IRB Application Approval for Cervical Cancer Screening Research
The researcher must send reports to ALL patients (both positive and negative results) to gain IRB approval, making option B the correct answer. This is a fundamental ethical requirement for research involving cervical cancer screening.
Ethical Requirements for Return of Research Results
The core issue preventing IRB approval is the failure to notify participants of their screening results. This violates multiple ethical principles:
- The CDC guidelines explicitly state that positive cervical cancer screening results require immediate notification because appropriate follow-up is essential to prevent progression to invasive cancer 1
- A written plan with a timeline for returning ALL results to participants must be developed during the research design phase and incorporated into the study protocol, as recommended by the NIH 1
- The plan must capture "alert" values (positive results) that should be reported immediately to individuals, according to ACOG 1
Why Partial Notification Is Insufficient
Options C and D (notifying only negative cases or only positive cases) are inadequate:
- Providers must communicate the meaning of BOTH cytology and HPV test results directly to patients, as stated by the CDC 1
- 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
- Withholding negative results denies patients important health information and violates the principle of respect for persons 2
Required Protocol Elements for IRB Approval
To gain approval, the researcher must specify:
- Method of contact and backup contact method for result notification 1
- Specific referral locations or providers for follow-up care 1
- Timeline for result notification 1
- Documentation procedures to confirm participants received and understood their results 1
Common Pitfall to Avoid
The researcher cannot assume that simply calling positive cases (option D) satisfies ethical obligations. Both positive AND negative results must be communicated to maintain transparency and respect participant autonomy 1. Failing to notify negative cases leaves participants uncertain about their health status and undermines informed consent.
Clinical Context
This requirement is particularly critical because:
- Abnormal screening results can cause short-term anxiety, including concerns about sexually transmitted infections, requiring proper counseling 2
- Cervical cancer screening has proven effectiveness in reducing incidence and mortality through early detection and treatment of precancerous lesions 2
- Unscreened women account for more than half of cervical cancer cases, making proper follow-up essential 2