Serving Michigan
Informed Consent Development
The Informed Consent process is a prerequisite to the conduct of any clinical trial activity, in which the permission of the potential clinical trial subject is obtained. This applies to all research activities involving human subjects whether that research is done as part of a drug trial or investigator initiated research. The research subject may be a patient, but also may be a staff member or physician/provider.
During this process the following must take place:
- Study specific risks and benefits are discussed with potential participant and, if applicable, the potential participant's legal representative
- Ample time and opportunity are allotted for potential participant to ask questions in regards to the trial prior to deciding whether or not to enroll in the study
- By signing and dating the IRB approved, written informed consent document, the potential participant provides voluntary consent to participate in research activity
- Research personnel obtaining the consent must also sign the consent form
- Potential participant receives a copy of the signed and dated informed consent document
- Potential participant understands that he/she has the right to withdraw consent at any time, for any reason, without penalty
The written Informed Consent Form (ICF) must contain all specific required elements which are outlined in the ICH GCP Guidelines, Section 4.8.10 and FDA 21 CFR 50.25. This form, as well as the overall informed consent process, must be approved by the local IRB before utilizing to enroll patients into the clinical trial or conducting any research activity. If new information becomes available during the trial, the ICF may need to be updated and the trial subjects may need to re-consent.
Some research proposals may meet criteria for a waiver of Informed Consent, however the Principal Investigator must obtain approval from the IRB. The IRB makes the final decision regarding the need for written Informed Consent or if a waiver of Informed Consent is allowed.
The Trinity Health Office of Research & Innovation – West Michigan has experienced staff who are available to provide support with the development of the ICF and process. For further assistance, please submit a request to consult with a member of the Research and Innovation staff prior to IRB submission.