Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Presented by: C. Karen Jeans, MSN, CCRN, CIP COACH Program Analyst,

Slides:

Advertisements

Similar presentations

The Role of the IRB An Institutional Review Board (IRB) is a review committee established to help protect the rights and welfare of human research subjects.

Advertisements

Informed consent requirements

UTHSC IRB Donna Hollaway, RN, CCRC 11/30/2011 Authority to Audit 45 CFR (e) An IRB shall conduct continuing review of research covered by this.

Sherry Davis, Manager Pacific Northwest National Laboratory Human Research Protection Program AAHRPP As A Self-Assessment Tool May, 2008.

IRB Review Mechanics: Looking under the hood IRB Administrators 2012 PRIDE Lucindia Shouse, MS, CIP May 31, 2012.

IRB Determinations 1. AAHRPP Site Visit Results Site visitors observed a real commitment to human subject protections Investigator and research staff.

1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the.

Recently Issued OHRP Documents: Guidance on Subject Withdrawal and Draft Revised FWA Secretary’s Advisory Committee on Human Research Protections October.

VHA Handbook K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 201 March 24, 2011.

Human Subjects Protection: Creation and Maintenance of an IRB Regulatory Requirements & Recommendations 45 CFR part 46 Freda E. Yoder Office for Human.

Pharmacists Responsibilities in Clinical Studies Mike R Sather, PhD Crystal L Harris, PharmD February 26, 2004.

IRB 101: Introduction to Human Subject Research

IRB 101: Informed Consent Columbia University Medical Center IRB September 22, 2005.

Columbia University IRB IRB 101 September 21, 2005 George Gasparis, Executive Director, CU IRB Asst. V.P. and Sr. Asst. Dean for Research Ethics.

CUMC IRB Investigator Meeting Special IND/IDE Considerations: Emergency Use of Investigational Product Compassionate Use & Emergency Research July 21,

CUMC IRB Investigator Meeting November 9, 2004 Research Use of Stored Data and Tissues.

IRB Basics Helen Panageas New York University School of Medicine Institutional Review Board Portion of slides courtesy of Suzanne M. Smith, University.

Research Methods for the Social Sciences: Ethics Ryan J. Martin, Ph.D. Thomas N. Cummings Research Fellow March 9, 2010.

Is this Research? Exempt? Expedited?

Continuing Review VA Requirements Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst Program for Research Integrity Development and Education (PRIDE)

Federalwide Assurance Presentation for IRB Members.

Cornell Evaluation Network The Use of Human Participants in Research Office of Research Integrity and Assurance ~ May 14, 2007.

Avoiding the Pitfalls of an IRB Submission Chris Ayres Chair, Institutional Review Board Social & Behavioral Science & Chair, Department of Kinesiology,

International Research & Research Involving Children K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development.

Adverse Events and Unanticipated Problems Presented by: Karen Jeans, PhD, CCRN, CIP COACH Program Analyst.

Human Research Protection Program Institutional Review Board Requirements and Expectations of Researchers and Research Staff Moira A Keane, MA, CIP Executive.

ORO Reviews: Frequent Findings Related to IRBs Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight.

Copyright © 2009 AAHRPP ® All rights reserved Update on AAHRPP – Revised Standards and Procedures Marjorie A. Speers, Ph.D. President and CEO.

What you need to know about the Saint Leo IRB review process.

Institutional Review Board (IRB) Human Subject Dr. John N. Austin, Director and Ms. Renee S. Jones, Associate Director Delaware State University Office.

Office of Research Oversight ORO Reporting Adverse Events in Research to ORO Paula Squire Waterman, MS, CIP Department of Veterans Affairs Office of Research.

Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Tough Love: Understanding the Purpose and Processes of Quality Assurance.

University of Miami Office of Research Compliance Assessment Lynn E. Smith, JD, CIM, CIP Johanna Stamates, RN, BA, CCRC With assistance from Elizabeth.

ORO Reviews: Frequent Findings Bob Brooks Associate Director Research Compliance Education and Policy VHA Office of Research Oversight May, 2012.

RESPONSIBLE CONDUCT IN HUMAN SUBJECTS RESEARCH MARGARITA M. CARDONA DIRECTOR OF SPONSORED RESEARCH Institutional Review Board.

VA Central IRB Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator HRPP 101, September 2010.

IRB BASICS: Issues in Ethics and Human Subject Protections Prepared by Ed Merrill Department of Psychology November 12, 2009.

UC DAVIS OFFICE OF RESEARCH Overview of Good Clinical Practices (GCP) Investigator and Study Team Responsibilities Miles McFann IRB Administration Training.

Marian University is sponsored by the Sisters of St. Francis, Oldenburg. Human Subjects Research and the Marian University Institutional Review Board (IRB)

Human Research Protection Program & IRB Responsibilities Marisue Cody, PhD Director Center on Advice & Compliance Help.

VHA Handbook What’s new. General Requirements for Informed Consent A Legally Authorized Representative may not always qualify as a ‘personal representative’

Institutional Review Board Issues for Classroom Research Sharon McWhorter IRB Administrator, The University of Akron (With assistance from Phil Allen,

Is IRB Review or an OHSRP Determination Required?.

Welcome New IRB Members! Today we will discuss: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.

Guidance Training CFR §483.75(i) F501 Medical Director.

Continuing Review Presented by: Karen Jeans, PhD, CCRN, CIP Program Analyst, COACH.

VA Central IRB Annette R. Anderson, MS, RHIA, CIP VA Central IRB Administrator Local Accountability Meeting June 2011.

AAHRPP ACCREDITATION (Association for the Accreditation of Human Protection Programs)

What Institutional Researchers Should Know about the IRB Susan Thompson Senior Research Analyst Office of Institutional Research Presented at the Texas.

Investigational Devices and Humanitarian Use Devices June 2007.

Case Studies: Puzzles in Human Research Kevin L. Nellis, M.S., M.T. (A.S.C.P.) Program Analyst, Program for Research Integrity Development and Education.

HRPP Policies & Forms Chapter Two Created/Revised for AAHRPP June 1, 2007.

1 Auditing and Monitoring Gerald Beccia/RCO VA CT Healthcare System.

Welcome New IRB Member! This brief presentation covers: Your Role in the IRB: What to Know The IRB Review Process Resources Human Research Protections.

VA HRPP Accreditation October 18, 2011 Accreditation Conference Call PRIDE/Soundia Duche, MA, MS.

INVESTIGATOR RESPONSIBILITIES C. Karen Jeans, MSN COACH Project Analyst.

Legal Responsibilities for Studies Conducted or Supported by HHS Michael A. Carome, M.D. Associate Director for Regulatory Affairs Office for Human Research.

Marianne M. Elliott Office of Research Integrity and Ethics Bureau of Medicine and Surgery U. S Navy.

Informed Consent Presented by Marian Serge, RN. Goals Informed consent process and form Title 38 CFR , Common Rule required elements and additional.

Quality Metrics of Performance of Research Ethics Committees Cristina E. Torres, PhD FERCAP Coordinator.

IRB Minutes Karen Jeans, MSN, CCRN, CIP COACH Program Analyst.

Slide 1 Standard Operating Procedures. Slide 2 Goal To review the standard operating procedures Creating the informed consent document Obtaining informed.

HRPP METRICS Cynthia Monahan, MBA, CIP IRB Director Boston University Charles River Campus IRB.

Conditional IRB Approval

IRB reporting updates.

Beverley Alberola, CIP Associate Director, Research Protections

Reportable Events & Other IRB Updates February 2017

Jeffrey M. Cohen, Ph.D. CIP President HRP Associates, Inc.

How I Would Revise the Human Subject Regulations Tom Puglisi Medical Research Summit 2004 Plenary Session, Day 2, 4:45 PwC.

Office of Research Integrity and Protections

Presentation transcript:

Questions: AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Presented by: C. Karen Jeans, MSN, CCRN, CIP COACH Program Analyst, PRIDE

2 DISCLAIMER The information presented in this webinar and in these slides does not represent formal positions of AAHRPP. Each of the issues addressed were queried to AAHRPP and this presentation represents responses to those issues.

3 Topics for Today Brief Summary of Revised AAHRPP Standards and Evaluation Instrument Specific Questions and Answers on Selected Issues: Domain I Domain II

4 Summary of Revised AAHRPP Standards for Accreditation Released October 1, 2009 Only 3 Domains 15 Standards and 60 Elements

5 Summary of AAHRPP Evaluation Instrument for Use with Final Revised Accreditation Standards Released October 1, 2009 Revised 2 times with most recent revision on November 13, 2009 Pending revision 114 Pages in Length Not VA Specific

6 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states that the organization “should” define a systematic investigation and generalizable knowledge. Is “should” a “must”?

7 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states that the organization “should” define a systematic investigation and generalizable knowledge. Is “should” a “must”? Answer: No.

8 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states to provide guidance concerning activities which can or cannot be human research depending upon the intent, such as quality improvement. How specific does AAHRPP want it to be?

9 Specific Questions and Answers – Domain I: Organization Element I.1.A The Element states to provide guidance concerning activities which can or cannot be human research depending upon the intent, such as quality improvement. How specific does AAHRPP want it to be? Answer: AAHRPP does not expect detailed specific guidance. One of the key issue is whether the activities are conducted with research intent.

10 Specific Questions and Answers – Domain I: Organization Element I.1.D The Element requires policies and procedures to describe the ethical obligations and expectations of employees and students, yet it also addresses the requirement to describe the obligations and expectations of researchers and research staff, including students involved in the conduct of research. Is there a redundancy?

11 Specific Questions and Answers – Domain I: Organization Element I.1.D The Element requires policies and procedures to describe the ethical obligations and expectations of employees and students, yet it also addresses the requirement to describe the obligations and expectations of researchers and research staff, including students involved in the conduct of research. Is there a redundancy? Answer: There is a level of redundancy with a caveat.

12 Specific Questions and Answers – Domain I: Organization Element I.1.E The Element requires policies and procedures for actions the IRB takes if training requirements are not fulfilled. Will AAHRPP accept a general statement such as, “If training requirements are not fulfilled by the date required for renewal, the IRB will determine actions to be taken, which will include notification of the RCO and ACOS/R&D”?

13 Specific Questions and Answers – Domain I: Organization Element I.1.E The Element requires policies and procedures for actions the IRB takes if training requirements are not fulfilled. Will AAHRPP accept a general statement such as, “If training requirements are not fulfilled by the date required for renewal, the IRB will determine actions to be taken, which will include notification of the RCO and ACOS/R&D”? Answer: No.

14 Specific Questions and Answers – Domain I: Organization Element I.1.F How is AAHRPP defining “scientific review”?

15 Specific Questions and Answers – Domain I: Organization Element I.1.F How is AAHRPP defining “scientific review”? Answer: AAHRPP is defining scientific review as it applies to the IRB approval criteria in 38 CFR (a) (1-2) for purposes of evaluation of this Element. This is not referencing a scientific peer review process as used in merit reviews.

16 Specific Questions and Answers – Domain I: Organization Element I.1.G What does AAHRPP mean when they state that policies and procedures describe the application of laws relevant to research involving humans as participants, when the research is conducted: * In the jurisdiction where the Organization resides * Outside the jurisdiction where the Organization resides?

17 Specific Questions and Answers – Domain I: Organization Element I.1.G – Application of State Laws Answer: Where the subject is participating in the research is how applicable state laws are applied. It is not expected nor required that your HRPP SOPs state applicable state laws for all the states and U.S. territories.

18 Specific Questions and Answers – Domain I: Organization Standard I-2 For organizations using the VA Central IRB or the IRB of an academic affiliate seeking its own AAHRPP accreditation, is AAHRPP expecting the Organization to conduct a secondary evaluation to ensure that it meets AAHRPP accreditation standards?

19 Specific Questions and Answers – Domain I: Organization Standard I-2 For organizations using the VA Central IRB or the IRB of an academic affiliate seeking its own AAHRPP accreditation, is AAHRPP expecting the Organization to conduct a secondary evaluation to ensure that it meets AAHRPP accreditation standards? Answer: Not in the literal sense. AAHRPP is expecting your HRPP to include evaluation of that service or component outside of the organization as part of the evaluation of your HRPP.

20 Specific Questions and Answers – Domain I: Organization Element I.4.C How is AAHRPP going to evaluate this element which addresses community-based participatory research designs in the absence of regulatory and guidance references?

21 Specific Questions and Answers – Domain I: Organization Element I.4.C How is AAHRPP going to evaluate this element which addresses community-based participatory research designs in the absence of regulatory and guidance references? Answer: This is an exploratory element.

22 Specific Questions and Answers – Domain I: Organization Element I.5.A This element requires the organization to state the goals of the quality improvement plan with respect to achieving and maintaining compliance. How specific should these goals be stated?

23 Specific Questions and Answers – Domain I: Organization Element I.5.A – Goals of Quality Improvement Plan Answer: State at least one goal, such as “100% of all signatures required by VHA requirements will be present on IRB-approved informed consent forms” “No more than 10% of all active IRB-approved research studies will have lapses of IRB approval.”

24 Specific Questions and Answers – Domain I: Organization Element I.5.B This element requires the organization to state the goals of the quality improvement plan with respect to achieving targeted levels of quality, efficiency, and effectiveness of the HRPP. Does AAHRPP require specific differentiation between measures of quality, efficiency, and effectiveness?

25 Specific Questions and Answers – Domain I: Organization Element I.5.B This element requires the organization to state the goals of the quality improvement plan with respect to achieving targeted levels of quality, efficiency, and effectiveness of the HRPP. Does AAHRPP require specific differentiation between measures of quality, efficiency, and effectiveness? Answer: No

26 Specific Questions and Answers – Domain I: Organization Element I.6.A This element addresses institutional conflict of interest issues. How does the evaluation of this element differ with this evaluation instrument compared to the 2007 evaluation instrument?

27 Specific Questions and Answers – Domain I: Organization Element I.6.A This element addresses institutional conflict of interest issues. How does the evaluation of this element differ with this evaluation instrument compared to the 2007 evaluation instrument? Answer: It does not. Use Guidance Document on PRIDE SharePoint Site.

28 Specific Questions and Answers – Domain I: Organization Element I.6.B This element addresses individual financial conflict of interest issues. How is the evaluation of this element differing with this evaluation instrument compared to the 2007 evaluation instrument?

29 Specific Questions and Answers – Domain I: Organization Element I.6.B This element addresses individual financial conflict of interest issues. How is the evaluation of this element differing with this evaluation instrument compared to the 2007 evaluation instrument? Answer: It does not.

30 Specific Questions and Answers – Domain I: Organization Element I.7.C This element states that policies and procedures consider emergency use of a test article to be a clinical investigation and under FDA regulations, that the patient is a participant, and that the FDA may require data from an emergency use to be reported in a marketing application. Is this an accurate statement?

31 Specific Questions and Answers – Domain I: Organization Element I.7.C Answer: FDA may require data to be reported regardless of whether it is part of a marketing application.

32 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.1.C This element requires the organization to have and follow written policies and procedures to separate competing business interests from ethics review functions. How does AAHRPP define business interests?

33 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.1.C This element requires the organization to have and follow written policies and procedures to separate competing business interests from ethics review functions. How does AAHRPP define business interests? Answer: AAHRPP is primarily referencing those individuals in the private sector (for-profit institutions) whose have interests to promote the business.

34 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to describe the development of the agenda. Does AAHRPP require policies and procedures to place limits on the number of agenda items for a convened IRB meeting?

35 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to describe the development of the agenda. Does AAHRPP require policies and procedures to place limits on the number of agenda items for a convened IRB meeting? Answer: No. There is no requirement to place numerical limits on agenda items within an HRPP policy and procedure.

36 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C This element requires policies and procedures to indicate that at least one unaffiliated member is present at convened meetings. Does AAHRPP require an unaffiliated member to be present during convened IRB meetings as part of quorum requirements?

37 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.C – Unaffiliated Member Answer: There are three possible ways to address this within policies and procedures: (a) Percentage rule: Members must be present at least (range) in convened IRB meetings to remain on the IRB (b) Passive Evaluation: As part of the HRPP evaluation, the attendance of the members is evaluated (c) Quorum requirement

38 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.E Does AAHRPP require organizations to have policies and procedures listing specific types of modifications considered to be “minor”?

39 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.E – Defining minor modifications Answer: No. They are expecting general guidance for IRB members to use, such as the following for protocols requiring review by the convened IRB: “Modifications are not minor if they represent substantial clarifications or modifications needed by the IRB in order to make determinations regarding the IRB approval criteria.” “ Modifications that require more than minimal evaluation (more than simple concurrence) are not minor and must be reviewed by the convened IRB.”

40 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.G Does AAHRPP consider an “enrolled” participant to be a participant in whom informed consent has been obtained?

41 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.2.G Does AAHRPP consider an “enrolled” participant to be a participant in whom informed consent has been obtained? Answer: Yes

42 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.C This element requires organizations to have policies and procedures to include information that prospective participants need to determine their eligibility and interest, such as a summary of the criteria that will be used to determine eligibility in the study. Is AAHRPP stating that all criteria must be in advertisements?

43 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.C Is AAHRPP stating that all criteria must be in advertisements? Answer: No. The information that will be included in advertisements will depend upon what the IRB determines is appropriate.

44 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element requires organizations to have applications that include a description of the consent process, including the person who will provide consent or permission. Is AAHRPP requiring names of the individual obtaining consent to be placed in applications?

45 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element requires organizations to have applications that include a description of the consent process, including the person who will provide consent or permission. Is AAHRPP requiring names of the individual obtaining consent to be placed in applications? Answer: No.

46 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F This element states that the VA requires the long-form of consent documentation to include a statement that in the event of a research-related injury the VA has to provide necessary medical treatment to a subject injured by participation. Is this in conflict with VHA Handbook requirements?

47 Specific Questions and Answers – Domain II: Institutional Review Board or Ethics Committee Element II.3.F – Statement Regarding Compensation and Treatment for Research-Related Injuries Is this in conflict with VHA Handbook requirements? Answer: VHA Handbook only requires this statement to be included for research involving more than minimal risk.

48 Summary This is an evolving evaluation instrument.

49 Questions