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Special Informed Consent ConsiderationsApproaches for Obtaining Consent in a Research ProjectA common approach, sometimes referred to as the "traditional" approach, to obtaining consent for genetics/genomics research is to ask the participant to agree to participate in all aspects or parts of a study. In this model, if an individual does not agree to all of these aspects or parts of the study, they are asked not to participate. The three example consent forms use this approach. Alternatively, a "tiered" consent approach refers to giving the participants a set of choices and allowing them to choose some choices over others to give them greater control of the use of their biological samples and medical information. Dr. Amy McGuire and colleagues reported findings from focus group discussions that addressed participant attitudes and judgments about data release and their preferences for varying levels of control over decision-making.1 Most of the focus group participants preferred tiered consent because this approach might encourage participation by providing the greatest degree of control over decision-making. However, they also recognized that too many decisions might be confusing for participants and could impede participation in research. One caution with the tiered consent approach is that if a study investigator provides research participants with a set of choices or levels of participation in the research project, then it is important that the investigator and as appropriate, the data repository, has the appropriate tracking mechanisms in place to respond to individual choices. Top of page Obtaining Consent in Diverse Populations(Adapted from Simplification of Informed Consent Documents [cancer.gov]) It is essential to include diverse populations in research, including those that have not typically been included in genomics research. Developing the informed consent document and communicating with the potential research participant, family members, and in some cases the community through the informed consent process requires cultural sensitivity. The standards for valid consent should not be compromised in the face of language, cultural, or physical challenges, but the process may need to be adapted to accommodate cultural preferences. Oral and written translations are part of the process of presenting informed consent information to non-English-speaking persons. Culturally-appropriate consent documents and supplemental materials such as videos, audiotapes, and interactive computer programs may be especially helpful in communicating information to individuals from diverse populations, whether or not English is their primary language. Consent documents should also be adapted to the needs of individuals with limited literacy skills and those who are vision impaired. A single research project may require several versions of the informed consent document to tailor the information to a variety of populations. Top of page Community Consultation/Community EngagementResearch on human genetic variation has implications not only for the individuals who donate 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 and disease prevalence among groups with different geographic ancestries, sometimes in a context where societal, racial or ethnic discrimination already 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/consultation is to give a broad range of members of the communities approached for the donation of samples an opportunity to:
In some cases it may also be appropriate to establish a Community Advisory Group to provide ongoing feedback about the project and about how the community's samples are being used. The NIH Office of Science Policy (OSP) has developed a bioethics resource: Bioethics Resources on the Web [bioethics.od.nih.gov]. This resource includes the Points to Consider When Planning a Genetics Study That Involves Members of Named Populations [bioethics.od.nih.gov] that was developed by the National Institute of General Medical Sciences (NIGMS).2 This is an excellent resource and contains an introduction to community consultation, working with tribal communities to conduct genetics research and frequently asked questions. Top of page Studies Involving Children or Individuals with Diminished Decision-Making CapacityStudies involving children For children or others who are not legally able to provide consent to participate in a study, a parent or legal guardian provides permission for the person to participate. Even though a person may not be legally able to provide consent, they are still informed about the clinical research to the degree that they are able to understand. They may also have the opportunity to provide their agreement to participate in an alternative way that includes the process of assent.6 The Office of Human Research Protection (OHRP) summarizes the requirements for assent and parental permission in research and children in their FAQ response: What are the requirements for assent and parental permission in research with children? [hhs.gov]. Studies involving participants with diminished decision-making capacity Top of page Educational MaterialsAs mentioned in the above section on "Obtaining Consent in Diverse Populations," supplemental materials such as videos, audiotapes, and interactive computer programs may be helpful tools to incorporate into the informed consent process to communicate information to research participants. [1] McGuire, A.L., Hamilton, J.A., Lunstroth, R., McCullough, L.B. & Goldman, A. DNA data sharing: research participants' perspectives. Genet Med 10, 46-53. 2008. Top of page Last Reviewed: December 18, 2008 |
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