Responsible Conduct of Research:Guidelines and Regulations

Office of Regulatory Research Compliance

To provide an overview of the Office of Regulatory Research Compliance and the role of

institutional review committees;

To provide an overview of ethical guidelines and research regulations;

To discuss the importance of responsible conduct of research.

Objectives:

ABOUT THE OFFICE OF REGULATORY RESEARCH

COMPLIANCE

About The Office of Regulatory Research Compliance (ORRC)

Location: The Office of Regulatory Research Compliance (ORRC)

1840 Seventh Street, NWHURB-1, Suite 309Washington, DC 20001202-865-8597(O) 202-232-5286 (Fax)

Yonette F. Thomas, PhDAssociate Vice President for Research

Compliance

ORRC Organizational ChartYonette F. Thomas, Ph.D.

Associate Vice President for Research Compliance

Roderick Harrison, Ph.D., Senior Scientist/Sr. Compliance Officer

Marline Brown Walthall, MPH Sr. Compliance Administrator

Inez Moore, MEdCompliance Officer

Jamie Rotimi, MSCompliance Officer

Jazzmyn Brown, BAc Compliance Support Specialist

Fahad Mahmood, MSCompliance Data Manager

Odette Godwin-Davis Executive Assistant

Calvin Smith, MDivGraduate Assistant

October 21, 2011

About The ORRC (cont.)

The ORRC currently supports 5 federally mandated review committees:

1. Non-Medical Institutional Review Board (IRB)

2. Medical Institutional Review Board (IRB)

3. Institutional Animal Care and Use Committee (IACUC);

4. Institutional Biosafety Committee (IBC) [health and select

agents needs to be added to this committee or a separate

committee needs to be formed];

5. Research Misconduct Committee (RMC)

Pending: A Clinical Trials IRB; Institutional Radiation Safety Committee

About The ORRC (cont.) The Research Misconduct Committee (RMC) is a

faculty peer review committee tasked with reviewing allegations of research misconduct

The Associate Vice President for Research Compliance is the Research Integrity Officer (RIO).

The work of this Committee is monitored by the Office of Research Integrity (ORI) within the U.S. Department of Health and Human Services (HHS).

Regulatory Committee Chairs• Thomas O. Obisesan, MD, MPH• Chief, Section of Geriatrics, HUHMedical IRB

• Broderick Eribo, PhD• Associate Professor, Biology Dept.

Non-Medical IRB

• Thomas Heinbockel, PhD• Associate Professor, Anatomy Dept.IACUC

• Stanley Tai, PhD• Associate Professor, Microbiology Dept.IBC

• Allan Johnson, PhD• Associate Dean, CNAHSRMC

Function of the ORRC

ORRC supports HU in promoting ethical conduct of research and educating faculty and students about human subjects protections, responsible conduct of research, animal care regulations, and bio-safety.

ORRC has oversight of all research approved by an institutional review committee to ensure regulatory compliance and the protection of all human and animal participants involved in research.

IRB Metrics 2009-2011

Non-Medical refers to all non-biomedical studies; Medical refers to all biomedical studies.**A Non-Medical IRB was created in March 2011.

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Non-Medical refers to all non-biomedical studies; Medical refers to all biomedical studies.**A Non-Medical IRB was created in March 2011.

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IRB Metrics 2011

Non-Medical refers to all non-biomedical studies; Medical refers to all biomedical studies.**A Non-Medical IRB was created in March 2011.

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Red = Non-Medical IRBBlue = Medical IRB

Function of the ORRC (cont.) The ORRC is available:

1. To assist faculty, students, researchers throughout all phases of the research protocol submission process.

2. To provide educational training on research misconduct.

3. To assist researchers in understanding appropriate regulations affecting their proposed research.

• ORRC is required to foster the protection of all human participants and animals used in research.

To provide an overview of the Office of Regulatory Research Compliance and the role of institutional

review committees;

To provide an overview of ethical guidelines and research regulations;

To discuss responsible conduct of research.

Objectives:

SPECIAL NOTE!

NO HUMAN SUBJECTS RESEARCH, ANIMAL RESEARCH, OR RESEARCH INVOLVING BIOAGENTS AND RADIATION CAN BEGIN UNTIL IT HAS RECEIVED APPROVAL BY AN INSTITUTIONAL REVIEW COMMITTEE.

ETHICAL FOUNDATION OF

HUMAN RESEARCH PROTECTION

Belmont Report Ethical Principles

ETHICAL PRINCIPLES

The “Belmont Report,” formally known as the Ethical Principles and Guidelines for

the Protection of Human Subjects of Research, was written in 1979 by the

National Commission for the Protection of Human Subjects of Biomedical and

Behavioral Research.

ETHICAL PRINCIPLES

Respect for Persons

Justice

Beneficence

The Belmont Report identified the following three fundamental ethical principles that must be carefully considered to ensure the ethical practice of research involving human participants:

Respect for Persons• Participants have a right to informed consent.

• Treat participants as autonomous agents capable of making an independent decision to enter into the research study voluntarily.

• Additional provisions must be taken to protect participants that have a diminished capacity to act as an autonomous agent (children, prisoners, etc.).

• Researcher should design procedures and safeguards which minimize the risk of invasion of privacy and assure confidentiality of data.

Justice• No individual or group of participants should unduly bear

the risks of research nor inequitably receive its benefits.

• Fair distribution of risks and benefits of research.

• Equitable selection of subjects..

• IRB has the responsibility of reviewing any requests by researchers to exclude selected subject populations.

Beneficence• Do no harm.

• Refers to the responsibility of the researcher to maximize possible benefits and minimize possible risks.

• The benefits should outweigh the risks..

• IRB has separate applications for studies with “minimal risk” and “greater than minimal risk”.

REGULATORY FOUNDATION

OF HUMAN RESEARCH PROTECTION

History Regulations Policies HIPAA

HistorySignificant recent events in research

experimentation since the Hippocratic Oath.

The Tuskegee Syphilis Study

The Nuremberg Code

The Milgram Study

Declaration of Helsinki

The Beecher Article

The Syphilis Study Expose

1932 1947 1963 1964 1966 1970s

The Code follows the Nazi experiments (1930s-40s)

Yale psychologist Stanley Milgrim conducted a study to test this theory of obedience.

“Ethics and Clinical Research Article” published citing 22 examples of human research being conduct not complying with Nuremberg

Article appears in the New York Times in 1972 that caused the Tuskegee study to be shut down.

History (cont.)

The National Research Act

The Belmont Report

Consolidated HHS/FDA Regulations

CIOMS Guidelines The Common Rule (45 CFR 46)

National Bioethics Advisory Committee

1974 1978-79 1981 1982 1991 1995

Federal law that established the requirement of human subjects research review by IRBs

HHS and FDA attempted to consolidate their regulations

International Ethical Guidelines for Biomedical Research Involving Human Subjects prepared by the Council of International Organization for Medical Science

* Recent findings on Guatemala and Henrietta Lacks.

What regulations govern human subjects research? Department of Health

and Human Services (DHHS)

Food and Drug Administration (FDA)

Sponsors

Howard University Policies

What regulations govern human subjects research? (cont.)All research involvinghuman subjects mustadhere to DHHSregulation 45 CFR 46,also known as theCOMMON RULE,unless the requirementis waived by the IRB.

DHHS

45 CFR 46

COMMON RULE

45 CFR 46: The Common Rule

The Common Rule is a federal policy regarding Human Subjects Protection. The main elements include:

(1) requirements for assuring compliance by research institutions;

(2) requirements for researchers’ obtaining and documenting informed consent;

(3) requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and recordkeeping.

Revisions under consideration affecting informed consent, security and data collection.

http://www.hhs.gov/news/press/2011pres/07/20110722a.html

What is HIPAA? The Health Insurance Portability and

Accountability Act, commonly known as HIPAA, is another piece of legislation that impacts the conduct of human subjects research.

Establishes national standards for the protection of private health information know as Protected Health Information (PHI).

PHI is defined as any individually identifiable health information that is created or maintained by a Covered Entity (CE) department.

HIPAA applies when:

An investigator working in a Non CE department receives PHI from a CE department.

An investigator working in a CE department creates, receives and/or discloses PHI for research purposes.

The IRB is responsible for reviewing proposed HIPAA authorization forms, de-identification forms, and requests to waive the authorization process for research projects.

To provide an overview of the Office of Regulatory Research Compliance and the role of institutional

review committees;

To provide an overview of ethical guidelines and research regulations;

To discuss responsible conduct of research.

Objectives:

RESEARCH MISCONDUCT

Responsible Conduct of Research Regulations and HU Scientific Misconduct Policy Research Misconduct Tutorial How to Report Alleged Research Misconduct

Responsible Conduct of Research

According to the Federal Office of Research Integrity, in general terms, Responsible Conduct in Research (RCR) is simply good citizenship applied to professional research activity.

Researchers should conduct and report their work honestly, accurately, efficiently, and objectively.

Research institutions (such as universities) are required by law to have policies that cover aspects of research for which the institution received funding.

Let us not Forget…Tuskegee Syphilis Study (1932-1972):

No informed consent Participants are not informed of all

known dangers. Participants are not given a cure, even

when the cure was widely known and easily available

Led to 1974 passage of the National Research Act.

What is Research Misconduct?

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reported research results.

Fabrication is making up results and recording or reporting them.

Falsification is manipulating research materials, equipment, or processes or changing or omitting data or results such that the research is not accurately represented in the research record.

Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts.

HU Policy on Research Misconduct

The federal regulations require Howard University, as a recipient of funding, to:

Define Research Misconduct Outline procedures for reporting and investigating

allegations of Research Misconduct Provide protection for whistleblowers and persons

accused of Research Misconducthttp://www.provost.howard.edu/Documents/scimisconduct4.htm

**This policy supersedes policy in the Faculty Handbook , Employee Handbook and/or Guidelines.

Reporting Alleged Misconduct & Adverse Events The University must protect the complainant who has made an

allegation in good faith, even if the allegation is not sustained.

It is the responsibility of the researcher to report adverse events and deviations from protocol immediately to the Office of Regulatory Research Compliance at 202-865-8597.

Reports of research misconduct can be made by calling the Office of Regulatory Research Compliance at 202-865-8597 or the University Whistleblower Hotline at 202-238-2479. Written communications should be directed to: interalauditor@howard.edu or

HOTLINEOffice of the Internal Auditor2225 Georgia Avenue NW, Room

701Washington, DC 20001

Research Misconduct: Possible Disciplinary Actions Letter of reprimand Suspension or termination of research Removal from the particular research project If a student, possible suspension or expulsion If a staff member, possible termination of employment If a faculty member, referral by the President to the

Senate Committee on Faculty Tenure and Promotions for dismissal proceedings against the faculty member

Research Misconduct: Possible Disciplinary Actions (cont.) Provost/SVP-Health Sciences may choose to notify:

Co-authors, co-investigators, collaborators Professional societies and licensing boards Editors of journals in which fraudulent research was published Editors or journals or other publications, or institutions, etc,

with which the individual has been affiliated, and Where appropriate, criminal authorities.

**The Research Integrity Officer is required to notify the ORI if there is a finding of research misconduct. The ORI may conduct an additional investigation.

Questions and Answers

The Office of Regulatory Research Compliance

Location: The Office of Regulatory Research Compliance (ORRC)

1840 Seventh Street, NWHURB-1, Suite 309Washington, DC 20001202-865-8597 (Office)

Yonette F. Thomas, PhDAssociate Vice President for Research

Compliance