APPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION

Transcription

1 FORM W/H-01 APPLICATION FOR RESEARCH REQUESTING AN IRB WAIVER OF CONSENT AND HIPAA AUTHORIZATION Research for which this form is appropriate generally involves only existing patient records or specimens. If there will be any intervention or interaction (e.g. questionnaires, interviews, randomization), or any direct contact of any kind with the subjects of this research, STOP HERE. Consent/authorization will need to be obtained, and a full IRB application will be required. IRB Project Number: Date of This Request: Principal Investigator: Have you completed Biomedical Research training? No Yes (If the answer is NO, please complete and send certification in with this form.) Associate Investigator(s): Mailing Address: Title of Project: Information Submitted by: Phone #: Address: Fax #: Name of Sponsor: Proposal for Research Involving: Patient Specimens (tissues, blood, serum, etc.) Medical Records Electronic 1. Scientific purpose of the study: Attach a word summary of the background information, state the research question(s), and tell why the study is needed. Include a full description of the study design, methods and procedures. 2. Where are the data and/or specimens located now? 3. The data were originally gathered for: Clinical use Research use Not Applicable The specimens were originally gathered for: Clinical use Research use Not Applicable Has the purpose for which the specimens were collected been met before removal of any excess, as certified by the pathologist in charge or clinical laboratory director? Yes No Not Applicable 4. Will the data be recorded and/or specimens labeled using any of the identifiers on the following list? (Remember that Protected Health Information = health information + identifiers) Yes No If yes, check all that apply: Names IRB Form HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 1 of 6

2 Any geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code and their equivalent geocodes, except for the initial three digits of a zip code Any elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death. For ages over 89: all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 and older Telephone numbers Fax numbers Electronic mail addresses Social security numbers Medical record numbers Health plan beneficiary numbers Account numbers Certificate/license numbers Vehicle identifiers and serial numbers, including license plate numbers Device identifiers and serial numbers Web universal resource locators (URLS) Internet protocol (IP) address numbers Biometric identifiers, including finger and voice prints Full face photographic images and any comparable images Any other unique identifying number, characteristic or code, other than dummy identifiers that are not derived from actual identifiers and for which the re-identification key is maintained by the health care provider and not disclosed to the researcher If yes or any item checked, with whom will Protected Health Information be shared during the course of the research? Coordinating Center Statisticians Consultants Other researchers Registries Sponsors (listed above) Labs Journals Other: 5. How will confidentiality be protected? (Must be answered in detail.) 6. How will data be protected? (Data should be stored behind at least two of the following safeguards. Please check all that apply). For electronic data: Secure network Password access Other: For hardcopy data: Data de-identified by research team (stripped of 18 identifiers listed above) Locked suite Locked office Locked file cabinet Data coded by research team with a master list secured and kept separately Other: 7. Describe your plan to destroy identifiers. 8. When will identifiers be destroyed? 9. To justify a waiver of the requirement to seek informed consent and/or HIPAA authorization from the subjects, you must be able to answer YES to items (a)-(f) below. Insert explanations that support your request for waiver. IRB Form HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 2 of 6

3 a) Will the research involve no greater than minimal risk to subjects or Yes No to their privacy? (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.) b) Is it true that the waiver will not adversely affect the rights and welfare Yes No of subjects? (Consider the right of privacy and possible risk of breach of confidentiality in light of the information you wish to gather.) c) Is the risk to privacy reasonable in relation to benefits to be gained or the Yes No importance of the knowledge to be gained? d) Would the research be impracticable without the waiver? Yes No (If you checked yes, explain how the requirement to obtain consent would make the research impracticable, e.g. are most of the subjects lost to follow-up or deceased?). e) Would the research be impracticable if you could not record protected health Yes No Information (PHI)? (If you checked yes, explain how not recording PHI would make the research impracticable). f) When appropriate, do you have plans to provide subjects with pertinent Yes No information after their participation is over? (e.g. Will you provide details withheld during consent, or tell them if you found information with direct clinical relevance for the subjects? This may be an uncommon scenario) STATEMENT OF PRINCIPAL INVESTIGATOR: I certify that the above information is correct, that it will apply throughout the performance of the proposed research, and that I will be responsible for safeguarding the confidentiality of the human subjects who are involved. I am aware of the confidential nature of the information obtained for the purposes of this research. No protected health information (PHI) from this research will be shared with or disclosed to others, for purposes other than conducting the research as described above. I will vouch for any person other than myself who will work with this information under my direction. The names of these persons are: I agree to a continuing exchange of information with the IRB. I agree to obtain IRB approval before making any changes or additions to the project. I will provide progress reports at least annually, unless this application is determined by the IRB to be exempt from continuing review. Signature of Principal Investigator Date Signature of Faculty Advisor, if Principal Investigator is Student Date For specimens: Signature of Director of Laboratory where Specimens are Stored Date IRB Form HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 3 of 6

4 Peer Review Statement (Please note that this section may not apply. For groups using peer review please complete EITHER Part A OR Part B.) Part A. For projects originating locally, a group of peers of the Principal Investigator and associate investigators must be assembled to review the project. To avoid any real or perceived conflict of interest, principal and associate investigators should abstain from protocol approval by the peer group should they be members. Name of Peer Group: Name of Chair: Date of review: (Chair of peer review committee should complete this portion of the form.) This research proposal has been reviewed and approved by our committee as to scientific merit, research design and methodology, and applicability to local practice. Check appropriate statement: In our judgment the project does not put subjects or patients at risk, and does not involve any significant In our judgment the project does involve a degree of risk, but we judge that the potential benefits outweigh the risks. Hence, there may be significant issues of human rights to be considered, and we request a full review by the IRB. We are unable to judge if the project presents risks and issues relating to human rights sufficient to warrant a full review, and we request that this judgment be made by others. Signature: Chair of peer review group Date: IRB Form HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 4 of 6

5 Part B. For multicenter and cooperative research projects with other institutions and research organizations (e.g., national oncology and cardiology studies) which have received scientific review and approval by the NIH, NCI, or FDA; or in the case of academically-based peer review groups (UNC-Chapel Hill School of Medicine; UNCG School of Nursing), the PI should complete this section of the form: Organization that reviewed and approved the project: Date of review (if available): Section VI: Administrative Advance Approval of Proposed Research If the research is to be carried out in a division, department or unit of Cone Health, (e.g., Pharmacy Division; Emergency Department; Nursing Unit) the unit manager must be consulted in advance. Approval to pursue the project must be obtained so as to assure that there are no conflicts in the use of human or financial resources of the unit. Unit where project is to be carried out: Unit Manager: Name: Title: Manager s statement: I have reviewed this research project with the principal investigator and I assent to the project s implementation in this unit. Signature: Unit Manager Date: Conflict of Interest Do any of the Key Personnel involved in conducting this study have a Conflict of Interest related to the study? (These are not limited to financial conflicts of interest) No Yes If so, has a Conflict of Interest Management Plan been developed? No Please include a copy of the plan with the application. Yes IRB FORM HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 5 of 6

6 For IRB completion and return to Principal Investigator: Action taken: Exempt from IRB Review Expedited Review Full Board Review Signature of IRB Chair: Date: / / IRB Form HIPAA-02 Waiver of Consent and HIPAA (Version 4, Revised 07/2016) Page 6 of 6