Volume 2, Issue 8 -- October 1999

Research Ethics? What's That and How Does it Relate to My Work?

Do you want to distribute a questionnaire, run a focus group, collect some data about patients, evaluate a program, or look at outcomes? Chances are pretty good that you need to obtain ethics approval before you go much further.

Ethics is not a new buzz-word. Philosophers have been talking about ethics since 350 BC (Aristotle). Today we read about ethics in the popular press when there are technological advances in areas such as cloning and transplants or during debates over issues such as euthanasia or assisted suicide. However, ethics also play an important part in studies involving human subjects.

In general terms, ethics is seen as the pattern of values and norms that is "taken for granted" in a given culture, professional or institutional setting.¹ Ethics is the branch of philosophy that deals with distinctions between right and wrong conduct and with the moral nature of human actions ranging from intentions to outcomes.^{2,3 .}

Research is any systematic enquiry conducted for the purpose of acquiring new knowledge. Often this enquiry involves individuals or communities of human beings. While it is accepted that research is important to improving humanity, it is not an unqualified good, so we must be careful about how subjects of research are treated.

Research ethics has its roots in cases where individuals and communities have been harmed in the course of research. For example, during the second World War prisoners of war were used in experiments without any choice about their participation or explanation as to what would happen to them. Events such as this have led to a number of documents outlining standards for ethical research. One example of this is the Declaration of Helsinki which addresses ethical considerations in research on human subjects.^4.

Ethics review of studies/research helps ensure a more general accountability to society.^5. It ensures that studies abide by certain "rules" that are set by society and that reflect society's basic values. These values include respect for: human dignity, free and informed consent, vulnerable persons, privacy and confidentiality. Ethics review of a research protocol is meant to be a safeguard against practices that fall outside these values.

Which studies need ethics approval?

Not all types of research need consent of the subject (for example, biographies, artistic criticism or public policy research). However, most research that involves interviews, focus groups, surveys or tests with human subjects does require ethics approval. This includes randomised controlled trials, clinical trials, evaluations, outcome measurements, and some quality assurance. Studies that either directly or indirectly use information that could put individuals or communities in vulnerable positions require ethics approval.

Studies need to be reviewed from an ethics perspective whether:

• research is funded or not,
• funding is internal or external,
• subjects are paid or unpaid,
• research is conducted inside or outside the institution,
• research is conducted by staff or by students,
• information is collected directly from subjects or from existing records,
• research is published or not,
• a similar project has been approved elsewhere or not,
• research is a pilot study or a fully developed project. (adapted from the University of Alberta, General Faculty Council Policy Manual).

If you are not sure if your project needs ethics review, always ask. Most ethics review boards can quickly tell you if you need to apply for ethics approval.

Who is protected by research ethics?

It is important to remember that communities as well as individuals can be identifiable and can be harmed in research - for example by studies that expose behaviours or practices that are different or frowned upon by the rest of society. Ethics reviews are therefore meant to protect communities as well as individuals.

For example, if it is discovered that a given community being studied values a certain practice (e.g. polygamy) that is seen as "different" or is outside the norms of society, the members of this community could be ostracised by others who do not agree with the practice. One role of the ethics review process is to ensure that sufficient measures are taken to protect the identity of the individuals or community being studied, or to ensure that any research conducted in this community does not harm the community.

In Canada, a policy statement regarding ethical conduct for research involving humans has been issued jointly by the Medical Research Council of Canada (MRC), the Natural Sciences and Engineering Research Council of Canada (NSERC) and the Social Sciences and Humanities Research Council of Canada (SSHRC).^6. The "Tri-Council" document identifies ethical principles that should guide the way research is planned and conducted. These principles include:

• Respect for human dignity: protecting the interests of the person - from bodily to psychological to cultural integrity

• Respect for free and informed consent: respecting the individual's capacity and right to make free and informed decisions

• Respect for vulnerable persons: persons whose diminished competence and/or decision-making capacity make them vulnerable are entitled, on grounds of human dignity, caring, solidarity and fairness, to special protection against abuse, exploitation and discrimination

• Respect for privacy and confidentiality: protecting the access, control and dissemination of personal information.

Ethics review is designed to protect and enhance the value, dignity and respect that we attach to human life and society. The process offers the opportunity for reflection on the ethical integrity of a research project, thereby protecting both the research subjects and investigators.

Ethics review also ensures that individuals and communities are not used indiscriminately for studies that are not scientifically sound. It is unethical to conduct a study which is not properly grounded scientifically. This is why scientific review is an important part of ethics review.

The process of ethics review can seem like just another hurdle that needs to be jumped and it can add 1-2 months to the process of beginning a study, but it can also be a positive experience. Having a committee of people from different backgrounds (law, clergy, medicine, ethics, the lay community) review a project can identify potential problems that are not obvious to the investigator, before the problem prevents completion of the project.

Ethics review boards?

There are a number of ethics review boards in Alberta. The issue of which review board your project should be taken to depends on your professional affiliations and where the research will be conducted. If unsure which review board to approach, contact the Provincial Health Ethics Network for advice.

I would like to thank Valerie Matwick for her assistance with this article.

References

1. Monagle, JF. Ethically Responsible Creativity - Friendship of an Understanding Heart: A Cognitively Affective Model for Bioethical Decision Making (pp. 566-577). In Monagle, JF & DC Thomasma. Health Care Ethics: Critical Issues for the 21st Century. Gaithersburg, MD: Aspen Publishers, Inc. 1998.

2. Bankowski Z, Bryant JH, Last JM eds. Ethics and Epidemiology: International Guidelines. Geneva:CIOMS/WHI, 1991.

3. Fayerweather WE, Higginson J. Beauchamp TL, eds. Ethics in Epidemiology. New York: Pergamon Press, 1991 (also J Clin Epidemiol 1991; 44, suppl.).

4. Coughlin SS, & TL Beauchamp. Ethics and Epidemiology. New York: Oxford University Press, 1996.

5. Last, JM & JH Abramson, eds. A Dictionary of Epidemiology. New York: Oxford University Press, 1995.

6. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (MRC, NSERC & SSHRC). Ottawa: Public Works and Government Services Canada, 1998.

Community Health Research

The Community Health Research Ethics Review Committee (CHRERC) is pleased to announce that it is accepting submissions for ethics review. The CHRERC was established by the Alberta Heritage Foundation for Medical Research to support the work of the SEARCH (Swift, Efficient Application of Research in Community Health) program, and has extended its mandate to be available to any Alberta researcher seeking prospective ethics review of protocols that do not fall under the scope of authority of the other existing Research Ethics Boards in the province. The Committee will be particularly concerned with the impact of research on communities and collectivities. For more information, please visit www.ahfmr.ab.ca/search/commethics.html or contact a PHEN office.

Announcements

• A reminder that Network staff are continuing the process of compiling a resource page for PHEN's website profiling the work of Albertans who are completing or have completed theses, dissertations or research projects in the area of Health Ethics. If you have undertaken such a project and would be willing to share this with other Albertans through the Network, please contact Melissa Trono at the Southern Alberta PHEN office by phone, or by email at trono@phen.ab.ca.

• The Alberta Children's Hospital Ethics Education and Support Committee is hosting a conference in Calgary entitled "The Right Decision... According to Whom?" on Friday November 26, 1999, 8:30 AM - 4:00 PM, Alberta Children's Hospital Solarium. Cost is $15 for staff, $10 for parents. Speakers include Lori Kovacs & Debra Eresman, specialists in conflict resolution, collaborative problem solving & organizational change with Resolve Consulting. For more information, call (403) 229-7831.

• The next session of the Medical Bioethics Study Group, Office of Medical Bioethics, U of C, will be held on December 9 from 12:00 - 1:00 PM, G383 Health Sciences Centre, 3330 Hospital Dr. NW, Calgary. The topic is "Who pays for the free lunch? Issues in Pharmaceutical Involvement in Medical Education", by Dr. C. Bjornson. For more information, call 220-7990.

• The Bethany Care Society Ethics Committee is pleased to host a session entitled "The Ethics of Competency Determination" by Dr. Michael King on November 17, 10:30 AM. All are welcome. Please call (403) 284-6087 for more information.

Views offered in this article are those of the author and do not necessarily reflect the position of the Provincial Health Ethics Network.