IRBs Flashcards
Continuing Reviews must be submitted at least
Once a year
34 CFR 350.4
Disability & the Department of Education & IRB Requirements
if reserach purposefully requires the inclusion of children with disabilities, or individuals with mental disabilities as research subjects, the IRB must have at least 1 members who is primarily concerned with the welfare of these subjects
Documents that must be submitted to the IRB
- Protocol and Amendments
- ICF & updates to
- Recruitment
- Written information provided to subjects
- IB and updates to
- New info that affects safety
- SAEs
- Changes increasing the risk or affecting the conduct of the study
Exempt Research Categories
- In educational settings, normal practices
- Educational tests, surveys, interviews, observation of public behavior with 1 of these criteria
-identity cannot be ascertained
-no disclosure harms subjects
-Can be identified but limited and IRB says okay
-For children, only if the researcher does not participate - Benign Behavior interventions & info, with same criteria as 2 (not deception)
- Secondary research consent not required, public, no identify, public health, government research
- Federal research for public benefit
- Taste & food without additives, below levels safe at
- Broad consent storage/maintenance
- Secondary Research, broadh cosnent with ICF, IRB, no results to subjects
Expedited IRB Review Categories
-minor changes for previously approved studies
-no more than minimal risk
-entire projects meets federally defined categories:
1. IND/IDE not required, approved labeling use
2. collection of blood samples from health, non-pregnant adults, weight at least 110 lbs,
a. for other adults, children, you may include considering the age, weight, health of the subjects, collection amount, procedure, and requence (cannot exceed less of 50ml or 3 ml per kg in an 7 week period & collection cannot occur more frequently than 2x per week)
3. Prospective Collection of biological specimens for reserach by noninvasive procedures
4. Collection of data through non-invasive procedures, routinely used in clinical practice-anestheisa, sedation, approved medical devices
5. Research involving data, documents, specimens, or records that have been collected or will be collected solely for nonresearch purposes
6. Collection of data from voice, video, digital, or image recordings made for research purposes
7. Reserach on individual or group characteriscts/behavior
8. Continuing review of reserach previously approved, now permanently closed to enrollment, with LTFU onloy, or no enrolled subjects, or only remaining research activies are data analysis
9. Continuing review of research with no IND or IDE that other categories don’t apply, but IRB determines it is no more than minimal risk
FDA & ICH require that IRB/IEC Membership
At least 1 member is independent of the institution/trial site
FWA & Compliance Assurance
Federalwide Assurance-written assurance of compliance
organization compliance to HHS
In a non-emergency situation, under what condition can subjects be enrolled prior to IRB/IEC approval?
None, no subjects can be enrolled until IRB/IEC approval is obtained
IRB Makeup (ex. HS-IRB)
5 members
varying backrounds
1 of scientific background (licensed physician if FDA requires)
1 of non-scientific background
1 member not affiliated with the institution and no family member affialited with the institution
-if a vulnerable population is included, someone knowledgable of must be incldued
-qualified, diverse, knowledgable of commitments
IRB Quorum
- at least 1/2 of voting members, including at least 1 nonscientific member
- FDA studies, at least 1 licensed physician, cannot be reviewed without
IRB vs. IEC
IEC-Independent Ethics Committee-ICH Guidelines
IRB is the type of IEC specfic to the U.S.
IRB/IEC Decisions
Approval
Modifications required
Disapproval
Termination/Suspension
IRBs/IECs/Reserach Ethics Boards (REBs)
Review boards that oversee reserach involving human subjects to assure the protection & well-being of their rights, safety, & welfare
-Independent body constituted fo medical professionals & non-medical members
Minimum required info to submit to the IRB
- risk/benefit analysis
- informed consent
- assent if applicable
- selection of subjects
- privacy/confidentiality
- research plan for data
- research design/methods
- special populations
- PI qualifications for FDA studies
- description of research
- protections for the rights/welfare of subjects
- compliance with laws/regulations
- IB for FDA studies
Studies that can’t be exempt
- Prisoners
- Survey/Interview iwth children
- observation of public behavior of children when the researcher participates
The IRB, not the researcher
decides who to appoint as the guardian for wards of the state
What is the minimum number of IRB members?
5
When are continuing reviews not required under HHS guidelines? (Does not apply to FDA or ICH)
No more than minimal risk
With respect to IRB/IEC membership, both the FDA and the ICH require that:
At least one member’s primary area of interest is in a nonscientific area
