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Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel Hill EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS …or… What’s an “IRB” and why should you care? Presentation for IBD Patient Governance Committee February 4, 2014

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Page 1: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Daniel Nelson

Director, Office of Human Research Ethics

Professor of Social Medicine, Adjunct Professor of Pediatrics

University of North Carolina - Chapel Hill

EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS

…or…What’s an “IRB” and why should you care?

EVOLVING PROTECTIONS FOR HUMAN RESEARCH SUBJECTS

…or…What’s an “IRB” and why should you care?

Presentation for IBD Patient Governance Committee

February 4, 2014

Page 2: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

But research is a good thing… why do research subjects

need “protection?”

But research is a good thing… why do research subjects

need “protection?”

Concerns for protecting subjects grew out of a long

history in which people were abused in the name of science

Concerns for protecting subjects grew out of a long

history in which people were abused in the name of science

Page 3: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Celsus, 1st century AD

“It is not cruel to inflict on a few criminals sufferings which may benefit multitudes of innocent people through all centuries.”

Page 4: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Informed consent “contract” used by Maj. Walter Reed for yellow fever transmission experiments in Cuba, signed 26 Nov 1900(duplicate in Spanish)

Courtesy of Col. Arthur Anderson, U.S. Army

Page 5: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Nazi Medical Experiments During WWIINazi Medical Experiments During WWII

Page 6: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

15 of 23 guilty, 7 hanged, 5 life sentences

Case No. 1 of the Nuremberg Military Tribunal U.S.A. vs. Karl Brandt et al.Dec 9, 1946 - Aug 20, 1947

Case No. 1 of the Nuremberg Military Tribunal U.S.A. vs. Karl Brandt et al.Dec 9, 1946 - Aug 20, 1947

Page 7: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

NUREMBERG CODE1947

NUREMBERG CODE1947

• Voluntary informed consent absolutely essential• Research should yield useful results• Base research on prior work• Avoid physical and mental suffering• No expectation of death or disabling injury• Risk must be outweighed by importance• Subjects must be protected from injury• Qualified scientists, adequate facilities• Subject free to stop at any time• Investigator must be ready to withdraw subject

Page 8: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

“Before IRBs, the only consent required was that of a researcher's department head. The Nuremberg Code was ignored in practice. As I look back on it, the interpretation of these codes was that they were necessary for barbarians, but not for fine upstanding people... In this prestigious unit we had a very strong obligation to behave in a civilized manner.”

Dr. William Silverman, Columbia pediatrician, on the postwar mentality (ACHRE interviews)

Page 9: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Willowbrook State School Staten Island, 1956-1963

Willowbrook State School Staten Island, 1956-1963

• Institutionalized children• Deliberate infection with hepatitis A• Coercive recruitment through restricted admission

• Rationalization

Introducing Jerry Rivers, 1971

Page 10: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

“Tuskegee Syphilis Study” Conducted by US-PHS in Rural Alabama

1932-1972

“Tuskegee Syphilis Study” Conducted by US-PHS in Rural Alabama

1932-1972

Page 11: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Syphilis ExposeSyphilis Expose

Page 12: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Philadelphia Inquirer, 1972

Page 13: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

“Sometimes, with the best of intentions, scientists and public officials… working for the benefit of us all, forget that people are people. They concentrate so totally on plans and programs, experiments, statistics- on abstractions- that people become objects, symbols on paper, figures in a mathematical formula…”

Atlanta Constitution, July 27, 1972

Page 14: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

US National Research ActJuly, 1974

US National Research ActJuly, 1974

Established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978) The Belmont Report (1979)

Code of Federal Regulations (1981) Institutional Review Boards (IRBs) Informed consent

Public Law 93-348

Page 15: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

THE BELMONT REPORTEthical Principles and Guidelines for the

Protection of Human Subjects of Research

THE BELMONT REPORTEthical Principles and Guidelines for the

Protection of Human Subjects of Research

Respect for Persons

Beneficence

Justice

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979

Page 16: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Translating Ethical Principles Into Regulations

Translating Ethical Principles Into Regulations

Page 17: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Translating Ethics into Regulations“The Twin Pillars of Protection”

Translating Ethics into Regulations“The Twin Pillars of Protection”

Rights and Welfare of Human Subjects

Informed Consent

Independent Review

Page 18: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

WHAT IS AN IRB?Institutional Review BoardWHAT IS AN IRB?Institutional Review Board

Independent review of proposed research, to protect the rights and welfare of participants

At least 5 members, not all men, not all women (UNC IRBs have 10-25 members)

Not all members of one profession Diversity Expertise appropriate to the research At least one scientist, one non-scientist At least one member not otherwise affiliated

with the institution

Page 19: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

WHAT IS AN “IRB?”Institutional Review Board

WHAT IS AN “IRB?”Institutional Review Board

• 5 IRB committees at UNC-Chapel Hill• Social and Behavioral Sciences• Biomedical Sciences (x4)

• Members include 80 faculty, staff and community representatives

• Oversee approx 4000 active research studies

Page 20: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

What does an IRB do when it reviews a research study?

• Risks minimized• Balance of risks and benefits• Equitable selection of subjects• Informed consent• Monitoring plan for safety• Privacy and confidentiality• Additional safeguards for vulnerable

populations

Page 21: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Informed ConsentInformed Consent

Page 22: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

INFORMED CONSENTINFORMED CONSENT• Obtaining consent is a PROCESS in which...

• investigator discloses all relevant information• potential subject has opportunity to ask

questions• investigator answers questions• subject signs a consent form

• The consent form is a permanent record of...• information conveyed• subject’s willingness to participate

Page 23: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

What Questions Should You Ask Before Participating in a Research Study?

What Questions Should You Ask Before Participating in a Research Study?

• What is the study about?• Who put this study together?• Who is going to be in this study?• What will I get out of this study?• What are the possible risks?

• How will I be protected from harm?• What do I have to do in this study?• What will happen after the study is over?

Page 24: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Our National System for Protecting Research

Subjects has Come Under

Scrutiny

Our National System for Protecting Research

Subjects has Come Under

Scrutiny

Page 25: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

Current Challenges and Opportunities Current Challenges and Opportunities • Continuing legacy of Tuskegee• Storing specimens and data for future unspecified research• Genetic testing• Return of results to participants

• Research results?• Incidental findings?

• Data sharing data security• Waiver of consent• Community engagement • Study design issues

• Multisite research• “Standard of Care” research• Cluster randomized trials

Page 26: Daniel Nelson Director, Office of Human Research Ethics Professor of Social Medicine, Adjunct Professor of Pediatrics University of North Carolina - Chapel

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