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Research Ethics Focusing on research involving human subjects.

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1 Research Ethics Focusing on research involving human subjects

2 Research & Planning 2004 Session Objectives  Overview research ethics.  History of research involving human subjects.  Ethical guidelines for research.  Integrity in research and scholarship.

3 Research & Planning 2004 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.” Source: Tri-Council Policy Statement

4 Research & Planning 2004 What do we mean by “ethics?”  Ethic “A body of moral principles or values”  Ethical “of or pertaining to ethics” “in accordance with professional or moral standards for right conduct or practice”  Ethics “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”

5 Research & Planning 2004 What is research? … a systematic investigation to establish facts, principles or generalizable knowledge. Source: Tri-Council Policy Statement

6 Research & Planning 2004 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

7 Research & Planning 2004 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

8 Research & Planning 2004 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.

9 Research & Planning 2004 Milestones  Nuremberg Code War Trials by the Allies in Nuremberg  Declaration of Helsinki World Medical Association  Belmont Report U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research  TCPS 1998 NSERC, SSHRC, CIHR

10 Research & Planning 2004 Nuremburg Code  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 on prisoners of war.  Subsequently, in 1947, the Nazi War Crimes Tribunal issued the Nuremberg Code, which was the first internationally recognized code of research ethics.

11 Research & Planning 2004 The Nuremberg Code  Voluntary consent of the participant.  Results need to benefit society in some way.  Human experimentation should be based on animal research results as well as knowledge of the natural course of events.  All unnecessary mental or physical harm should be avoided.  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.]

12 Research & Planning 2004 The Nuremberg Code  Risk should never exceed the benefits.  Every precaution should be taken to protect subjects from harm.  Only qualified personnel should be allowed to conduct experiments.  Subjects must be able 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.]

13 Research & Planning 2004 Continuing research problems  Abuses of research subjects came to public attention in the U.S. between 1953 and  This led some people to conclude that researchers could not be trusted to conduct studies involving humans.

14 Research & Planning 2004 Infamous research studies  Tuskegee Syphilis Study ( )  Harvard Radiation Tests ( )  Willowbrook Study ( )  Jewish Chronic Disease Hospital Study

15 Research & Planning 2004 Tuskegee Syphilis Study ( )  Nearly 400 black men in Macon County, AL in  Originally a treatment/study (mercury rubs).  Subjects not informed when treatment stopped.  Became a “Study in Nature’ - Observe natural history of disease.  Penicillin available as treatment in  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 Source:

16 Research & Planning 2004 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:

17 Research & Planning 2004 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. Source:

18 Research & Planning 2004 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. Source:

19 Research & Planning 2004 Declaration of Helsinki  Ethical Principles for Medical Research Involving Human Subjects.  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.

20 Research & Planning 2004 Belmont Report  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:

21 Research & Planning 2004 TCPS Tri-Council Policy Statement The joint policy expresses the continuing commitment of the three Councils to the people of Canada, to promote the ethical conduct of research involving human subjects. TCPS i.1 Source: Tri-Council Policy Statement

22 Research & Planning 2004 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

23 Research & Planning 2004 Why Protect Research Subjects? … it is they who bear the risks of the research …

24 Research & Planning 2004 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 Source: Tri-Council Policy Statement

25 Research & Planning 2004 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 Source: Tri-Council Policy Statement

26 Research & Planning 2004 Source: Seattle Times

27 Research & Planning 2004 “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. “

28 Research & Planning 2004 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. Source: Tri-Council Policy Statement

29 Research & Planning 2004 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 Source: Tri-Council Policy Statement

30 Research & Planning 2004 Freedom of decision  Consent must be voluntary given, without manipulation, undue influence or coercion ?no deprivation ?no exercise of control ?no authority over prospective subjects ?no extortion of information (acting as informants for the authorities in place) Source: Tri-Council Policy Statement

31 Research & Planning 2004 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

32 Research & Planning 2004 Dependency relationships  REBs and researchers should be especially careful when the research is being conducted in a dependant relationship setting: ?doctor conducting research with his or her patients ?professor conducting research with his or her students Source: Tri-Council Policy Statement

33 Research & Planning 2004 Basic information package  At the commencement of the free and informed consent process, the researcher must provide subjects, or authorized third parties, with a basic information package appropriate for the subjects’ cultural settings Source: Tri-Council Policy Statement

34 Research & Planning 2004 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 Source: Tri-Council Policy Statement

35 Research & Planning 2004 Concerns about obtaining identifiable personal information  The type of data to be collected;  The purpose for which the data will be used;  Limits on the use, disclosure and retention of the data;  Appropriate safeguards for security and confidentiality;  Any modes of observation;  Any anticipated secondary uses of identifiable data from research;  Any anticipated linkage of data gathered in the research with other data about subjects, whether those data are contained in public or personal records;  Provisions of confidentiality of data resulting from the research. Source: Tri-Council Policy Statement

36 Research & Planning 2004 Released data  Researchers should ensure that the data released does not contain names, initials or other identifying information.  While it may be important to preserve certain types of identifiers (e.g. region of residence), these should be masked as much as possible using a standardized protocol before the data are released for research purposes. Source: Tri-Council Policy Statement

37 Research & Planning 2004 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

38 Research & Planning 2004 Minimal risk, human & social sciences, & biomedical sciences  Special issues are raised in clinical research, especially clinical trials, in which patients suffering from disease participate in research on interventions undertaken for purposes of therapy.  This does not mean that human and social sciences research do not pose any threat to the safety and well-being of subjects. Source: Tri-Council Policy Statement

39 Research & Planning 2004 Right to withdrawal  They also have to know that they can withdraw at any time without prejudice to pre-existing entitlements ?A physician should ensure that continued clinical care is not linked to research participation ?Teachers should not recruit subjects from their classes, or students under their supervision without REB approval Source: Tri-Council Policy Statement

40 Research & Planning 2004 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.

41 Research & Planning 2004 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

42 Research & Planning 2004 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.

43 Research & Planning 2004 REB decisions  Types approved as submitted; approved with suggestions for minor changes; approved with conditions (that must be met before final approval is granted); deferred, pending receipt of additional information or major revisions; not approved.  Notice To researchers in writing.  Approvals are for one year only.  Researchers right to ask for reconsideration.  Appeals.

44 Research & Planning 2004 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.

45 Research & Planning 2004 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.

46 Research & Planning 2004 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.

47 Research & Planning 2004 The opinion of the REB should be sought whether: the research is conducted by faculty, students or staff, or external researchers; the research is conducted in person or remotely (e.g., by mail, electronic mail, fax or telephone); the information is collected directly from subjects or from existing records not in the public domain. TCPS, Appendix 1. Source: Tri-Council Policy Statement

48 Research & Planning 2004 The opinion of the REB should be sought whether: the research is funded or not; the funding is internal or external; the subjects are from inside or outside the institution; the subjects are paid or unpaid; the research is conducted inside or outside the institution. TCPS, Appendix 1. Source: Tri-Council Policy Statement

49 Research & Planning 2004 T he REB should be sought whether: the research is observational, experimental, correlational or descriptive; a similar project has been approved elsewhere or not; the research is a pilot study or a fully developed project. TCPS, Appendix 1. Source: Tri-Council Policy Statement

50 Research & Planning 2004 Specific inclusion criteria Information collected through intervention or interaction with a living individual(s); Identifiable private information about individuals; Information collected through naturalistic observation of humans, Human organs, remains, tissues and body fluids, cadavers, embryos or fetuses; and/or Written or recorded information derived from individually identifiable human subjects. Source: Tri-Council Policy Statement

51 Research & Planning 2004 Exclusions Use of a public database with aggregated data and /or information already in the public domain (e.g. autobiographies, biographies or public archives). Naturalistic observation of participants in, for example, political rallies, demonstrations or public meetings where it can be expected that participants are seeking public visibility. Preliminary, informal interviews or casual 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

52 Research & Planning 2004 More exclusions  Quality assurances studies, performance reviews or testing within normal educational requirements. To diagnose problems, identify appropriate solutions, provide advice for operation management, or assess performance. To collect data primarily designed to affect the operations of the College through affirming satisfaction with the status quo or leading to quality improvements.  Student in-class research exercises. Source: Tri-Council Policy Statement

53 Research & Planning 2004 However...  All research involving human subjects must adhere to recognized ethical standards even if REB review is not required!

54 Research & Planning 2004 What is a code of ethics for Researchers?  Traditionally, codes can be cast in positive or negative language.  Expressed in RRC Integrity Policy.  Example: Research & Planning Code of Ethics at

55 Research & Planning 2004 A Positive View  Do the right thing.  Tell the truth about what your work.  Share your work.  Be critical of your own work and the work of others. Source:

56 Research & Planning 2004 Another approach: Do not lie, cheat, or steal A code of ethics can also be formulated by forbidding certain actions. Collectively, these actions can be grouped under Scientific Misconduct. Source:

57 Research & Planning 2004 Why have an integrity in research & scholarship policy?  To promote and advance a high standard of integrity in research and scholarship involving: careful supervision of research, including that conducted by students;  competent use of methods;  adherence to ethical standards of discipline; and  the refusal to engage in or to condone instances of fraud or misconduct.  Required by external funding agencies.  Define misconduct.

58 Research & Planning 2004 What is scientific misconduct? "...fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted in the scientific community for proposing, conducting or reporting research." Source:

59 Research & Planning 2004 Definitions  fabrication: "making up data or results,"  falsification: "changing data or results,"  plagiarism: "using the ideas or words of another person without giving appropriate credit." Source:

60 Research & Planning 2004 What is misconduct in research? - 2  Failure to acknowledge or recognize the contribution of others.  Use of material in violation of the Copyright Act.  Abuse of supervisory power  Financial misconduct  Failure to comply with policies for the protection of researchers, human participants, or the health and safety of the public, or for the welfare of laboratory animals.  Failure to reveal any material conflict of interest,.

61 Research & Planning 2004 Role of REB  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.

62 Research & Planning 2004 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.

63 Research & Planning 2004 If you want to know more … Tri-Council Policy Statement Tutorial is available at:


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