Justification for Change

Change request for: Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care, OMB #0920-1019 exp. 5/31/2017

Request Date: June 6, 2014

Justification for the change: Before a patient receives medical care at a medical clinic they are asked, by the clinic, to sign a general consent for medical treatment. This consent may include consent for care including evaluation, diagnosis, procedures and treatment by the clinic’s clinical staff. This consent also includes consent for the release of medical information to other healthcare providers as necessary for the patient’s medical care. As such, the patient-centered HIV model care services (as proposed by this project) are currently covered under the general consent for medical care received by the clinic prior to initiation of patient care. We propose to replace the project consent form with a project Information Sheet which details the services participants will receive, the information that will be shared between the pharmacist, clinic medical provider and the project team. Clinic staff will use the Information Sheet to explain the project to patients. No additional time burden on project staff is anticipated.

Form	Current item	Requested change
Consent form (English)	Consent form (English)	Replace with Information Sheet (English)
Consent form (Spanish)	Consent form (Spanish)	Replace with Information Sheet (Spanish)

Note: The following paragraph has been added to the Supporting Statement A page 14:

Program participants (clients of the project medical clinics and of the project pharmacies) will be given an information sheet which details the services participants will receive, the information that will be shared between the pharmacist, clinic medical provider and the project team (attachments 9a and 9b). Clinic staff will use the Information Sheet to explain the project to patients. Program participants will be informed that participation is voluntary. Patients who do not wish to participate in the model program will continue to receive their usual care at the medical clinics and pharmacies. Although medical clinics and pharmacies collect personally identifying patient information, in order to conduct their normal business operations and for clinics and pharmacies to collaborate on patient care, no personally identifying information will be sent to CDC.