Participant Rights in Screening Test Research
All three options (A, B, and C) represent fundamental participant rights in screening research: participants can withdraw at any time, positive cases must be informed of their diagnosis, and there is ongoing debate about returning negative results, though many experts advocate for this as well.
Core Participant Rights
Right to Withdraw (Option A)
- Participants have an absolute right to withdraw from research at any time without penalty. This is a fundamental principle of research ethics that applies universally to all human subjects research, including screening studies 1.
- Even when studies use an "opt-out" approach or waiver of consent, participants must be clearly informed of their ability to refuse participation, and the mechanism for withdrawal must not be unduly complex or burdensome 1.
- Parental education and choice are essential regarding participation in pilot screening protocols, regardless of the specific permission model used 1.
Right to Know Positive Results (Option B)
- It is necessary to return all positive results in all circumstances where clinical efficacy of screening is being evaluated 1.
- Several critical requirements must be met when returning positive results 1:
- Only results from CLIA-certified laboratories may be provided to participants for clinical decision-making
- Individuals returning results must be able to accurately interpret test results and provide informed counsel
- The approach for handling ancillary or unanticipated findings (such as carrier status) must be predetermined and communicated to participants
Right to Know Negative Results (Option C)
- There is substantial debate about returning negative results, with strong opinions on both sides 1.
- Some experts argue that parents have a right to all research results, particularly when research is conducted under a waiver of permission 1.
- However, others note that the logistical challenges of returning large numbers of negative results could threaten the feasibility of population-based pilot studies 1.
- No consensus was achieved on this specific point in major guideline development 1.
Additional Fundamental Rights
Right to Information and Education
- Substantial efforts must be made to inform participants about screening protocols and enable informed decision-making 1.
- High-quality, linguistically appropriate educational materials should be provided through multiple avenues, including prenatally when possible and during the immediate postpartum period 1.
Protection of Welfare and Autonomy
- Research participants' autonomy and welfare interests must be protected according to national and international ethics standards 1.
- The waiver of consent must not adversely affect the rights and welfare of research subjects 1.
Clinical Caveat
In real-world practice, all three options represent legitimate participant rights, though the obligation to return negative results remains more controversial and context-dependent than the other two rights. The strongest consensus exists for the right to withdraw (Option A) and the right to know positive results (Option B) 1.