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.  

To learn more about the principles that guide the conduct of ethical research, see the NIH Clinical Center's  Ethics in Clinical Research web page.

To learn more about informed consent, including the relevant policies, see the  Informed Consent  web page from the HHS Office for Human Research Protections. 
 

Certificates of Confidentiality (CoCs) 

Certificates of Confidentiality (CoCs) protect the privacy of research participants by prohibiting disclosure of identifiable, sensitive research information to anyone not connected to the research except when the participant consents or in a few other specific situations.

Since 2017, NIH-funded research meeting specific criteria are automatically deemed to have a CoC. Learn more about CoCs on the NIH Grants and Funding CoC web page. 
 

Digital Health Technologies and Informed Consent 

One type of research that can be protected by a CoC is research involving digital health technologies. Digital health technologies, such as wearable devices, sensor technologies, and mobile software applications (“apps”), have increasingly been deployed in biomedical and behavioral research, leading to enhanced scientific discovery and improved health outcomes.

Informed Consent for Research Using Digital Health Technologies: Points to Consider & Sample Language is a consent resource for research using digital health technologies. Researchers may use this optional language in consents where digital health technologies are used. 
 

Informed Consent for Vulnerable Populations 

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.

Exceptions to the rule of informed consent by the individual can occur, for example, 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.  

For more information on vulnerable populations, including children and pregnant women, see the NIH Office of Extramural Research website on Vulnerable and Other Populations Requiring Additional Protections.