Waiver and Alteration of Informed Consent and Authorization for Research

This Policy provides the following information:

• Overview of Common Rule and HIPAA Privacy Rule standard regarding waiver/alteration of informed consent and authorization.
• The process for submitting a request for a waiver of informed consent and authorization.
  Description of the new individual rights that the Privacy Rule requires for any research conducted pursuant to a waiver of authorization.
• The process for obtaining oral consent and authorization.

1. The research involves no more than minimal risk to the subjects;
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. The research could not practicably be carried out without the waiver or alteration; and
4. Whenever appropriate (generally, when there is a health justification), the subjects will be provided with additional pertinent information after participation.

a) An adequate plan to protect identifiers from improper use and disclosure.
b) An adequate plan to destroy the identifiers at the earliest opportunity. Identifiers can be maintained if there is a health or research justification or if retention is required by law. The investigator must document such justification.
c) Adequate written assurances that the identifiable information will not be reused or disclosed except:
· As required by law
· For authorized oversight of the research project
· For other research for which the use or disclosure would be permitted

• Research Limited to the Use of Medical Records
• Request for Waiver of Informed Consent and Authorization for Research
• Please note: existing forms will be updated to include the waiver criteria and will be listed here, including Research Related Use of Discarded Human Material and Secondary Uses of Samples/Data, among others.

Description of new individual rights that the Privacy Rule requires for any research conducted pursuant to a waiver of authorization:

1. Disclosures must be tracked: Investigators should note that disclosures of subjects' individually identifiable health information outside the Partners system that are made as part of research conducted with a waiver of authorization must be tracked in accordance with the accounting requirements of the Privacy Rule. Specifically, the Privacy Rule gives subjects the right to request a list of disclosures of their individually identifiable health information outside Partners (indicating how, when, why, what information, and to whom this information has been disclosed) over the previous six years.

For more detailed information concerning the Privacy Rule's accounting requirements, see "Individual Rights in the Research Context" and the Partners policy, "Accounting of Disclosures".

2. The minimum necessary standard must be met: Investigators conducting research under a waiver may use or disclose only the minimum necessary identifiable information needed for the research. (Please see Minimum Necessary Standard: Research Activities)

The process for obtaining oral consent and authorization:

The Common Rule allows an IRB to approve research in which consent is obtained orally from subjects under limited circumstances. Typically, scripts are required (especially if non-medically trained staff is getting oral consent) and these must be submitted for IRB review and approval. Ideally, some written study information is provided to the subject during his/her participation in the research.

The Privacy Rule allows a waiver or alteration of the written authorization requirement. Researchers obtaining oral consent may obtain oral authorization as well if the waiver of authorization criteria listed above are met.

Oral consent and/or authorization should be documented by the investigator. If obtaining oral consent/authorization, researchers should ask subjects if they wish to receive a copy of the Privacy Notice and provide the Notice if requested. The minimum necessary standard and the requirement to track disclosures do not apply.