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Changes to, or Waiver of, the DHHS or FDA Requirements for Informed Consent

May 2007

  1. Examples of changes or waivers the JHM IRB may consider
  2. Justification for changes or waiver of the consent process
  3. Waiver of documentation of informed consent
  4. FDA Regulated Studies: Different Standards for Waiver of Informed Consent

The JHM IRB has some authority to alter or waive the required elements of informed consent, the consent process, and the documentation of informed consent. Under the DHHS regulations ("the Common Rule"), numerous variations of elements of consent, the process, and documentation are possible, depending on the nature of the study, the risk to the subjects, and the justification for the alteration or waiver requested.  The JHM IRB may not waive informed consent for any FDA regulated studies involving human subjects unless the research meets the criteria for "emergency research."  The FDA will exercise “enforcement discretion” regarding the requirement for informed consent for certain in vitro diagnostic (IVD) studies which use de-identified tissue samples or specimens (see Organization Policy FDA 50.1).  The FDA permits waiver of documentation of informed consent if certain criteria are met.

1. Examples of changes or waivers the JHM IRB may consider

a.   Oral Consent
If the JHM IRB approves an oral consent process, the investigator must submit for approval a script that the person obtaining consent will use to guide the discussion with each subject.

b. Telephone Consent
If a study involves JHM IRB approved advertising to recruit subjects, the JHM IRB will require submission of a telephone script for review.  If the caller will disclose PHI to the recipient of the call, the investigator must also submit to the JHM IRB a HIPAA Form 4 Waiver of Privacy Authorization (because, under HIPAA, all such disclosures must be authorized by a signed document prior to the disclosure), and inform the subject through the telephone script of his/her privacy rights.

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2. Justification for changes or waiver of the consent process.

“Alteration or waiver of informed consent” means a departure from the traditional consent process.  Generally speaking, that process includes a thoughtful and thorough discussion of the study with the subject and confirmation that the subject understands the study and will participate voluntarily.  Under the Common Rule, the JHM IRB may approve alteration or waiver of consent if:

a. The research involves minimum risk to subjects;
b. The waiver or alteration will not adversely affect the rights and welfare of the participants;
c. The research could not practicably be carried out without the alteration or waiver; and
d. Whenever appropriate, the subject will be given additional information about the research after it is completed.

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3. Waiver of documentation of informed consent.

Waiver of documentation is different from waiver of informed consent.  If the JHM IRB waives documentation, the investigator may still obtain informed consent from the study participant, but will not document the existence of that consent on paper.  The JHM IRB may waive documentation if it finds that:

a. The link of the subject’s signature on the consent form and the research poses a potential risk of harm to the participant if there is a breach of confidentiality; or
b. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is generally required outside of the research context.  In such cases, the JHM IRB has the option of requiring that the researcher give the subjects a written statement about the research.

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4.  FDA Regulated Studies: Different Standards for Waiver of Informed Consent.

With a few narrow exceptions (emergency and some DOD research), FDA regulations do not permit waiver of consent, even when studies are minimal risk and would meet criteria for waiver of consent under DHHS regulations. Under FDA regulations, informed consent is required for IVD studies involving samples that are identifiable (i.e., are labeled with identifiers or accompanied by the patient’s identifiable clinical information), as well as for studies in which the samples are not identifiable but are coded or linked to identifiable information.

Current FDA guidance (4/25/06), however, indicates that under some circumstances, when samples taken from excess clinical or research specimens cannot be identified (e.g., all linking codes and identifiers have been removed, or the investigator has no access to the code keys or identifying information), the agency will exercise “enforcement discretion” and permit the IRB  to approve the study without requiring informed consent of the sample sources.

To be eligible for approval without a requirement for informed consent, FDA indicates that IVD research must meet the following criteria:

  • The research must be conducted under an IRB-approved protocol;
  • The research must meet criteria for an IDE exemption (see above);
  • The research must use specimens left over from clinical care, specimen repositories, or other research (i.e., the specimens may not be collected specifically for the proposed research, and no additional specimen may be collected for the purpose of research);
  • Individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation;
  • The specimens are provided for research without identifiers (codes are permissible only if neither the investigator nor anyone associated with the study has access to the code key or can identify the person who was the source of the specimen);
  • Any clinical information supplied with the specimen must not be individually identifiable;
  • No test results from the research may be reported to any subject or that subject’s health care provider; and
  • The supplier of the specimens must have established policies and procedures to prevent the release of identifying information.

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