In a cervical cancer screening study that intends to keep results blinded, which approach will satisfy the ethics review board: informing participants with a positive screening result and directing them to diagnostic follow‑up?

Ethical Requirements for Cervical Cancer Screening Research

The researcher must inform positive cases about their results and provide specific referral instructions for diagnostic follow-up (Option D) to gain ethics approval. Withholding positive screening results violates fundamental research ethics principles and directly threatens patient safety by allowing potentially precancerous lesions to progress to invasive cancer.

Why Blinded Studies Are Ethically Unacceptable in This Context

The CDC explicitly states that withholding positive cervical cancer screening results violates fundamental research ethics and patient safety principles, emphasizing the need for immediate notification to ensure timely follow-up care 1, 2. This is not merely a procedural requirement—it is a matter of preventing morbidity and mortality, as cervical precancerous lesions can progress to invasive cancer if left untreated 1.

• Cervical cancer screening has proven effectiveness in reducing incidence and mortality through early detection and treatment of precancerous lesions 2
• Positive cytology and HPV tests are markers of cervical precancerous lesions that often do not cause symptoms until they become invasive 1
• The stepwise development from HPV infection to invasive cervical cancer takes approximately 20 years on average, but appropriate follow-up is essential to prevent this progression 3

Required Protocol Elements for IRB Approval

A written plan with a timeline for returning results to participants must be developed during the research design phase and incorporated into the study protocol for full transparency 1, 2. The ethics committee will specifically look for:

• The protocol must specify the method of contact, a backup contact method, specific referral locations or providers for follow-up care, and a timeline for result notification 1, 2
• The plan should capture "alert" values (positive results) that should be reported immediately to individuals 2
• Documentation procedures must be in place to confirm participants received and understood their results 2

Informed Consent Requirements

The consent form must explicitly state that positive screening results will be communicated directly to participants, along with the approximate timeline for receiving results and where to seek follow-up care 1, 2. This transparency is mandated by the National Institutes of Health and ensures participants understand they are not entering a purely observational study where results are withheld 1, 2.

Why Other Options Are Inadequate

• Option A (Nothing, it will be accepted): Fundamentally wrong—withholding any results violates ethical principles 1, 2
• Option B (Hand reports over the phone to all patients): While communication is important, this doesn't address the critical ethical requirement of providing actionable follow-up for positive cases
• Option C (Tell negative cases only): This inverts the ethical priority—withholding negative results denies patients important health information, but withholding positive results directly threatens their health and violates the principle of respect for persons 2

Communication Strategy for Positive Results

When notifying participants of positive results, the researcher should:

• Frame HPV positivity in a neutral, nonstigmatizing context and emphasize its common, asymptomatic, and transient nature to reduce patient anxiety 1
• Recognize that abnormal screening results can cause short-term anxiety, stress, fear, and confusion, possibly decreasing the patient's ability to absorb and retain information 1, 2
• Provide clear instructions about where to seek follow-up care, as patient navigators can be effective in improving both screening and follow-up after abnormal results 1

Common Pitfall to Avoid

The researcher cannot justify withholding results by claiming the study is "evaluating a new screening method" that requires blinding. European guidelines explicitly state that before routine implementation of a new screening strategy, quality-controlled piloting must still ensure participants receive their results and appropriate follow-up 4. The evaluation of screening effectiveness does not supersede the ethical obligation to protect individual participants from harm 4.