Elyse I. Summers, J.D. President and CEO. Copyright 2018 AAHRPP All rights reserved.

Transcription

1 Overcoming Challenges Faced by International IRBs Sharing of Best Practices Among IRBs: Breakout 6 Inaugural Singapore Research Ethics Conference March 1-2, 2018 Singapore Elyse I. Summers, J.D. President and CEO Copyright 2018 AAHRPP All rights reserved.

2 Outline Background -- what is AAHRPP? Overcoming challenges: -- Build an HRPP -- Embrace flexibility -- Protect participants Questions

3 What is the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)? Nonprofit NGO Offers accreditation to organizations that conduct, review, or manage research involving human participants Seeks to identify quality programs; promote innovative practices; and, ensure regulatory compliance

4 AAHRPP Global non-profit organization founded in 2001 Contract research organizations, hospitals, independent ECs/IRBs, research institutes, sponsors, universities and government agencies (e.g., NIH, NCI, VA, State Departments of Health) Small (fewer than 20 protocols) and large (greater than 6,000 protocols) institutions Clinical and non-clinical research programs The world s premier research organization (NIH) The world s largest research-based pharmaceutical company (Pfizer) 8

5 AAHRPP-Accredited organizations As of December 2017, almost 250 organizations representing over 600 entities Truly global AAHRPP-accredited organizations in Belgium, Brazil, Canada, China, India, Korea, Mexico, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United States 9

6 Why This Is Important 6

7 Moving Toward a Global Standard Globalization of clinical research Encourage trust and collaboration among research partners Sponsors seek to reduce compliance risk and increase data quality Building a strong infrastructure to protect research participants based on agreed upon standards promotes public trust and enhances the research enterprise as a whole 17

8 Overcoming Challenges Build an HRPP - One Model: AAHRPP Accreditation AAHRPP Accreditation = Logical, robust, and elegant manifestation of an organization s commitment to and ownership of the responsibility to protect the volunteers who make the human research enterprise possible Establishes and demonstrates a worldwide standard against which to gauge the quality of a human research protection program 8

9 The focus of AAHRPP accreditation Organization } REB or IRB Researchers and Research staff Human Research Protection Program Protecting research participants is a shared responsibility 10

10 Human Research Protection Program Researcher and Research Staff Education Programs Conflict of Interest Compliance Oversight Organizational Plan Pharmacy Services Communications System IRB or REB Contracts and Grants 11

11 AAHRPP Accreditation standards Relevant Country laws, codes and guidelines Based on ICH-GCP Guideline (E6) If organization conducts research under U.S. federal regulations for conducting human research: U.S. Department of Health and Human Services (45 CFR part 46); U.S. Food and Drug Administration (21 CFR parts 50, 56) 12

12 Overcoming Challenges Embrace Flexibility: AAHRPP Accreditation Standards AAHRPP process is outcomes-based approach many possible avenues to achieve shared goal: Protection of the health and welfare of research volunteers, whose participation makes the whole enterprise possible. 14

13 Overcoming Challenges Embrace Flexibility: Examples What laws does AAHRPP require we follow? How to implement quality improvement? Do we have to reporting to US agencies? What is community-based research? What are organizational conflicts of interest? What regulations does AAHRPP require we follow for drugs and devices? 13

14 Challenge: What laws do we have to follow? US regulations? Standard I-1 Define which rules apply AAHRPP accredits to country law and funding agency requirements If no US DHHS funding (NIH), then no need to follow US regulations ICH-GCP (E6) comprehensive protections for vulnerable populations, including adults unable to consent (more extensive than US regulations) If follow ICH-GCP (E6) or country-specific GCP meets US FDA requirements Define ethical standards Declaration of Helsinki or Singapore Medical Council Ethical Code and Ethical Guidelines; alternately Belmont Report

15 Challenge: What is community-based research? Standard I-4 May not apply, if organization does not conduct this type of research Community-based research: Community members involved in design, recruitment, evaluation of results More common in public health, social science Unusual in clinical studies of new drugs and devices Organization can provide education about research, how to get involved (website, handouts, education events), when appropriate

16 Challenge: Implementing Quality Improvement Programs Standard I-5 Quality Improvement Define a goal, define a measure, review periodically Start with just one goal learn how the process works Examples quality, efficiency, effectiveness (I.5.A.): 80% of studies will be approved (submission to approval) within 2 months 50% of minimal risk studies use waivers of signed consent and provide an information sheet instead of using a signature (example of greater flexibility, reduced burden) Examples quality of the compliance program (I.5.B.): 100% of minutes document the IRB s or EC s protocol-specific determinations that the study includes additional protections when research involves vulnerable participants (children, pregnant women, prisoners, adults unable to consent), when applicable 100% of minutes differentiate between substantive and minor changes Substantive changes return to the convened IRB, information needed to determine if criteria for approval are met

17 Challenge: Reporting requirements? Implementing Standard I.5.D. review of non-compliance Report to Singapore regulatory agencies as required Generally do not need to report to US FDA When research is not funded by a US DHHS-agency (NIH) Do not need to report non-compliance to US regulatory agencies Also, do not need to report unanticipated problems involving risks to participants or others to US regulatory agencies (See Element II.2.G.)

18 Challenge: Organizational Conflicts of Interest Standard I-6 Conflicts of Interest Does organization: Own patents or other intellectual property related to research? Own start up companies to commercialize research? Conduct investigator-initiated research involving new drugs / devices developed by a researcher at the organization? If not, then organizational conflict of interest may be limited to interests of leadership Address investments of senior leadership (e.g., President s investment in specific drug company general funds or mutual funds do not involve conflicts) Potential conflicts do not necessarily have to be reviewed by the IRB or EC

19 Challenge: AAHRPP s requirements for drugs / devices Standard I-7 Oversight of Drugs and Devices Approval is required from the relevant authority in the jurisdiction This means Singapore regulatory authorities Not US FDA Policies should describe approval process for Singapore regulatory agencies An IND or IDE from the US FDA is not required

20 Summary Keys to Overcoming Challenges Promote the development of an HRPP through an Organization-wide commitment to quality in which everyone understands his or her role in the endeavor and its importance Embrace flexibility wherever possible All of which leads to: protecting human research participants the ultimate goal 20

21 Contact AAHRPP Elyse I. Summers, J.D. President and CEO Michelle Feige, MSW, LCSW-C Executive Vice President Harry Frazier Controller Robert Hood, Ph.D. Director of Accreditation Rob Withrow Director of Operations 19

22 Thank You! Questions? 22