Three Overarching Requirements of Informed Consent
Informed: Prospective participants and their guardians must be told the purpose, the expected duration and procedures, foreseeable risks and benefits, the name, affiliation, and how to contact the investigator; and whom to contact about research rights, the extent and limits of confidentiality, and the nature of any incentives or costs of participation. Participants must be informed if investigators are legally obligated to report child abuse, illegal activities such as drug or alcohol abuse, or reportable communicable diseases such as HIV.
Voluntary: Prospective participants must be informed of the voluntary nature of participation, their right not to answer questions, their right to withdraw at any time without penalty, and the consequences of withdrawing with respect to receipt of incentives. The timing and setting of consent must be conducive to good decision making. Informed consent may not contain any exculpatory language (e.g., subjects may not be asked to waive their legal rights).
Rational: Investigators need to take steps to ensure that a participant or guardian's age, language, social status, risk status, or health or mental disorder does not compromise adequate comprehension of the research and participant rights. Distinctions between treatment and research and the various roles of personnel (e.g., clinician, researcher) must be clearly described.
Consent as a Continuing Process: Consent is not a single event; it is a process. In longitudinal studies, the IRB must decide whether, when, and how consent should be formally renegotiated.
Fisher, C. B., Hoagwood, K, & Jensen, P. (1996). Casebook on ethical issues. In K. Hoagwood, P. Jensen, & C. B. Fisher (Eds.). Ethical issues in mental health reearch with children and adolescents. Mahwah, NJ: Erlbaum.
Office for Protection from Research Risks [OPRR]. (1993). Protecting human research subjects: Institutional review board guidebook. Washington, DC: Government Printing Office.
For information about informed consent concerning children and youth, click here.
Apply your knowledge of informed consent to the following case study: Development Differences in the Psychologial Sequelae of Rape Trauma.