IRB Application Acceptance for Cervical Cancer Screening Research
The researcher must call positive cases about their results and provide clear instructions on where to seek follow-up care (Option D). This approach addresses the fundamental ethical requirement for return of research results while protecting participants from harm through appropriate follow-up guidance.
Ethical Requirements for Return of Research Results
The IRB will reject any protocol that fails to adequately address the return of clinically actionable results to research participants. 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. This is not optional—it is a core ethical requirement that IRBs are specifically empowered to enforce 1.
Why Positive Results Must Be Communicated
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 guidelines explicitly state that positive cytology and HPV tests are markers of cervical precancerous lesions, which often do not cause symptoms until they become invasive 1.
- Abnormal screening results can identify cervical cancer precursors that can be treated before progression 1
- Without proper follow-up, precancerous lesions may advance to invasive cervical cancer, directly impacting morbidity and mortality 1
- The plan should capture "alert" values that should be reported immediately to individuals 1
Why Option D Is the Only Ethically Acceptable Choice
Calling positive cases and instructing them where to go for follow-up care fulfills the ethical obligation to return actionable results while providing the necessary guidance to prevent harm 1. This approach:
- Ensures timely communication of critical health information that requires action 1
- Provides clear direction for appropriate medical follow-up, which is essential for preventing progression to invasive cancer 1
- Demonstrates respect for research participants by enabling them to benefit from their participation 1
- Meets the IRB requirement for transparency about timing and type of results distribution 1
Why Other Options Are Inadequate
Option A (doing nothing) will result in immediate IRB rejection because withholding clinically actionable screening results violates basic research ethics principles and could result in preventable cancer deaths 1.
Option B (sending reports with high alarm systems) is insufficient because it lacks the direct communication and specific follow-up instructions necessary for positive cases 1. Providers should communicate the meaning of both cytology and HPV test results directly to patients 1.
Option C (telling only negative cases) is ethically backwards because negative results do not require urgent action, while positive results demand immediate follow-up to prevent cancer progression 1.
Additional Protocol Requirements for IRB Approval
Patient Education Component
The protocol must include a plan for educating participants about cervical cancer screening, as providers should communicate the meaning of both cytology and HPV test results to patients at screening 1. Key messages that must be conveyed include:
- Cervical cancer can be prevented with regular screening tests 1
- Positive tests are markers of precancerous lesions, not cancer itself 1
- HPV is a common infection often controlled by the body without medical intervention 1
- Appropriate follow-up is essential to ensure cervical cancer does not develop 1
Informed Consent Requirements
During the consent process, study participants must be informed about the timing and type of results that will be distributed, whether at the individual level or as a summary of findings 1. The consent form should explicitly state:
- That positive screening results will be communicated directly to participants 1
- The approximate timeline for receiving results 1
- Where participants should seek follow-up care for abnormal results 1
- That participants will not be left uninformed about clinically significant findings 1
Common Pitfalls to Avoid
The most critical error would be designing a study where participants undergo screening but receive no information about their results 1. This violates the fundamental principle that research participants should have the opportunity to benefit from their participation, particularly when actionable health information is generated 1.
Another pitfall is assuming that providing results only in aggregate or summary form is sufficient—individual results must be returned when they have clinical significance 1. For cervical cancer screening, positive results clearly meet this threshold given the need for timely follow-up 1.
Implementation Strategy
The protocol should specify:
- The method of contact (phone call is most appropriate for positive results requiring urgent follow-up) 1
- A backup contact method if initial attempts fail 1
- Specific referral locations or providers for follow-up care 1
- A timeline for result notification (should be prompt given the clinical implications) 1
- Documentation procedures to confirm participants received and understood their results 1
This comprehensive approach to returning results, with particular emphasis on direct communication of positive findings with clear follow-up instructions, will satisfy IRB requirements and protect participant welfare 1.