Health research in the developing world: a gastroenterological view from Bangladesh

OBJECTIVES: To identify knowledge levels of academic surgeons about Food and Drug Administration (FDA) and Institutional Review Board (IRB) regulations for clinical research and to determine whether being a member in an IRB, conducting or participating in clinical trials, or being a member in surgical societies affected knowledge levels. DESIGN: Survey of surgical department faculty members in 20 universities. RESULTS: Sixty-five responses were received from 14 sites. Overall mean (+/- SEM) correct score was 6.7 +/- 0.2 of a possible 20 points. The best predictor of overall score was being a primary investigator of a clinical trial (P < .001), followed by being or having been a member of an IRB (P < or = .02). The total mean score of members of the Surgical Infection Society (8.2 +/- 0.5) was significantly higher (P < .001) than that of nonmembers (6.1 +/- 0.2), a phenomenon not observed with other surgical societies. In certain hypothetical clinical scenarios, all respondents were mistakenly willing to conduct clinical trials without obtaining appropriate approval from the FDA. Four (22%) of 18 IRB member respondents and 16 (25%) of the 65 respondents were willing to conduct human research without appropriate approval from patients, the IRB, or both. CONCLUSIONS: Knowledge deficits exist in the academic surgical community about the role and requirements of the FDA and local IRBs for conducting clinical research. Further study is required to determine the reasons for this deficit and to identify appropriate interventions.     

Medical research and the ethics committee. A questionnaire study among project leaders in the health region 4

All 159 principal investigators whose projects had been assessed by the biomedical research ethics committee in Health Region 4 (Central Norway) during 1986-92 were asked to complete a questionnaire about medical research ethics and the work of the ethics committee. Their answers about scientific fraud and misconduct have been published previously. This paper reports how the 119 respondents (70% of those addressed) regard the role and work of the ethics committees and how they perceived the committee's assessment of their own project. A majority agreed that medical ethics committees are an important part of the scientific community (90%), that scientific quality is an important ethical element of any project (85%), and that researchers put more effort into their study protocol as they knew it would be assessed by an ethics committee (85%). More than 70% agreed that the committee's comments were useful and relevant, but a majority of these agreed only partly. The results are discussed in relation to the characteristics of the investigators.     

Ethical evaluation of hypnosis research: a survey of investigators and their institutional review boards

We surveyed hypnosis researchers and Institutional Review Boards (IRBs) with regard to the ethical evaluation of research protocols. Researchers and IRB administrators were independently surveyed within the same institutions. Both objective and free response items were used to address substantive issues such as deception and at-risk populations, as well as practical matters such as paperwork. Parallel questions allowed a point-counterpoint between researchers and IRBs. Overall, the results suggest that IRBs do not treat hypnosis research differently than other types of research. We end with recommendations for facilitating interactions between hypnosis researchers and their IRBs.     

The institutional review board as a mirror of scientific and ethical standards

Decisions by institutional review boards (IRBs) are presumed to reflect the norms and standards of the scientific community. Such criteria have shifted as changes have occurred in experimental interventions and protocols, codes of federal regulatory agencies, norms among investigators, and expectations of participants. The tension created by shifting norms and standards raises two questions: (a) Should IRBs evaluate the scientific (e.g., design) features of the proposed research, and (b) should consistent standards be expected even in areas that are in constant flux (e.g., AIDS research)? We discuss these questions and propose a mechanism to keep IRBs abreast of emergent issues and sensitized not only to the costs of doing research but also to the costs of not doing it.     

Human subjects review, personal values, and the regulation of social science research.

157 university human-Ss committees (i.e., institutional review boards [IRBs]) provided reviews of 9 hypothetical proposals that were identical in their treatment of human Ss but differed in sociopolitical sensitivity and in level of ethical concerns (e.g., presence or absence of deception, debriefing). The socially sensitive proposals were designed to document discrimination or reverse discrimination according to race or sex in corporate hiring practices, whereas nonsensitive proposals were designed to document discrimination based on height or weight. All aspects of the proposals were otherwise identical. Results show that socially sensitive proposals were twice as likely to be rejected by IRBs. Reasons for nonapproval varied: For sensitive proposals containing ethical concerns (e.g., deception), the foremost reason given for nonapproval was the violation itself. For sensitive proposals that did not involve ethical concerns, the reason most often given for nonapproval was "methodological" (e.g., poor control group). Nonsensitive proposals that did not involve ethical problems were approved 95% of the time vs only 40–50% of the time for comparable sensitive ones. Content analysis of the narratives that accompanied decisions revealed that the primary reason for rejection of sensitive proposals was the potential political impact of the proposed findings (e.g., discrediting of affirmative action policies). (43 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Importance of factors in the review of grant proposals.

50 National Institutes of Health program directors, executive secretaries, and administrators rated hypothetical evaluations of grant proposals. Presence or absence and the value of 8 evaluative factors were varied in a fractional factorial design. Ratings of scientific merit and traditional "priority scores" were analyzed using an information integration model. Results indicate large differences in the effects of the information due to both level and presence or absence in the review. The most important factors had to do with the scientific relevance of the proposed research, the clarity of the proposal, the soundness of the experimental methods, and the evaluation of the principal investigator. A strong set-size effect was found such that more information led to more extreme rating when the value of the information was in the same direction. Implications for reviewers' implicit policies and the resulting strategies adopted by those seeking funding are discussed. (21 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Medical investigators' views about ethics and fraud in medical research

The objective of this study was to ascertain the views and attitudes of medical investigators on medical ethics, and ethics and fraud in medical research. We sent postal questionnaires to all principal investigators whose study protocols had been assessed by their regional medical ethics committee for biomedical research (mid-Norway) in the years 1986-92 (n = 159). The response rate was 70% (n = 119). Some 80% agreed that ethical considerations had influenced their research and 12% that they would have had ethical scruples today about some of their previous projects. One in ten agreed that they might have achieved better results if they could have paid less attention to ethics. About 70% of the respondents found that the committee's comments were useful and relevant, but most agreed only in part. Around 85% agreed fully or in part that scientific quality is an important ethical element of any project and that researchers put more effort into their study protocol when they knew it would be evaluated by an ethics committee. One in six (18%) respondents agreed fully or in part that they had been exposed to scientific misconduct. Also, 27% knew about one or more cases of fraud or misconduct while 42% stated that this knowledge was not public. We concluded that ethics in medicine and medical research have an important and increasing role among investigators with little or no theoretical background and training in ethics. Scientific fraud and misconduct in medicine is a growing concern among researchers, who welcome a professional body that can manage allegations and cases of fraud.     

Omentoplasty in the management of filarial lymphoedema

OBJECTIVE: Peer review is an important part of the publication of scientific results. We analysed the peer review process of abstracts submitted to the European Association for the Study of the Liver (EASL) congress in Copenhagen in 1995. DESIGN: Comparative study. All abstracts were reviewed by all six members of the EASL scientific committee. Furthermore, each abstract was evaluated by three to six experts within 17 specific study fields, appointed by the scientific committee. All abstracts received a score on a scale from 1 to 5, one being the best. For each abstract the average was calculated for the scores of the committee members and the expert reviewers separately. MAIN OUTCOME MEASURE: Abstract score. RESULTS: There was a significant difference in the scores between the committee members, who scored 3.31 on average, and the expert reviewers, who scored 3.02 on average. Within most of the study fields the tendency was that the expert reviewers gave the highest scores. Moreover, there was a significant variation in the estimates among the individual reviewers as well as between the 2 groups of reviewers. Only 25% of the abstracts that received the best scores by the expert reviewers were classified in the same way by the committee members. The predictive value of a positive evaluation by the committee members was 0.6, the predictive value of a negative evaluation was 0.90. CONCLUSIONS: There was a considerable variation in the peer review process for abstracts submitted to the 1995 EASL congress depending on selection of reviewers. Various types of peer review strategies should be tested and evaluated to secure the highest possible scientific quality of published research results.     

Evaluation of Institutional Review Board review and informed consent in publications of human research in critical care medicine

OBJECTIVE: To examine the frequency of obtaining Institutional Review Board (IRB) approval and informed consent in critical care research. DATA SOURCES AND DATA EXTRACTION: One-year retrospective review of original critical care research in humans published in seven journals, including American Journal of Respiratory and Critical Care Medicine, Chest, Critical Care Medicine, Intensive Care Medicine, The Journal of the American Medical Association, Lancet, and The New England Journal of Medicine. Studies were examined for general information (country/state where the research was performed, affiliation of the hospital to a medical school, and whether the work was supported by a grant and specifically by a pharmaceutical company), approval by IRB, method of consent, design of research, and interventions involved in the study. DATA SYNTHESIS: Two hundred seventy-nine studies were reviewed, 124 (44%) of which were conducted in the United States. Two hundred forty-three (87%) studies were performed in a university institution, 96 (34%) studies were supported by a grant, and 23 (24%) studies were supported by a pharmaceutical company. In 66 (24%) studies, there was no evidence of IRB review and informed consent approval. IRB approval was obtained but the method of consent was not specified in 36 (13%) studies. No significant differences were found in obtaining IRB approval and informed consent between research conducted in the United States (n=71, 57%) or outside the United States (n=92, 59%). Grant support was obtained in ten (9%) of the 116 studies not fully approved, compared with 70 (50%) of the 140 studies that obtained full approval (p < .05). All studies (23) supported by the pharmaceutical industry were fully approved. CONCLUSIONS: Many published studies in critical care lack IRB approval and/or informed consent. All research supported by the pharmaceutical industry was fully approved. The findings raise ethical concerns about critical care research.     

The relationship between the psychological investigator and the public schools.

In an effort to create a reciprocating arrangement between university and various school systems, "a facility, designated the Office of Child Research was recently established at the University of Texas." This unit provides assistance to the investigator in the preparation of the research proposal, submits the research proposal, informs the investigator of the disposition of his proposal and assists in preliminary arrangements, reports to the school on completion of the study, provides a variety of reciprocating services, and maintains records. From Psyc Abstracts 36:02:2KA01C. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Reliability in ethics reviews: Some initial empirical findings.

Assessed the reliability of peer judgments about the ethical acceptability of research proposals by examining independent review of 111 submissions to a psychology department ethical review committee during a 10-mo period. With a 3-category rating protocol, independent reviewers agreed exactly on 67.7% of submissions. However, this level of observed agreement accounts for only 8% of the possible beyond-chance agreement. Lack of success in obtaining reliability is attributed to insufficient attention to reliability issues, and suggestions are discussed for improving interjudge agreement. (French abstract) (8 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Experimental electrocoagulation of dog esophageal and duodenal mucosa

The per review system for the assessment of research proposals is widely respected by working scientists. Nevertheless two problems associated with the operation of this system by the US National Institutes of Health are identified. First the scientist has no control over which committee will review an application and it may be considered by a quite inappropriate group. Second analysis of the committee composition suggests that in some of the groups several members are not active scientists and therefore not the "peers" of the applicant.     

Proceedings of the American Psychological Association, Incorporated, for the year 1985: Minutes of the annual meeting of the Council of Representatives August 22 and 25, 1985, Los Angeles, California, and January 31-February 2, 1986, Washington, D.C.

Presents the official record of actions of the American Psychological Association (APA) taken during the year by both the Board of Directors and the Council of Representatives. Actions in the following areas are outlined: minutes of meetings in 1985–1986; elections, awards, membership, and human resources; ethics; the psychology defense fund; development program; education and credentialing; public affairs; insurance issues; legal and legislative issues and functions; divisions; state associations; structure of the APA; liaison/participant system; council procedures; publications and communications; convention affairs; educational affairs, including accreditations, continuing education, undergraduate curriculum, psychology in secondary schools, and national conference on issues of graduate education; professional affairs, including peer review, advocacy, practitioner policy, and changes in the Committee on APA/State Association Relations; scientific affairs, including animal research, test issues, a chief scientific advisor, and a traveling psychology exhibition; social and ethical responsibility, including proposals on the elimination of boxing, acquired immune deficiency syndrome, polygraph testing, and the establishment of a committee on children, youth, and families; ethnic minority affairs; international affairs; central office; financial affairs; and communications concerning outside organizations. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Experiences with the rectal use of chemotherapeutic agents. 2. Pharmacokinetic examinations with animals

Pediatric oncology nursing would benefit from more research directed toward questions that relate to the care of children with cancer. There are many ideas and proposals that are begun but never carried to fruition. This article will detail how to assess and rework a research proposal to provide the basis for a research project that will add to the scientific knowledge of nursing care of children with cancer.     

Termination guidelines for a magnet school review committee: Application of decision theory.

The purpose of a magnet school is to assist the school system in reaching its desegregation goals while providing a quality education. One of the roles of the magnet review committee is to evaluate the degree of success of particular magnets and make recommendations to the United States District Court, Eastern District of Missouri, about proposals to terminate magnet schools. The committee members have found it difficult to reach consensus on these proposals. We conducted an empirical case study of the process by which applied experimental psychology consultants helped to develop the review procedure. We constructed a decision guideline by quantitatively modeling the attitudes, beliefs, and legal positions of the decision makers and representing them as a series of weighted utility functions. The decision aid was accepted by the magnet review committee and the federal court and is currently being used by the committee to evaluate schools for termination. In this article we discuss the development of the decision aid from methodological and consultative perspectives. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Political intervention in scientific peer review: Research on adolescent sexual behavior.

In 1991, the secretary of Health and Human Services (HHS) rescinded funding for a survey of adolescent health risk-taking behavior. The decision overturned a series of scientific and ethical peer and administrative reviews of the research, which had been chosen in a competitive evaluation of proposals to advance knowledge about the prevention of AIDS and other diseases. The cancellation, coupled with congressional action to block similar research, left a gap in scientific data about adolescent health risk taking. The cancellation may also encourage the further use of political criteria in evaluating proposals for scientific research. Procedures for funding scientific research should be reformed to protect peer review from arbitrary political intervention. Through a discussion of this decision and its consequences for AIDS prevention research, principles that justify autonomous peer review are clarified and a reform that could strengthen it is discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Philosophy and psychotherapy.

In the course of responding to Elliott's (2008) provocative article, the authors tour some precincts of the intellectual foundations of psychotherapy. In particular the authors review the philosophical underpinnings of contemporary research on psychotherapy and provide a context that allows for an examination and critique of Elliott's proposals for new research methods and new approaches to conceptualizing the data of psychotherapy research. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Perceptions of scientific misconduct in nursing

Recently, scientific misconduct and ethical problems in research have been widely discussed. Some have created embarrassment and shaken the scientific community. In response to concerns about the adequacy of the scientific community's self-regulations, attempts are being made to refine policies and procedures for handling allegations of misconduct.     

How reliable is peer review? An examination of operating grant proposals simultaneously submitted to two similar peer review systems

To determine level of agreement and correlation between two similar but separate peer review systems, proposals simultaneously submitted during the same funding year to two agencies using the same scoring system were identified and analyzed (n = 248). There was a direct linear relationship between the scores of the two agencies (r = 0.592, p < 0.001). Raw agreement within whole-digit ranges was moderate (53%) but a Cohen's kappa indicated that agreement beyond chance was only fair (kappa = 0.29, 95% CI = 0.198, 0.382). When proposals were arbitrarily categorized as being "clearly fundable" (on a 0-5 scale, score > or = 3.0) or "not clearly fundable" (score < 3.0), raw agreement was 73% and agreement beyond chance was moderate (kappa = 0.444, 95% CI = 0.382, 0.552). In cases where there was inter-agency disagreement on the fundability of the project, the difference in scores was greater than in those in which there was agreement. In a subsample of 128 pairs, variables describing the application and the applicant (i.e., principal investigator) were coded, but none explained inter-agency agreement on the "fundability" of proposals.