"Mount Carmel Institutional Review Board - Download as DOC"
Mount Carmel Institutional Review Board Human Subject Protection Office Mount Carmel Corporate Services Center Date Received: 6150 East Broad Street IRB Protocol #: Columbus, OH 43213 Phone: 614-546-4325 | Fax: 614-546-4328 Internal # Email: email@example.com For Office Use Only Determination: [ ] Authorization waived HIPAA [ ] Authorization required [ ] Partial waiver issued for recruitment Waiver of Authorization Form only [ ] Limited data set with Data Use Apply for (check one of the following): Agreement approved Complete Waiver of Authorization Partial Waiver of Authorizationfor recruitment purposes James M. Sinard, M.D. Date Review Preparatory to Research Chairman, Limited data set Data Use Agreement attached Mount Carmel Institutional Review Board Administrative Information Study Title: Sponsor Protocol Number: Version Date: Proposed length of Start date: End date: research study: Research Site(s): Mount Carmel West Mount Carmel East Mount Carmel St. Ann’s Mount Carmel New Albany Surgical Hospital Fairfield Medical Center Physician’s Office Other, specify: Principal Investigator: Name: Address: Telephone: Fax: E-mail: Primary Contact / Coordinator [person receiving all correspondences]: Name: Address: Telephone: Fax: E-mail: Co-Investigator(s): (1) Name: (2) Name: (3) Name: IRB HIPAA Waiver of Authorization Form (5.1.2008) Page 1 of 3 Supersedes previous versions HIPAA Considerations Under the HIPAA Privacy Rule, research data that includes any of the 18 identifiers listed below cannot be considered deidentified. Authorization from the subject or a waiver of authorization granted by the IRB is required. Does your study involve the access, use or disclosure of protected health information (PHI)? Yes No PHI – individually identifiable If “no” stop here because HIPA does not apply health information that is If “yes” proceed to the next section. collected for treatment, diagnosis, or research purposes If yes, indicate any PHI identifiers you will be accessing, recording, or disclosing from the following list: PHI Identifiers Accessing Recording Disclosing 1 Patient/Subject Name 2 Address street location 3 Address town or city Address state* Address code* Elements of dates (except year) related to person, i.e., date of birth, admission or discharge dates, date of death* 4 Telephone number 5 Fax number 6 Electronic mail (email) address 7 Social security number 8 Medical record numbers 9 Health plan beneficiary numbers 10 Account numbers 11 Certificate/license numbers 12 Vehicle identification numbers and serial numbers including license plates 13 Medical device identifiers 14 Web URLs 15 Internet protocol (IP) address 16 Biometric identifiers (finger and voice prints) 17 Full face photographic images 18 Any unique identifying number, characteristic or code Will there be a link (code) to identifiers? Yes No List all the locations of the records you are accessing: List all outside entities (i.e. sponsor, insurance company, regulatory agencies, data management, etc.) to whom PHI will be disclosed: Describe how PHI will be kept confidential so that those not materially involved in the study will not be able to view or record this information: Are you obtaining this information for recruitment No purposes and requesting a partial waiver of authorization? Yes If yes, complete the Partial Waiver of HIPAA Authorization For Recruitment section below. Are you obtaining this information for study purposes (i.e. Yes No data analysis, follow-up)? If yes, are you obtaining informed consent and authorization to use or disclose PHI? Yes No IRB HIPAA Waiver of Authorization Form (5.1.2008) Page 2 of 3 Supersedes previous versions Request for Partial Waiver of HIPAA Authorization for Recruitment Describe how the data will be collected and maintained: Describe your plan for destruction of identifiers: NOTE: Information collected through a partial waiver for recruitment cannot be shared or disclosed to any other person or entity. Explain why you need the partial waiver: Explain why the research could not practicably be conducted without the partial waiver: Request for Waiver of HIPAA Authorization According to HIPAA Privacy Rule regulations, in order to use or disclose an individual’s PHI in the conduct of research without the express authorization of the individual, the use or disclosure must not represent more than minimal risk to the subjects and the following criteria must be met. Data Collection Sheet (submit a hard copy) How will information be recorded? Electronically (submit electronic or hard copy) Describe your plan to protect the identifiers from improper use or disclosure: Describe your plan to destroy the identifiers at the earliest opportunity consistent with the conduct of the research? Will PHI be used or disclosed to any other person or entity, (except as required by Yes law, for authorized oversight of the No research project, or for other research for which the use or disclosure of PHI would If yes, describe how/to whom: be permitted by regulation)? Explain why the research could not practicably be conducted without the waiver: Explain why the research could not practicably be conducted without access to and use of the PHI: Use of Limited Data Set Of the 18 PHI items listed above, items with an asterisk (*) may be included and considered a “Limited data set.” Use of data under the provision of a “limited data set” requires the signing of a data use agreement by the researcher (the recipient of the PHI in the limited data set). Will you be using a limited Yes data set for your study? (i.e. No you checked only those boxes next to the asterisk (*)?) If yes, attach a completed Data Use Agreement. Data Use Agreement can be found at www.mountcarmelhealth.com/696.cfm I the undersigned principal investigator hereby agree that I will ensure (a) that I and my research team, in accordance with HIPAA’s Minimum Necessary Rule, will collect only the minimum amount or protected health information necessary to conduct the study described herein; (b) that access to protected health information will be limited to the greatest extent reasonably possible within the research team; and (c) that neither I, nor any other member of my research team, will re-use or disclose protected health information to any other person or entity except for those uses and disclosures outlined above and specifically approved by the IRB (or by subject authorization), required by law, or required by research oversight. Signature: _____________________ _______________________ _________ Principal Investigator (printed) Principal Investigator’s Signature Date IRB HIPAA Waiver of Authorization Form (5.1.2008) Page 3 of 3 Supersedes previous versions