Waiver of Informed Consent
In some cases it may be appropriate for an Investigator to not gain Informed Consent from participants or not provide participants will all of the elements of consent. In these cases, the Investigator may submit a Request for a Waiver of Informed Consent or Elements of Consent.
Waiving the Informed Consent Process
- A Researcher wishes to analyze archival data that was previously collected for another research project
- A Researcher wishes to observe and record identifying information about individuals in a public place without asking consent from individuals or informing them that he/she is a researcher
- A Researcher wishes to review 200 students grades and test scores from a school from 2005 and 2007
Waiving Elements of Informed Consent
Requests to Waive Elements of Informed Consent generally are submitted for research designs that utilize deception. In projects where participants will not be fully informed of the purpose of the study or where methods will be used to deceive participants the IRB must approve a Waiver of Informed Consent as participants will not be provided with all of the required elements that constitute Informed Consent.
- A Researcher does not want to inform participants of the full or true purpose of the research
- A Researcher wants to provide a participant with false feedback or information
- A Researcher wants to observe how a participant will react to a compatriot who is pretending to be another participant
Criteria for Waiving the Informed Consent Process or Elements of Informed Consent
In order for the IRB to approve a waiver or alteration of the consent process, the IRB must determine that:
- The research involves no greater than minimal risk to participants;
- The waiver or alteration will not adversely affect the rights and welfare of the participants;
- The research could not practicably be carried out without the waiver or alteration; AND
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
Investigators can request that the IRB approve a waiver or modification of the consent process. In no case, however, should an investigator propose, nor can the IRB ever approve, an informed consent procedure in which possible or potential risk is knowingly or purposely minimized, misrepresented, or otherwise distorted.