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Consent is more than a legal release, a document to limit institutional liabilities or a formality for research. It is not a one-time event but rather is an ongoing, interactive process between participant and researcher throughout the research study.
The process begins with the goal of assuring a participant’s full understanding of the research study and obtaining a formal agreement to participate. This process demonstrates honesty, transparency and respect for the person. It is further important to establish trust between researcher and participant as well as open lines of communication.
Such partnership activities are central to the development of the research home (PDF).
Michael Green, MD, provides information and guidance as to the components and process of informed consent. Video with Transcript
View Dr. Green’s PowerPoint presentation, Mastering Informed Consent (PDF), for helpful tips and insights into the informed consent process.
In the course of conducting a clinical trial, researchers in the Division of General Academic Pediatrics at Children’s Hospital of Pittsburgh of UPMC conducted a survey to assess the role of factors that influence parental decision-making in the decision of whether to enroll their children in a research study. Our objective was to understand the factors associated with the decision process and, accordingly, identify strategies to enhance enrollment in pediatric clinical research.
The results of this study were published in the Journal of the American Medical Association in an article entitled What Factors Influence Parental Decisions to Participate in Clinical Research: Consenters versus Non-consenters.
Although parents and legal guardians provide consent when enrolling minors in clinical research studies, it may sometimes be appropriate to also obtain agreement from the child or youth who will be the actual participant. This is called assent, and the determination as to whether assent is required will depend on the age, cognitive abilities and maturity of the prospective research participant.
A child can demonstrate willingness to participate in research in several ways. The research study should be discussed with the child at a developmentally appropriate level and the use of photographs, images or videos may assist with conveying what information and enhancing comprehension. Children should be directly asked if they understand and to repeat back, in a sentence or two, what they are being asked to do. In addition to this verbal assent, the child’s behavior should be observed. Behavior may provide additional clues as to eagerness or reluctance to cooperate with study procedures.
Your Institutional Review Board can provide guidance in helping the investigator judge a child’s ability to assent for a particular research study. For research studies that include young adults and adolescents who are clearly able to assent, this process should be similar to the encounter that occurs when obtaining informed consent from an adult or parent.
The U.S. Department of Health and Human Services Office of Human Research Protections provides additional information and guidance on matters of child assent.
Informed consent documents are typically lengthy and difficult to understand. For potential participants who are unfamiliar with medical or legal jargon, or who have low literacy, it can be difficult to be fully confident that they are truly giving informed consent.
Electronic consent tools can address some of these barriers to informed consent. For example, animated videos can illustrate the research protocol and educate viewers about concepts such as randomization and equipoise. Electronic tools can permit viewer self-assessment to assure their own understanding. Informed consent tools on a tablet may make it easier to manage documents and maintain records electronically. Such digital approaches can also be used to conduct an informed consent process from a distance, enhancing convenience for participants.
Checklist for the Informed Consent Process (PDF)
This checklist assures the researcher that all elements of the consent process are addressed. It can be adapted as needed.
Tips for Making Pediatric Consent Forms (PDF)
Provided by the PittNet Practice-Based Research Network.
The Ethical Conduct of Clinical Research Involving Children (book)
National Academy of Sciences. Committee on Clinical Research Involving Children; Board on Health Sciences Policy; Institute of Medicine; Field MJ, Behrman RE, editors. National Academies Press (2004)
U.S. Dept. of Health and Human Services, Office for Human Research Protections
Toolkit for Making Written Material Clear and Effective
A low-literacy resource from the Centers for Medicare and Medicaid Services
The Fry Graph Readability Formula
It is important to assure that the literacy level of materials reaches a majority of potential participants.
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