Healthcare Correction Study

Healthcare Correction Study — Participant Consent and Authorization

Study Identification

Study Title:    Protocol ID:

Principal Investigator:

Participant Information

Patient Name:

Male    Female    Other / Prefer not to say

Insurance Information

Medical History — Relevant to Study

Study Description and Procedures

The purpose of this study is to evaluate processes for identifying and correcting inaccuracies in patient health records and to measure the clinical and administrative outcomes of those corrections. Participation involves review of your medical record, comparison against source documentation, interview(s) of clinical staff, and, where necessary, correction of erroneous entries in your record.

Record review and audit
Clinical staff interview
Patient interview regarding factual events
Correction or amendment of entries in the medical record where documentation supports change
Use of de-identified data for aggregate analysis

Risks, Benefits, and Alternatives

Risks: Correction activities may reveal previously undocumented conditions or errors that could lead to changes in care. There is a low risk of loss of confidentiality despite safeguards. Corrections to records may affect insurance billing or eligibility assessments. Emotional discomfort may result from discussions about prior care or record entries.

Benefits: Possible improvement in the accuracy of your medical record, which may improve continuity and quality of care; contribution to improved systems to prevent future errors. There is no guarantee you will receive direct clinical benefit.

Alternatives: You may decline to participate. Declining or withdrawing will not affect your access to clinical care or benefits to which you are otherwise entitled.

Data Use, Confidentiality, and Correction Procedures

Data Use: Identifiable information will be accessed and used by authorized study personnel to verify facts, compare source documentation, and effect corrections. De-identified datasets may be used for analysis and publication. Identifiable data will only be used as described in this authorization.

Confidentiality Protections: Reasonable administrative, technical, and physical safeguards will be employed to protect your information. Authorized personnel will have access only to the minimum information necessary to perform their study duties. Access logs will be maintained for review.

Correction Procedures: If the study team determines a correction to the medical record is warranted, corrections will be made in accordance with applicable facility policy and law. Corrections will include a clear explanation of the basis for the correction and the identity of the person making the correction. You will be notified of any substantive changes that affect your clinical care or insurance obligations.

HIPAA Authorization for Use and Disclosure of Protected Health Information

I authorize the release and use of my protected health information (PHI) as described below for the purposes of conducting the Healthcare Correction Study. This authorization permits access to past and future medical records, including but not limited to progress notes, diagnostic reports, medication lists, and billing information as necessary to verify facts, identify errors, and document corrections.

Right to Revoke: I understand I may revoke this authorization at any time by written notice to the study contact, except to the extent that action has already been taken in reliance on this authorization.

Voluntary Participation and Withdrawal

Voluntary Participation: Participation is voluntary. If you choose not to participate, care and benefits to which you are otherwise entitled will not be affected. You may withdraw from the study at any time without penalty.

Effects of Withdrawal: If you withdraw, information collected prior to withdrawal will remain part of the study records and may continue to be used. Any corrections already made in your official medical record prior to withdrawal will remain in the record in accordance with policy and law.

Compensation and Costs

Compensation:    Costs:

Acknowledgment and Consent

By signing below, I acknowledge that I have read this form, all my questions have been answered to my satisfaction, and I voluntarily agree to participate in the Healthcare Correction Study and to the uses and disclosures of my health information as described herein.

Consent to record review and audit
Consent to proposed corrections/amendments to my medical record
Consent to use of de-identified data for research and publication
Consent to be contacted for follow-up clarification or verification

Participant Rights and Certifications

I understand that I have the right to request restrictions on the use or disclosure of my PHI, and to request an accounting of disclosures. I certify that the information I have provided on this form is true and complete to the best of my knowledge.

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