**OHRP-Sponsored Program at VCU: [Informed Consent]{.underline} - Sept.
16, 2008**

**"Informed Consent and More: Improving Human Research Protections"**

**Conference Description**

*The Belmont Report*, promulgated in 1978 by the National Commission for
the Protection of Human Subjects, identifies three related principles
intended to characterize the manner in which human subjects should be
involved in research. They are: ***Respect for Persons***;
***Beneficence*;** and ***Justice.*** The principle of ***Respect for
Persons*** usually finds expression in the process by which human
subjects consent to participate in research as subjects.

Tragically, some thirty years after the publication of *The Belmont
Report,* contemporary studies suggest that informed consent is often
elicited in a manner that manifests little respect for the dignity of
volunteers who, for the sake of the common good, place themselves in the
hands of research investigators.

The jargon used in virtually every institution -- "consenting subjects"
or "getting consents" \-- betrays the fact that eliciting informed
consent has often been reduced to the level of an action taken by a
Principal Investigator or a member of the research team to obtain a
signature on a legal document in order to comply with the law. All too
often "consenting" means little more than a halfhearted and misguided
attempt to provide legal cover for investigators and for their
institutions.

This conference is intended to: 1) identify shortcomings in the ways
that informed consent is elicited, 2) promote a mindset in which
receiving permission from a subject to proceed with research is
recognized as a privilege; and 3) endorse informed consent procedures
conducted in the context of ***Justice*** and ***Beneficence*** that
manifest profound respect for human dignity.

**[Monday, September 15, 2008]{.underline}**

**Registration opens** -- 6:00 -- 8:00 PM in hotel lobby

**Faculty and planning committee reception**: 6:00 to 7:30 PM at hotel

**[Tuesday, September 16, 2008]{.underline}**

7:00AM Registration and Continental Breakfast.

8:00AM Welcome and Introduction

8:20AM Acknowledgements

8:25AM Keynote Address

> *Research on Informed Consent: What Do We Know? How Can It Be
> Improved?*
>
> **Jeffrey Kahn, PhD, MPH,** Maas Family Endowed Chair in Bioethics
> Professor and Director of the Center for Bioethics, University of
> Minnesota.
>
> Dr. Kahn's teaching, speaking, and writing have placed him among the
> leading bioethicists in America. He will summarize results of research
> on informed consent, and offer suggestions for improving the informed
> consent process.

9: 30 AM Federal Update

> The audience will receive updates and information about projects that
> are in process from a panel of senior representatives of major federal
> research regulatory agencies.

10:45 AM Break

11:00 AM Breakout Session A

> I: *Tailoring Recruitment and Retention to Minority Participants:
> Focus on American Indian and African American* *Populations*
>
> Research that targets minority groups calls for challenging
> recruitment and retention strategies. This session explores how the
> informed consent process enhances trust among prospective study
> participants.
>
> II: *Responsible Conduct of Research: Conflict of Interest
> Considerations*
>
> 'Elimination of Bias' is a bedrock principle of sound research design.
> Bias elimination must be extended to all persons who design, review,
> conduct, or interpret the research. This session addresses the
> management of conflict of interest as a means to protect the integrity
> of the research, the informed consent process, and the public trust.

III: *Identifying, Screening, and Recruiting Subjects: When Should*

*Prospective Participants be Asked to Consent to Research?*

> Many research projects require that prospective participants fulfill
> extensive
>
> eligibility criteria. Screening activities are often employed to
> determine eligibility while
>
> affording efficiency for the investigator and sparing the prospective
> subject from inconvenience . This session discusses how and when
> informed consent should be obtained during activities to determine
> study eligibility.

IV: *Informed Consent for Registries and Genetic Research*

> Biomedical research increasingly includes plans to collect data or
> specimens for storage in registries or tissue banks for future
> research. This session discusses meaningful informed consent
> considerations for explaining privacy and confidentiality as well as
> unknown future research.
>
> V: *Research Issues in the VA system*
>
> For over 60 years, the VA Research & Development Program has been
> improving veterans\' lives through innovation and discovery that has
> led to advances in health care for veterans and all Americans. This
> session will be devoted to initiatives like the VA Central IRB that
> the VA has adopted to keep up with the growing sophistication of VA
> research.
>
> VI: ***Basics Track:** Nuts and Bolts of Human Subject Protections
> (with only a touch of Informed Consent Regulations)*

This session is a basic overview of the human subject protections
codified within 45 CFR 46, Part A, or "The Common Rule." The informed
consent regulations are briefly discussed as they will be given more
extensive coverage in session B-VI.

12:00 PM Luncheon

*Informed Consent from the Point of View of the "Normal" Volunteer*

**Charles R. McCarthy, PhD,** Office of Education and Compliance
Oversight, Vice

President's Office for Research, Virginia Commonwealth University

> Dr. Charlie McCarthy has thirty years of experience in viewing
> research as an administrator (from the top down), and as a subject
> (from the bottom up). The two views are very different.

1:30 PM Breakout Session B

I: *Informed Consent for Decisionally Challenged Persons: State*

*Law Considerations*

> State law defines how the federal regulations for human research
> protections are applied to populations and individuals involved in
> research, such as "children" and "legally authorized representatives."
> This session discusses the interaction between federal regulations and
> state law for human research. A portion of this session is reserved
> for available updates on the recent OHRP "Call for Comments" about
> research protections for decisionally impaired individuals.

II: *Collaborations in Human Subject Research: Considerations of*

*Investigator and IRB Responsibilities*

> How can institutions facilitate collaborative research and meet the
> terms of their Federalwide Assurance? This session discusses
> institutional agreements for using one IRB, independent investigator
> agreements, and deciding when additional IRB review is needed.

III. *Moving Past the "Therapeutic Misconception": Recruitment and*

> *"Consent" of the Very Ill*
>
> The "therapeutic misconception" describes the received impression that
> a research
>
> study offers treatment or cure for a condition or illness, especially
> when known
>
> therapeutic options have been exhausted. This session explores the
> "therapeutic misconception" from the perspective of an oncologist, an
> ethicist, and a patient advocate.
>
> IV: *Informed Consent Challenges of Research in the Community:
> Research in*
>
> *the Schools and Community-Based Participatory Research*
>
> Research collaborations within the community and within school
> settings present challenges for investigators and IRBs. Assuring a
> meaningful informed consent, assent, and parental permission process
> among all participants is explored in this session.

V: *Does Paying Subjects Distort the Recruitment and Consent Process?*

The federal regulations at 45 CFR 46 state that study participation is
to be free from "undue influence" or coercion. This session explores the
concept of "undue influence," research compensation, perspectives of
research participants, investigators and IRB members, and early findings
of an NIH study on subject payment.

VI: ***Basics Track:** Nuts and Bolts of Informed Consent*

> This session discusses the informed consent requirements in 45 CFR 46,
> with emphasis on the required and additional elements, waiver of all
> or some elements of informed consent, and waiver of documentation.

2:30 PM Break

2:45 PM Breakout Session C

I: *Evaluating the Consent Process: What Do Participants Understand and*

*Retain?*

> A review of research studies evaluating a wide range of informed
> consent practices and procedures, including informed consent in acute
> care settings. How can informed consent processes be improved?
>
> II: *Research in Emergency Settings: Informed Consent and*
>
> *Exception from Informed Consent for FDA-Regulated Research*
>
> An extensive community consultation process is required for IRB
>
> consideration of exception from informed consent for research in
> emergency
>
> settings. This session discusses how the investigator and IRB
> collaborate on
>
> the development, implementation, and review of the community
> consultation
>
> process before the research begins.

III. *Using the Internet for Research: Recruitment, Informed Consent,
     and Reliability of Results*

> The Internet is often used for research purposes, such as survey
> completions, as well as a recruitment tool. This session explores
> issues related to student recruitment, meaningful informed consent,
> and reliability of findings generated in a setting where the actual
> participant usually cannot be confirmed.

IV: *Self-Evaluation of the Human Research Protection Program: Quality*

*Improvement and Accreditation*

> Preparing for accreditation of the human research protection program
> emphasizes self-evaluation. This session discusses how the Association
> for the Accreditation of Human Research Protection Programs, Inc.
> (AAHRPP) accreditation process impacts quality improvement within the
> Veterans Affairs health care system and a comprehensive university and
> academic health care center.

V.  *Educating IRB Members and the Research Community about Human
    Research Protections: Large and Smaller Scale Options*

> How can knowledge and a working understanding about human subject
> protections be disseminated to diverse constituencies with differing
> informational needs? This session discusses options for educating
> IRBs, investigators, and research staff in large and small
> institutional settings.

VI. ***Basics Track:** Informed Consent Processes for Vulnerable
    Populations: Pregnant Women/Fetuses/Neonates, Prisoners, and
    Children*

> This session reviews the regulations in Subparts B, C, and D of 45 CFR
> 46 that require additional considerations for the protection of these
> identified vulnerable populations.

3:45 PM ***Panel:** Perspectives on the Informed Consent Process:
"Lessons and*

*Advice"*

> The panelists demonstrate that the content, method and tone of
> Informed consent should differ under different circumstances. The
> process and approach to obtaining informed consent from seriously ill
> patients should differ from the approach with outpatients, and both
> should differ from consent obtained from normal volunteers who have
> little to gain but much to give to research.

4:45 PM **Panel:** *Recap: Questions and Answers from the Federal
Agencies*

This panel will provide a recap of the conference and provide an
opportunity for participants to ask questions and receive clarification
and guidance from the federal experts, featuring senior representatives
from the Office of Human Research Protections, the U.S. Food and Drug
Administration, the U.S. Department of Veterans Affairs, and the
National Institutes of Health.

5:15 PM **Conference Wrap-Up**

**Adjourn**

For more information contact:

**Zena Singh-Bailey**

Program Manager

Administrative/Office Support Tech

Office of Education and Compliance Oversight

Vice President\'s Office for Research

Virginia Commonwealth University

\(804\) 827-2156

zbailey@vcu.edu