Research Ethics ARC Speakers Series v4.0
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Transcript of Research Ethics ARC Speakers Series v4.0
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
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
What is research?
… “a systematic investigation to establish facts, principles or generalizable knowledge.”
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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).
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
Historical MilestonesNuremberg Code 1947.
War Trials by the Allies in NurembergDeclaration of Helsinki 1964.
World Medical AssociationBelmont Report 1979.
U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
TCPS 1998 NSERC, SSHRC, CIHR
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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.]
RRC Research Ethics Board2006
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.]
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
Infamous research studies
Tuskegee Syphilis Study (1932-72) Harvard Radiation Tests (1946 -56) Willowbrook Study (1963-1966) Jewish Chronic Disease Hospital
Study - 1963
RRC Research Ethics Board2006
A “Study in Nature’ - Observe natural history of disease.
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
RRC Research Ethics Board2006
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.
Source: http://darkwing.uoregon.edu/~pmwhite/1
RRC Research Ethics Board2006
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.
Source: http://darkwing.uoregon.edu/~pmwhite/1
RRC Research Ethics Board2006
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.
Source: http://darkwing.uoregon.edu/~pmwhite/1
RRC Research Ethics Board2006
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 …
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
Free & informed consentFree 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.
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006Source: Seattle Times
RRC Research Ethics Board2006
“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/
RRC Research Ethics Board2006
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
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
Privacy & confidentialityDignity 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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
Tri-Council Policy StatementInclusion in ResearchHistorically: 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.
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
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.”
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
Dependency relationshipsREBs 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
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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.
Source: Tri-Council Policy Statement
Research requiring review
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
Tri-Council Policy StatementEthics ReviewResearch requiring Ethics ReviewAll 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
RRC Research Ethics Board2006
Tri-Council Policy StatementEthics ReviewResearch 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.
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
Tri-Council Policy StatementEthics Review
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.
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
Program Evaluation/Quality Assurance and Research
Characteristic Research EvaluationGoal or Purpose Generate new
knowledge for predictionProgram 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
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
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.
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
Research Ethics Boards
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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.
Source: Tri-Council Policy Statement
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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
RRC Research Ethics Board2006
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
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
Arising Issues/Hot Topics (cont.)
Sharing Databases:
Procedures to link databases and ensure conformance to research ethics
Procedures to aggregate or suppress data
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
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
Source: www.research.utoronto.ca/ethics/pdf/presentations/ Research%20Ethics%20Workshop_HS_Oct%2005.ppt
RRC Research Ethics Board2006
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.
RRC Research Ethics Board2006
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