Informed consent for research

Informed consent means an individual’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or undergo a diagnostic, therapeutic, or preventive procedure. Consent is the means by which researchers uphold the ethical principle of respect for persons. Consent is a continual process throughout the participant's involvement in the research. Consent involves both both the process of ongoing dialogue between the researcher and participant in research, and documentation of consent. Informed consent for research is distinct from informed consent for medical treatment; the Department's informed consent for medical treatment does not meet regulatory requirements for consent for research.

Process of Informed Consent

Informed consent is a result of an ongoing process between the researcher and participants. The researcher explains the study, and participants have an opportunity to have their questions answered. The process of consent reflects the importance of the dialogue between researcher and participants. The process should be distinguished from the documentation of consent. The IRB needs to evaluate both the process and documentation of consent.

• In certain situations the IRB may waive or alter the consent process in accordance with federal regulations.
• Investigators should review information about the process of consent, and understand the difference between the process of consent, and documentation of consent.
• For information about the process of consent, including waivers and alterations of the process of consent, see the Help page on the ongoing process of informed consent.

Documentation of Informed Consent

The presumption is that consent will be documented, unless the IRB determines the research meets regulatory criteria allowing a waiver of documentation of informed consent. Even if research meets the criteria for a waiver of documentation, the IRB may still require written documentation of consent.

Regulations require specific disclosures for all research (“basic elements of consent”), and additional disclosures for some research (“additional elements of consent”). Disclosures should be written in a way that is understandable to the population. The following example shows how the required basic elements of consent can be communicated at less than a 6th grade level (the numbers in parentheses show how each sentence corresponds to a required regulatory element listed below; links to regulation should not be included in the consent document).

This is a research study.(1) If you take part, this tells you what to expect.(2-6) Talk to the research team if you:(7)

• Have questions, including questions about your rights.
• Have concerns or complaints.
• Think you have been injured.

You can contact the research team at (555) 111-1111.(7) If you cannot reach the research team or want to talk to someone else, call the Florida Department of Health IRB. The phone number is (866) 433-2775 (toll free in Florida) or (850) 245-4585. Taking part is up to you. You can refuse to take part. You can join now and quit later. Either way it won't affect how we treat you.(8)

• • (1) 45 CFR 46.116(a)(1); 21 CFR 50.25(a)(1)
  • (2) 45 CFR 46.116(a)(2); 21 CFR 50.25(a)(2)
  • (3) 45 CFR 46.116(a)(3); 21 CFR 50.25(a)(3)
  • (4) 45 CFR 46.116(a)(4); 21 CFR 50.25(a)(4)
  • (5) 45 CFR 46.116(a)(5); 21 CFR 50.25(a)(5)
  • (6) 45 CFR 46.116(a)(6); 21 CFR 50.25(a)(6)
  • (7) 45 CFR 46.116(a)(7); 21 CFR 50.25(a)(7)
  • (8) 45 CFR 46.116(a)(8); 21 CFR 50.25(a)(8)

Investigators should also include the following additional disclosures as appropriate:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study
• For FDA-regulated research, does the informed consent document include a statement informing participants that the FDA may inspect their records?

Waiver of the requirement to obtain documentation of informed consent

In certain situations, the IRB may waive the requirement to document the consent process.

• Waiver of the requirement to document the consent process is different from a waiver or alteration of consent (see help on the process of consent).
• If the DOH IRB determines the study meets criteria for a waiver of the requirement to document consent, the investigator may still obtain informed consent from the study participant, but will not document the existence of that consent on paper.
• Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1 and Option #2) lists the criteria in federal regulation under which the IRB may determine a waiver of the requirement to document the consent process is permissible.
• The following examples indicate situations when an investigator might request a waiver of documentation of consent, if the research meets all the required regulatory criteria for a waiver of the requirement to document the consent process.
  • When there is a possible legal, social or economic risk to the subject entailed in signing the consent form. For example, studies of immigrants who might be identified as being illegal aliens, or for HIV antibody-positive individuals who might be identified as such by signing the consent form.
  • When obtaining signed consent is not appropriate or feasible according to the cultural standards of the population being studied, and there is minimal risk involved in the study.
  • When the identities of subjects will be completely anonymous and there is minimal risk involved in the study. The signed informed consent would be the only record linking the subject to the study therefore it would be the only identifier in the study.
  • When the study will involve only a telephone interview or an internet chat interview

• FDA Information Sheets: Frequently Asked Questions: Informed Consent Process, A Guide to Informed Consent
• OHRP Informed Consent Frequently Asked Questions