Healthcare Research Addendum

HEALTHCARE RESEARCH ADDENDUM

Patient Name:     Medical Record No.:

Study Title:

Principal Investigator:     Institution:

Purpose

This Addendum documents the patient's permission to permit the use of health information, biological specimens, and related materials for research purposes in connection with the study identified above. This Addendum supplements any clinical consent and does not replace a clinical consent or treatment agreement.

Authorization — Scope of Use

By selecting the items below, the patient authorizes the research team and its designees to access, collect, use, and disclose the specified information and materials for the purposes of the research study. Authorization is effective as to each selected item only.

Duration and Revocation

This authorization is effective on the date signed and will remain in effect until the expiration date indicated below or until revoked in writing by the patient. Revocation will not affect uses or disclosures already made in reliance on this authorization prior to receipt of the revocation.

Risks, Benefits, and Alternatives

There may be no direct benefit to the patient from participation. Risks include potential loss of privacy, psychological discomfort, or risks associated with additional procedures. The research team will take reasonable steps to protect confidentiality. Participation is voluntary and refusal or withdrawal will not affect clinical care, payment, enrollment in a health plan, or eligibility for benefits.

Confidentiality and Privacy

Reasonable safeguards will be used to protect identifiable information. Identifiable information may be shared with the research team, collaborators, and regulatory bodies as required. Information that identifies the patient may be removed and de-identified; such de-identified information may be used or disclosed for future research without further authorization.

I authorize the use and disclosure of my protected health information as described above: Yes

Costs and Compensation

There will be no additional cost to the patient for authorizing use of existing clinical data or leftover specimens unless otherwise stated. The patient will be informed of any cost or payment related to research procedures performed solely for research purposes.

Commercial Use and Intellectual Property

The patient understands that discoveries or products developed from research may have commercial value. The patient will not be entitled to compensation for commercial development of discoveries derived from de-identified information or specimens.

No Effect on Clinical Care

Declining to sign this Addendum will not affect the patient's right to receive treatment or the quality of clinical care. Clinical decisions will be made independently of this authorization.

Patient Information (for records)

Insurance Information

Medical History (brief)

Withdrawal and Contact

To revoke this authorization or to obtain further information, contact the research team identified below. Revocation must be submitted in writing.

Authorization Statement

I have read and understand the information in this Addendum. By signing below I authorize the uses and disclosures described herein and acknowledge that I may revoke this authorization in writing at any time, except to the extent that action has already been taken in reliance on it.

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