Regulatory Knowledge Self-Assessment May 15, 2017 WSU IRB Member Retreat

Question #1 A waiver of the requirement for obtaining documentation of informed consent means you do not need to tell a subject (s)he is participating in a research study. True or False?

Answer #1 False. Waiver of the requirement for obtaining documentation of informed consent means the subject does not put in writing/document his/her agreement to participate in the study. The subject is still informed about the study and given the opportunity to decide whether to participate (e.g., mail survey, telephone survey). Waiver of the requirement for obtaining informed consent means the subject is not informed about his/her participation in the research (e.g., deception research, medical record review).

Question #2 Studies involving a level of risk no greater than that encountered in the daily lives of those in the general population (i.e. healthy subjects) should be considered minimal risk. True or False?

Answer True. “Minimal risk” means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45 CFR 46.102].

Question #3 You are preparing a proposal for research which involves pregnant women. You remember there is a well-known pregnancy counseling center in town that should be a good resource for recruiting your target subject population. You have scheduled time for in-the-field recruitment, and you think it would be easiest to ask women if they want to participate in your research as they approach the counseling center. But, you take into consideration the women may want to remain anonymous during the identification and initial contact stage, so you develop alternate strategies for recruitment from this facility with that in mind. Are you addressing confidentiality or privacy issues in this part of your proposal?

Answer #3 You are addressing privacy issues in this part of your proposal when developing strategies for recruitment which take into consideration an individual’s desire to control the access of others to themselves. Privacy concerns people, whereas confidentiality concerns data. In developing strategies for the protection of subjects’ privacy, consideration should be given to: The methods used to identify and contact potential participants. The settings in which an individual will be interacting with an investigator. The appropriateness of all personnel present for research activities.

Answer, Cont… The methods used to obtain information about participants and the nature of the requested information. Information that is obtained about individuals other than the “target participants,” and whether such individuals meet the regulatory definition of “human participant” (e.g., a subject provides information about a family member for a survey). Privacy guidelines developed by relevant professional associations and scholarly disciplines (e.g., oral history, anthropology, psychology). How to access the minimum amount of information necessary to complete the study.

Answer, Cont.… Confidentiality refers to the researcher’s agreement with the participant about how the participant’s identifiable private information will be handled, managed, and disseminated. To address confidentiality in a research proposal, you should outline strategies to maintain confidentiality of identifiable data, including controls on storage, handling, and sharing of data.

Question #4 Professor Grain is conducting research on human behavior related to consumption of brand-name health foods in schools. Professor Grain sits on the board for School Vendor Marketing, Inc. and owns $12,000 in stock with them. The company has recently begun investigating new methods for promoting health foods in schools, with the intent of competing with “junk food” brands already in the market. The results of Professor Grain's study, if positive, could have a significant impact on product development within School Vendor Marketing, Inc. Does Professor Grain’s situation meet the definition of significant financial interest that requires reporting to the WSU IRB?

Answer #4 Yes. WSU has established policies, principles, and procedures to ensure that the financial interests of investigators do not compromise the objectivity with which research is designed, conducted, and reported. Investigators are required to complete the IRB’s project-specific disclosure form for each study. Positive disclosures are forwarded to the Director of Research Compliance who together with the Outside Interest Committee determines whether a conflict of interest exists and if so, develops an appropriate management plan. Before approving research, the IRB must ensure that the study application reflects the requirements of the management plan and can require additional protections. .

Question #5 Per federal regulation, the Food and Drug Administration (FDA) and/or the Office for Human Research Protections (OHRP) should be notified when any of the following are directly related to the conduct of federally funded or FDA regulated research protocol, EXCEPT: Any protocol deviation Any unanticipated problem involving risks to subjects or others Any serious or continuing noncompliance with the regulations or requirements of the IRB Any suspension or termination of IRB approval for research due to noncompliance

a. Any protocol deviation Answer #5 a. Any protocol deviation

Question #6 A member or consultant with a conflict of interest cannot vote in any type of review including initial, continuing, modifications, adverse event/unanticipated problem, non-compliance, etc. This requirement applies to studies being reviewed using expedited or Full Review procedures. True or False?

Answer #6 True

Question #7 Which review mechanism does not allow for disapproval of a research protocol? a. Exemption Certification b. Expedited Review c. Full Review

Answer #7 b. Expedited Review

Question #8 Coded health information from MVH medical records that does not contain any identifiers is considered de-identified. True or False?

False – Coded does not equal de-identified Answer #8 False – Coded does not equal de-identified

Question #9 Research involving prisoners can be exempted if it meets the requirements of one or more exemption categories and is minimal risk. True or False?

Answer #9 False, regulations do not permit exemptions for research involving prisoners.

Question #10 Research involving prisoners must always be reviewed at a convened meeting. True or False?

Answer #10 False, research involving prisoners can be expedited, however, OHRP recommends convened review.

Question #11 Dr. Smith wants to conduct a family 10-year genetic study on 5 families with a total of 20 subjects. She will collect medical records data from the medical records at Milwaukee Hospital and remove all identifiers at the end of the study. She says this makes the work exempt under the Privacy Rule since the data will be de-identified. Milwaukee Hospital, the HIPAA Entity, says it must either do the de-identification, or it will provide Dr. Smith the PHI after she provides signed Authorization Forms to access and use the PHI. Who is correct?

Answer #11 The HIPAA Entity must ensure the privacy protection of the PHI, so since Dr. Smith will need to have PHI for this study, she will need a signed Authorization Form from each subject. An IRB Waiver of Authorization probably would not be granted by an IRB because of the small number of subjects, unless, because of other circumstances, obtaining authorization to use the PHI was impracticable.

Question #12 PHI only includes individually identifiable health information that is maintained electronically by Premier or another covered entity. True or False?

Answer #12 False, per the definition…transmitted or maintained in any form or medium, whether electronic, paper or oral.

Question #13 Research sponsors only have access to de-identified data. True or False?

Answer #13 False – Data submitted to sponsors likely has identifiers such as dates and/or is coded. In additional monitors usually have access to medical records.

Question #14 Research data that meets the OHRP definition of not readily identifiable might not be considered “de-identified” under HIPAA. True or False?

Answer #14 True - terms are not equivalent.

Question #15 Coded data set means that identifying information in the data set was replaced with replaced with a number, letter, symbol, or combination thereof (i.e., the code); and a key to decipher the code exists. True or False?

Answer #15 True

Question #16 Research that involves access to and use of PHI, but that is determined to be exempt from IRB review, does not require written authorization. True or False?

Answer #16 False – Authorization required based on use of PHI for research

Question #17 Privacy Boards are responsible for granting waivers of authorization. True or False?

Answer #17 True

Question #18 A researcher’s lack of sufficient funding can be used as a justification that the research cannot be practicably conducted without a waiver of authorization. True or False?

Answer #18 False, funding cannot be used as a justification to waive authorization.

Question #19 If all members of the study team are also members of Premier’s workforce then no waiver of authorization is needed to contact potential participants to recruit them for the study, but written authorization is still required for those same participants to join the study. True or False?

Answer #19 True

Question #20 A Miami Valley physician requests to collect cardiac health status, device type, surgery date and device serial numbers from medical records of 60 of his own patients who have or will have had surgery to implant a cardiac catheter. Involve PHI? Exempt or Expedited?

Answer #20 Yes, meets definition of PHI and can receive expedited review as there will be “prospective” collection of data.

InfoED and Revised Common Rule Implementation May 15, 2017 WSU IRB Member Retreat

InfoED Implementation June 1, 2017 – All New Submissions July 1, 2017 – Continuing Reviews of Ongoing Studies July 1, 2018 – All studies managed via InfoED

InfoED Implementation Studies that will require continuing review after July 1st will either: Be closed by completing current paper form Be transferred into HS Module by investigator completing/attaching: Initial Application Form (Indicate Old HSP or SC## in “Short Title/HIRC#) Continuing Review Form Currently Approved Consent Form (PDF) Consent Form for Approval (DOC) New Local Protocol (DOC) New Project Specific Disclosure Form (PDF) Initial and Last IRB Approval Letter (PDF) Any data collection instruments, surveys, recruitment items, etc.…that will continue to be used for the study (PDF, Excel, DOC)

Revised Common Rule Compliance Date: January 19, 2018. As such, ongoing research studies that were initially approved by an IRB, waived, or determined to be exempt before this date will not be required to comply with the changes in the Final Rule.  However, the Final Rule allows institutions to voluntarily comply with the Final Rule on a study-by-study basis.  The single IRB requirement for cooperative research (discussed above) adopts a separate 3-year compliance date (2020) for this requirement to allow institutions sufficient time to develop institutional policies and procedures to implement this requirement. No harmonization with FDA regulations  No “Box” on Federalwide Assurance

Revised Common Rule Federally-Funded, Not FDA Regulated, and Approved on or After January 19, 2018 Federally-Funded, FDA Regulated, and Approved on or After January 19, 2018 Not Federally-Funded, Not FDA Regulated, and Approved on or After January 19, 2018 Not Federally-Funded, FDA Regulated, and Approved on or After January 19, 2018 Research Approved before January 19, 2018

Revised Common Rule To have IRBs consider the equitable selection of subjects focus on issues related to coercion or undue influence in research with vulnerable populations; Inclusion of special considerations related to the involvement of vulnerable populations; Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.

Revised Common Rule The provision that would authorize an IRB to approve a research proposal in which investigators obtain identifiable private information without individuals’ informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research (but without a requirement that investigators adhere to the NPRM’s proposed privacy safeguards, since they were not included in the Final Rule); and The provision that would require that a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency be posted on a publicly available Federal website that will be established a repository for such consent forms.

Thank You!! Christian LaMantia Research Compliance Counselor Christian@rccounselor.com (440)241-3609