OHRP Virtual Research Community Forum - Northwell Health, Feinstein Institutes of Medical Research, Human Research Protection Program "Embracing Diversity and Innovation in Research" on May 11-12, 2022

Welcome and Opening Remarks

Keynote Address – Improving Health Equity in Clinical Research

According to the FDA’s 2020 Drug Snapshot report, 53 novel drugs were approved that year for trials enrolling over 32,000 patients. Of those, 75% were white, 6% were Asian and 8% were Black or African American. There is growing evidence that, whether for environmental or genetic reasons, drugs may have different effects on different populations. The sample bias of these trials can lead to misleading results for all people. The FDA does not mandate drug companies to enroll a greater diversity of patients, but doing so improves the quality on human subjects research and validity of life-saving research on a range of diseases. This keynote address will discuss the value of designing inclusive trials for diverse (and growing!) patient populations, explore the barriers to attaining diversity in recruitment, provide some examples of how academic medical centers and companies are tackling this problem through innovative and inclusive clinical trial designs, community engagement and education, and discuss how IRBs can offer crucial support to ensure equitable enrollment and retention to clinical trials.

Jonathan Jackson, PhD, Community Access, Recruitment, and Engagement (CARE) Research Center at Massachusetts General Hospital and Harvard Medical School

1 CIP credit will be offered for this session.

Vulnerability, Justice, Equity, and Engagement: A conversation about public health and human subjects research focusing on what works, what doesn't, and how to transition the research enterprise for communities and populations that are not supported properly or included.

The pandemic exposed, again, the engrained issues in public health and human subjects research concerning vulnerability, justice, equity, and engagement of different communities and populations. This session will be a moderated conversation among public health and research leaders who have dedicated their careers to engaging with communities often ignored, marginalized, exploited, or oppressed in society. They will share past experiences of what works, what doesn't, and offer a vision for what a more just public health and research landscape could look like.

Jeremy Block, PhD, MPP, Baruch College
Robert Fullilove, PhD, Columbia University
Carla Boutin-Foster, MD, MS, SUNY Downstate Health Sciences University

1 CIP credit will be offered for this session.

Two-Spirit in Health Research: Collecting, Working with and Handling Data in Culturally Affirming Way(s)

Centering Two-Spirit and Indigenous experiences and ways is critical for more respectful, reciprocal, relevant, and responsible health research. Two-Spirit is often equated to an LGBTQI+ Indigenous participant; thereby, rendering this community’s unique experience and history invisible and erasing important distinctions. When done, this type of scholarship may be a site of colonization. The challenge is how to collect Two-Spirit data that in culturally safe and affirming ways, so health research(ers) are given the opportunity to do rigorous sex- and gender-based analysis that promotes science that considers biological sex and accounts for all genders in an effort to expand our collective understanding(s) within a diversity framework. This presentation examines some decolonizing practices to better formulate health research, policies and programs that are relevant, respectful and mindful to Two-Spirit peoples and communities, so research is reconcilia(c)tion (reconciliation and action).

Harlan Pruden, BC Centre for Disease Control
Travis Salway, PhD, Simon Fraser University

1 CIP credit will be offered for this session.

Including Pregnant Women in Clinical Research

Exclusion of pregnant and lactating women from clinical research without scientific or ethical basis, is an ongoing challenge to society. The pandemic has revealed that these challenges continue – despite having a higher risk of COVID-19 complications, pregnant women were excluded from vaccine trials, leading to mixed messaging from national and international regulators, confusion amongst patients and providers, and costly hesitancy. This session will focus on the price to society and public health of not including pregnant women in COVID-19 vaccine trials (and clinical research status for the PRGLAC recommendations, and what IRBs can do (and need to do differently) to ensure that subject selection is equitable for this population in clinical research.

Maggie Little, PhD, Kennedy Institute of Ethics, Georgetown University

1 CIP credit will be offered for this session.

Break

Promoting Research Representation and Engagement – Opportunities Under the Common Rule

The pandemic has highlighted issues with social equity and justice in our society. In response, there’s increasing interest in broadening representation and expanding engagement in research. This session will revisit the Belmont principle of justice and explore opportunities in the Common Rule to promote representation and engagement in research.

Yvonne Lau, MBBS, MBHL, PhD, OHRP
Marianna Azar, OHRP

.75 CIP credit will be offered for this session.

Closing Remarks – Day 1

Welcome and Opening Remarks

Plenary Session – “The Covid Drug Wars” – What We Learned from the Front Lines

On August 5th, 2020, the New York Times Magazine published the article, “The COVID Drug Wars That Pitted Doctor vs. Doctor” with the subtitle, “How much freedom should front-line clinicians have in treating Covid-19 patients with unproven drugs? The question opened up a civil war in some hospitals.” This session will explore the experiences of the clinicians and researchers who experienced this tension first-hand.

This session explores the themes and issues outlined in “The Covid Drug Wars That Pitted Doctor vs. Doctor”. Forum attendees are strongly encouraged to read the article in advance of the plenary session.

Moderator:
Jerry A. Menikoff, M.D., J.D., OHRP

Panelists:
Mangala Narasimhan, DO, FCCP, FASM, FACP, Northwell Health
Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC, Northwell Health
Adey Tsegaye, MD, Northwell Health
David Fajgenbaum, MD, MBA, MSc, University of Pennsylvania

1 CIP credit will be offered for this session.

Which trial should proceed, when not all can? An ethics framework for prioritizing trials during the pandemic and beyond.

Given the dearth of established safe and effective interventions to respond to COVID-19, there was (and remains) an urgent ethical imperative to conduct meaningful clinical research. The good news is that interventions to be tested have not been in short supply. Unfortunately, the human and material resources needed to conduct these trials are finite. It is essential that trials be robust and meet enrollment targets and that lower-quality studies not be permitted to displace higher-quality studies, delaying answers to critical questions, or providing misleading “answers.” Yet, with few exceptions, existing research review bodies and processes are not designed to ensure these conditions are satisfied. This session will: (1) relay guidance for research institutions about how to prioritize among proposed COVID-19 clinical trials and (2) present some preliminary findings of a qualitative study of those who lead COVID-19 trial prioritization at their institutions, including the potential value of prioritizing other kinds of clinical trials outside the setting of a pandemic.

Michelle Meyer, PhD, JD, Geisinger Health System

1 CIP credit will be offered for this session.

Physicians and the Provision of Nonstandard Care: Some Ethical Aspects.

The Covid-19 pandemic has highlighted the tension that can exist between a physician doing what might be in the best interests of current patients, versus enrolling sufficient numbers of people into the clinical trials that will produce the information needed to help future patients. What does medical ethics tell us with regard to the situation where a possible unproven treatment can be legally provided to patients outside of a research trial, and it might be in their best interests to receive it? What should a doctor do? This presentation will discuss some past instances in which this type of scenario occurred.

Jerry A. Menikoff, M.D., J.D., OHRP

.5 CIP credit will be offered for this session.

Unusual Practices Masquerading as Usual Care

This session will explore how IRBs should evaluate proposals that claim to compare “Standards of Care” in Comparative Effectiveness Research(CER); what evidence needs to be submitted to support a practice as genuinely “usual care practice”; and what reasonably foreseeable risks should be disclosed to subjects in research comparing “standards of care.”

This presentation will demonstrate that:

• Treatment groups in CER trials are not always “usual practices.” IRBs should not assume they are usual standard care just because they are in a CER trial.
• IRB reviewers should ascertain that the study has a comparator arm against which meaningful inferences could be made.

Willard Applefeld, MD, Duke University

1 CIP credit will be offered for this session.

Adaptive Platform Trials – What are they and what do IRBs and participants need to know?

During the pandemic period, adaptive platform trials have played a pivotal role in identifying effective therapies. In June 2020 the RECOVERY trial at the University of Oxford found that dexamethasone reduced death by up to one third in hospitalized patients with severe respiratory complications of COVID-19. RECOVERY has also effectively ruled out popular therapies as ineffective, such as HCQ. Adaptive platform trials employ study designs that allow for the perpetual study of multiple interventions, making modifications on-the-go as interventions are found to be more/less effective. They also have efficiency advantages, allowing interventions to be tested that would be too difficult or too expensive to evaluate in traditional free-standing, parallel-group randomized controlled trials (RCTs).

This session will focus on a) defining the adaptive platform model, b) describing advantages and disadvantages of this study design, and c) focusing on special ethical considerations that IRBs and participants should be aware of when reviewing or considering enrolling in these types of trials.

Spencer Phillips Hey, PhD, PRISM BIO
Derek C. Angus, MD, MPH, FRCP, University of Pittsburgh Medical Center

1 CIP credit will be offered for this session.

Break

"Ask the Feds”

This provides an opportunity for RCF attendees to interact with OHRP staff and ask them questions on the regulations and policies for protecting research participants.

OHRP staff

Closing Remarks – Day 2