1. Research Ethics Board Focusing on research involving human subjects
4/13/2017
Research Ethics
Focusing on research involving human subjects
Red River College

2. Session Objectives Overview research ethics.
Research Ethics Board
4/13/2017
Session Objectives
Overview research ethics.
History of research involving human subjects.
Ethical guidelines for research.
Integrity in research and scholarship.
Research & Planning
2004
Red River College

3. Why is human research ethics review necessary?
Research Ethics Board
4/13/2017
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.”
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

4. What do we mean by “ethics?”
Research Ethics Board
What do we mean by “ethics?”
4/13/2017
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”
Research & Planning
2004
Red River College

5. Research Ethics Board
4/13/2017
What is research?
… a systematic investigation to establish facts, principles or generalizable knowledge.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

6. What is meant by human research?
Research Ethics Board
4/13/2017
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).
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

7. Why conduct human research?
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

8. Why research ethics? Correct past and prevent new problems and abuses.
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

9. Milestones Nuremberg Code 1947. Declaration of Helsinki 1964.
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Red River College

10. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

11. The Nuremberg Code Voluntary consent of the participant.
Research Ethics Board
4/13/2017
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.]
Research & Planning
2004
Red River College

12. The Nuremberg Code Risk should never exceed the benefits.
Research Ethics Board
4/13/2017
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.]
Research & Planning
2004
Red River College

13. Continuing research problems
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

14. Infamous research studies
Research Ethics Board
4/13/2017
Infamous research studies
Tuskegee Syphilis Study ( )
Harvard Radiation Tests ( )
Willowbrook Study ( )
Jewish Chronic Disease Hospital Study
Research & Planning
2004
Red River College

15. Tuskegee Syphilis Study (1932-72)
Research Ethics Board
4/13/2017
Tuskegee Syphilis Study ( )
Nearly 400 black men in Macon County, AL in 1932.
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 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.
Research & Planning
2004
Source:
Red River College

16. Harvard Radiation Tests
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

17. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

18. Jewish Chronic Disease Hospital Study - 1963
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

19. Declaration of Helsinki
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

20. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

21. Tri-Council Policy Statement
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

22. Tri-Council Policy Statement
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Red River College

23. Why Protect Research Subjects?
Research Ethics Board
4/13/2017
Why Protect Research Subjects?
… it is they who bear the risks of the research …
Research & Planning
2004
Red River College

24. What are the guiding ethical principles?
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

25. A Moral Imperative Respect for Human Dignity
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

26. Research Ethics Board 4/13/2017 Research & Planning 2004
Source: Seattle Times
Red River College

27. Research Ethics Board
4/13/2017
“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. “
Research & Planning
2004
Red River College

28. Free & informed consent
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

29. Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

30. Research Ethics Board
4/13/2017
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)
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

31. What is the principle of minimal risk?
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

32. Dependency relationships
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

33. Basic information package
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

34. Privacy & confidentiality
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

35. Concerns about obtaining identifiable personal information
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

36. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

37. Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

38. Minimal risk, human & social sciences, & biomedical sciences
Research Ethics Board
Minimal risk, human & social sciences, & biomedical sciences
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

39. Research Ethics Board
4/13/2017
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
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

40. What requires ethics review?
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

41. What is a Research Ethics Board (REB)?
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

42. What is the REB composition?
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

43. REB decisions Types Notice Approvals are for one year only.
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

44. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

45. What are some RRC REB review guidelines? - 1
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

46. What are some RRC REB review guidelines? - 2
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

47. The opinion of the REB should be sought whether:
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

48. The opinion of the REB should be sought whether:
Research Ethics Board
The opinion of the REB should be sought whether:
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

49. The REB should be sought whether:
Research Ethics Board
4/13/2017
The 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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

50. Specific inclusion criteria
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

51. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

52. Research Ethics Board
More exclusions
4/13/2017
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.
Research & Planning
2004
Source: Tri-Council Policy Statement
Red River College

53. Research Ethics Board
4/13/2017
However . . .
All research involving human subjects must adhere to recognized ethical standards even if REB review is not required!
Research & Planning
2004
Red River College

54. What is a code of ethics for Researchers?
Research Ethics Board
4/13/2017
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
Research & Planning
2004
Red River College

55. A Positive View Do the right thing.
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

56. Another approach: Do not lie, cheat, or steal
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Source:
Red River College

57. Why have an integrity in research & scholarship policy?
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

58. What is scientific misconduct?
Research Ethics Board
4/13/2017
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."
Research & Planning
2004
Source:
Red River College

59. Definitions fabrication: "making up data or results,"
Research Ethics Board
4/13/2017
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."
Research & Planning
2004
Source:
Red River College

60. What is misconduct in research? - 2
Research Ethics Board
4/13/2017
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,.
Research & Planning
2004
Red River College

61. Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

62. Conclusion- balance of ethics and science
Research Ethics Board
4/13/2017
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.
Research & Planning
2004
Red River College

63. If you want to know more …
Research Ethics Board
4/13/2017
If you want to know more …
Tri-Council Policy Statement Tutorial is available at:
Research & Planning
2004
Red River College