Ethics Approval Requires Disclosure of Positive Cancer Screening Results
The researcher must modify the protocol to inform patients with positive screening results and provide guidance on appropriate follow-up care (Option D) to obtain ethics approval. Withholding clinically actionable cancer screening results from participants violates fundamental ethical principles of research conduct and would result in immediate rejection by any ethics review board.
Core Ethical Obligation to Return Results
The Declaration of Helsinki, which governs medical research ethics globally, establishes that researchers have a duty to inform participants of clinically significant findings that could impact their health 1. This is not optional—it is a foundational requirement for ethical approval.
For cancer screening specifically, positive results represent potentially life-threatening findings that require immediate clinical action. The ethical imperative is particularly strong because:
- Early detection and treatment of cancer directly impacts mortality and quality of life 2
- Withholding positive cancer screening results could lead to disease progression and preventable death 2
- Participants have a right to information about their own health status that emerges from research participation 1
Why the Current Protocol Will Be Rejected
The proposed "blind" approach where no results are disclosed violates multiple ethical principles:
- Beneficence: Researchers must act in participants' best interests, which includes disclosing actionable health information 1, 3
- Respect for persons: Participants have autonomy over their health decisions, requiring access to their own screening results 3
- Justice: Withholding results creates harm without offsetting benefit to participants 1
Ethics committees specifically scrutinize protocols for adequate plans to communicate clinically significant findings to participants 3. The absence of such a plan is grounds for immediate rejection.
Required Protocol Modifications
Mandatory Elements for Approval:
Positive results disclosure plan 2:
- All participants with positive cancer screening findings must be notified
- Notification should occur as soon as results are confirmed
- Clear referral pathways for diagnostic follow-up must be established 2
- Contact information for appropriate specialists or facilities must be provided 2
Informed consent modifications 2, 3:
- Participants must be informed during consent that they will receive their screening results
- The consent document must specify how and when results will be communicated
- Potential risks and benefits of receiving results must be disclosed 2
Communication mechanism 2:
- Direct communication (phone call or in-person) is preferred for positive findings 2
- Written documentation should follow verbal notification 2
- A system to track notification and follow-up completion must be implemented 2
Why Partial Disclosure Is Insufficient
Option C (telling only negative cases) is ethically unacceptable because it withholds the most critical information—positive findings that require urgent action. This inverts the ethical priority and would still result in rejection 1.
Option B (handing reports over the phone) is incomplete without specifying that positive cases will receive results and appropriate follow-up guidance 2.
Common Pitfall to Avoid
Researchers sometimes conflate "research" with "clinical care" and assume research findings need not be disclosed. This distinction does not exempt researchers from disclosing clinically actionable findings discovered during research 1, 3. Cancer screening results, by their nature, are clinically actionable and must be returned to participants.
The protocol must explicitly state that positive screening results will be communicated with clear follow-up instructions to obtain ethics approval 2.