Informed ConsentConsent to participate in research must be obtained from every potential participant who is a mentally and physically able adult. Consent must be obtained prior to the conduct of any research activates.
Elements of Informed Consent
In clear and non-technical language which is appropriate to the participant, participants must be informed of:
- The fact that the study is research.
- The purposes of the research.
- The expected duration of the subject's participation.
- The procedures to be followed.
- Any reasonably foreseeable risks or discomforts.
- Any benefits to the participant or to others that may reasonably be expected from the research.
- Appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant.
- The extent, if any, to which confidentiality of data and privacy of participants will be maintained
- For research involving more than minimal risk, whether any compensation and whether any medical treatments are available if injury occurs.
- Whom to contact for answers to pertinent questions about the research, participants' rights and research-related injury to the participant.
- The fact that participation is voluntary and that the participant may withdraw his or her consent at any time without penalty or loss of benefits.
Written Consent: The participant or a legal representative signs a written consent document, which explains all of the elements of informed consent.
Oral Consent: The participant or a legal representative signs a document indicating the participant had the all of the elements of informed consent explained orally and that s/he understands this description and s/he agrees to participate in the activity described In addition, an auditor-witness to the oral presentation must be present and must sign the consent form as “witness.” A written script of the oral presentation must be approved by the IRB and will be retained as a part of the IRB records.
Surveys/Anonymous Questionnaires: Surveys and questionnaires are “anonymous” only when the individual’s identity is unknown to the investigator. Requirements of informed consent can be fulfilled by instructions or a cover letter that explains (as applicable) the project, purpose and duration of participation time; how to contact the investigator for more information; a statement that assures anonymity; indication that voluntarily returning the questionnaire constitutes consent to participate.
Audio or Video Taping
A research project that proposes use of audio or video taping must include a separate consent form that states what type of medium will be used to record the participant. This form must also state how the audiotape or videotape will be secured after the research project has concluded.
There may be cases in which the use of either of these procedures for obtaining informed consent may be considered inappropriate by the investigator because they would adversely affect the experimental design or procurement of valid results. Accordingly, modifications to the above informed consent procedures can be recommended to the IRB.
However, all modifications must be approved prior to implementation of the proposed research this approval must be recorded in the board's minutes. No such modification will be approved unless, and until, the IRB or designee determines:
- That the risk to any human subject is, in fact, minimal, justifying a less full disclosure in the informed consent procedures than would normally be required; or
- That the use of either consent procedure would, in fact, invalidate objectives of considerable immediate consequence, and that the use of any reasonable alternative means for attaining these objectives would be less advantageous to the participant.