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

Eubios Journal of Asian and International Bioethics 14 (2004), 42-48.

 

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.


Table 1: Characteristics of physicians in 11 medical school hospitals / medical centers (MSH/MCs) in Taiwan

Characteristic

n

%

N

Specialty

2,425

 

Primary care or internal medicine

1,036

42.7

Surgery

528

21.8

Psychiatry

56

2.3

Others

663

27.3

Dental

142

5.9

Gender

 

 

Female

339

14.0

Male

2,086

86.0

Education Degree

 

 

Bachelor's

2,022

83.6

Masters Degree

216

8.9

Ph.D.

181

7.5

Current position

 

 

Resident physician

769

31.7

Chief resident physician

406

16.7

Attending physician

880

36.3

Vice superintendent or superintendent

28

1.1

Head of the department

292

12.0

Other

50

2.1

Experience in research abroad

596

24.9

Medical ethics courses taken (mandatory or compulsory)

1,833

75.6

IRB member (previous and inactive)

108

4.5

 

Table 2: Internal consistencies of physicians' attitudes, intentions and subjective norms

 

Variables

 No. of items

 

Cronbach Alpha

Behavioral intention

2

 

0.73a

0.77b

0.82c

0.80d

Awareness

6

 

0.82o

-

-

-

Behavioral attitude

8

 

0.74 a

0.76 b

0.79 c

0.78 d

Subjective norm

4

 

0.71 b

0.75 c

0.58 d

-

a: Intervention Study - Regulated by Medical Care Act

b: Intervention Study - Not regulated by Medical Care Act

c: Interaction Study - Observation

d: Interaction Study- Survey

o: Overall

-:Indicates not applicable

 


Table 3: Physicians' awareness of Human Research Participant Protection (HRPP) information

 

 

All Physicians

IRB Member

 

Never

Yes

 p-value*

Awareness of HRPP

Heard of it and familiar n (%)

Joint Institutional Review Boards

239 (9.9)

             175 (7.6)

             64 (61.0)

<0.01

IRB

144 (6.0)

             105 (4.6)

             39 (37.1)

<0.01

Nuremberg Code

43 (1.8)

                32 (1.4)

             11 (10.5)

<0.01

Belmont Report

21 (0.9)

                14 (0.6)

                 7  (6.7)

<0.01

Declaration of Helsinki

151 (6.3)

             113 (4.9)

             37 (35.2)

<0.01

Uniform Requirement for Manuscripts Submitted to Biomedical Journals

213 (8.8)

             171 (7.4)

             42 (40.0)

<0.01

 *:Chi-square test


Table 4: Physicians' attitudes, subjective norms and intentions regarding human subject protections

(Percentage of physicians who think the statements on the left are important, agree or serious)  n (% of those who answered)

 

Items

 

 

 

 

Behavioral Attitudes

Intervention

Interaction

Behavioral beliefs

A

B

C

D

When conducting studies of the types listed on the right, we should fully inform the patients or subjects (including interviewees) of the study's purposes and methods, the possible benefits of participating in the study, and the potential risks and side effects induced by the study.

 2,322 (97.4)

 2,147 (90.3)

1,475 (62.1)

1,394 (58.6)

When conducting studies of the types listed on the right, we should obtain the informed consent of the patient or subject (including interviewees) or his (her) guardian in advance.

2,335 (98.0)

2,170 (91.2)

1,506 (63.3)

1,500 (63.1)

When conducting studies of the types listed on the right, the subjects shouldn't be involved in research solely for administration convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

2,055 (87.0)

1,995 (84.6)

1,812 (76.9)

1,772 (75.2)

The draft plans of studies of the types listed on the right must be reviewed and approved by the (Joint) Institutional Review Board or Ethical Review Committee in advance.

2,205 (93.1)

1,855 (78.5)

1,005 (42.6)

851 (36.1)

Evaluation of behavioral outcome

 

 

 

 

When conducting studies involving human subjects of the types listed on the right, do you think it very important that researchers should end a study immediately if it is  found that the study has adverse effects (e.g., infringement of privacy or side effects) on the patients or human subjects (including interviewees)?

 2,255 (94.7)

2,221 (93.3)

1,965 (82.7)

1,896 (79.8)

When conducting studies involving human subjects of the types listed on the right, do you think that not obtaining informed consent from subjects (including interviewees) will have serious consequences?

2,271 (95.3)

 2,120 (89.0)

1,344 (56.6)

1,226 (51.6)

Do you think it very important to assess carefully the risk and the expected benefits before selecting subjects (including interviewees) such as children,  indigenous people, patients without behavioral self-consciousness and those with mental retardation?

2,077 (88.1)

 2,048 (87.0)

1,783 (75.7)

1,705 (72.5)

Making informed consent of the patients or subjects  (including interviewees) a prerequisite will complicate the administration process and deter the study.

988 (41.6)

 1,009 (42.6)

1,119 (47.2)

1,115 (47.1)

The procedure of review by the (Joint) Institutional Review Board or Ethical Review Committee in advance of studies of the types listed on the right will deter a study's smooth progress!

511 (21.7)

572 (24.3)

749 (31.8)

767 (32.6)

Subjective norms

 

 

 

 

Normative belief

 

 

 

 

Do your colleagues or friends think it important to have the (Joint) Institutional Review Board or Ethical Review Committee review studies?

-

362 (74.9)

162 (33.0)

93 (23.2)

Motivation to comply

 

 

 

 

If your colleagues or friends think it important to have the (Joint) Institutional Review Board or Ethical Review Committee review studies, do you agree with them?

-

279 (84.3)

117 (80.1)

69 (77.5)

According to your estimate, will they inform the patients before conducting studies?

-

364 (69.6)

289 (52.2)

290 (65.2)

According to your estimate, will they inform the hospital before conducting studies?

-

280 (51.6)

254 (46.5)

192 (44.3)

Behavioral Intention

 

 

 

 

Before conducting a study in the future, how likely would it be for you to have the research project reviewed by the (Joint) Institutional Review Board (IRB) or the Ethics Review Committee (ERC)?

2,198 (93.3)

1,972 (83.8)

1,190 (50.7)

1,080 (46.0)

Before conducting a study in the future, how likely would you obtain the informed consent of the patients or subjects in advance?

 2,286 (96.4)

2,135 (90.2)

1,438 (60.7)

1,355 (57.3)

a: Intervention Study - Regulated by Medical Care Act

b: Intervention Study - Not regulated by Medical Care Act

c: Interaction Study - Observation

d: Interaction Study- Survey

-: Indicates not applicable

 


Table 5: Physicians' intention, attitude and subjective norms toward HRPP

 

Intervention

Interaction

 

a

b

 

c

d

 

(Mean S.D.)

Specified by research type

Behavioral Intention (Range from 1 to 7)

IRB

6.5 1.0

6.0 1.3

4.7 1.8

4.5 1.9

Informed consent

6.6 0.8

6.2 1.2

5.1 1.8

5.0 1.8

(n)

(2,385)

(2,382)

(2,380)

(2,382)

 

 

 

 

 

Behavioral Attitude (Range from 1 to 49)

At-score

40.2 7.3

36.4 8.9

27.0 10.6

26.1 10.7

(n)

(2,385)

(2,382)

(2,380)

(2,382)

 

 

 

 

 

Subjective Norm (Range from -2.3 to 7.6)

Sn-score

-

4.5 1.9

3.2 2.1

3.1 2.0

(n)

 

(568)

(569)

(459)

 

 

 

 

 

Non-specified by research type

Awareness of HRPP (Range from 1 to 3)

Aw-score

1.5 0.4

(n)

(2,416)

 

 

a: Intervention Study - Regulated by Medical Care Act

b: Intervention Study - Not regulated by Medical Care Act

c: Interaction Study - Observation

d: Interaction Study- Survey       

-: Indicates not applicable

 

 

 

Table 6: Predicting physicians' behavioral intention by awareness, attitude, subjective norm.

 

Intervention study

Interaction study

 

Regulated by MCA

NOT regulated by MCA

 

 Observation

Survey

 

β

S.E.

 

β

S.E.

 

β

S.E.

 

β

S.E.

Intent to submit proposals to IRB

 

 

 

 

 

 

 

 

Gender

0.033

0.048

0.165

0.145

 

0.134

0.174

       0.093

0.204

Experience in abroad

0.127**

0.042

0.037

0.102

 

     -0.089

0.127

     -0.045

0.154

Behavioral Attitude

0.069**

0.002

0.077**

0.005

 

0.101**

0.006

0.100**

0.007

Awareness

0.206**

0.045

0.103

0.107

 

0.121

0.139

0.167

0.164

Subjective norm

-

-

0.086**

0.026

 

0.172**

0.030

0.122**

0.038

R2

0.30

 

0.38

 

 

0.48

 

0.40

 

Intent to obtain informed consent

 

 

 

 

 

 

 

 

Gender

0.081

0.042

0.085

0.128

 

0.164

0.163

0.133

0.192

Experience in abroad

0.012

0.037

     -0.104

0.090

 

     -0.178

0.119

0.039

0.145

Behavioral Attitude

0.059**

0.002

0.079**

0.005

 

0.114**

0.006

0.108**

0.007

Awareness

0.039

0.039

0.005

0.095

 

       0.015

0.130

     -0.089

0.155

Subjective norm

-

-

0.047*

0.023

 

0.128**

0.028

0.097**

0.036

R2

0.28

 

0.41

 

 

0.54

 

0.45

 

MCA denotes Medical Care Act         * : p<0.05                **: p<0.0                                    -: Indicates not applicable

 


Attitude and Subjective Norms

Attitude

Survey responses to the main descriptive results for attitude, subjective norms, and intention of physicians toward HRPP in the four kinds of research are summarized in Table 4.  Our findings show that over 78.5% of physicians had strong belief in the importance of HRPP in intervention studies in all four items of behavioral belief. However, over 20% of physicians saw no importance in IRB reviews for intervention studies unregulated by the MCA. Physicians' beliefs about HRPP review for interaction studies showed that almost 60% agreed with requirements to inform research participants, obtain informed consent, and fairly select research participants.  However, just over 40% regarded IRB review as important for interaction studies. In addition, physicians tended to consider the careful selection of patients to be more important than the fully informing research participants, obtaining their informed consent or submitting a proposal for IRB review. 

Results from evaluating behavioral outcome of intervention studies, showed that more than 93% of physicians considered it important to end an intervention study immediately when adverse effects occurred. For those intervention studies regulated by the MCA, over 95% of physicians considered that the consequence would be serious if they did not obtain research participants' consent. A smaller percentage, about 89% of physicians, considered this also to be true for intervention studies not regulated by the MCA. More than 72% considered it very important to assess both expected risks and benefits before selecting subjects. Some negative reaction was shown toward the need for IRB review and informed consent of the patients as a prerequisite to gaining permission. Physicians' attitudes toward HRPP also varied between intervention and interaction studies, and these variations were larger with regard to interaction studies than to intervention studies. 

 

Subjective Norms

Physicians were asked about their subjective norms regarding HRPP for the 3 studies other than intervention studies regulated by the MCA. Results of analysis of subjective norms are given (Table 4).

About 75% of physicians reported that their colleagues or peers who were currently conducting intervention research not regulated by the MCA had submitted their proposal for IRB review before beginning the studies. Furthermore, 84% of physicians reported that they agreed with this behaviors in others.  Only a very small percentage reported that their colleagues or peers submitted observational research proposals. A much smaller percentage reported that their associates submitted survey research proposals.  Almost 70% of the physicians reported that their colleagues or peers would inform the participants before conducting intervention studies not regulated by MCA, 52% would do so before conducting observational studies, and 65% would do so before conducting survey studies. 

In addition, about 52% of physicians reported that their colleagues or peers would inform their hospitals when conducting intervention studies not regulated by MCA, less than 47% would do so when conducting observational studies, and 44% would do so when conducting survey studies. 

 

Regression Results

Means and standard deviations are given for each measure (Table 5). According to the regression results (Table 6), physicians' attitudes were highly associated with their intention to submit proposals for IRB review and obtain informed consent from research participants, while their awareness was not statistically correlated to intention except for regulated interventional studies. 

For research regulated by the MCA, experience in conducting research abroad was significantly associated with the intention to submit a proposal for IRB review. For other research not regulated by the MCA, subjective norms were significantly associated with physicians' intention. 

 

Discussion and Conclusion

Our study reveals that physicians in Taiwan are largely unaware of research ethics and HRPP. Although current or previous IRB members showed the highest level of awareness, the low scores (Table 5) suggest a strong need for improved education, particularly HRPP, either in medical school itself or as continuing education.

In addition, physicians' behavioral attitudes toward HRPP varied among the 4 kinds of studies. A greater number of physicians showed positive attitudes toward the need for HRPP in intervention studies than they did toward interaction studies. This difference could be attributed to the nature of research physicians who were experienced with or currently involved in such studies. The possible harm caused by social and behavioral research was generally underestimated, and very little importance was given to privacy or confidentiality issues. Our study also showed that a larger variation existed in opinions about the need for HRPP in interaction studies than opinions on intervention studies. These results support a needs analysis done by the National Bioethics Advisory Commission in 2001. They recommended that research participant protection should be flexible enough to be applied to widely different research settings ( National Bioethics Advisory Commission, 2001). 

Regression analysis results indicate that for MCA-regulated research, other factors such as experience abroad, awareness and attitudes affected physicians' intention to submit their research proposal for an IRB review. Despite legislation governing human research, few physicians appear to understand how the laws apply (Chief Medical Officer of Department of Health and Department for Education and Employment Home Office, 2001). This may explain compliance problems, which still exist even in regulated research environments such as the United States. Therefore, regulations may not be sufficient in and of themselves to improve the HRPP system in Taiwan.

Our study also showed that a small proportion of physicians reported that the IRB system would deter research development. Most respondents had positive attitudes toward questions regarding analysis of risk benefit ratio, the informed consent requirement, and fairness in selecting of research participants, while some physicians seemed to have negative reaction to the need for IRB review. These findings may have been due to the lack of understanding or knowledge of the main functions of the IRB by physicians. In addition, some physicians might have encountered previous difficulty in dealing with IRB submission, or have thought that the IRB system might complicate the process of research and development. These explanations suggest that excessive oversight may encourage disdain among researchers, as well as create an impossible or pointless workload for the ethics review committee. However, in order to determine the validity of these speculations it will be necessary to carry out research to address these new questions. Some question whether requiring informed consent would deter research because of the increased administrative load. There is still no evidence on specific difficulties the researcher may face, nor on additional costs for the research. 

Since the concepts of informed consent and IRB originated in western countries, their applicability to Taiwan or other Asian countries continues to be highly-debated.  In Taiwan, there is a traditional reluctance to sign documents. In itself this should not be sufficient justification to avoid informing participants. Although written documents can in some circumstances be extremely important, the process of mutual communication may in fact be more important. Taiwan needs more education and information dissemination not only for researchers and IRB members but also for laypersons so that they can gain better understanding of the meaning of participating in human research and will not be afraid to communicate with researchers or sign papers when necessary.     

Our regression model demonstrated that physicians' attitude was a major determinant influencing their intentions toward HRPP. Currently, except for research covered in the MCA, all research is unregulated. In this environment physicians may be most influenced by their colleagues and peers.  Therefore, it is essential to promote HRPP in other types of research not regulated by the MCA. Due to lack of evidence of the effectiveness of regulatory HRPP policies and the long process of establishing such a regulation, other strategies such as creating a supportive environment and strengthening institutions' action in order to influence physicians' attitudes in general, might serve as adjuncts to HRPP reform in Taiwan.

Some limitations were inherent in our study. First, not all physicians who met our inclusion criteria were included in our study sample.  Second, most of the measures of awareness in our study were based on international ethics codes or standards because Taiwan has based its development of related concepts on western literature. This may have resulted in some bias in measures of physicians' awareness, but we expect that these biases are very small. This also elicits the question of whether western guidelines are suitable for Taiwan or other Asian countries.

 

Acknowledgement

The research on which this paper is based was supported by a National Health Research Institutes intramural grant (Grant Number: 89A1MP). We acknowledge the support from the CEOs of 11 medical centers or medical school hospitals as well as their nurses or staffs for performing an excellent job of administering the questionnaires. 

 

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