What approach can a researcher take to inform patients about their cervical cancer screening results and increase the likelihood of their Institutional Review Board (IRB) application being accepted?

IRB Approval for Cervical Cancer Screening Research

The researcher must call positive cases about their results and instruct them where to go for follow-up care (Option D) to gain IRB approval. 1

Ethical Imperative for Result Disclosure

Positive cervical cancer screening results require immediate notification because appropriate follow-up is essential to ensure that cervical abnormalities do not progress to invasive cancer. 1 The CDC explicitly states that withholding positive results violates fundamental research ethics and patient safety principles. 2, 1

Why Positive Results Must Be Disclosed

• Cervical precancerous lesions can progress to invasive cancer if left untreated, making timely notification and referral a matter of preventing morbidity and mortality. 2, 1
• Appropriate follow-up is essential to ensure that cervical cancer does not develop, as positive cytology and HPV tests are markers of cervical precancerous lesions that often do not cause symptoms until they become invasive. 2
• Unscreened women account for more than half of cervical cancer cases, highlighting that failure to ensure proper follow-up directly contributes to preventable cancer deaths. 1, 3

Required IRB Protocol Elements

The researcher must develop a comprehensive plan for returning results that includes:

• 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
• The protocol should 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
• The consent form should 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
• Documentation procedures should be in place to confirm participants received and understood their results. 1

Why Other Options Are Inadequate

Option A (Nothing, it will be accepted)

This is ethically unacceptable. Withholding screening results—whether positive or negative—denies patients important health information and violates the principle of respect for persons. 1 No IRB following current guidelines would approve a protocol that fails to return clinically actionable results. 2

Option B (Send reports with high alarm systems)

While notification is necessary, passive reporting without direct contact and follow-up instructions is insufficient. The communication strategy for cervical cancer screening must be underpinned by robust ethical principles and ensure that information is delivered effectively, enabling women to make informed choices at each step in the screening process. 2 Simply sending reports does not ensure comprehension or appropriate follow-up action. 1

Option C (Tell negative cases only)

This inverts the ethical priority. While withholding negative results denies patients important health information, the immediate harm from withholding positive results is far greater given the risk of cancer progression. 1 However, best practice requires disclosure of both positive and negative results. 2, 1

Communication Considerations

When notifying patients of positive results, the researcher must:

• Frame HPV positivity in a neutral, nonstigmatizing context and emphasize its common, asymptomatic, and transient nature. 2
• 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. 2, 1
• Emphasize that HPV infections often are shared between partners and it is often not possible to know the origin of an HPV infection, as HPV tests might become positive many years after initial exposure. 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. 2

Common Pitfalls to Avoid

• Do not assume that mailing results is sufficient—direct contact with positive cases is required to ensure comprehension and facilitate follow-up. 1
• Do not delay notification—the protocol must capture "alert" values that should be reported immediately to individuals. 1
• Do not fail to provide specific referral information—vague instructions to "see your doctor" are inadequate; specific providers and locations must be identified. 1