Informed Consent: Ethical Considerations for Investigators Proposing to Collect Samples for the H3Africa Program
This document describes ethical considerations for investigators proposing to collect samples for inclusion in the H3Africa Program. It also lists the elements to be addressed in the informed consent processes and informed consent documents developed for studies to be included in the program.
The guidance in this document is consistent with, and intended to be complementary to, applicable international ethical guidelines for biomedical research. However, investigators may need to customize the guidance in order to comply with applicable local laws, regulations, policies, or cultural norms. The guidance provided in this document should thus be considered only as a starting point. Investigators should consult with appropriate local experts to ensure that their understanding of the applicable regulatory requirements is accurate and up-to-date.
An international compilation of human research protections, which lists the laws, regulations, and guidelines governing human subjects research in various countries, as well as guidelines from a number of international and regional organizations, can be found at: http://www.hhs.gov/ohrp/international. Investigators must also comply with the requirements of the Basic HHS Policy for Protection of Human Research Subjects, 45 CFR 46; these can be found at http://www.ohsr.od.nih.gov/guidelines/45cfr46.html.
The Informed Consent Process
Informed consent involves two essential components: a document (consent form) and a process. The consent form provides a description of the research project (including the purpose of the research, the study procedures, potential benefits and risks, alternatives to participation, the voluntary nature of participation, etc.) and explains the individual's rights as a research participant. It is just one part of the informed consent process, which generally involves a series of conversations between the research team, the participants and sometimes the community of the participants. The informed consent process provides potential participants with extensive information about the project to help them make educated decisions about whether to participate. It frequently also involves ongoing interaction with the participants once they have enrolled and sometimes with communities. Informed consent is thus an ongoing, interactive process?not a one-time information session followed by the signing of a document.
Consent forms should be written at a reading level appropriate for the population being recruited for the study. Procedures should also be in place for administering the informed consent orally, for prospective participants who cannot read or write.
Issues to be Addressed in the Informed Consent Process and Consent Forms
Informed consent processes and consent forms developed for the H3Africa projects should include all elements required by the HHS Policy for Protection of Human Research Subjects, 45 CFR 46, as well as any elements specifically required by applicable local laws, regulations, or other guidance. In addition, to the extent applicable given the particular study design, all consent materials should include discussion of the topics listed below.
Please note that an especially important part of the consent materials will be a clear description of the plans for the samples and data to be sent to the biorepository that will be developed for the H3Africa Program. Because specific policies and procedures to govern the operation of the H3Africa biorepository cannot be finalized until a site for the biorepository has been selected and the H3Africa Research Network has become operational, it will not be possible initially to include in the consent materials a complete description of the plans regarding the handling of access to samples and data. However, an applicant should address as many of the issues as possible, such as explaining where the samples will be stored and to whom they will be available. At a later date, however, as those policies and procedures are established by the H3Africa Research Network, reference to those details should be incorporated into the consent materials.
- Purpose and Scope of the Research
- The types of studies in which the samples and data may be used (including not only the initial study, but any possible future studies that may use the samples or data)
- The plans to (potentially) generate extensive genomic data from the samples, including whole genome sequence data, gene expression data, etc.
- What participants will be asked to do (e.g., provide a blood sample, provide medical information)
- Voluntary nature of participation
- What will happen to the samples
- The plans to send the samples to a biorepository in Africa established for the H3Africa Program
- How the samples will be coded or de-identified so that the participants' privacy will be protected
- Who will have access to the samples (e.g., researchers in universities, hospitals, government agencies, companies)
- How the biorepository will control and monitor access to the samples
- Any plans to develop cell lines from the samples
- That the samples will not be sold, but that researchers may develop commercially valuable products based on studying the samples, and that if they do, participants will not be able to share in any profits
- What will happen to the data
- The plans to send the data (including any medical information collected from participants) to a biorepository established for the H3Africa Program
- How the data will be coded or de-identified so that the participants? privacy will be protected
- How the data will be maintained (e.g., in a database available to investigators over the Internet?)
- Who will have access to the data (e.g., researchers in universities, hospitals, government agencies, companies)
- How the biorepository will control and monitor access to the data
- That the data will not be sold, but that researchers may develop commercially valuable products based on studying the samples, and if they do, participants will not be able to share in any profits
- Potential benefits associated with the research:
- Benefits to society
- Likely lack of immediate benefit to participants (that the study involves research, not medical care)
- Potential reisks associated with the research:
- Physical risks (e.g., risks associated with blood draw)
- Non-physical risks:
- Risks to individuals (e.g., loss of privacy)
- Risks to groups (e.g., group discrimination, stigmatization)
- Any particular psychosocial risks unique to the local cultural context
- Possible future risks that we can't yet foresee
- How participants' privacy will be protected
- Plans for ongoing interaction with participants and communities
- What mechanisms will be used to distribute general information to participating communities about how the samples and data are being used and about general research findings
- Whether, when, and through what mechanisms individual research results (including incidental findings) will be returned to participants
- Participant compensation
- Right to withdraw
- Whether and how participants may withdraw samples from the biorepository
- Whether and how participants may withdraw data from the bioepository
- Whom to contact for answers to pertinent questions about the research, or in the event of a research-related injury
Additional special provisions in consent forms may be necessary for studies that involve children or members of other vulnerable populations (e.g., adults that lack the legal competence to consent), for studies that involve the collection of samples from multiple family members, etc.
Beyond Individual Informed Consent: Considering the Appropriateness of Community Engagement/Consultation
Genetics and genomics research may have implications not only for the individuals who donates samples, but also for the broader communities and populations of which they are a part. This is because the research involves the potential for comparing allele frequencies among groups whose ancestors come from different geographic regions, sometimes in a context where societal, racial, or ethnic discrimination exists.
Thus, in some situations, in addition to obtaining informed consent from individual sample donors, it may be appropriate to conduct a process of community engagement or community consultation. The goal of community engagement of consultation is to give a broad range of members of the communities in which the research will be conducted an opportunity to:
- Obtain information about the study so that the decisions of individuals about whether to participate will be better informed;
- Share their views about the ethical, social, and cultural issues the study raises for them, their immediate communities, and the broader communities and populations of which they are a part;
- Provide input into such matters as how the samples from their locality will be collected and described;
- Remain informed about how the samples and the data are being used and about findings from future studies that use the samples or the data.
In some cases it may be appropriate to establish a Community Advisory Group or similar body to facilitate the providing of ongoing feedback about the study and about how the samples and data are being used.