Research Ethics: what does it mean

Research Ethics: what does it mean
Research Ethics Board 4/6/2017 Research Ethics: what does it mean Focusing on research involving human subjects Jim Goho Chair, RRC Research Ethics Board March 7, 2006 Red River College

RRC Research Ethics Board
4/6/2017 Session Objectives Answer some questions. History of research involving human subjects. Overview human research ethics [Tri-Council Policy Statement]. Arising issues / hot topics. Discussion. RRC Research Ethics Board 2006 Red River College

Some Questions/Answers
Research Ethics Board 4/6/2017 Some Questions/Answers Research ethics is the study, practice and monitoring of the ethical conduct of research Red River College

Why is human research ethics review necessary?
Research Ethics Board 4/6/2017 Why is human research ethics review necessary? Protects research subjects AND Protects 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.” RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

What do we mean by “ethics?”
Research Ethics Board What do we mean by “ethics?” 4/6/2017 Ethic A body of moral principles or values Ethical in accordance with professional or moral standards for right conduct or practice Ethics 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 Code of ethics for research and planning RRC Research Ethics Board 2006 Red River College

4/6/2017 What is research? … “a systematic investigation to establish facts, principles or generalizable knowledge.” RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

What is meant by human research?
Research Ethics Board 4/6/2017 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). RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Why conduct human research?
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

4/6/2017 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. Encourage high quality research accompanied by high standards of research ethics. RRC Research Ethics Board 2006 Red River College

“ Those who cannot remember the past are condemned to repeat it ."
Research Ethics Board 4/6/2017 Some History “ Those who cannot remember the past are condemned to repeat it ." - George Santayana Red River College

History of Research Ethics
Research Ethics Board 4/6/2017 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 Trials in Nuremberg, Germany– physicians convicted of crimes against humanity RRC Research Ethics Board 2006 Red River College

Historical Milestones
Research Ethics Board 4/6/2017 Historical Milestones Nuremberg 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 RRC Research Ethics Board 2006 Red River College

Nazi Experiments World War II
Research Ethics Board 4/6/2017 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 Twin Infected one twin with a “germ”. When he/she died, the other twin was killed and their organs compared at autopsy. “No one ever attempted to explain anything to us. There was never an attempt to minimize our risks…we were there for one reason: to be used as experimental object and then to be killed.” RRC Research Ethics Board 2006 Red River College

4/6/2017 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. 23 physicians and administrators were indicted before the War Crimes Tribunal at Nuremberg RRC Research Ethics Board 2006 Red River College

4/6/2017 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 Washington, D.C.: U.S. G.P.O, 1949–1953.] RRC Research Ethics Board 2006 Red River College

4/6/2017 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 Washington, D.C.: U.S. G.P.O, 1949–1953.] RRC Research Ethics Board 2006 Red River College

Continuing research problems
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

Infamous research studies
Research Ethics Board 4/6/2017 Infamous research studies Tuskegee Syphilis Study ( ) Harvard Radiation Tests ( ) Willowbrook Study ( ) Jewish Chronic Disease Hospital Study RRC Research Ethics Board 2006 Red River College

4/6/2017 A “Study in Nature’ - Observe natural history of disease. RRC Research Ethics Board 2006 Red River College

Tuskegee Syphilis Study (1932-72)
Research Ethics Board 4/6/2017 Tuskegee Syphilis Study ( ) 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. For forty years between 1932 and 1972, the U.S. Public Health Service (PHS) conducted an experiment on 399 black men in the late stages of syphilis. These men, for the most part illiterate sharecroppers from one of the poorest counties in Alabama, were never told what disease they were suffering from or of its seriousness. Informed that they were being treated for “bad blood,” their doctors had no intention of curing them of syphilis at all. The data for the experiment was to be collected from autopsies of the men, and they were thus deliberately left to degenerate under the ravages of tertiary syphilis—which can include tumors, heart disease, paralysis, blindness, insanity, and death. “As I see it,” one of the doctors involved explained, “we have no further interest in these patients until they die.” By the end of the experiment, 28 of the men had died directly of syphilis, 100 were dead of related complications, 40 of their wives had been infected, and 19 of their children had been born with congenital syphilis. How had these men been induced to endure a fatal disease in the name of science? 40 wives infected 19 children born with congenital syphilis RRC Research Ethics Board 2006 Source: Red River College

4/6/2017 RRC Research Ethics Board 2006 Red River College

Harvard Radiation Tests
Research Ethics Board 4/6/2017 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. Ethics Violations 1.Voluntary, informed consent. 2. The research should be useful to society. 3. Based on animal research. 4. Unnecessary physical or psychological harm to the subjects. 5. No Research if death or disability occurs. 6. risk involved should be proportional to the benefits. 7. protect the subject from harm. 8. highly qualified scientists only. 9. freedom to withdraw at any time 10. The researcher must be prepared to discontinue the experiment RRC Research Ethics Board 2006 Source: Red River College

4/6/2017 Willowbrook Study 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. Willowbrook Studies •These studies were designed to gain an understanding of the natural history of infectious hepatitis and subsequently to test the effects of gamma globulin in preventing or ameliorating the disease. •The subjects, all children, were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations. •Investigators defended the deliberate injection of these children by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and perhaps it would be better for them to be infected under carefully controlled research conditions. • During the course of these studies, Willowbrook closed its doors to new residents, claiming overcrowded conditions. RRC Research Ethics Board 2006 Source: Red River College

Jewish Chronic Disease Hospital Study - 1963
Research Ethics Board 4/6/2017 Jewish Chronic Disease Hospital Study 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. RRC Research Ethics Board 2006 Source: Red River College

4/6/2017 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 RRC Research Ethics Board 2006 Red River College

Responses To protect research subjects
Research Ethics Board 4/6/2017 Responses To protect research subjects … it is they who bear the risks of the research … Red River College

Declaration of Helsinki
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

4/6/2017 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. RRC Research Ethics Board 2006 Source: Red River College

Tri-Council Policy Statement
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Act of Parliament Creates Councils 1985 Medical Research Council (MRC), now CIHR Natural Sciences and Engineering (NSERC) Social Sciences and Humanities (SSHRC) Start of Joint Initiative 1994 First Tri-Council Draft 1998 RRC policy and guidelines. Applies to all research involving humans affiliated with, and undertaken by members of, research institutions administering funds awarded by CIHR, NSERC & SSHRC Recognizes the need for, and importance of, research. Guidelines, not legislation. RRC Research Ethics Board 2006 Red River College

Tri-Council Policy Statement (cont.)
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Research Ethics Board 4/6/2017 An Overview of TCPS Red River College

What are the guiding ethical principles?
Research Ethics Board 4/6/2017 What are the guiding ethical principles? Human Dignity Free and Informed Consent Vulnerable Persons Privacy and Confidentiality Justice and Inclusiveness Balancing Harms and Benefits Minimizing Harm Maximizing Benefits RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

A Moral Imperative Respect for Human Dignity
Research Ethics Board 4/6/2017 A Moral Imperative Respect 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 RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Free & informed consent
Research Ethics Board 4/6/2017 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. RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

4/6/2017 Formal requirements Research 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 Board 2006 Source: Tri-Council Policy Statement Red River College

4/6/2017 RRC Research Ethics Board 2006 Source: Seattle Times Red River College

4/6/2017 “Uniformed Consent” “PATIENTS DIED PREMATURELY in two failed clinical trials at Seattle'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. “ The story of Protocol 126, a blood-cancer experiment at the Fred Hutchinson Cancer Research Center in which at least 20 people died. They were never told that The Hutch and some of its doctors had a financial interest in drugs being tested in the experiment, nor that there were safer, more effective alternative treatments. RRC Research Ethics Board 2006 Red River College

Tri-Council Policy Statement Privacy & Confidentiality
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Privacy & 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 Recorded data: audio, video, photo Quotes: direct quotes or specific anecdotes (e.g. “this tall guy who works at O’Grady’s”) could be identifying RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Privacy & confidentiality
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Tri-Council Policy Statement Inclusion in Research
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Inclusion 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 fair distribution of the benefits/burdens of research across populations. RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Tri-Council Policy Statement Inclusion in Research (cont.)
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Inclusion 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.” RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

4/6/2017 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 RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Dependency relationships
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

What is the principle of minimal risk?
Research Ethics Board 4/6/2017 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. RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Research requiring review
Research Ethics Board 4/6/2017 Research requiring review Red River College

What requires ethics review?
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

Tri-Council Policy Statement Ethics Review
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Ethics Review Research requiring Ethics Review All research involving living human subjects at an institution administering Tri-Council funds. 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. Last point: but TCPS acknowledges that there may be points where this overlaps with research RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Research Ethics Board 4/6/2017 Tri-Council Policy Statement Ethics Review 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. Undergraduate course-based research is reviewed by a departmental TCPS-compliant REB. The instructor must submit a template to the REB. Graduate course-based research is reviewed by the University’s Ethics Boards. RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Research Ethics Board 4/6/2017 Tri-Council Policy Statement Ethics 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. RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

Program Evaluation/ Quality Assurance and Research
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Tri-Council Policy Statement Ethics Review (cont.)
Research Ethics Board 4/6/2017 Tri-Council Policy Statement Ethics Review (cont.) Proportionate Review The TCPS requires that the more invasive the research, the greater care to be taken in the process of reviewing that research. For biomedical research, ethics review of greater than minimal risk research involves scientific review of the research protocol. RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Research Ethics Boards
4/6/2017 Research Ethics Boards Red River College

4/6/2017 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 Board 2006 Red River College

What is a Research Ethics Board (REB)?
4/6/2017 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. REBs take into account national and, when appropriate, international ethical standards of research on a protocol-by-protocol basis. Protecting human research subjects is their primary responsibility. Protection of the rights and welfare of research subjects is a high priority worldwide. RRC Research Ethics Board 2006 Source: Tri-Council Policy Statement Red River College

What is the REB composition?
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

4/6/2017 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 Board 2006 Red River College

What are some RRC REB review guidelines? - 1
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

What are some RRC REB review guidelines? - 2
Research Ethics Board 4/6/2017 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. RRC Research Ethics Board 2006 Red River College

Research Ethics Board 4/6/2017 Arising issues Red River College

Arising Issues/Hot Topics
Research Ethics Board 4/6/2017 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 RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Arising Issues/Hot Topics (cont.)
Research Ethics Board 4/6/2017 Arising Issues/Hot Topics (cont.) Sharing Databases: Procedures to link databases and ensure conformance to research ethics Procedures to aggregate or suppress data RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Arising Issues/Hot Topics (cont.)
Research Ethics Board 4/6/2017 Arising Issues/Hot Topics (cont.) International Research Ethics Review required, if possible, in the jurisdiction in which the research will be carried out. Safety in Field Research (Policy) Standard of Care Randomized Controlled Trials “Bleed and flee” or “Helicopter” studies: There must be some benefit to the individual or community According to a May 16 report in USA Today, giant drug outfits are outsourcing increasing numbers of drug trials outside the United States and Europe. Merck is now conducting 50 percent of its trials outside the United States. By 2006, 70 percent of Wyeth Pharmaceuticals trials are expected to occur offshore. Across Latin America, Eastern Europe, Asia and Africa, the sick are abundant, desperate and doc-trusting, and so recruitment into clinical trials is rapid. As one executive from an outfit specializing in running drug trials in Asia put it, patients in developing countries are "more willing to be guinea pigs." RRC Research Ethics Board 2006 Source: Research%20Ethics%20Workshop_HS_Oct%2005.ppt Red River College

Conclusion- balance of ethics and science
Research Ethics Board 4/6/2017 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 Board 2006 Red River College

If you want to know more …
Research Ethics Board 4/6/2017 If you want to know more … Tri-Council Policy Statement Tutorial:: RRC REB: POLICIES & PROCEDURES # Pages 22 Number H1 Originator: Director, Research & Planning Approved by: President’s Council TITLE: Research Involving Human Subjects Effective Date Replaces November 16, 2004 May 18, 2004 RRC Research Ethics Board 2006 Red River College

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