects’ privacy
- Extra costs to subjects for their participation in the study
- Inclusion/exclusion of women, minorities, and/or children
- Investigator’s brochure (when one exists)
- The case report form (when one exists)
- The proposed informed consent document, including translated consent documents, as necessary, considering likely subject population(s); or request for waiver of the requirement to obtain informed consent
- Copies of advertisements and surveys, questionnaires, or other materials provided to subjects
- Copies of relevant grant applications (if any)
- Requests for changes in study after initiation including changes to consent forms
- Reports of unexpected adverse events and unanticipated problems involving risks to subjects, including, if available, data safety monitoring reports
- Progress/interim reports that include reports of protocol violations and/or deviations and any other instances of investigator non-compliance.