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Recruiting Subjects: A Presentation for the Clinical Trials Working Group UW-Madison ICTR

2. Two Phases of Research. Many studies, including clinical trials, involve the use or disclosure of HIPAA protected health information (?PHI") in two phases of the research study:1. For identification of potential subjects and actual recruitment of subjects (e.g. PHI for determining potential elig

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Recruiting Subjects: A Presentation for the Clinical Trials Working Group UW-Madison ICTR

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    1. Recruiting Subjects: A Presentation for the Clinical Trials Working Group UW-Madison ICTR Rebecca Hutton, UW-Madison HIPAA Privacy Officer January 21, 2009

    2. 2 Two Phases of Research Many studies, including clinical trials, involve the use or disclosure of HIPAA protected health information (“PHI”) in two phases of the research study: 1. For identification of potential subjects and actual recruitment of subjects (e.g. PHI for determining potential eligibility of subjects and for contacting subjects – e.g., name, phone number, address, etc.) 2. For study itself (e.g., PHI related to the study question –e.g., diagnosis, treatment, outcomes, etc.). This presentation concerns the use and disclosure of PHI for the first phase only.

    3. 3 Protected Health Information under HIPAA Patient contact information needed for recruitment such as name, telephone number, and address (alone or in combination with health information) constitutes PHI under HIPAA if it is obtained from information held by a HIPAA covered entity.

    4. 4 HIPAA, Common Rule, and Ethical Principles UW-Madison policies and procedures for human subjects research, including research recruitment, are based on HIPAA and Common Rule requirements (federal laws), plus important ethical principles observed by UW-Madison (and most other academic medical centers)

    5. 5 Important Ethical Principle Patients should not be contacted about research by someone not involved in their healthcare, if the basis for the contact is information related to their healthcare. (i.e., no “cold” contacts)

    6. 6 HIPAA – Basic Rules Regarding Preparatory to Research Activities A covered entity may allow its own researchers to use PHI or it may disclose PHI to outside researchers for preparatory to research purposes under certain conditions, without patient authorization. (However, disclosure of PHI to outside researchers requires the covered entity to account for this disclosure, so rarely done in practice.) Preparatory to research activities include, for example, developing eligibility criteria, determining feasibility of study, refining study question, identifying eligible subjects

    7. 7 HIPAA Preparatory to Research Cont’d. Under preparatory to research provisions, eligible subjects can be identified but NOT contacted. Minimum necessary rule must be observed by covered entity holding the PHI in use or disclosure of PHI for preparatory to research purposes. Preparatory to research certification (UW-Madison form) gives rules for researcher in preparatory to research activities (e.g., PHI cannot be removed from covered entity).

    8. 8 HIPAA – Basic Rules Regarding Contacting Subjects Under HIPAA, researchers within a covered entity may use PHI, without authorization, to contact potential subjects for purpose of obtaining research authorization (this has been interpreted to include contacting potential subjects for research recruitment purposes). However, remember, UW researchers, even those within the UW HIPAA covered entity, who are not also the health care provider for the potential subjects must observe the “no cold contact” principle and therefore usually cannot take advantage of this HIPAA provision.

    9. 9 HIPAA – Basic Rules Regarding Contacting Subjects cont’d. Researchers outside of the covered entity must have authorization from potential subject or IRB approved waiver of authorization in order for covered entity to be able to disclose PHI to them for recruitment purposes. (However, waiver of authorization would usually result in violation of the “no cold contact principle”, so waiver approach is usually not an option.)

    10. 10 Common Rule Recruitment Rules Recruitment must be done pursuant to IRB approved protocol If, as part of preparatory to research activities, a researcher records individually identifiable information (i.e., includes identifiers in the data collected), this is considered research under the Common Rule, and may be done only pursuant to an IRB approved protocol. Otherwise, preparatory to research activity is generally not considered research under the Common Rule (and so does not need to be done pursuant to an approved protocol).

    11. 11 Researchers Who are the Health Care Providers for Their Potential Subjects A researcher who is also a health care provider within the UW HCC/ACE who wants to recruit own patients can contact potential subjects for recruitment without authorization or waiver of authorization. Contact must be pursuant to an approved protocol, to meet Common Rule requirements. Contact automatically meets ethical principle of no cold contacts.

    12. 12 Researchers Who Are Not Health Care Providers for Potential Subjects Must observe the “no cold contact” principle (whether the researcher is inside the UW HIPAA covered entity or not). Two ways for these researchers to contact potential subjects for recruitment: Have health care provider obtain written authorization (this can be an abbreviated or altered authorization) from patient/potential subject to share contact PHI with researcher so that researcher can contact potential subject directly or Have health care provider provide patient/potential subject with information on contacting the researcher directly if interested in study

    13. 13 Tips Information systems staff of covered entity can help researcher devise way of identifying and notifying health care providers of which patients may be eligible as potential subjects. IRB staff or UW-Madison HIPAA Privacy Officer can assist in development of abbreviated or altered authorization for sharing of contact information for recruitment. Method of contacting subjects must be described in protocol submission to IRB.

    14. 14 HIPAA Covered Units at UW-Madison (The UW Health Care Component) Units that provide health care or have staff that provide health care (e.g. clinical departments of UWSMPH, State Lab of Hygiene, Waisman clinics) Units that use identifiable health information to provide health care operation services to HIPAA covered health care provider units (e.g., Office of Administrative Legal Services)

    15. 15 Complete Listing A complete listing of all units in the UW health care component (UW HCC) can be found at the UW-Madison HIPAA website at www.wisc.edu/hipaa (in Policy #1.1 in the Privacy Manual).

    16. 16 UW Affiliated Covered Entity Many of the units of the UW HCC are also part of an organizational arrangement that includes UWHC and UW Medical Foundation, called the UW Affiliated Covered Entity or UW ACE. The UW ACE is considered to be a single covered entity under HIPAA. The UW HCC units that are part of the UW ACE can be found in Policy #1.2 of the Privacy Manual at www.wisc.edu/hipaa .

    17. 17 Inside or Outside the UW HCC/ACE? An individual is inside or outside of the UW HCC/ACE depending on appointing/employing unit. If appointing/employing unit is within the UW HCC/ACE, then so is individual. If PI is within UW HCC/ACE then study is covered by HIPAA if it involves PHI; if individuals from outside the UW HCC/ACE are added as key personnel, then those individuals become covered by HIPAA for their activities in connection with the study. If PI has appointments in more than one unit, protocol should specify under which appointment the study is being done.

    18. 18 UW HCC/ACE and Access to Patient Information UWMF, UWHC and UW-Madison HCC units retain their individual responsibilities for the medical records of their patients and remain the legal custodian of these records (even though under HIPAA they have organized into a single ACE). These units make the day-to-day decisions regarding the use and disclosure of their patient data (including for example, if minimum necessary requirement is being met). Therefore, when a researcher is seeking patient information, the rules and procedures of the entity actually holding the patient data must be followed. So, it is important for a researcher to identify the exact health care provider entity that has the patient information being sought for research and to follow the rules and procedures of that health care provider in obtaining the patient information.

    19. 19 VA Hospital Note: the VA hospital is NOT part of the UW HCC/ACE. It is a legally separate HIPAA covered entity. It maintains its patient records separately from UWMF, UWHC, and UW-Madison. The VA patient records cannot be obtained through UWHC, UWMF, or UW-Madison. VA has some different interpretations of HIPAA.

    20. 20 QUESTIONS??? Consult with IRB staff Consult UW-Madison HIPAA Website: www.wisc.edu/hipaa www.wisc.edu/hipaa/researchguide Contact UW-Madison HIPAA Privacy Officer: Rebecca Hutton, JD, MS 608-263-7400 rchutton@vc.wisc.edu Office of Administrative Legal Services, Room 361, Bascom Hall

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