Healthcare Patient Study Consent Form

HEALTHCARE PATIENT STUDY CONSENT FORM

Study Title:

Principal Investigator:    Institution / Sponsor:

Patient Information

Patient Name:

Female    Male    Other / Prefer not to say

Insurance Information

Medical History

I am able to become pregnant or am currently pregnant / breastfeeding
I have an implanted device (e.g., pacemaker, neurostimulator)
I am immunocompromised or on immunosuppressive therapy

Study Procedures, Risks, and Benefits

I acknowledge that the Principal Investigator has explained the reasonably foreseeable risks, discomforts, and potential benefits associated with this study. I understand that risks may include, but are not limited to, physical injury, allergic reaction, emotional distress, loss of privacy, and unknown risks that cannot be anticipated. I have had the opportunity to ask questions about risks and receive answers.

I acknowledge that potential benefits may include contributions to medical knowledge, possible direct medical benefit, or no direct benefit. No guarantee of benefit has been made.

Confidentiality and Use of Health Information

My medical records and information collected for this study may be reviewed by study staff, monitors, the sponsor, and regulatory authorities for purposes of oversight and safety. Reasonable efforts will be made to protect my confidentiality. Identifiable information may be used for study conduct and monitoring, and de-identified data may be used for future research and publication.

I consent to the collection, use, and disclosure of my protected health information (PHI) as described in this form for purposes of this research study. This authorization expires on:

I consent to the following (select all that apply):
Use of de-identified data for future research and publication
Audiotaping or videotaping during study procedures if required
Collection and storage of biological samples for analysis and future research

Compensation, Costs, and Treatment for Injury

Compensation for participation, if any, and any costs or reimbursements are described below. There is no guarantee of payment for study-related injury. Medical treatment for direct injury resulting from study procedures will be provided as described; the availability of compensation and payment for treatment is further described below.

Voluntary Participation and Withdrawal

My participation in this study is voluntary. I may refuse to consent or may withdraw from the study at any time without penalty, loss of benefits to which I am otherwise entitled, or effect on my medical care. If I withdraw, I will inform the study staff and arrangements will be made concerning the handling of data and samples already collected.

I acknowledge that the following alternatives to participation were explained to me, including receiving standard medical care outside of the study.

Questions and Contacts

Consent and Authorization

By signing below, I certify that I have read (or someone has read to me) the information in this document, that the study has been explained to my satisfaction, that my questions have been answered, and that I voluntarily agree to participate in this research study. I understand that I will receive a copy of this Consent Form.

I authorize the use and disclosure of my protected health information as described above. I understand that I may revoke this authorization at any time by delivering a written revocation to the Principal Investigator, except to the extent that action has already been taken in reliance on this authorization.

I have been given the opportunity to ask questions and have received satisfactory answers. I understand that participating is voluntary and that I may withdraw at any time.

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