PREPARATORY TO RESEARCH & PRESCREENING Appreciating Our Differences

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1 & PRESCREENING Appreciating Our Differences Gretchen McMasters, MBA, CIM, CIP, CHRC Northern Arizona Healthcare IRB Administrator

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3 HIPAA Privacy Rule at 45 CFR Covered entities may use or disclose PHI to a researcher without an individual's Authorization, a waiver or an alteration of Authorization, or a data use agreement under certain circumstances A HIPAA covered entity directly handles Personal Health Information (PHI) or Personal Health Records (PHR). Common examples include hospitals, doctors offices/clinics and health insurance providers.

4 Covered entities may use or disclose PHI to a researcher without an individual's Authorization, a waiver or an alteration of Authorization, or a data use agreement IF the covered entity obtains from a researcher representation that: (1) the use or disclosure is solely to review PHI to prepare a research protocol or for similar purposes preparatory to research,

5 Covered entities may use or disclose PHI to a researcher without an individual's Authorization, a waiver or an alteration of Authorization, or a data use agreement IF the covered entity obtains from a researcher representation that: (1) the use or disclosure is solely to review PHI to prepare a research protocol or for similar purposes preparatory to research, (2) the PHI will not be removed from the covered entity during the course of review, and

6 Covered entities may use or disclose PHI to a researcher without an individual's Authorization, a waiver or an alteration of Authorization, or a data use agreement IF the covered entity obtains from a researcher representation that: (1) the use or disclosure is solely to review PHI to prepare a research protocol or for similar purposes preparatory to research, (2) the PHI will not be removed from the covered entity during the course of review, and (3) the PHI sought is necessary for the research.

7 Regulations state the covered entity may permit the researcher to make these representations in written or oral form. Northern Arizona Healthcare requires researchers submit the Preparatory to Research Authorization Agreement form to NAH IRB for review. Check with the overseeing IRB regarding its procedures. Different IRBs do it differently.

8 Can the preparatory to research provision of the HIPAA Privacy Rule at 45 CFR (i)(1)(ii) be used to recruit individuals into a research study? An employee or a member of the covered entity's workforce can use PHI to contact prospective research subjects. Researchers could identify prospective research participants to seek Authorization to use or disclose their PHI for research.

9 Can the preparatory to research provision of the HIPAA Privacy Rule at 45 CFR (i)(1)(ii) be used to recruit individuals into a research study? An employee or a member of the covered entity's workforce can use PHI to contact prospective research subjects. Researchers could identify prospective research participants to seek Authorization to use or disclose their PHI for research. A covered entity may also permit a researcher who is not a workforce member of that covered entity to review PHI (within that covered entity) for purposes preparatory to research.

10 Can the preparatory to research provision of the HIPAA Privacy Rule at 45 CFR (i)(1)(ii) be used to recruit individuals into a research study? An employee or a member of the covered entity's workforce can use PHI to contact prospective research subjects. Researchers could identify prospective research participants to seek Authorization to use or disclose their PHI for research. A covered entity may also permit a researcher who is not a workforce member of that covered entity to review PHI (within that covered entity) for purposes preparatory to research. PHI cannot be removed from the covered entity during review.

11 Can the preparatory to research provision of the HIPAA Privacy Rule at 45 CFR (i)(1)(ii) be used to recruit individuals into a research study? An employee or a member of the covered entity's workforce can use PHI to contact prospective research subjects. Researchers could identify prospective research participants to seek Authorization to use or disclose their PHI for research. A covered entity may also permit a researcher who is not a workforce member of that covered entity to review PHI (within that covered entity) for purposes preparatory to research. PHI cannot be removed from the covered entity during review.

12 PRESCREENING Office of Human Research Protections (OHRP) 45 CFR 46 Prescreening by phone or in person to determine eligibility and interest in a study is common. All prescreening activities are considered part of the subject selection and recruitment process and thus should be reviewed by the appropriate IRB. When prescreening, protecting privacy and confidentiality is critically important. NOTE: Drug and Device studies are generally subject to Food and Drug Administration (FDA) regulations. Investigators are advised to review FDA regulatory requirements and guidance in this area.

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14 Gretchen McMasters, MBA, CIM, CIP, CHRC Northern Arizona Healthcare IRB Administrator (O)