How do I get a Consent Waiver or Alter the Consent Form?
Approval for Consent Waiver or Permission to Alter the Consent Process
In certain cases, the Federal Regulations allow for approval of procedures which alters the elements of informed consent or waives the requirement to obtain any informed consent. A waiver must be completed and submitted with the application form. The following criteria must apply:
- The research involves no more than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration;and
- Whenever appropriate, the subject will be provided with additional pertinent information after participation.
Waiver of Obtaining Signed Consent Forms
Federal regulations allow for approval of a waiver of obtaining signed consent forms if:
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, or
- The research presents no more than minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside of the research context.
A waiver must be completed and submitted with the application form.
Other Questions about Informed Consent?
See The US Department of Health Office for Human Research Protections FAQ section on Informed Consent (http://answers.hhs.gov/ohrp/categories/1566)