The Necessity of Drafting a Newborn ICF in Clinical Trials
In recent discussions within the biopharmaceutical industry, a critical question has emerged regarding the necessity of drafting a separate Informed Consent Form (ICF) for newborns when data collection extends beyond pregnancy outcomes in clinical trials. Typically, this arises when a female partner of a male research participant becomes pregnant, and the exposure of the fetus to experimental drugs necessitates health assessments of the newborn.
Traditionally, data about the pregnancy and its outcome are collected under the consent provided by the pregnant woman. However, expanding this data collection to include the newborn introduces complex ethical, legal, and procedural challenges. Primarily, the issue centers around whose consent is necessary to lawfully include the newborn in the trial’s data collection scope.
Legal and Ethical Considerations
The Clinical Trial Regulation (EU Regulation No 536/2014) mandates that all research participants—or in the case of minors, their legal representatives—provide informed consent. This consent must be freely given, well-informed, and documented in writing, covering the nature, significance, implications, and risks associated with the research.
For newborns, who are unequivocally considered vulnerable participants, the designation of their legal representative becomes crucial. EU member state laws vary significantly; some require the consent of both parents, while others deem the consent of one parent—typically the mother—as sufficient. This disparity presents a challenge for global clinical trials and necessitates a tailored approach to consent forms based on local legal requirements.
Current Practices and Experiences
Feedback from colleagues in various Contract Research Organizations (CROs) reveals diverse practices concerning the drafting of ICFs for newborns. Some organizations draft separate ICFs for pregnancy data and newborn data, while others extend the pregnancy ICF to include newborn data collection, contingent upon the approval of Ethics Committees (ECs).
Interestingly, some ECs have approved the use of the pregnant ICF to collect newborn’s data either allowing the signature of the mother only, or requesting it to be signed by both parents in jurisdictions where this is required by law. This approach, although legally sound, may raise ethical considerations about the adequacy of consent and the transparency of information provided to both parents.
Challenges and Concerns
The primary concern in using a shared ICF for both mother and newborn is whether this approach sufficiently addresses the rights and safety of the newborn. Additional challenges can be identified as:
Inadequate Representation: The mother's consent may not fully represent the interests or rights of the newborn, especially regarding interventions specific to the newborn that were not contemplated at the time the mother's consent was obtained.
Ethical & Privacy Dilemmas: There is an ethical concern about whether consent provided by the mother during pregnancy can be considered fully informed regarding the newborn’s participation, which may also raise privacy issues.
Legal Compliance Issues: If both parents are legally considered guardians, using the consent of only one parent may not meet legal standards, leading to potential legal challenges or invalidation of the data collected.
Parental Discrepancies: Disagreements between parents over the newborn’s participation can complicate the consent process, potentially leading to ethical and logistical issues if not all guardians agree.
Risk of Overreach: Extending the scope of the pregnant ICF to cover new interventions or data collection related to the newborn may constitute an overreach of the pregnant consent parameters, thus calling into question the validity and ethical sufficiency of the consent process.
Conclusion and Recommendations
Given the complexities and varying legal requirements across jurisdictions, it is advisable for biopharma companies and CROs to consider the following best practices:
1. Draft Separate ICFs: Whenever feasible, draft separate ICFs for pregnancy and newborn data collection. This ensures clarity and addresses specific consent requirements for the newborn, enhancing ethical compliance.
2. Clarify Legal Representatives: Identify and obtain consent from all legal representatives as defined by the local law of each participating country. This may mean securing consent from both parents, even if local laws are more tolerant.
3. Enhance Transparency: Provide comprehensive information to all parties involved. This includes clearly explaining the nature and risks of the newborn’s involvement in the trial to both parents, ensuring they are fully informed before giving consent.
4. Consult Ethics Committees: Prior to trial commencement, consult with ECs to confirm that the consent process complies with both local and international ethical standards.
5. Monitor and Adapt: Continuously monitor legal and ethical guidelines for changes that could affect consent requirements. Be prepared to adapt consent processes accordingly.
By adopting these practices, biopharma companies and CROs can uphold the highest standards of ethical responsibility and legal compliance, ensuring that the rights and safety of newborn participants are protected throughout clinical trial processes.
Call to Action
We urge biopharma companies to reflect on the complexities discussed and consider the implications for their own clinical trial protocols. If you have any queries or concerns about drafting or implementing Informed Consent Forms for newborns or any other aspect of clinical trial conduct, please do not hesitate to reach out. Engaging in discussions can provide clarity and contribute to the development of more refined, ethical, and legally compliant practices.
Let's collaborate to enhance the standards of our research protocols and safeguard the wellbeing of all participants. To initiate a conversation or to seek guidance on these matters, please contact us directly. Together, we can ensure that our research practices not only meet the highest ethical standards but also respect the intricate legal landscapes we navigate.
