Geisinger IRB Member Orientation Session 2. Debra L. Henninger, MHS RN CCRC Associate Director, Research Compliance
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1 Geisinger IRB Member Orientation Session 2 Debra L. Henninger, MHS RN CCRC Associate Director, Research Compliance 1
2 How does the IRB make decisions? Guiding Ethical Principles Regulatory Considerations Geisinger Policies 2
3 How does the IRB make decisions? Guiding Ethical Principles Regulatory Considerations Geisinger Policies 3
4 The Common Rule 1991 National Research Act + National Commission, 1974 Author: F. Daniel Davis, PhD,
5 5
6 Belmont Principles & Applications RESPECT FOR PERSONS Treat individuals as autonomous agents + protect those with diminished autonomy BENEFICENCE Maximize benefits; minimize risks of harm JUSTICE Distribute benefits and burdens of research fairly Obtain voluntary informed consent Systematically analyze risks and benefits; minimize risks Select subjects fairly; distribute benefits and burdens of research fairly Author: F. Daniel Davis, PhD, 2016
7 How does the IRB make decisions? Guiding Ethical Principles Regulatory Considerations Geisinger Policies 7
8 The Common Rule 1991 BELMONT PRINCIPLES Respect for persons Beneficence Justice APPLICATIONS Informed consent Information Comprehension Voluntariness Risk-benefit assessment Selection of subjects COMMON RULE (HHS) 45 CFR : informed consent requirements : informed consent documentation (a)(1): risks are minimized (a)(2): risks are reasonable in relationship to benefits (a)(6): safety monitoring (a)(7): privacy & confidentiality 46/111(a)(3): equitable selection of subjects (b): additional safeguards for vulnerable populations
9 9
10 Risks to participants are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result 10
11 Risks to subjects are minimized By using procedures consistent with sound research design that do not unnecessarily expose participants to risk already being performed on the participants for diagnostic or treatment purposes, when appropriate 11
12 Risks to subjects are minimized Research proposal Addresses likelihood of harm and magnitude of harm Potential physical, psychological, social and/or economic risks to participants Research is likely to achieve its proposed aims The importance of the knowledge expected to result is clear 12
13 Risks to subjects are minimized Any potential conflicts of interest are minimized or managed Management plan (disclosure in consent; limits who can obtain consent, etc.) Credentials and/or qualifications of investigators and research staff are appropriate to perform their responsibilities in the study The research setting supports adequate safeguards for protection of participants Location of research Facilities Drug/device controls & accounting 13
14 Selection of subjects is equitable, taking into account Purposes of the research Setting in which the research will take place Recruitment methods & participant payments Inclusion/exclusion criteria Special problems of research involving vulnerable populations pregnant women prisoners 14
15 Informed consent will be sought from each prospective participant or his/her legally authorized representative (LAR) Adequate plans for seeking informed consent Proposed consent process Provides participants/ participant s LAR with sufficient opportunity to consider whether to participate Adequate information Adequate time Minimizes possibility of coercion or undue influence Information relayed during consent process Is understandable - language, comprehension Does not include exculpatory language that appears to: Waive any of participant s legal rights Release the investigator, sponsor, institution from liability or negligence 15
16 Informed consent will be sought from each prospective participant or his/her legally authorized representative (LAR) Comprehension consent assent parental permission waiver 16
17 Informed consent will be appropriately documented in accordance with, and electronic waiver of documentation of consent written verbal 17
18 Study includes plan for monitoring data to ensure participant safety When study is greater than minimal risk When NIH-funded clinical research When FDA-regulated clinical trial 18
19 Study includes plan for monitoring data to ensure participant safety Consider: Is plan appropriate for nature, size, complexity of research and degree of risk? Include plan for promptly detecting harm & mitigating potential injuries? What safety information is collected? How collect? How often? What data will be monitored & who will monitor? What is frequency of review or analysis of cumulative safety data to determine whether harm is occurring? Are there procedures for ensuring appropriate reporting of findings to IRB? Are there any conditions/criteria that could trigger immediate suspension/termination of research & procedures for reporting same? Is establishment of independent data safety monitoring board (DSMB) warranted? If so, is there a plan for providing DSMB reports to IRB? 19
20 Study includes adequate provisions to protect privacy of participants How are potential participants identified & contacted? Where is consent obtained? Where do study activities take place? maintain confidentiality of data Data elements? Data sources? Who obtains data? How? Where & how is data stored? When & how destroyed? How is data transported? Is data disclosed outside of Geisinger? Is data transferred and stored securely? Encryption? 20
21 Where any of the participants are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect participants students prisoners pregnant women 21
22 22
23 HIPAA Privacy Rule Geisinger is a covered entity 23
24 HIPAA Identifiers Name Street address, city, county, precinct, zipcode Dates Telephone Number Fax Number Electronic mail address Account Numbers Certificate/license numbers Vehicle identifiers and serial numbers Device identifiers and serial numbes Web addresses (URL) Internet addresses (IP) Social Security Number Biometric identifiers including fingerprints and voiceprints Medical record number Full face photographic images and comparable images Health plan identification numbers Any other unique identifying number, characteristic or code 24 24
25 Use vs. Disclosure of PHI Use: accessing, using, or sharing of PHI within Geisinger Disclosure: the sharing of PHI outside of Geisinger (i.e., with another institution or even with Geisinger Health Plan) 25
26 HIPAA Regulations Outside of treatment, payment and healthcare operations (TPO), the permitted use and disclosure of PHI requires: PHI Personal Health Information Use Disclosure Authorization Accounting for Disclosure Waiver of authorization De-identified Review Preparatory to Research Decedent Research
27 How does the IRB make decisions? Guiding Ethical Principles Regulatory Considerations Geisinger Policies 27
28 Institutional Requirements for IRB submissions Research Education requirements Research Financial Conflict of Interest requirements Principal Investigator requirements MCA & Billing Determination Investigational Pharmacy Radiation Safety Committee Institutional Biosafety Committee Information Security Office (ISO) Clinic/Provider/External Institution Approval for Recruitment Psychiatry Review for use of mental health data with identifers Nurse Research Council (nurse researchers) MyCode Governing Board (use of MyCode data/samples) Geisinger Health Plan Proposal (use of GHP data) 28
29 Objectives Human Research Protection Program & IRB Resources 29
30 HRPP Webpage 30
31 Geisinger Research Process Flow 31
32 Geisinger IRB Information NAME: Geisinger Institutional Review Board IRB REGISTRATION #: INSTITUTION: FWA ASSURANCE: ACCREDITATION: ADDRESS: Geisinger Clinic FWA Geisinger Health System is accredited by the Association for the Accreditation of Human Protection Programs, Inc. (AAHRPP) Geisinger Institutional Review Board 100 North Academy Avenue Danville, PA TELEPHONE: or
33 Contacts Barb Kent, Administrative Assistant - (570) (bkent@geisinger.edu) Chuck Brightbill, MS, IRB Specialist (cebright@geisinger.edu) Gissel Martinez, BS, IRB Specialist (gnmartinez@geisinger.edu) Rosa Sober, BS, CIP, IRB Manager (rmsober@geisinger.edu) Jeanie Wesner CCRC CHRC, IRB Project Manager (jwesner@geisinger.edu) Deb Henninger, MHSA RN CCRC, Associate Director (dhenninger@geisinger.edu) Les Kirchner, PhD, IRB Chair hlkirchner@geisinger.edu Tom Challman, MD, IRB Chair tdchallman@geisinger.edu 33
34 QUESTIONS?? 34
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