Informed consent is an agreement between the investigators and the research participants. A signed informed consent form notifies potential research participants of their obligations and rights, and lets them know in advance what they are agreeing to do as a participant in a particular research study. Informed consent ensures that participants know that their participation is voluntary and that they may withdraw from the study at any time. Participants also have a right to know how their personal information will be protected, secured and destroyed.
All participants in a study should sign a copy of the approved informed consent form. The investigator should retain all signed copies of the form, as well as provide a copy for each participant to keep. Study participants are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and to provide contact information should any questions or concerns about the study arise in the future.
Checklist for Informed Consent Forms
The Federal Code (46.116) specifies the requirements for informed consent. Check the federal code if your project involves risk, vulnerable populations or complex interventions. We have provided a brief checklist that is sufficient for some projects:
- A statement that the study involves research
- An explanation of the purposes of the research
- The expected duration of the subject’s participation
- A description of the procedures to be followed
- Identification of any procedures that are experimental
- A description of any reasonably foreseeable risks or discomforts to the subject
- A description of any benefits to the subject or to others which may reasonably be expected from the research
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled
Special Considerations for Vulnerable Populations
- Minor Participants
- The use of minors as participants requires consent by a parent or legal guardian as well as assent by the minor.
- Illiterate or Mentally Impaired Participants
- Participation of persons considered mentally incapable of consenting on their own requires consent by a court-appointed guardian.
- Illiterate persons may have the consent form read to them and “make their mark.” Regulations require a signature of a witness to the consent process and signature of the person conducting the consent interview.
- Investigators should not enroll participants who may not truly understand what they have agreed to do.
Language Interpretation Issues
- The informed consent form should be in the primary language of the research participant, or at least in a language in which the participant is considered fluent.
- The investigator should submit a translated consent form for IRB review along with a certification from the translator that the English and non-English versions are the same.
- Although a translator may be used to facilitate conversation with the participant, routine ad hoc translation of the consent document may not be substituted for a written translation.