Subject Recruitment, Screening & Retention Flashcards

In clinical research, 'lost to follow-up' refers to subjects who:

Answer: Cannot be contacted or located to complete protocol-required follow-up visits

'Lost to follow-up' describes enrolled subjects who become unreachable and cannot complete scheduled visits, which must be documented as protocol deviations and reported as required.

Who is responsible for reviewing and approving the amount and method of compensation offered to research subjects to ensure it does not constitute undue inducement?

Answer: The IRB, as part of its review of recruitment and consent procedures

IRBs review subject compensation as part of consent oversight to ensure payment amounts are reasonable and do not impair the subject's voluntary decision-making.

When a subject voluntarily withdraws from a clinical trial, the PI is required to:

Answer: Document the withdrawal and reason (if provided), and complete protocol-required safety follow-up assessments

Withdrawal must be documented with the subject's stated reason (if given), and any safety follow-up visits required by the protocol must be completed to protect the subject's well-being.

Which of the following recruitment scenarios most clearly constitutes undue inducement?

Answer: Offering a $5,000 payment to low-income subjects for a two-week minimal-risk study

A disproportionately large payment, especially to a financially vulnerable population, can impair rational decision-making by making refusal economically unreasonable—the hallmark of undue inducement.

To protect subject confidentiality, what is the minimum appropriate information to capture in a subject enrollment log?

Answer: A unique subject identifier (not personal identifiers) and the date of screening and/or enrollment

Enrollment logs use unique subject identifiers (not names or SSNs) linked only by a confidential code list held separately, preserving auditability while protecting subject privacy.

Which federal law specifically mandates the inclusion of women and minorities in NIH-funded clinical research and prohibits their unjustified exclusion?

Answer: The NIH Revitalization Act of 1993

The NIH Revitalization Act of 1993 requires that women and racial/ethnic minorities be included in NIH-funded research to ensure broadly applicable results and correct historical exclusion patterns.

Before recruitment advertising materials for a clinical trial may be distributed or posted, they must be reviewed and approved by:

Answer: The IRB, because advertisements are considered part of the informed consent process

Recruitment materials constitute initial contact with potential subjects and are therefore considered part of the informed consent solicitation process, requiring IRB approval to ensure they are accurate and non-coercive.