Ask the Experts: Informed Consent Requirements
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. This issue features advice from Patience Stevens, vice chairperson at WCG Copernicus Group IRB, and Lindsay Abraham, regulatory lead for IRB chairs at WCG Western IRB (WIRB).
Question: In a pediatric study, who should sign the informed consent form? One or both parents/guardians? When is it acceptable to only have one signature?
Answer: The decision is made by the IRB. For research that is federally funded, the IRB relies on HHS regulations at 45 CFR Part 46, and on 21 CFR Part 50 for FDA-regulated research.
The IRB may determine that consent of one parent is sufficient. In making this determination, the IRB must consider the research to involve either:
- No greater than minimal risk to children; or
- Greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
In all other cases, the federal regulations require the researcher to obtain consent from both parents unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. In these cases, the IRB must determine the research is:
- Greater than minimal risk and offering no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition; or
- Not otherwise approvable that present(s) an opportunity to understand, prevent or alleviate a serious problem affecting the health or welfare of children.
The requirement of two parent signatures is intended by the IRB and federal regulations as an additional safeguard and protection for children and not as an obstruction for researchers.
Generally, the signature of one legal guardian is sufficient; however, the investigator should be familiar with state or local requirements that may be more stringent.
Question: Is it possible to omit the principal investigator’s name and/or affiliate institution on the consent form distributed to subjects in order to maintain confidentiality?
Answer: In short, the answer to the question is no. Human research participants have the right to know whom to contact for answers to questions about the research and whom to contact in the event of a research-related injury. This requirement is grounded in the ethical principles of respect for persons and informed consent, as well as the federal regulations.
Required elements that must be included in consent forms are covered in 45 CFR 46.116 and 21 CFR 50.25. Both regulations require that the consent form include a statement describing how confidentiality of records identifying the subject will be maintained, as well as an explanation of whom to contact with questions about the research and to report a research-related injury.
The FDA expands on the requirement in both a draft guidance from 2014 and a final guidance from 1998 that cover informed consent. Both guidance documents affirm that the consent form should specifically explain who will have access to research records and provide a specific name and contact information.
While a sponsor may be able to answer questions about the research and might be an appropriate contact to list for that purpose, if there is a research-related injury, subjects generally should reach out to the institution and/or investigator conducting the research for questions or assistance and should be listed as a contact for that purpose.
If protected health information (PHI) is being collected and the study is required to comply with the Health Insurance Portability and Accountability Act (HIPAA), the regulations at 45 CFR 164.508 require the request for authorization to collect PHI include “the name or other specific identification of the person(s), or class of persons, to whom the covered entity may make the requested use or disclosure.” These regulatory requirements lead to the conclusion that any and all entities or persons receiving or accessing the information should be specifically listed in the consent form, and that would by necessity include both the investigator and the institution.
In addition to the specific requirements regarding the elements of consent that require the investigator and institution to be listed in the consent form, the investigator has regulatory responsibilities related to the conduct of research that also lead to the necessity of their inclusion in the consent form. Because the investigator is tasked with personally conducting or supervising the research, as well as obtaining informed consent, the investigator should be referenced in the consent form as the investigator overseeing the study and as a contact for the research, as well as for questions related to the consent form or consent process.