A National Survey of Physicians'
Attitudes toward Protecting Human Research Participants in Taiwan
-
Yaw-Tang Shih*, M.D., Dr. P.H.
Director,
Division of Health Policy Research
National
Health Research Institutes, Taipei, Taiwan, R.O.C.
2F, 109, Min-Chuan East Road, Sec. 6
Taipei
114, Taiwan, R.O.C.
-
Shu-Fang Shih, M.B.A., M.S.
Research
Assistant, Division of Health Policy Research
National
Health Research Institutes, Taipei, Taiwan, R.O.C.
-
Nan-Shen Chen, M.S.
Research
Assistant, Division of Health Policy Research
National
Health Research Institutes, Taipei, Taiwan, R.O.C.
-
Szu-Hsien T. Lee, Ph.D.
Assistant
Professor
Department
of Humanities and Social Sciences
National
Defense Medical Center, Taipei, Taiwan, R.O.C.
- Cheng-Shing Chen, M.D., Ph.D.
Chairman, Daniel
Executive Holding Corp, Taipei, Taiwan, R.O.C.
- Matthew Tayback, Sc.D.
Professor, Department of International
Health
The Johns Hopkins School of Public Health
*Address all
correspondence to: Dr. Yaw-Tang Shih, Email: annsshih@nhri.org.tw
Abstract
To understand the attitudes,
awareness, subjective norms and intention of physicians toward human research
participant protection (HRPP), we surveyed 2,425 physicians between September 2000 and January 2001
in a cross-sectional survey of 11 medical centers and medical school hospitals
in Taiwan. Response rate was
81%. Physicians' attitudes,
awareness, subjective norms and intention to comply with HRPP requirements were
measured via a self-administered questionnaire. We found that while 90% of respondents had never heard of IRB,
Nuremberg Code, Declaration of Helsinki, Belmont Report, U.R.M.S.B.J., or JIRB,
more than 78% of total respondents showed strong response in 4 items of
behavioral belief about the significance of HRPP in intervention studies. Around 22% did not recognize IRB
reviews as important for those intervention studies not regulated by the
existing Medical Care Act.
In the measure of physicians' beliefs toward HRPP as related to
interaction studies, over 59% favored requirements that research participants
be well informed and that informed consent be obtained. Only 43% believed an
IRB review was unimportant in conducting an interaction study. Physicians report that they place more
attention on selecting patients carefully than on fully informing research
participants, obtaining informed consent or submitting a proposal for IRB
review. Based on our regression results, physicians' attitudes were
highly correlated with their intent to be involved in IRB reviewed
process.
The results of our study suggest that physicians in Taiwan are not now
generally aware of HRPP. Attitudes about protecting research participants
varied among different types of studies.
This consistent lack of awareness combined with a lack of official
regulation shows that the HRPP system in Taiwan may not now be able to
adequately protect the safety and rights of human research subjects. In addition, our evidence shows that by
changing physicians' attitudes towards HRPP, we may accelerate progress in
developing, improving, and implementing HRPP.
Key Words: Human
Research Participants Protection; Ethical Review; Informed Consent; Physicians;
Attitude; Behavior.
Introduction
Medical
scientists devote their whole careers to the prevention and treatment of
disease, and thus to the improvement of human health. However, prior to the
1960s, relatively little attention was given to standards and practices of
bioethics in human research (Moreno & Lederer, 1996). Since that time, a prolific literature has accumulated on
ethical standards for human research, in particular on clinical trials. Much of the research is macro-level
analysis. Some reviews deficiencies of regulations or policies (Shalala, 2000),(McCrary, Anderson, Jakovljevic,
Khan, McCullough, Wray et al., 2000),(Amdur, 2000),(Moreno, Caplan, & Wolpe,
1998), others provide an analytical
framework for evaluating ethical factors in clinical studies (Emanuel, Wendler, & Grady,
2000). Based on such reviews, several reform proposals have been
proposed (Shalala, 2000),(Bodenheimer, 2000),(Moreno, Caplan, & Wolpe,
1998),(Rennie & Yank, 1997). However, as emphasized in the US National Bioethics Advisory
Commission 2001 report, few empirical studies address the significance of
reform and evidence-based policymaking.
In addition, very little has been done to study investigators' attitudes
toward HRPP. Regulation has been
used as a tool in protecting human research participants, but recent studies
have shown that the role of investigators or physicians' attitude should not be
overlooked (Moreno & Lederer, 1996),(Anonymous, 1996). Povl Riis (Riis, 1995) pointed out that a scientist's
moral values and behaviors is one important ethical demand.
While ethical issues surrounding human research have been
intensively researched and discussed among the members of the international
medical community in particular, there remains a gap between medical
advancements and the protection of participants in human research in
Taiwan. Before the 1986 Medical
Care Act (MCA), there was no official protection of participants' rights in
clinical trials. This Act only
covers the trial studies of new drugs, new medical techniques or new medical
devices that involve human participants.
In 1993, the Department of Health (DOH) required a local clinical trial
report in order for a new drug to be registered. In 1996 DOH developed Guidelines
for Good Clinical Practice (GCP). Only
in 2000, when the first drug clinical trial liability insurance policy was
approved by the Ministry of Finance's Department of Insurance, was a policy
created to assure compensation for research injuries as stated in the GCP.
The "Joint Institutional
Review Board" (JIRB) was jointly established in 1997 by five medical
centers and the Cancer Research Alliance. The JIRB was established with the
intention of facilitating trial research approval. The idea was that if a trial
were conducted in a hospital that participated in the JIRB, and that trial was
approved by the JIRB, then it would not be necessary for the investigators to
obtain the approval from the hospital, itself. Otherwise, the investigators
would need to obtain approval from the hospital where the trial was to take
place.
Only in 2000 did government-funded research
require IRB approval. At this time the DOH began to require IRB approval with
grant application. Because government-funded agencies used the term "human
experiment" in their grant application announcements, these policies are only
considered applicable to clinical trials using human participants. Therefore,
the regulations and guidelines extend to other research only to the extent that
investigators or their
institutions voluntarily follow them.
With the increases in R & D in medical science and technology,
and with Taiwan's 2002 accession to the WTO, the government, IRBs, research
institutes, universities, and professional associations will be required to pay
increasing attention to human research participants protection. Since the individual research
investigator is an important key factor within the HRPP system, the main
objective of this study was to survey the awareness and attitudes of physicians
regarding the protection of participants in human research. By assessing these measures, the
behavioral factors that might influence the prospect for successful
implementation of a HRPP policy can be identified.
Methods
Participants
A total of 2,425 physicians were surveyed between September 2000
and January 2001. Because Taiwan's
MCA specifies that only teaching hospitals are permitted to conduct human
experiments, according to the hospital accreditation report in 1999 only 12
hospitals were eligible. Of those, 11 were willing to participate in our
survey. The participants of this study were physicians who had worked in these
medical centers or medical school hospitals since at least 2000. Because new
staff members are normally not familiar with institutional policy, this study
excluded the residents who self-reported that they had worked for less than one
year in a medical setting.
Instrument
A self-administered anonymous questionnaire was designed to
measure a physician's awareness, attitudes, subjective norms and intention to
comply with HRPP requirements. In
order to assure reliability and validity of the measurement instruments, the
original questionnaire was then administered to two pilot groups from June to
August 2000 in Taipei Medical University - Municipal Wan Fang Hospital.
Five domains were assessed in the final questionnaire and used in
this study, including socio-demographic data, awareness, attitudes, subjective
norms, and intentions. The
socio-demographic variables consisted of age, gender, education, medical
specialty, current job position, medical ethics courses taken, and research and
ethics review experience.
There were 6 items on HRPP awareness. Data for these items were collected on a 3-point
semantic-differential scale, i.e. "never heard of it", "heard of it but not
familiar", and "heard of it and familiar."
A total of 8 items, rated on a 7-point scale, were generated to
assess physicians' attitudes toward HRPP. Each physician rated the importance
of these 4 items: participants' risk and research benefit; obtaining informed
consent; fairness in selecting research participants; submission of proposal to
an IRB. For each one they also rated the importance of the legal or moral
consequences of not considering these four items. The attitude score was
generated by the sum of the multiplication of each belief and corresponding
evaluation item (Ajzen &
Fishbein, 1980).
Subjective norm scores were also rated on a 7-point scale, coded
-3 to 3. Physicians rated their normative beliefs about how much importance
their colleagues or peers gave to having a research proposal go through the IRB
review process. Then they were asked their own attitude toward these actions of
their peers. Questions about
whether their colleagues or peers would inform hospitals or patients before
conducting research had choices also coded from 1 to 7. The subjective norm score was then
calculated by summing up the products of normative belief and motivation to
comply and the scores of further questions asked for each person.
Physicians' intention
regarding HRPP was also measured on a 7-point scale. It was determined by asking,
"Before conducting a study in the future, how likely would it be for you to
have the research project reviewed by the (J) IRB or the Ethics Review
Committee (ERC)?" and "Before conducting a study in the future, how likely is
it that you would obtain the informed consent of the patients or participants
in advance?"
Because of the limited effect of MCA on HRPP, physician responses
to attitudes, subjective norms and intention may vary depending on the kind of
study. Therefore, the study
questions were divided into four kinds of research: (1) intervention study -
regulated by Taiwan MCA; (2) intervention study - not regulated by MCA; (3)
interaction study - observation; and, (4) interaction study - survey.
Procedure
An official letter was sent to each
hospital before conducting the survey to solicit the hospital's support. A
one-day training program was held in each hospital so that each of the 126
nurses or administrative staff serving as the facilitators could go through the
process of obtaining informed consent from physicians, distributing
questionnaires and collecting responses. Administration of the questionnaires
was smooth. This research was
approved by the JIRB in October 2000.
Statistical Analysis
Statistical analysis was performed using SAS software. Univariate
analyses were performed on each variable.
Cronbach α coefficients were calculated to determine the internal
consistency of the measures. Two tailed t-tests were applied to test whether,
after multiple comparison adjustment, the physicians' attitudes, subjective
norms, and intention differed at a 5% level between intervention and
interaction studies. Multiple regression analysis was used to test the
independent associations of awareness, attitudes, and subject norms with
participants' intention of complying with the IRB and obtaining informed
consent.
Results
Characteristics of Participants
Surveys were distributed to 2,425 physicians
between September 2000 and January 2001. There was an 81% response rate.
Major descriptive statistics of responding
physicians are given (Table 1). Participating physicians had a mean age of 36.5
years and 86% (2,086) were male.
Sixteen percent of them held advanced research degrees (MS or PhD), and
52% were attending physicians.
Twenty-five of the physicians had experience conducting research in
other countries, and 4.5% had experience in ethics review. Most physicians had taken medical
ethics courses that were elective or required by their schools. Of those who met our inclusion criteria
mentioned above, 81% could be contacted.
Except for measures of awareness and subjective
norms, Cronbach α coefficients were calculated for all four research studies. Four
measures had a high internal consistency (Table 2).
Physician Awareness of HRPP-related
Information
Over 90% of physicians were unfamiliar with
international ethics codes or standards (Table 3). JIRB was the most familiar term, perhaps because it is the
domestic review board for human experiments. Over 90% of physicians, however,
were unaware of its existence. The
Belmont report was the least familiar of the terms, at only 0.9%.
Physicians who had been IRB members or were active IRB members in
2000 were found to be significantly more aware of international ethics codes or
standards, though 60% of this group were not familiar with any of the
international ethics codes or standards asked.