PRC Institutional Review Board Processes 3 — Questions and Answers
Question 1: A researcher proposes to waive written informed consent for an online study. Under what condition may an IRB grant this waiver?
- The researcher has more than five years of experience
- The only record linking participant to the study would be the consent document itself and the principal risk is breach of confidentiality (Correct answer)
- The study is funded by a federal grant
- The study involves deception
Correct answer: The only record linking participant to the study would be the consent document itself and the principal risk is breach of confidentiality
An IRB may waive written consent when the consent form itself would be the primary identifier and confidentiality is the main risk.
Question 2: What is the purpose of an IRB's 'unanticipated problems' reporting requirement?
- To notify funding agencies of budget overruns
- To ensure the IRB learns of unexpected risks or harms so it can take protective action (Correct answer)
- To alert participants about changes in study design
- To satisfy HIPAA documentation requirements
Correct answer: To ensure the IRB learns of unexpected risks or harms so it can take protective action
Unanticipated problems involving risks to participants or others must be reported so the IRB can assess whether additional safeguards are needed.
Question 3: Which scenario describes a conflict of interest that an IRB member must disclose?
- The member previously published in the same journal as the PI
- The member holds equity in a company that manufactures the intervention being studied (Correct answer)
- The member attended the same university as the PI 20 years ago
- The member disagrees with the PI's theoretical framework
Correct answer: The member holds equity in a company that manufactures the intervention being studied
Financial interests such as equity in a company with a stake in the research outcome constitute a conflict of interest requiring disclosure and recusal.
Question 4: How does the IRB handle research that takes place in a foreign country but is funded by a US federal agency?
- Foreign research is automatically exempt from US regulations
- The research must meet US regulations or equivalent protections under an OHRP-approved assurance (Correct answer)
- The researcher only needs host country approval
- Only the FDA has jurisdiction over international studies
Correct answer: The research must meet US regulations or equivalent protections under an OHRP-approved assurance
Federally funded research conducted abroad must comply with the Common Rule or provide equivalent protections recognized by OHRP.
Question 5: In a multi-site study, how is IRB review typically coordinated under the revised Common Rule?
- Each site must conduct independent full board review regardless of risk
- A single IRB of record must be used for domestic cooperative research (Correct answer)
- Sites in different states may opt out of all IRB review
- The sponsoring company substitutes for IRB review at all sites
Correct answer: A single IRB of record must be used for domestic cooperative research
The 2018 revised Common Rule requires use of a single IRB for domestic multi-site research to reduce duplicative review.
Question 6: What is the primary distinction between 'assent' and 'consent' in pediatric research?
- Assent is required for adults with cognitive impairments; consent is for minors
- Assent is the child's affirmative agreement; consent is the legally binding permission from a parent or guardian (Correct answer)
- Assent replaces parental consent when a child is over age 12
- Assent is only required for therapeutic research
Correct answer: Assent is the child's affirmative agreement; consent is the legally binding permission from a parent or guardian
Assent reflects the child's willingness to participate, while parental consent provides the legal authorization required for minors.
Question 7: A researcher submits a protocol to the IRB that involves retrospective chart review with HIPAA authorization waived. Which IRB criterion must be satisfied?
- The research cannot practicably be conducted without access to the protected health information (Correct answer)
- Participants must be notified by certified mail before data access
- The researcher must be a licensed physician
- Full board review is always required for chart reviews
Correct answer: The research cannot practicably be conducted without access to the protected health information
To waive HIPAA authorization, the IRB or Privacy Board must find that the research could not practicably be done without the PHI.
PRC Institutional Review Board Processes 3
A researcher proposes to waive written informed consent for an online study.
Under what condition may an IRB grant this waiver?