Research Ethics: what does it mean Focusing on research involving human subjects Jim Goho Chair, RRC...

Research Ethics: what does it mean

Focusing on research involving human subjects

Jim GohoChair, RRC Research Ethics Board

March 7, 2006

RRC Research Ethics Board2006

Session Objectives

Answer some questions. History of research involving human

subjects. Overview human research ethics

[Tri-Council Policy Statement].

Arising issues / hot topics. Discussion.

Some Questions/Answers

Research ethics is the study, practice and monitoring of the

ethical conduct of research


Why is human research ethics review necessary?

Protects research subjects ANDProtects researchers.

Tri-Council Policy Statement (1998)Memorandum of Understanding (2002)

“… to promote the ethical conduct of research involving human subjects.”

“. . .will consider funding (or continued funding) only to individuals and institutions which certify compliance with

this policy.”

Source: Tri-Council Policy Statement


What do we mean by “ethics?”

Ethic A body of moral principles or values

Ethical in accordance with professional or moral standards

for right conduct or practiceEthics

the discipline of dealing with what is good and bad, with moral duty and obligation

a system of moral principles the right and wrong of certain actions and the good

and bad of such actions often embedded in a code the principles of conduct governing an individual or

group


What is research?

… “a systematic investigation to establish facts, principles or generalizable knowledge.”



What is meant by human research?

A systematic investigation to establish facts, principles or generalizable knowledge in which humans take part as research subjects. refers to any project that involves the collection of

specimens, data or information from persons, through intervention or otherwise.

included are procedures that have a low degree of invasiveness (e.g. surveys, interviews, naturalistic observations, exercise or psychometric testing, examination of patient records), as well as more invasive procedures (e.g. blood sampling, administration of a substance).



Why conduct human research?

Research involving humans is premised on a fundamental moral commitment to advancing human welfare, knowledge, and understanding, and to examining cultural dynamics.

Tri-Council p. i.4



Why research ethics?Correct past and prevent new problems

and abuses.Human subjects have not always been

well protected.Research is big business with enormous

amounts of money involved.The future impact of such issues as

genetic engineering, cloning, gene therapy, etc. is not known.

Privacy issues for individuals is a growing societal concern.

Some History

“ Those who cannot remember the past are condemned to repeat it ."

- George Santayana


History of Research Ethics Pre-World War II Research standards left up to the discretion

of the individual researcher World War II Experiments conducted on inmates of Nazi

concentration camps 1945-1949 - Trials in Nuremberg, Germany–

physicians convicted of crimes against humanity


Historical MilestonesNuremberg Code 1947.

War Trials by the Allies in Nuremberg

Declaration of Helsinki 1964. World Medical Association

Belmont Report 1979. U.S. National Commission for the Protection of

Human Subjects of Biomedical and Behavioral Research

TCPS 1998 NSERC, SSHRC, CIHR


Nazi Experiments World War II

"Medical experiments" were performed on thousands of concentration camp prisoners

Examples of tortures: Forced killings Injecting people with toxins Sterilization studies Mutilation Immersing people in ice water Forcing people to ingest poisons Twin studies


Nuremburg Trials

The formal elaboration of ethical guidelines for the conduct of research involving humans began in the late 1940's.

In 1946, Nazi physicians were tried at Nuremberg because of research atrocities performed in concentration camps.

Subsequently, in 1947, the Nazi War Crimes Tribunal issued the Nuremberg Code, which was the first internationally recognized code of research ethics.


The Nuremberg Code

Voluntary consent. Benefit society in some way. Avoid mental or physical harm. Experiment with animals Researchers should serve as subjects if there is

reason to believe that death or injury may occur.

[from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]


The Nuremberg Code

Risk should never exceed the benefits. Protect subjects from harm. Only qualified personnel. Right to withdraw from a study at any time. The researcher must be ready to terminate the

experiment if it appears that the subjects are being harmed.

[from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O, 1949–1953.]


Continuing research problems

Abuses of research subjects came to public attention in the U.S. between 1953 and 1972.

This led some people to conclude that researchers could not be trusted to conduct studies involving humans.


Infamous research studies

Tuskegee Syphilis Study (1932-72) Harvard Radiation Tests (1946 -56) Willowbrook Study (1963-1966) Jewish Chronic Disease Hospital

Study - 1963


A “Study in Nature’ - Observe natural history of disease.


Tuskegee Syphilis Study (1932-72)

Over 400 black men with syphilis and about 200 men without syphilis, who served as the controls, were the subjects.

The men were recruited without informed consent. Participants were misinformed and told that some of

the procedures done in the interests of research (e.g., spinal taps) were actually "special free treatment" and told that they had “bad blood.”

Penicillin available as treatment in 1943. Provisions were taken to prevent Tuskegee subjects from

getting penicillin. The study was exposed in 1972, the subjects given

treatment by 1973 and the treatment was extended to the families of the subjects in 1975.

Source: http://darkwing.uoregon.edu/~pmwhite/1



Harvard Radiation Tests

From 1946 to 1956, 19 boys who thought they were participating in a science club were fed radioactive milk by researchers who wanted to learn about the digestive system.

The experiments were performed at the Fernald State School in Massachusetts. Researchers from Harvard University and MIT fed radioactive forms of iron and calcium to the boys, sometimes in their breakfast milk, to study the body's ability to digest minerals.



Willowbrook Study - 1963-1966 State School for mentally challenged persons in

New York. Study natural history of infectious hepatitis. Subjects were all children who were deliberately

infected. Defended by saying that the vast majority of

them acquired the infection anyway and it was better for them to be infected under controlled research conditions.

School closed to new residents - but study took new patients - parents only able to place children there if they participated in study.



Jewish Chronic Disease Hospital Study - 1963

Injection of live cancer cells into chronically ill patients to develop information on the nature of the human transplant rejection process.

Researchers said consent was given orally but not documented because it was customary to undertake much more dangerous procedures without consent forms.

Patients weren’t told they would receive cancer cells because it would frighten the patients unnecessarily.



The Beecher Article

Beecher HK. Ethics and clinical research. The New England Journal of Medicine, 1966, 274: 1354–1360.

Cited serious ethical problems including inappropriate risk exposure, questionable scientific design and no documentation of consent in 22 research studies.

Research studies with ethical violations had been published in some of the most prestigious journals and conducted at some of the most prestigious institutions

Responses

To protect research subjects

… it is they who bear the risks of the research …


Declaration of Helsinki

Ethical Principles for Medical Research Involving Human Subjects. (1964, 1975, 1983, 1989, 1996)

Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights.

Every patient – including those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.


Belmont Report (1979)USA

RESPECT FOR PERSONS: This principle acknowledges the dignity and freedom of every person. It requires obtaining informed consent from all potential research subjects (or their legally authorized representatives).

BENEFICENCE: This principle requires that researchers maximize benefits and minimize harms associated with research. Research-related risks must be reasonable in light of expected benefits.

JUSTICE: This principle requires equitable selection and recruitment and fair treatment of research subjects.

Source: http://www.rgs.uci.edu/ora/rp/hrpp/1


Tri-Council Policy StatementAct of Parliament Creates Councils

1985Medical Research Council (MRC), now

CIHRNatural Sciences and Engineering

(NSERC)Social Sciences and Humanities (SSHRC)

Start of Joint Initiative 1994First Tri-Council Draft 1998


Tri-Council Policy Statement (cont.)

Considered a “living” document – undergoing revision and re-evaluation to respond to new developments and any gaps that are identified

Last updated in September, 2002 Panel on Research Ethics (PRE) currently

undergoing consultation for revisions, particularly to behavioural and social sciences provisions

Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt

An Overview of TCPS


What are the guiding ethical principles?

1. Human Dignity2. Free and Informed Consent3. Vulnerable Persons4. Privacy and Confidentiality5. Justice and Inclusiveness6. Balancing Harms and Benefits7. Minimizing Harm8. Maximizing Benefits



A Moral ImperativeRespect for Human Dignity

It is unacceptable to treat persons solely as means (mere objects or things), because doing so fails to respect their intrinsic dignity and thus impoverishes all of humanity.

Tri-Council i.5



Free & informed consent

Free and informed consent derives from respect we owe to human dignity, for respecting persons means respecting their capacity and right to make free and informed choices.

It is also a continuing dialogical process: it starts when prospective subjects are first approached and ends when their actual involvement is over.



Formal requirementsResearch may begin only if the following conditions have been met:

Subjects need a comprehensible statement of the research purpose, the identity of the researcher, the expected duration and nature of participation, and a description of research procedures

Subjects have to be given the assurance that their participation is totally voluntary and that they have the right not to participate if they so wish

free and informed consent has been given and maintained throughout the subjects’ participation in the research


RRC Research Ethics Board2006Source: Seattle Times


“Uniformed Consent”“PATIENTS DIED PREMATURELY in two failed clinical trials atSeattle's Fred Hutchinson Cancer Research Center — experiments in which the Center and its doctors had a financial interest. The patients and their families were never told about those connections, nor were they fully and properly informed about the risks of the experiments, an investigation by The Seattle Times has found. The patients in these trials were ill with cancers that, left untreated, would almost certainly have killed them. But many stood a good chance of survival or at least prolonged life with traditional care. Instead, many actually died from the experiments — sooner than they would have with no treatment at all. “

http://seattletimes.nwsource.com/uninformed_consent/


Tri-Council Policy StatementPrivacy & Confidentiality

Duty to protect personal information “to the extent permitted by law” must report child abuse, intent to harm oneself or others

Access, control and dissemination of personal information must be subject to safeguards: Anonymity – data stripped of identifying characteristics

(incl. recorded data, quotes) Locks Computer Passwords



Privacy & confidentiality

Dignity and autonomy of human subjects is the ethical basis of respect for the privacy of research subjects

Privacy is perceived to be an essential means of protecting and promoting human dignity



Tri-Council Policy StatementInclusion in Research

Historically: Poor and institutionalized people have been

overused in research Women of reproductive age have not been

included in research (e.g. CVD studies) 1990s: shift in policy emphasis from protectionism to

access

The Principle of Justice requires the fairdistribution of the benefits/burdens ofresearch across populations.



Tri-Council Policy StatementInclusion in Research (cont.)

“Where research is designed to study generic activities, researchers cannot exclude participants on the basis of culture, religion, race, mental or physical disability, sexual orientation, ethnicity, sex or age, unless there is a valid reason.”

“Those not competent to consent for themselves shall not be automatically excluded from research which is potentially beneficial to them as individuals, or to the group which they represent.”



Harms and benefits

Subjects have the right to be given a comprehensible description of reasonably foreseeable harms and benefits that may arise from research participation and should be informed about likely consequences of non-action

this is especially relevant in the case of therapeutic research, or research involving invasive methodologies or research potentially resulting in physical or psychological harm



Dependency relationships

REBs and researchers should be especially careful when the research is being conducted in a dependent relationship setting: doctor conducting research with his or her

patients instructor conducting research with his or

her students



What is the principle of minimal risk? If potential subjects can reasonably be expected

to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subjects in those aspects of his or her everyday life that relate to the research,

then the research can be regarded as within the range of minimal risk.


Research requiring review


What requires ethics review?

All research that involves human subjects requires review and approval by a Research Ethics Board (REB).

All human research undertaken by members of, or conducted at, RRC require ethics review by the RRC REB.


Tri-Council Policy StatementEthics Review

Research requiring Ethics Review

All research involving living human subjectsat an institution administering Tri-Councilfunds. Includes: Research with human remains, cadavers,

tissues, biological fluids, embryos and foetuses.

Interviews, surveys and questionnaires. Secondary data analysis of data from living

human subjects.Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt



Research exempt from Ethics Review: Research about living individuals in the public

arena or artists, based exclusively on publicly available information.

Participant observation of public demonstrations, political rallies and public meetings.

Quality assurance studies, performance reviews or normal educational testing.




More exclusions: conversations that are carried out to help

clarify the design of a research project. Information gathering procedures in support of

the general administration of the College.



Program Evaluation/Quality Assurance and Research

Characteristic Research Evaluation

Goal or Purpose Generate new knowledge for prediction

Program or Policy Decision-Making

Questions/

Nature of Problem

To fill a gap in the literature – derived by scientist

Derived to assess impact and outcome of program

Guiding Theory/ Techniques

Hypothesis testing Theory underlying program interventions

Dissemination Scientific Journals Internal and External Reports

Allegiance Scientific Community Policy makers



Tri-Council Policy StatementEthics Review (cont.)

Proportionate Review

The TCPS requires that the more invasivethe research, the greater care to be taken inthe process of reviewing that research.

For biomedical research, ethics review ofgreater than minimal risk research involvesscientific review of the research protocol.


Research Ethics Boards


What a REB is not.

NOT the college ‘research police’. NOT a committee set up for the prime

purpose to critique and mandate research design.

NOT an overly burdensome, bureaucratic hoop to discourage research.


What is a Research Ethics Board (REB)?

Ensures that the highest ethical standards in the conduct of research involving human participants are maintained.

Reviews all proposed research to ensure meets ethical standards.



What is the REB composition?

REB Composition Expertise in relevant sciences (2) Expertise in ethics (1) Interest in a non-scientific area (1) Community Member (1)

Ad hoc members Substitute members

Institutional Review Boards (IRBs) in U.S.


REB authority

The RRC REB has jurisdiction over all research involving human participants.

The REB has the authority to approve, reject, propose modifications to, or terminate any proposed or ongoing research involving human participants which is conducted within, or by members of, RRC.


What are some RRC REB review guidelines? - 1 Clear who is conducting the research. Risks are minimized. Whether the risks are reasonable (balanced) in

relation to the anticipated benefits to the subjects. Informed and freely volunteered consent, including

providing for withdrawal from the research. Adequate protection of the privacy of the subjects

and the confidentiality of the information /data being obtained.

Selection and recruitment of subjects is inclusive and appropriate in relation to the research.


What are some RRC REB review guidelines? - 2 Purpose of the study is fully outlined to subjects,

or if deception is necessary, there is appropriate debriefing.

Research design is appropriate for the nature of the research.

Clarify researcher(s) position of power with subjects.

Previous REB reviews must be declared & submitted.

Methods of dissemination should be disclosed. Conflict of interest are disclosed and mechanisms

for handling outlined.

Arising issues


Arising Issues/Hot Topics Advances in Biotechnology

Fetal stem cell research genetic testing, transplantation, drug development

The Internet Informed consent On-line questionnaires – protecting participants’

confidentiality (cookies, history) Observation of listservs – reasonable expectation of

privacy, intent



Arising Issues/Hot Topics (cont.)

Sharing Databases:

Procedures to link databases and ensure conformance to research ethics

Procedures to aggregate or suppress data



Arising Issues/Hot Topics (cont.)

International Researchо Ethics Review required, if possible, in the

jurisdiction in which the research will be carried out.о Safety in Field Research (Policy)о Standard of Care

Randomized Controlled Trials “Bleed and flee” or “Helicopter” studies: There

must be some benefit to the individual or community



Conclusion- balance of ethics and science

Balance interest in advancing scientific knowledge with a mandate to protect the rights and welfare of people.

Ethics protects research subjects and researchers.

Sound ethics and good science are compatible.


If you want to know more …

Tri-Council Policy Statement Tutorial::

http://www.pre.ethics.gc.ca

RRC REB:http://www.rrc.mb.ca/researchplan/REB.htm

POLICIES & PROCEDURES

# Pages 22

Number H1

Originator: Director, Research & PlanningApproved by: President’s Council

TITLE:Research Involving Human Subjects

Effective Date Replaces

November 16, 2004

May 18, 2004

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