Principle 1 Respect for Persons

Principle 1: Respect for Persons • The informed consent process • Requirements for documentation of informed consent • Waivers of informed consent • Diminished autonomy and legally authorized representatives • Participation of pregnant women in research • Assent from children and permission from parents • Obtaining informed consent from prisoners • Community consent 1 The objectives are: • To outline the requirements for informed consent • To state when waivers of informed consent and legally authorized representatives are appropriate 2 1 Respect for Persons • The principle of respect for persons can be broken down into two basic ideas: – Individuals should be treated as autonomous agents – Persons with diminished autonomy are entitled to additional protections 3 Informed Consent • Principle of respect for persons is primarily applied by requiring that all human subjects research participants provide voluntary informed consent to participate in research. • The three fundamental aspects of informed consent are: – Voluntariness – Comprehension – Disclosure 4 2 Voluntariness and Comprehension Voluntariness • Individualsʼ decisions about participation in research should not be influenced by anyone involved in conducting the research: “...consent must be freely given or truly voluntary.” Comprehension • Individuals must have the mental or decisional capacity to understand the information presented to them in order to make an informed decision about participation in research. 5 Disclosure • Researchers must disclose: 1. 2. 3. 4. 5. The purpose of the study Any reasonably foreseeable risks to the individual Potential benefits to the individual or others Alternatives to the research protocol The extent of confidentiality protections for the individual 6. Compensation in case of injury due to the protocol 7. Contact information for questions regarding the study, par cipantsʼ rights, and in case of injury 8. The conditions of participation, including right to refuse or withdraw without penalty 6 3 Disclosure • This disclosure must be made in such a way that it provides a reasonable person the information she or he would need in order to make an informed decision. • Regulations require that investigators obtain legally effective informed consent from prospective participants in a way that allows them to consider whether or not to participate and that minimizes the possibility for coercion or undue influence. • Potential participants must understand that enrolling in the research is voluntary and that they may withdraw from the study at any time without penalty or loss of benefits • In order for participation in research to be voluntary, the potential for coercion and undue influence must be minimized. 7 Case Study: Sleeping Sickness Study on Campus An investigator, who is a professor at a large university, is developing a grant application for submission to the NIH to study sleeping sickness (trypanosomiasis). This study will investigate surface antigen expression in trypanosomes, the parasite that causes sleeping sickness, in order to develop a vaccine. These parasites grow in human blood and lymph. The study will require fresh human blood daily for several months, and thus will require research participants. A research assistant will maintain a schedule of research participants to ensure that the study performs one collection per day and that blood collections are in accordance with American Red Cross Blood Donation Eligibility Guidelines i.e., healthy, weigh at least 110 pounds, and have not donated a pint (570 ml.) of whole blood in the last 8 weeks (56 days). Participants will be compensated. 8 4