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Attachment A to SACHRP November 23, 2010 Letter to the Secretary

ATTACHMENT A:  MODELS OF COMPOUND AUTHORIZATION

FOR A CLINICAL TRIAL & BANKING COMPONENT

Model 1:  Combined consent/authorization for clinical trial and banking component, with check-boxes for banking option, and one signature

 

The covered entity uses a combined consent/authorization, in which the authorization elements for the optional banking activity “piggyback” on authorization statements for the clinical trial.  In other words, the recitation of authorization elements is not entirely separate for the banking component, but relevant differences for banking authorization are noted.  Through check-boxes, an individual is asked for consent and authorization for the clinical trial and for the optional banking research.  A single signature would be provided.

 

For an example, please see the mark-ups to the Authorization on the next page.  This Authorization is the sample published in the NIH/OCR guidance entitled “HIPAA Authorization for Research,” available at http://privacyruleandresearch.nih.gov/pdf/authorization.pdf.  Mark-ups are shown in bold red CAPS.

 

Model 2:  Combined consent/authorization form for clinical trial and banking component, with one signature for clinical trial and another signature for banking

 

The covered entity uses a combined consent/authorization, in which the authorization has two sections: one for the clinical trial, and one for the optional banking research (e.g., in a separate paragraph or section).  An individual is asked for consent and authorization for the clinical trial and the optional banking research.  Separate signatures are requested.

 

Model 3:  Combined consent/authorization form for clinical trial and banking component, with check boxes for banking option, but with detailed information about banking presented in a separate brochure or information sheet

 

The covered entity uses a combined consent/authorization form for a clinical trial with an optional banking component.  As part of the IRB-approved informed consent process, the covered entity gives individuals an informational brochure that describes banking research, including in part whether identifiable health information will be used or shared and for what purposes.  The consent/authorization form notes that detailed information will be provided in a separate informational brochure.  The consent/authorization, together with the informational brochure, meaningfully inform individuals of the banking option.  An individual is asked for consent/authorization to the clinical trial and optional banking component.  A single signature would be provided.

 

SAMPLE AUTHORIZATION LANGUAGE FOR RESEARCH USES AND DISCLOSURES OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION BY A COVERED HEALTH CARE PROVIDER

 

Authorization to Use or Disclose (Release) Health Information

that Identifies You for a Research Study AND OPTIONAL BANKING STUDY

 

REQUIRED ELEMENTS:

If you sign this document, you give permission to [name or other identification of specific health care provider(s) or description of classes of persons, e.g., all doctors, all health care providers] at [name of covered entity or entities] to use or disclose (release) your health information that identifies you for the research study described below:

[Provide a description of the research study, such as the title and purpose of the research.][ADD OPTIONAL BANKING STUDY]

The health information that we may use or disclose (release) for this research includes [complete as appropriate]:

[Provide a description of information to be used or disclosed for the research project. This may include, for example, all information in a medical record, results of physical examinations, medical history, lab tests, or certain health information indicating or relating to a particular condition.][STATE WHETHER INFORMATION IS THE SAME OR DIFFERENT FOR THE OPTIONAL COMPONENT]

The health information listed above may be used by and/or disclosed (released) to:

[Name or class of persons involved in the research; i.e., researchers and their staff]

[Footnote to the Template provides additional examples of who may have access to PHI for the study, including but not limited to research collaborators, sponsors, data coordinating centers, IRBs, Data Safety and Monitoring Boards, and any other entity [or governmental party] to whom the covered entity is expected to make the disclosure.]

[FOR THE BANKING COMPONENT, INCLUDE WHO MAY USE PHI AND TO WHOM PHI MAY BE DISCLOSED]

[Name of covered entity] is required by law to protect your health information. By signing this document, you authorize [name of covered entity] to use and/or disclose (release) your health information for this research. Those persons who receive your health information may not be required by Federal privacy laws (such as the Privacy Rule) to protect it and may share your information with others without your permission, if permitted by laws governing them.  Please note that [include the appropriate statement]:

 

  • You do not have to sign this Authorization, but if you do not, you may not receive research-related treatment IN THE CLINICAL TRIAL. 
    (When the research involves treatment and is conducted by the covered entity or when the covered entity provides health care solely for the purpose of creating protected health information to disclose to a researcher)

 

  • IF YOU WANT TO ALLOW YOUR HEALTH INFORMATION TO BE USED OR SHARED FOR THE OPTIONAL BANKING RESEARCH, THEN PLEASE SELECT THE CHOICE BELOW THAT INCLUDES BANKING.  IF YOU DO NOT  AUTHORIZE THE BANKING RESEARCH, YOU MAY STILL PARTICIPATE IN THE CLINICAL TRIAL.

 

  • [Name of covered entity] may not condition (withhold or refuse) treating you on whether you sign this Authorization.
    (When the research does not involve research-related treatment by the covered entity or when the covered entity is not providing health care solely for the purpose of creating protected health information to disclose to a researcher)

Please note that [include the appropriate statement]

  • You may change your mind and revoke (take back) this Authorization at any time, except to the extent that [name of covered entity(ies)] has already acted based on this Authorization. To revoke this Authorization, you must write to: [name of the covered entity(ies) and contact information].
    (Where the research study is conducted by an entity other than the covered entity)
  • You may change your mind and revoke (take back) this Authorization at any time. Even if you revoke this Authorization, [name or class of persons at the covered entity involved in the research] may still use or disclose health information they already have obtained about you as necessary to maintain the integrity or reliability of the current research. To revoke this Authorization, you must write to: [name of the covered entity(ies) and contact information].
    (Where the research study is conducted by the covered entity)

[FOR BANKING COMPONENT, ADD CONTACTS IF DIFFERENT]

 

  • IF YOU AUTHORIZE YOUR HEALTH INFORMATION TO BE USED AND SHARED FOR BOTH THE CLINICAL TRIAL AND BANKING, AND LATER REVOKE YOUR AUTHORIZATION FOR ONLY ONE OF THESE ACTIVITIES, THIS AUTHORIZATION WILL REMAIN IN EFFECT FOR THE OTHER ACTIVITY.

This Authorization does not have an expiration date [or as appropriate, insert expiration date or event, such as “end of the research study.”] [ADDRESS WHETHER EXPIRATION DIFFERS FOR BANKING COMPONENT]

[ADD CHECK-BOXES OR OTHER MEANS TO CLARIFY WHETHER INDIVIDUAL IS AUTHORIZING THE CLINICAL TRIAL AND BANKING, OR ONLY THE CLINICAL TRIAL]

________________________

Signature of participant or participant’s personal representative

_________________________

Printed name of participant or participant’s personal representative

_________________________

Date

_________________________

If applicable, a description of the personal representative’s authority to sign for the participant.