Ethics in Human Research: On-line Tutorial

Description

McMaster Ethics in Human Research: On-line Tutorial



On-line Tutorial
Faculty Introduction
Tri-Council Policy
Statement
Guidelines &
Researcher's Handbook
Forms
Research Ethics Tutorial at McMaster University Checklists, Instructions,
Templates
This tutorial is about human research ethics at McMaster University. It is intended for all
On-line Tutorial researchers, (i.e. faculty, students, staff) and members of research ethics boards. The frame
of reference for this tutorial is Canada's Tri-Council Policy Statement: Ethical Educational Initiatives &
Conduct for Research Involving Humans. As you study this tutorial, your familiarity Resources
with this policy will develop.
Useful Links
List of Tutorial Topics
Frequently Asked
Questions 1. Research Ethics and Codes of Ethics
2. The Tri-Council Policy Statement
3. Defining Research
4. The Ethical Review Process
5. Informed Consent
6. Submitting an Application
7. The Approval ProcessMcMaster Ethics in Human Research: On-line Tutorial
8. The Ethics of Medical Research
9. Qualitative Research in Social/Behavioural Science and Humanities
10. Sample Cases
11. Codes of Ethics and Online Tutorials


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McMaster Ethics in Human Research: On-line Tutorial



Faculty Introduction Research Ethics and Codes of Ethics
Faculty Introduction
Tri-Council Policy
(by Dr. Elisabeth Gedge, Ethicist on the McMaster Research Statement
Ethics Board) ...

Sujets

• Indice d'octane
• Université McMaster
• Rebecq
• Application linéaire
• Risky Business
• Guidelines international network

Informations

• Publié par: Vewyer
• Nombre de lectures: 72
• Langue: English
• Poids de l'ouvrage: 1 Mo

Extrait

McMaster Ethicsi  nuHam neResra: ch-lOne intoTulair

 

 

 

This tutorial is about human research ethics at McMaster University. It is intended for all researchers, (i.e. faculty, students, staff) and members of research ethics boards. The frame of reference for this tutorial is Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. As you study this tutorial, your familiarity with this policy will develop.  

Research Ethics Tutorial at McMaster University  

 

 

 

On-line Tutorial Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Useful Links Frequently Asked Questions

1.Research Ethics and Codes of Ethics 2.The Tri-Council Policy Statement 3.Defining Research 4.The Ethical Review Process 5.Informed Consent 6.Submitting an Application 7.The Approval Process

List of Tutorial Topics  

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8.The Ethics of Medical Research 9.Qualitative Research in Social/Behavioural and Humanities Science 10.Sample Cases 11.Codes of Ethics and Online Tutorials

 

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(by Dr. Elisabeth Gedge, Ethicist on the McMaster Research Ethics Board)   The commonly held principles of research ethics find their origin in the philosophies ofImmanuel Kant, who defended the dignity of the individual, andJohn Stuart Mill, who insisted that ethical behaviour must maximise the good. All research, including research with human participant-subjects, aims at producing the good of reliable knowledge. However, in Kant's terms, ethical research must never use human beings only as means in pursuing the good of knowledge. A human being, says Kant, "...is not to be valued merely as a means to the ends of others or even to his (sic) own ends but as an end in himself; that is, he possesses a dignity (an absolute inner worth) by which he exacts respect for himself from all other rational beings....He can measure himself with every being of this kind and value himself on a footing of equality with them." (Kant, The Doctrine of Virtue) Thus in research, respecting and protecting the rights, needs, and interests of human participant-subjects is an important ethical constraint upon the pursuit of knowledge.

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

   Research Ethics and Codes of Ethics  

 

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Research Ethics and Codes of Ethics

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

The history of unethical research demonstrates that vulnerable human participant-subjects have often been used as means only, for research of questionable design. Most notoriously (though by no means exclusively) the mistreatment of human participant-subjects during World War II demonstrated the need for ethical guidelines for research. The first guideline wasthe Nuremberg Code.

The treatment of vulnerable populations is a third important concern in research ethics. Historically prisoners, women, children, indigenous populations, and the institutionalised have frequently been improperly used as participant-subjects. Furthermore, the thrust of research has been to benefit the advantaged. Thus vulnerable populations often bear a disproportionate burden for little or no benefit.

Another ethical constraint on research is that the research must, in fact, be likely to produce the good of knowledge. Research with human participant-subjects imposes a degree of risk, and risk, even when consented-to, must be balanced by the likelihood of benefit. If the benefit of new knowledge is to serve as a partial justification for subjecting humans to risk, then research must be designed so as to generate knowledge. Good research design is therefore a further ethical constraint on research.

 

 

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Research Ethics and Codes of Ethics  

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

The next statement or directive on ethical conduct in research came from the World Medical Association. It is called theHelsinki Declaration, which clearly demarcates medical practice from medical research. More recently has been theBelmont Reportfrom American hospitals and academic institutions, an ethical guideline for research that expounds the three ethical principles of "respect for persons", "beneficence" and "justice".

The Nuremberg Code:"Directives for Human Experimentation", is ten points of protocol for conducting research using human subjects. It was the direct result of the Nuremberg Military Tribunals, trials of warcriminals after World War II. The first sentence in the first point is:"The voluntary consent of the human subject is absolutely essential."That sets the tone as a code of ethics for research involving humans.

 

In Canada, the three major government research granting institutions; the Social Sciences and Humanities Research Council (SSHRC), the Natural Sciences and Engineering Research Council (NSERC), and the Medical Research Council (MRC), (now the Canadians Institutes for Health Research CIHR), combined to create theTri-Council PolicyStatement (TCPS): "Ethical Conduct for Research Involving Humans".The Tri-Council Policy Statement is the ethical guideline used by all ethical review at McMaster University.

 

 

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Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

 

The three councils that compose theTri-Council Policy Statementare the three major research granting agencies in Canada. The new   Inter- Agency Panel on Research Ethicswill provide stewardship for the evolution and development of the Tri-Council Policy Statement. This policy is not currently regulated byHealth Canada,but acts as a guideline for research. The three councils that compose the Tri-Council areSSHRC,CIHRandNSERC: The Social Sciences and Humanities Research Council (SSHRC)funds primarily non- medical research. The research ethics policy applies equally to medical and non-medical research.The Canadian Institutes of Health Research (CIHR)   is a new research institute that replaces the Medical Research Council. Most of its research is medical in nature but not exclusively so.The Natural Sciences and Engineering Research Council (NSERC)funds mostly scientific research, but researchers in social sciences are also frequently sponsored. The National Council on Ethics in Human Research (NCEHR)   acts as a leading interpretor, monitoring and education agency for the research ethics in Canada. It is funded partly by Health Canada, the Tri-Councils, and theRoyal College of Physicians and Surgeons.    

The Tri-Council Policy Statement  

 

 

  

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As an undergraduate, graduate student or faculty member at McMaster, it is important to know what qualifies as research requiring ethical review and what does not. Once you have determined that you are doing either course, individual or faculty research, you need to know how if the research is defined as research involving human subjects, thus requiring REB review. It might also help to become familiar with some of theacronymsused in the area of research

The Tri-Council Policy Statementstates theneed for research:"Research involving human subjects imparts at least three general categories of benefits:1.The basic desire for new knowledge and understanding is the driving force for research.2.The quest to advance knowledge sometimes benefits research subjects. Subjects may benefit from improved treatments for illnesses; the discovery of information concerning one's welfare; the identification of historical, written, oral or cultural traditions; or the satisfaction of contributing to society through research.3.groups and society as a whole. Thus,As well, research benefits particular insights into political behaviour may produce better policy; information about the incidence of disease may improve public health; sociological data about lifestyles may yield social reform; and disciplines based on, for example, texts, dance, theatre or oral history, continue to illuminate past and present realities.

The Belmont Reportdefines research as: "an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective."

Defining Research  

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

 

 

 

 

 

McMaster Ethics in Human Research: On-line Tutorial

 

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REBResearch Ethics Board ICH   International Conference on Harmonization

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions

CANADIAN AMERICAN AND INTERNATIONAL CAREB   Canadian Association ofCIOMS   Council for International Research Ethics Boards Organizations of Medical Sciences HHS/ FHS REB: Hamilton HealthCPA   Cooperative Project Assurance Sciences Faculty of Health Sciences REB COMMON RULE   American Research Ethics regulations, same as 45 CFR 46 MREBMcMaster Research Ethics Board DHHS   Department of Health and Human Services NCEHR:National Council on Ethics in Human Research FDAFood and Drug Administration   NOC   Notice of Compliance FWA   Federal Wide Assurance – American registration of REB/IRB PRE    with the OHRP responsibility Inter-Agency (The Tri- Councils) Panel on Research Ethics GCP   Good Clinical Practice

 

Acronyms Used in Research Ethics at McMaster  

 

 

 

 

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STH REB St. Joseph’s NIHNational Institutes of Health Healthcare, Hamilton REB OHRPOffice of Human Research TCPSTri-Council Policy  es Statement (Canadian Research  Protections (United Stat ) Ethics guidelines of the three councils, CIHR, SSHRC, NSERC) P M R e I di M ci & n R e   builP litysibisponc Ren  i nd aseR crae h TPDTherapeutic Products SPA   Single Project Assurance Directorate - Health Canada, Health Protection Branch 45 CFR 46: Code of Federal Regulations: Protection of Human   Subjects (United States Codes of Federal Regulations on Research Ethics)

SREC: Student Research Ethics Committee i.e. PSREC = IRBInstitutional Review Board Psychology Student Research Ethics Committee) MPA   Multiple Project Assurance

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To help determine whether or not your project qualifies as research, consider the following guidelines found inAppendix 1   of theirC-uocnli T Policy Statement,"Scope of Research Requiring Ethics Review"   that indicates the range of research projects or instances that should be reviewed by the REB.

l       Whether the research is funded or not l       Whether the funding is internal or external l       Whether the subjects are from inside or outside the institution l       the subjects are paid or unpaidWhether l       is conducted inside or outside of CanadaWhether the research l       Whether the research is conducted inside or outside the institution l       Whether the research is conducted by staff or by students l       Whether the research is conducted in person or remotely (e.g. by mail, electronic mail, fax or telephone) l       Whether the information is collected directly from subjects or from existing records not in the public domain l       Whether the research is to be published or not l       the focus of the research is the subjectWhether l       research is observational, experimental, correlational or descriptiveWhether the l       Whether a similiar project has been approved elsewhere or not l       Whether the research is a pilot study or a fully developed project l       Whether the research is to acquire basic or applied knowledge l       Whether the research is primarily for teaching or training purposes or whether the primary purpose is the acquisition of knowledge.

 

 

 

 

 

Defining Research  

Faculty Introduction Faculty Introduction Tri-Council Policy Statement Guidelines & Researcher's Handbook Forms Checklists, Instructions, Templates On-line Tutorial Educational Initiatives & Resources Frequently Asked Questions