Research ... is integral to health care as a science. It is part of the body of knowledge and the disciplined knowing of the health care professions. As members of a profession, with a knowledge base, massage therapists must seek not just to maintain their skills, but also to grow them.
September 16, 2009 By Cidalia Paiva
Research … is integral to health care as a science. It is part of the body of knowledge and the disciplined knowing of the health care professions. As members of a profession, with a knowledge base, massage therapists must seek not just to maintain their skills, but also to grow them.
The development and utilization of massage knowledge is essential for continued improvement in patient care. Massage therapists, like other health care professionals, are expected to adopt a research-based (or evidence-based) practice, using research findings to inform their decisions, actions, and treatment of patients.
Massage therapists will need to base specific treatments and decisions on evidence indicating that the treatment is clinically appropriate, cost effective and results in positive outcomes for patients.
Massage therapists who incorporate high quality research evidence into their clinical decisions and recommendations are being accountable to their patients. In doing so they are re-inforcing the identity of massage therapy as a healthcare profession.
Professionally speaking, it is every massage therapist’s responsibility to participate or engage in research in some capacity. For some therapists their participation in research will be minimal and indirect.
That is they will read research reports to keep up to date on relevant findings that may affect their practice. Other therapists may actually participate in designing and implementing research studies.
For still others, participation in research may include being part of a reading group which meets to critique research articles, attending research presentations at conferences, evaluating research for its possible use in practice, discussing research findings with clients, giving patients advice and information about
participation in studies, assisting in collection of research information, participating in a research ethics
committee that reviews the ethical implications of proposed research before it is undertaken and utilizing research by incorporating research results into practice.
The impetus for participation in profession-generated research will continue to grow in the 21st century.
Massage therapy research is, and will continue to be, a priority for our emerging profession as massage
therapists continue to strive to fulfill their socially ascribed role as health care professionals.
Certain trends are evident from developments arising in the late nineties. These include an increased focus on outcomes based research. That is research designed to assess and document the effectiveness of massage therapy services.
Outcome-based research has been stimulated by the need for cost effective care that achieves positive outcomes without compromising quality.
Secondly, we have the promotion of research utilization. We will see concerted efforts to translate research findings into practice and massage therapists will be encouraged to engage in evidence based patient care. This, in turn, will necessitate improvement in the quality of massage studies and therapists’ skills in understanding, critiquing and utilizing study skills.
We will need to strengthen our knowledge base through multiple conformation strategies. That is through deliberate replication or repeating of studies with different patients in different clinical settings and at different times to ensure that the findings are sound and scientifically verifiable. We will need to expand our utilization of research findings utilizing the Internet and other modes of electronic communication that can have a considerable effect on the dissemination of research information.
Today we are prone to think that violations of ethical principles within a research context occurred centuries ago rather than in recent times, but this is not the case. The Nazi medical experiments of the 1930s and 1940s are the most well-known examples of blatant disregard for human life.
The Nazi research agenda involved the use of prisoners of war and racial enemies in experiments designed to test the limits of human endurance and human reaction to diseases and untested drugs. The studies were unethical not only because they exposed these people to permanent physical harm and even death but also because the participants could not refuse participation.
Some recent incidents of unethical research practices in the United States provide even more poignant contemporary examples. Between 1932 and 1972, a study known as the Tuskegee Syphilis Study was sponsored by the United States. Public Health Service investigated the effects of syphilis on 400 men from a poor black community. Medical treatments were deliberately withheld to study the course of the untreated disease.
Another well-known case of unethical research involved the injection of live cancer cells into elderly patients at the Jewish Chronic Care Hospital in Brooklyn without the consent of the participants.
Even more recently it was revealed in 1993 that American federal agencies had sponsored radiation experiments since the 1940s on hundreds of people, many of them prisoners or elderly hospital patients. These and examples like these, some considerably less subtle, have emerged to raise concerns regarding research involving human participants.
Since the 1950s, predominantly in response to the human rights violations described above, various codes of ethics have been developed.
One of the first internationally recognized documents of this nature applicable to research involving human subjects is the Nuremberg Code, developed after the Nazi atrocities were made public in the Nuremberg trials.
Several other international standards have followed, the most notable being the Declaration of Helsinki, which was adopted in 1964 by the World Medical Assembly and then later revised in 1975.
Most health care professions have established their own codes of ethics.
Both British Columbia and Ontario (the two provinces which regulate the practice of massage therapy in Canada) have established their own codes of ethics. However neither of these at this time includes specific provisions dealing with research involving human participants.
Respecting persons …Protecting Participants
Human beings as participants in research are vulnerable persons. This vulnerability is directly connected to the possible misunderstandings that individuals are likely to have about the nature and significance of medical research.
Therefore, researchers have a moral obligation to use special care in obtaining the consent of would-be participants. They will need to avoid all forms of deception to which the subject does not consent, and abandon all forms of coercion. Informed consent must be clearly set out in terms of the need to warn would-be subjects of the circumstances of the research and of the opportunities for refusal and participation.
Some of the typical components of informed consent documents require, among other things, that a participant be provided with:
a) A statement that the study involves research, an explanation of its purposes and expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
b) A description of any reasonably foreseeable risks or discomforts;
c) A description of benefits to the subject, or others, which may be reasonably expected from the research;
d) A disclosure of appropriate alternative procedures of course of treatment, if any, that might be advantageous to the subject;
e) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
f) For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained;
g) An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights and whom to contact in the event of research-related injury to the subject;
h) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefit to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefit to which the subject is otherwise entitled.
The basic ethical principles at work in the participation of humans in research include beneficence
(Do Good) and non-maleficence (First Do No Harm).
Beneficence, from the Latin bene for well or good, and facio, for to do, denotes promoting someone else’s good or welfare. As an ideal ethical principle, beneficence requires us to act in such a way as to benefit others. Such benefits ought to take the form of preventing or removing some harm, or more directly acting to produce a good.
Because health care professionals are in a position to do harm as well as good, beneficence must be supplemented with non-maleficence.
Non-maleficence is the value expressed in the classic dictum “first do no harm.” This requirement finds concrete expression in the expectation that healthcare professionals exercise due care and caution in the performance of their duties to produce benefits for the patient.
The second moral principle that underlies research is the Kantian principle of respect for persons. It incorporates at least two important ethical beliefs: that individuals should be treated as autonomous agents and that persons with diminished autonomy are entitled to protection.
The principle of respect for persons is divided into two separate requirements. The first requirement is to acknowledge the autonomy of the patient and the second to protect those with diminished autonomy.
What does this mean or entail? In the first instance that human beings should be treated as autonomous agents, capable of choosing and directing their activities.
The principle of self-determination means that the prospective participants have the right to decide voluntarily whether to participate in a given study without the risk of incurring any penalty or prejudicial treatment.
It also means that participants have the right to ask questions, to refuse to give information, or to terminate their participation. A person’s right to self-determination includes freedom from coercion of any type.
Coercion involves explicit or implicit threats of penalty for failing to participate in a study or excessive rewards from agreeing to participate.
The obligation to protect potential participants from coercion requires careful consideration when the researcher is in position of authority, control, or influence over potential participants as might be the case in a massage therapist position.
Secondly, that special provisions must be in place to protect especially vulnerable groups, including children.
Ethically and legally speaking, children do not have the competence to give informed consent; therefore the informed consent of the parent(s) or legal guardian must be obtained.
Mentally or emotionally challenged people, that is people whose disability makes it impossible for them to weigh the risks and benefits of participation and make an informed decision, i.e., mental retardation, senility, mental illness, unconsciousness, etc.
In these cases the researcher must obtain the written consent of the person’s legal guardian.
If at all possible, informed consent from the prospective participant should be obtained as a supplement to consent from the guardian.
Deception in Research
Participants in research are also rendered vulnerable by virtue of the fact that they may as a result of their participation in research disclose confidential and private information about themselves. Ethical research must guard the participant’s privacy by ensuring that individual results are kept confidential.
This usually entails that each participant’s data cannot be linked to his or her name and that information about the identity of the participant is not communicated in any way without the participants’ consent.
Moreover, special provisions may have to be made for sensitive information, i.e., personality and intelligence test scores, academic grades, information about sensitive issues such as sexuality, mental and physical illness, physical and sexual abuse, substance abuse, death, and all issues involving children as participants in research.
The exception to the requirements to maintain confidentiality and privacy occurs when a researcher learns that an individual intends to do harm to himself. In this case, the researcher is required to take all reasonable steps to prevent this harm from occurring, including informing others if necessary.
Much of modern medical research depends on not disclosing to the subjects, for example in medicine, what drugs they are actually receiving or which treatment they will receive in order to compensate for distorted forces. Often both the investigator and the subject are not informed which set of drugs the patient is actually receiving. Instead, the investigators and the patients involved in the study are informed that the subjects will be receiving one of two or more drugs through a random assignment in order to compare the degrees of efficacy.
In random clinical trials subjects must be informed or at least offered information about what kind of information will not be disclosed, what form of randomization will occur, why it will take place, what information will be provided and when.
What is essential here, ethically speaking, is that subjects be offered sufficient information to allow them to decide if they will accept the risks and benefits of a research program.
The principle of respect requires that they are not unknowingly subjected to deception.
Ethically sound research includes debriefing at the conclusion of the study. Debriefing is helpful in disclosing information about the research so that participants may fully benefit from the research. Debriefing may also provide follow-up referral support such as counselling.
All research involving human subjects must be committed to protecting the rights of participants.
The following is a list of duties of researchers intended to protect the rights of participants.
- To respect the autonomy, privacy and confidentiality of subjects and others affected by the research.
- To get informed consent prior to conducting experimental research on competent adults.
- To prevent harm to all affected with special attention to the vulnerable (non-maleficence).
- To attempt to benefit all affected (beneficence).
- To keep promises (fidelity).
- To be honest as distinct from merely telling the truth. (Deception may be part of the experimental design, but these participants must be properly debriefed).
- To make reparation for harms done, even if they are unintentional harms.
- To be just.
- To advance knowledge.
- To give credit where it is due.
Why is it that Researchers Cannot Provide Ethics Approval for the Studies They Undertake?
It is difficult for researchers to be objective in their assessment of the risk/benefit ratio or in the development of procedures to protect participants’ rights. Biases may arise as a result of a researcher’s commitment to an area of knowledge and their desire to conduct the study.
For these reasons the ethical dimensions of a study must be subjected to external review. Therefore, most hospitals, universities and other institutions where research is conducted have established formal committees and protocols for research involving human subjects.
• This article is part one of a three part series on the topic of research ethics. Part two, to be featured in January 2003, will examine the role and purpose of institutional ethics review boards and explain some of the language and concepts used by these bodies in assessing research projects for ethics approval.
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