For research to be ethical, each individual should make his or her own decision about whether to participate or continue participating in a study. The consent process requires a person to be accurately informed of the purpose, methods, risks, benefits, and alternatives to the research. The person must understand this information and how it relates to his or her own clinical situation or interests and, based on this knowledge, autonomously decide whether to participate. 1
To learn more about the principles that guide the conduct of ethical research, see the NIH Clinical Center's Ethics in Clinical Research.
To learn more about informed consent, including the relevant policies, see the Informed Consent web page from the HHS Office for Human Research Protections.
Exceptions to the rule of informed consent by the individual occur in studies involving children and other people who lack the capacity to provide informed consent. In these cases, ensuring that the individual’s research participation is consistent with his or her values and interests usually requires empowering a proxy decision-maker (or legally authorized representative) to decide about the person’s participation. 2
For a woman who is or may become pregnant, the informed consent process must include any potential risks and the chance of unknown risks to her embryo or fetus. Particular regulations, such as 45 CFR 46 Subpart B, relate to pregnant women, human fetuses, and neonates and to the extra precautions that scientists must take when involving these populations in their research. For example, regulations stipulate that a fetus may only be put at risk by interventions or procedures that hold the prospect of directly benefitting the woman or the fetus or if the risk is minimal, the information gleaned from the research is extremely important, and the information can only be found through this research.
For more information on vulnerable populations, including children and pregnant women, see Research Involving Vulnerable Populations on the NIH Office of Extramural Research website.