Review Of Research Proposals Research Articles

Human research ethics in Australia: Ethical regulation and public policy

This paper critically assesses the National Statement on Ethical Conduct in Research Involving Humans as a piece of public policy concerning the regulation of research ethics. Two of the stated purposes of the National Statement are the provision of a “national reference point for ethical consideration relevant to all research involving humans” and the “protection of the welfare and rights of participants in research”. The process of Human Research Ethics Committee review of research proposals is evaluated in light of these two purposes. I argue that the approach taken in the National Statement has the potential to meet these purposes, but that, in its current form the statement does not provide sufficient guidance to HRECs to properly fulfil either purpose. For the National Statement to meet its promise, it needs to provide greater direction to HRECs which is properly informed by understanding of the full array of research involving human participants.

Developing capacity for ethical review: minutes of the TDR Planning Meeting*

The TDR Planning Meeting on Developing Capacity for Ethical Review was opened by Dr H. Engers, Co-ordinator for Research Capacity Strengthening Plus, TDR/WHO on behalf of Dr C. Morel, Director, TDR, followed by welcome remarks from Dr T. Pang, Director, Research Policy Evidence, WHO, and Dr John Bryant, President, CIOMS. Professor R. Lie, Bergen University, presented the objectives of the meeting. He indicated that the meeting would describe the work accomplished in capacity-building for ethical review of biomedical research and examine a way forward through partnership. Professor K. Hirayama of Japan then gave a presentation on the ‘The Local and National Need to Develop Ethical Review in an International Framework’, emphasizing the role of regional Fora for Ethics Committees in responding to the need for competent ethical review of research proposals. Professor F. Crawley, EFGCP, discussed the development of the Operational Guidelines for Ethics Committees That Review Biomedical Research and the resulting establishment of FERCAP, the Forum for Ethical Review Committees in Asia and Western Pacific Regions. He presented the ongoing regional development of capacity-building in ethical review as it is being undertaken through the establishment of fora in the regions of Latin America, Africa, the Caribbean, the Mediterranean, and Russia/NIS. These fora provide essential platforms for regional, national, and local ethics committees to develop SOPs, national guidelines and legislation, networking, GCP, bioethics education, and act as a voice for persons in developing countries in the international discussion on research. The meeting participants discussed the experience to date and the ongoing activities in the various regions. Nine months have elapsed since the formation of FERCAP, and the participants were interested to examined the lessons learned during this process. Dr V. Muthuswamy, ICMR and FERCAP, and Dr J. Karbwang, TDR, informed the participants that the project had demonstrated that a greater number of individuals can be involved in this exercise, especially those involved in community health actions and those involved in national policy development. Further, it will be beneficial to involve the various international research and sponsoring partners from the very beginning because of the common interests in this area. It was also felt necessary to develop within this framework more tools for the training programmes and training the trainers that would also increase participation at all levels. Dr E. Esber, FDA, suggested that the project also should consider developing Good Ethics Review Practices to complement the Operational Guidelines. The participants then discussed the role of the pharmaceutical industry and other sponsoring agencies with regard to the possibility for conflict of interest in supporting the development of ethical review committees. Dr B. Haumann of Glaxo Wellcome suggested that sponsors contributing funds to the development of particular ethics committees might give rise to a conflict of interest. However, by pooling the funding for a common project, conflict of interest would be avoided. Dr M. Salvi of the European Commission suggested that there could be a conflict of interest if the industry did not contribute to capacitybuilding in ethical review! Further, it was recognized that this is also a potential issue for all types of funders. There was consensus that conflict of interest could be avoided. The discussion also pointed out that if international agencies such as WHO, UNAIDS, and UNESCO, take a leading role and assist countries with taking up capacity-building in ethical review as a priority, the response will be stronger and the results more efficiently realized. In this context a proposal was made that the Advisory Committee on Health Research (ACHR) of WHO could take this matter to the Executive Board of WHO which could lead to a resolution for consideration by the World Health Assembly. If that were to happen, representatives of every nation would learn of the importance of capacity-building for ethical review. It was further suggested that an international

Blind review of research proposals in Korea: Its effectiveness and factors affecting applicant detection

This article addresses the potential effectiveness of blind review in selecting and funding research proposals in a “scientifically small” country. By analyzing 474 responses of the blinded reviewers ever worked for Korea Science and Engineering Fund, it was found that blind review is fairly effective. About two thirds of the blinded reviewers were unable to recognize the applicants accurately. The applicant detection was affected by (1) physical age, (2) professional experience, and (3) geographical location of doctoral education of the applicant, (4) review experience, (5) rank of employing universities of the reviewers, and (6) similirity of research interest between an applicant and a reviewer. It was also found that blind review was more strongly advocated by those who had made a wrong guess or who had given up guessing. Implications of the findings and future research directions were discussed.

Protecting Human Subjects of Biomedical Research

CONGRESS and the White House are weighing tighter measures to protect human subjects of biomedical research. At issue is adherence to the so-called common rule. The common rule is the core of the regulations governing research on human subjects; essentially, it requires that agencies engaged in such research set up committees to review research proposals for possible risk or harm ( JAMA . 1996;276:1627). The common rule sets out the requirements for informed consent and institutional review board oversight. It has been adopted by 17 federal departments and agencies that conduct or sponsor biomedical and behavioral research on humans. Addressing a meeting of the National Bioethics Advisory Commission, Chris Kline, a staff member of the US Senate Committee on Governmental Affairs, said the committee is preparing legislation that would require all government agencies to adhere to the common rule. The legislation would stipulate criminal sanctions for violations. The White House is preparing

Structure and Practice of Institutional Review Boards in the United States

The institutional review board (IRB) is a critical element in the protection of patients' and subjects' rights with regard to their participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States. A self-administered questionnaire was mailed to the IRB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size and structure, review of research proposals, and policies concerning scientific misconduct. Chairs also were asked what advice they would offer a young investigator preparing a proposal for submission. A total of 488 surveys (54%) were returned; 447 of the responding institutions had an IRB committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRB representation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go through 5 specific steps once submitted for review. Common reasons for proposal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal reasons (24%), and scientific merit (14%). When a research proposal is rejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy regarding research integrity. Despite variations in committee structure and representation, IRBs have similar procedures for governing research. Investigators should be familiar with these procedures and are encouraged to discuss their proposal with an IRB representative prior to formal review.

A Survey of University Institutional Review Boards: Characteristics, Policies, and Procedures

review research proposals, 15-17 the reliability and variability of IRB reviews,18',19 the satisfaction of researchers with IRBs,13 and the politicization of the IRB review process.14,20 An excellent summary of the IRB literature can be found in Levine.21 Gregory J. Hayes, MD, MPH, is chairman and associate professor, Department of Health Sciences; Steven C. Hayes, PhD, is chairman and professor, Department of Psychology, University of Nevada, Reno; and Thane Dykstra, BA, is a psychology intern, Brown University, Providence, R.I. Federal regulations have attempted to set national standards for IRBs.22

Attributes of reliable long-term landscape-scale studies: Malpractice insurance for landscape ecologists

Monitoring long-term change in forested landscapes is an intimidating challenge with considerable practical, methodological, and theoretical limitations. Current field approaches used to assess vegetation change at the plot-to-stand scales and nationwide forest monitoring programs may not be appropriate at landscape scales. We emphasize that few vegetation monitoring programs (and, thus, study design models) are designed to detect spatial and temporal trends at landscape scales. Based primarily on advice from many sources, and trial and error, we identify 14 attributes of a reliable long-term landscape monitoring program: malpractice insurance for landscape ecologists. The attributes are to: secure long-term funding and commitment; develop flexible goals; refine objectives; pay adequate attention to information management; take an experimental approach to sampling design; obtain peer-review and statistical review of research proposals and publications; avoid bias in selection of long-term plot locations; insure adequate spatial replication; insure adequate temporal replication; synthesize retrospective, experimental, and related studies; blend theoretical and empirical models with the means to validate both; obtain periodic research program evaluation; integrate and synthesize with larger and smaller scale research, inventory, and monitoring programs; and develop an extensive outreach program. Using these 14 attributes as a guide, we describe one approach to assess the potential effect of global change on the vegetation of the Front Range of the Colorado Rockies. This self-evaluation helps identify strengthes and weaknesses in our program, and may serve the same role for other landscape ecologists in other programs.

The New Zealand experience of a comprehensive fully costed science funding system

The publicly funded component of New Zealand's science system, which accounts for about two-thirds of the national R&D expenditure, has been almost completely restructured in the last five years. Like other far-reaching public sector reform in New Zealand, this has resulted in a separation of the policy, purchasing and operations roles and their placement in different organisations. The purchasing role is undertaken by the Foundation for Research, Science & Technology, which invests ca $287 million annually in R&D in line with broad priorities set by the government and more detailed Research Strategies of its own device. The Foundation has been required to establish a system of contestable funding, similar in principle to that in most other countries but previously absent from New Zealand. The Public Good Science Fund is described and compared with other systems for public funding of R&D. Remaining structural problems in the system, some of which constrain progress towards implementing the government's priorities, are identified and likely solutions are indicated. Future developments in the system will see increasing use ofex-post evaluation of research performance to complementex-ante peer review of research proposals, and the development of close linkages among research providers and research users, and between public investment and private investment in R&D.

Bicameral grant review: How a systems analyst with aids would reform research funding

A systems analyst (SA) with AIDS has applied his professional skills to determine whether available research funds are being spent optimally. After an initial briefing by the director (D) of a major funding organization and visits to various research laboratories, he now returns to suggest to the director a novel “bicameral”; method of reviewing research proposals. The “retrospective”; and “prospective”; parts of research proposals should be separated and independently routed. Peer‐review should be entirely retrospective and concerned with past performance relative to funds received. Prospective review, concerned solely with budget, should be performed in house by the funding bodies. The director is not entirely in agreement.

New forms of accumulation in Tanzania: The case of gold mining

Abstract In this article Chachage Seithy L Chachage shows that the legal framework and attitude towards private investments in Tanzania over the years has been favourable. “It is obvious,” he argues “that the World Bank's thesis that mining in Africa was hampered by controls and inappropriate policies is based on false premises. It rests at the very least on confusion between mining in general and mining by very large scale foreign private companies.” The article was prepared for a research proposal review workshop on structural adjustment and social change in Africa, held in Lesotho November 1992 as a part of the Scandinavian Institute of African Studies Research Programme ‘The Political and Social Context of Structural Adjustment in Sub-Saharan Africa’.

Do Australian researchers accept committee review and conduct ethical research?

We sought researchers' views on the ethics of research practice and the Australian system of review of research proposals by research ethics committees (RECs). Researchers were found to be supportive of review of research proposals, even though they thought that the process of review was time consuming and demanding. However, our findings suggest that not all researchers present their research proposals for review by committees, and that some researchers deviate from their approved proposals without seeking approval for those deviations from an REC. Researchers supported monitoring of research by RECs.

The research grant application process. Learning from failure?

Increasing competition for federal government research funds has resulted in a large number of good projects not being funded. This situation is unlikely to change in the near future and has generated uncertainty and frustration amongst many who are dependent on external funding for their research. In this context it is particularly important that the aims of federal government funding agencies are communicated effectively and that the procedures they establish to allocate research funds are seen as credible by the academic research community. This article reports the results of a survey which investigated the research grant process from the point of view of unsuccessful applicants from four universities for large 1991 initial Australian Research Council grants. The findings identify a number of limitations in the operations of the peer review mechanism as used by this Council and question the adequacy of the advice and instructions provided by the ARC to those nominated to review research proposals. The findings also raise questions concerning how the lists of external assessors are compiled as well as how these external assessors are later matched with individual applications.

Perspectives of research participants, psychologist investigators, and institutional review boards.

This study investigated the views of 100 student research participants, 107 psychologist investigators, and 45 members of Institutional Review Boards (Human Subject Committees). Participants in these three groups responded to questions regarding the ethical parameters of a fictitious psychological research protocol. Psychologist investigators' endorsements are similar to those of Institutional Review Board members when the debriefing procedure of the protocol and its potential benefits to others are questioned. The views of psychologist investigators are similar to those of students when the topic of risks to participant is at issue. Implications of these findings for review of research proposals in psychology by Institutional Review Boards are discussed.

Nobel Chemistry Prize Recognizes the Importance of Ernst's nmr Work

Richard R. Ernst of the Swiss Federal Institute of Technology (ETH) in Zurich was reviewing research proposals on a flight from Moscow to New York, on his way to collect Columbia University's 1991 Louisa Gross Horwitz Prize, when the captain informed him he had won the 1991 Nobel Prize in Chemistry. While the news was not important enough to interrupt screening of the in-flight movie, Ernst did go forward to the cockpit to receive the radioed congratulations of the Royal Swedish Academy of Sciences, the president of Switzerland and participants in a party organized on his behalf in Zurich.

The Physician's Stake in Animal Research-Reply

In Reply.— Apparently, Dr Odell is unaware of a number of steps the National Institutes of Health (NIH) have taken to effect the activities he views as necessary. In June 1984, led by the NIH, the Public Health Service revised its guidelines for the care and use of laboratory animals. These new guidelines were prepared well before legislation requiring them (PL 99-158) was enacted, but the requirements are virtually identical. The guidelines were developed after extensive review of public comments, including many from persons Dr Odell would categorize as animal rights advocates. One of the requirements is that every institution have an animal care and use committee to review research proposals and to oversee animal facilities and research. Generally, at least one committee member must be an individual not on the payroll or otherwise affiliated with the institution. These requirements clearly address Dr Odell's concern that the general public have

Human Rights Consultation: A 12-Year Experience of a Pediatric Bioethics Committee

For many years there has been a committee at the Children's Hospital of Pittsburgh to review research proposals to assure that the rights of children are protected. In 1974, its composition was changed and its mission broadened to include consultation and discussion of ethical issues in clinical care. The committee is called the Human Rights Committee to reflect this mission. Medical ethical consultations are performed by rotating on-call teams consisting of a physician and a nonphysician who are members of the committee. Selected cases from 48 consultations are presented to demonstrate the process and to illustrate some of the questions that were addressed. The clinical diagnoses were varied, but the commonest were congenital malformations. The most frequent reason for consultation was to question the advisability of assisted ventilation (27 cases), but other reasons concerned definitive surgery, intravenous hyperalimentation, cardiopulmonary resuscitation, and tracheostomy. Consultations are always optional and advisory. The recommendations of the consultation team are subsequently reviewed by the entire Human Rights Committee. The service has been well received by the medical staff. This method has some of the advantages of both the hospital ethics committee and the single consultant. Therefore, it should be considered when planning how to deal with these important problems.

Access to nurse-midwives and their clients for clinical research

Clinical research involving nurse-midwives and their clients has been steadily increasing over the past decade. In the future, more clinical nurse practitioners will be seeking advanced academic degrees that require the completion of comprehensive research projects, and clinical investigators from other disciplines will continue to view maternal-child health issues such as nurse-midwifery management as highly researchable. Nurse-midwives need to be involved in the process of research proposal review and the monitoring of all research activities that involve them and their clients.

Human Subjects Research: A Handbook for Institutional Review Boards

According to the editors, this book "is designed to fill the perceived need for an operational guide to IRB function... for the IRB member [and] the IRB staff person." There is a need for such a book, and this volume makes a reasonable, if flawed, attempt to meet it. Institutional Review Boards (IRBs) have existed in most teaching hospitals for more than 15 years. Their primary purpose is the protection of human subjects, but they also protect the institution and the research enterprise itself. Institutional Review Boards review research proposals to ensure that risks are outweighed by benefits, subjects are protected, and informed consent is obtained. Few dispute these goals, but IRBs have been criticized for getting involved in minutia and creating red tape. In response, both the Department of Health and Human Services and the Food and Drug Administration issued new regulations in 1981 that streamline review for most

Search for alternatives to animal testing expands

The Johns Hopkins University, Baltimore, has become the third major research institution this year to agree to seek alternatives to the use of animals for testing the safety of commercial products, and this may be only the beginning. The university's School of Hygiene and Public Health is accepting a $1 million grant from the Cosmetic, Toiletry, and Fragrance Association (CTFA), Washington, DC, to set up a Center for Alternatives to Animal Testing. Some research will be done at Hopkins but, according to Alan M. Goldberg, PhD, a professor of toxicology who will direct the center, Hopkins also will select investigators from other institutions. A panel of scientists not connected with the university will review research proposals that come in after a symposium is held to identify areas for research. Earlier this year, Rockefeller University, New York City, and Tufts University School of Medicine, Boston, agreed to engage in similar searches

Trend toward multiple authors in research publications: Mutual funding of scientists

In a recent editorial, Leopold [1979] drew attention to the large amount of time now being spent by the U.S. research community on the preparation and review of research proposals submitted to the principal federal granting agencies. More to the point of this letter, he quoted a ‘fanciful story’ by Szilard [1961] in which it was suggested that if some person or some group should ever want to bring research progress to a standstill, they could do so by establishing a competitive grants system under which all researchers would be required to prepare written proposals describing what they wished to work on. Leopold ended by suggesting that ‘perhaps it is now appropriate to ask whether Szilard's fanciful story is turning into a serious matter.’If there is any substance to Szilard's story and Leopold's concern, there should be evidence now available for a slowing down in the progress of U.S. science, since federal grants for research started to become a substantial factor in university budgets in the late fifties [Abelson, 1975]. Unfortunately, lacking a means of quantifying progress in science, it is difficult to argue objectively either for or against this slowing down. However, as I will now show, there has been a marked change in the way science is reported since the fifties.