Informed Consent and Waiver of Consent
Informed Consent
Informed consent procedures should be conducted in the context of Justice and Beneficence that manifest profound respect for human dignity.
Informed consent is not a single event or just a form to be signed; it is an interactive educational process that takes place between an investigator and a prospective subject beginning with recruitment and continuing throughout the subject's involvement in the research. The consent process should:
- provide full disclosure of the nature of the research and the subject's participation
- ensure adequate comprehension on the part of the potential subjects
- allow the subject's voluntary choice to participate.
Waiver or Alteration of Consent: Investigators may make a case for the waiver or alteration of the documented informed consent process. Consult Waiver or Alteration of Informed Consent for more information. The IRB will consider a waiver or alteration for reasons outlined in [45CFR46.116(c-d)] .
Retention: Consent forms must be maintained for three years following the completion of the study. Consent forms must be available for inspection by authorized officials of the Kenyon College administration, the Kenyon College IRB, regulatory agencies and sponsors.
Anonymous or Confidential?
-An anonymous study means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including by the investigator). Even if data is coded, it can be de-coded and become identifiable.
-A confidential study means that while the subject's identity potentially could be determined from the information they give, steps will be taken to insure that they will not be identified. Be sure to describe to participants the steps used to preserve confidentiality.
-If confidentiality or anonymity cannot be ensured, clearly state this under the "risk" section of the consent form.
Designing a Consent Form: Please consult the following Informed Consent /Assent templates, samples, and wizards for help in developing consent/assent procedures that provide potential research subjects the information they need to make an "informed" decision about participating in your research. The basics of informed consent include:
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Purpose of the research
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Description of procedures
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Description of risk
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Description of benefit (there may be no personal benefit to the subject)
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Extent confidentiality will be maintained
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Contact for research, subjects' rights, and adverse-event issues
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Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and
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The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
PLEASE keep your subjects in mind when designing the consent form. Readability is paramount.
***The informed consent procedures and documents that you include in/with your IRB application should be exactly what you intend to use in both content and format.*** The IRB will consider both.
These are templates and examples only and must be edited to your specific research project. You should design your consent process with your subjects in mind. Not all elements of consent will apply to all studies, but be sure to include all required elements.
Informed Consent Check List (OHRP)
Tips on Informed Consent (From the Social Psychology Network)
Online Survey Consent Example (Survey Monkey)
Informed Consent Example (for a Web based study from Social Psychology Network)
Informed Consent for Exempt Research (Kenyon info)
Informed Consent Template (guidelines, suggested text, verbal consent, Kenyon info)
Assent Form for Children Sample
Informed Consent "short form" Checklist
Consent Wizard (from the University of Wisconsin)
Informed Consent Workshop (University of Minnesota)