Informed consent is more than a just a form for the subject to sign, it is a verbal and written process by which the investigator provides adequate and appropriate information to the prospective subject so that the individual can make an educated decision about participation in research. When the IRB asks about the consent process, we are asking that the investigator describe the consent encounter to ensure the requirements for informed consent as outlined in the regulations are considered:
- Before any research activities are commenced, the investigator obtains consent from the subject or their authorized representative. The prospective subject has the opportunity to ask questions and have them answered.
- The investigator allows ample time for the individual to consider whether they wish to participate. For example, the consent discussion should occur at a pre-procedure visit for research activity occurring during a medical procedure.
- The consent form and consent discussion are in a language that is understood by the subject. This requirement refers not only to their native spoken/written language, but also refers to the level of vocabulary and should be written for the population being recruited. Any sophisticated or technical vocabulary that cannot be avoided should be accompanied by a lay definition. The UNC OHRE has a “Glossary” of terms which may help when identifying subject appropriate terminology.
- The consent form and consent discussion must include enough detail about the study procedures and timeline so that the individual has an understanding of the time and effort involved in participation.
- The consent process must avoid exculpatory language that indicates or implies the individual is waiving their rights or releases the study team from liability.
- The investigator conducting the consent discussion does not place undue influence on the individual to participate. This concern does not only apply to someone in a position of authority. The investigator should also consider the time, place, and physical and emotional state of the prospective subject.
- The consent process is documented in the research record. This documentation may be in the form of a narrative or checklist.
Remember that consent is an ongoing process. The subject should understand that they may withdraw at any time during their study participation. For studies involving multiple visits, an appropriate study team member should “check in” with the subject at each visit to answer any questions and confirm their continued willingness to participate.
Code of Federal Regulations 45 CFR §46.116: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=83cd09e1c0f5c6937cd9d7513160fc3f&pitd=20180719&n=pt45.1.46&r=PART&ty=HTML#se45.1.46_1116