The goal of this toolkit is to help make informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for potential research subjects more meaningful. This toolkit is needed because there is significant evidence that current practice does not fulfill ethical and regulatory standards.
Common shortcomings of current practices include:
- Documents are long and written at a reading level beyond the capacity of most potential subjects.1
- Institutional review boards (IRBs) fail to meet their own standards for readability in their own required boilerplate language.2
- Research subjects often do not understand fundamental concepts required for participation.3-5
- Research findings may be biased by failure to include vulnerable populations from whom it is difficult to obtain informed consent.6-7
This toolkit is designed to help both researchers and IRBs ensure that potential subjects are well informed. The guidance provided here is consistent with the regulations for obtaining and documenting informed consent for participation in minimal risk research and authorization for use of protected health information as required under HIPAA.
Highlights of the toolkit include:
- A model process for obtaining written consent and authorization.
- Sample easy-to-read consent documents for informed consent and authorization.
- A certification tool to promote the quality of the consent process.
- Links to resources from the Department of Health and Human Services.
Development of This Toolkit
This toolkit was developed by AHRQ staff and modified with input from experts in health literacy, clinical research, Federal regulations, HIPAA authorization requirements, and ethics. The toolkit was also tested by researchers at Boston University Medical School (ACTION Network Field Partnerships for Applied Research, awarded by AHRQ in 2007, Principal Investigator: Michael Paasche-Orlow, M.D., M.A., M.P.H.) with a diverse group of research subjects, researchers, and IRB professionals. To refine and validate the language of the sample consent documents in this toolkit, research subjects with different levels of literacy were interviewed in English and Spanish in focus groups and one-on-one session in five cities (Atlanta, GA; Baltimore, MD; Boston, MA; Tucson, AZ; and Waukegan, IL). These materials are not copyright protected.
This toolkit will need to be adapted to meet local and State regulations, as well as by each investigator according to the specifics of each protocol. The toolkit does not specifically address issues related to assent by minors, special classes of vulnerable populations (e.g., prisoners), sponsors, or specific study considerations (e.g., genetics, repositories, certificates of confidentiality). But the consent process and sample consent documents presented can inform the alterations that will be needed so that they can conform to the overarching aim of this toolkit, to advance patient comprehension.
Informed Consent, HIPAA Authorization, and Adult Health Literacy
The Department of Health and Human Services' (HHS) has promulgated regulations that define the process for obtaining and documenting informed consent in research supported by HHS (45 CFR 46.116 and 45 CFR 46.117). In addition, researchers who want to use and report on protected health information may be subject to the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), or may have to receive protected health information from a covered entity that is subject to the HIPAA Privacy Rule. In either case, the researcher (or the covered entity that maintains the health information) would have to obtain a HIPAA authorization from his or her research subjects. Researchers conducting nonexempt human subjects research must first obtain approval for the research from an IRB and then obtain the informed consent of each research subject, unless the requirement for obtaining informed consent has been waived appropriately by the IRB. Additionally, researchers may seek from an IRB approval for a waiver of, or alteration to, the required HIPAA authorization form.
Obtaining informed consent and HIPAA authorization are two separate but parallel activities. Both activities should be designed to inform potential subjects about the research and the use and sharing of their health information in terms that they can understand. The process is an educational activity in which potential subjects are the learners. Researchers have a responsibility to ensure that potential subjects understand the information provided.
This task can be challenging due to the complex nature of medical research and the limited literacy skills of many potential subjects. According to the National Assessment of Adult Literacy, 41% of American adults have basic or below basic literacy skills and do not have the proficiency necessary to perform more than basic literacy activities while working independently.8 While research subjects with limited literacy have been shown to benefit from easy-to-read consent documents, consent procedures to promote comprehension are also needed. Furthermore, more than 8% of U.S. residents do not speak English well (Refer to Census Bureau report: PDF File. To safeguard potential subjects:
- Provide very easy-to-read consent and authorization documents.
- Use an informed consent and HIPAA authorization process that does not rely on subjects' literacy.
- Use an informed consent and HIPAA authorization process that does not rely on subjects' English proficiency (in research not exclusively conducted with English speakers).
In addition, certain vulnerable populations may not be accustomed to or comfortable with signing written materials.9 When written formats are inadequate, investigators ought to consider supplementing the informed consent process with additional materials (e.g., diagrams, pictures, videos). IRBs must approve these supplemental materials. Investigators also need to be sensitive to the fact that many potential subjects are not familiar with basic concepts related to research and the researcher-subject relationship.10