a) Waiver or Alteration of the Consent Process

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent, provided the IRB finds and documents that:

• The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

  a. Public benefit or service programs;

  b. Procedures for obtaining benefits or services under those programs;

  c. Possible changes in or alternatives to those programs or procedures; or

  d. Possible changes in methods or levels of payment for benefits or services under those programs; and

  e. The research could not practicably be carried out without the waiver or alteration.

  f. The research is not subject to FDA regulation.

The IRB may also approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to obtain informed consent, provided the IRB finds and documents that:

• The research could not practicably be carried out without the waiver or alteration.
  
  
• The research involves no more than minimal risk to the participants;
  
  
• The waiver or alteration will not adversely affect the rights and welfare of the participants;
  
  
• Whenever appropriate, the participants will be provided with additional pertinent information after participation.
  
  
• The research is not subject to FDA regulation.

Where DHHS guidance requires specific findings on the part of the IRB the IRB will document such findings in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

b) Waiver of Documentation of Informed Consent

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all participants if it finds either:

That all of the following are true:

• The only record linking the participant and the research would be the consent document.
  
  
• The principal risk would be potential harm resulting from a breach of confidentiality.
  
  
• Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
  
  
• The research is not subject to FDA regulations.

That all of the following are true:

• The research presents no more than minimal risk of harm to participants.
  
  
• The research involves no procedures for which written consent is normally required outside of the research context.

In cases where the documentation requirement for informed consent is waived, the IRB may require the investigator to provide participants with a written statement regarding the research. Where DHHS guidance requires specific findings on the part of the IRB, such as approving a procedure which waives the requirement for obtaining a signed consent form, the IRB will document such findings in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

c) Exception from Informed Consent in Planned Emergency Research

Planned emergency research allows research on life-threatening conditions for which available treatments are unproven or unsatisfactory, and when it is not possible to obtain informed consent. Both the FDA and OHRP permit a waiver of the general requirements for informed consent for research involving greater than minimal risks to subjects when specific conditions are met (21 CFR 50.24). Currently, this Institution does not participate in planned emergency research.

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