Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand

Researchers designing and conducting studies using human data should consider the values and principles of ethical conduct. Research ethics committees (RECs) typically evaluate the ethical acceptability of research proposals. Sometimes, differences arise between how researchers and RECs interpret ethical principles, and how they decide what constitutes ethical conduct. This study aimed to explore the opinions of these two groups about the importance of core ethical issues in the proposal and in the informed-consent process. An anonymous online questionnaire was distributed to a target population in health-related academic/research institutes across Thailand; 219 researchers and 72 REC members participated. Significantly, more REC members than researchers attributed the highest importance to three core ethical considerations – risk/benefit, vulnerability, and confidentiality/privacy. For the informed-consent process, significant differences were found for communication of risks, decision-making authority for consent, process for approaching study participants, and availability of a contact for study deviations/violations. The different ratings indicate differences in the groups’ perspectives on ethical principles, which may affect focal congruence on ethical issues in the proposal. Communication of these findings should help close gaps between REC and researcher perceptions. Further study should investigate how RECs and researchers perceive equivocal ethics terms.     

Reforming the oversight of multi-site clinical research: a review of two possible solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems. Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

Reforming the Oversight of Multi-Site Clinical Research: A Review of Two Possible Solutions

The current system for the ethical oversight of clinical research suffers from structural, procedural, and performance assessment problems. Initially conceived primarily to handle local investigator-initiated single-site studies, the system of institutionally-based committee review has become progressively more inefficient given the increased prevalence of commercially or federally sponsored multi-center trials. To date, proposed solutions do not adequately address these problems.

Beginning with a review of these structural, procedural, and performance assessment problems, this article will then consider two proposals for addressing these deficiencies: (a) regional ethics organizations; and (b) IRBNet?, a newly developed web-based program for cooperative IRB review. The strengths and weaknesses of these two approaches will be evaluated in light of recent experience with centralized review. The proposal to establish a system of regional ethics organizations presents a comprehensive approach to many of the problems faced by the current system. However, IRBNet? offers an immediate and feasible solution to many of the problems faced by the review of multi-site clinical studies.     

Human embryonic stem cell research: an argument for national research review

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. AT the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.     

Research ethics review for the use of anonymized samples and data: A systematic review of normative documents

While the anonymization of biological samples and data may help protect participant privacy, there is still debate over whether this alone is a sufficient safeguard to ensure the ethical conduct of research. The purpose of this systematic review is to examine whether the review of an ethics committee is necessary in the context of anonymized research, and what the considerations in said ethics review would be. The review of normative documents issued by both national and international level organizations reveals a growing concern over the ability of anonymization procedures to prevent against reidentification. This is particularly true in the context of genomic research where genetic material’s uniquely identifying nature along with advances in technology have complicated previous standards of identifiability. Even where individual identities may not be identifiable, there is the risk of group harm that may not be protected by anonymization alone. We conclude that the majority of normative documents support that the review of an ethics committee is necessary to address the concerns associated with the use of anonymized samples and data for research.     

Human Embryonic Stem Cell Research: An Argument for National Research Review

The US National Academy of Sciences (NAS) recently published voluntary guidelines for human embryonic stem (hES) cell research. The NAS guidelines propose two levels of oversight. At the local level, research institutions are to create Embryonic Stem Cell Research Oversight (ESCRO) committees with a mandate to assess the scientific merit and ethical acceptability of hES cell research. At the national level, a new committee is to be created, not to review specific research proposals, but rather to periodically assess, and as needed revise, the NAS guidelines. In this article, we critically assess this proposal. In particular, we review the benefits and limitations of local research review. On this basis, we argue that local review is insufficient for hES cell research and that while there are obvious pragmatic and political reasons for the NAS to favor local research review, there are more compelling reasons for the NAS to have recommended national review of hES cell research proposals.     

Evaluation of Research Ethics Committees: Criteria for the Ethical Quality of the Review Process

Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.     

International research: Ethical imperialism or ethical pluralism? 1

Conflicts have arisen in international research when countries in which research is being carried out lack the ethical rules or mechanisms for review employed in the United States and Europe. It is objected that a requirement to adhere to regulations promulgated by the US government constitutes “ethical imperialism.”; But if researchers in some countries need not be bound by ethical standards widely accepted in the conduct of research, it could open the door to an ethical relativism allowing virtually any standard a country desires to accept. One example is the variations in informed consent, especially in countries that accord lesser importance to the individual than do the US and Europe. A recent controversy centered on a series of placebo‐controlled, HIV/AIDS trials sponsored by the United States and conducted in several developing countries. These trials could not ethically be carried out in the United States because a proven effective treatment exists. Attempts to avoid similar controversies in forthcoming HIV/AIDS vaccine trials have been initiated by the joint United Nations AIDS program, with a process of regional consultations in the countries where the research will be conducted.     

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.     

One size does not fit all: organisational diversity in New Zealand tertiary sector ethics committees

New Zealand tertiary ethics committees may work from similar ethical principles but this article demonstrates that the way in which they operate is idiosyncratic. The paper builds on commentaries offered by current or former members of five New Zealand ethics committees on the organisation and practices of their committees. It examines differences among the committees with the aim of initiating an ongoing conversation about the work of ethics committees in the New Zealand context. It argues for the merits of diversity, transparency and openness as core principles for the work of ethics committees and as a platform for dealing with critique.     

Canadian policy on reporting breaches of research integrity: When should Research Ethics Boards be informed?

ABSTRACT

In Canada, institutions that receive research funding from the three federal granting agencies must establish research ethics boards (REBs) to review the ethical acceptability of research involving humans. Institutions are also expected to promote the responsible conduct of research, fostering researchers’ abilities to act with integrity in the conduct of their research. Where a researcher fails to act with integrity in research with humans, institutional policies and procedures of the U15, Canada’s most research-intensive universities, vary in the extent to which they involve their REBs in response to such breaches. Some make no mention of the REB, whereas others state that their REB should be provided with information relating to upheld allegations. In this paper, we argue that when allegations of research integrity breaches are corroborated, the institution’s REB should be identified as a party required to receive that information. Only then can REBs ensure compliance with research ethics standards, which is essential to maintain the public’s trust.     

The Canadian agency for the oversight of research involving humans: a reform proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada's current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of "frequently asked questions" about the proposed agency design such as "What about 'local context'?" and "Why not have a system of accreditation of institutional REBs instead?" In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

The Canadian Agency for the Oversight of Research Involving Humans: A Reform Proposal

In this paper, I propose the creation of a Canadian agency for the oversight of research involving humans. I describe first a series of significant problems with Canada’s current system of oversight. I then argue for the creation of a national-level agency, covering all research involving humans, with three branches (policy and standards, education, and compliance). Of particular note, the proposed compliance branch consists of a number of independent national and regional Research Ethics Boards (i.e., REBs no longer reside within institutions). There is also an Audit Committee and a Non-compliance Committee (with supporting staff of auditors and compliance officers) to ensure compliance with the policies and standards set by the Policy and Standards Branch. Finally, I answer a series of “frequently asked questions” about the proposed agency design such as “What about ‘local context’?” and “Why not have a system of accreditation of institutional REBs instead?” In sum, radical reform is needed and, in this paper, I present a proposal for such reform.     

The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

Centralized and non-centralized ethics review: a five nation study

The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fully centralized, dual, and decentralized or multicommittee) in place; all are made up of two, interrelated components (the administrative and ethics review). We suggest that both components need to be considered in discussions about centralized review. Serious consideration of centralization of the administrative component may address many concerns. Centralization of the ethics review may provide a context that deals with other issues and may encourage reviews that more effectively focus on the ethical issues involved.     

Ethical dilemmas in social research: no easy solutions

Correspondence to Bernard Gallagher, Research Fellow, Department of Social Policy and Social Work, University of Manchester, Dover St., Mancester M13 9PL. Summary Ethical dilemmas have been encountered in many areas of socialresearch and have at times been the subject of much controversy.Despite this, the problem of how to tackle ethical dilemmashas received little attention in the literature. As a result,researchers faced with these dilemmas have little knowledgeto draw upon, and groups associated with research, such as participatingagencies and ethics committees, may not fully appreciate allthe issues involved in dealing with ethical dilemmas. Theseissues are not only philosophical in nature but relate alsoto the methodological and practical implications of followingone, rather than another, ethical principle. The researchersencountered a number of ethical dilemmas in their research inchild protection. By discussing different approaches to solvingethical dilemmas, they intend to show that this is a complexproblem and one which, along with ethics in general, requiresgreater attention in the literature.     

Supporting ethical use of electronic monitoring for people living with dementia: Social work’s role in assessment,decision-making,and review

Walking outdoors supports health and well-being, but some people living with dementia are at increased risk of getting lost and of harm while missing. Electronic monitoring can potentially play an important preventative role by enabling the person’s location to be continuously monitored by caregivers. However, there are considerable ethical concerns arising from electronic monitoring. This paper explores these thematically, drawing attention to its implications for autonomy and liberty; privacy; dignity; the rights and needs of caregivers and families; beneficence and nonmaleficence. Following from this, key questions for consideration in social work assessment are identified. The ethical issues necessitate assessment of the person’s unique circumstances and preferences and that of their caregivers, and careful ethical deliberation in decision-making. Social work can play an important role in facilitating inclusive assessment and decision-making, leading to consensus on intervening with electronic monitoring. The need for the ongoing review following implementation is discussed to track whether decisions need modification in light of the experience of usage. In conclusion, while legislative instruments and professional codes of ethics frame social work practice responses, there is need for a nuanced debate about ethical use of electronic monitoring and specific guidance to inform assessment, decision-making, and review.     

An International Study of Research Misconduct Policies

Research misconduct is an international concern. Misconduct policies can play a crucial role in preventing and policing research misconduct, and many institutions have developed their own policies. While institutional policies play a key role in preventing and policing misconduct, national policies are also important to ensure consistent promulgation and enforcement of ethical standards. The purpose of this study was to obtain more information about research misconduct policies across the globe. We found that twenty-two of the top forty research and development funding countries (55%) had a national misconduct policy. Four countries (18.2%) are in the process of developing a policy, and four (18.2%) have a national research ethics code but no misconduct policy. All twenty-two countries (100%) with national policies included fabrication, falsification, and plagiarism in the definition of misconduct, but beyond that there was considerable diversity. Unethical authorship was mentioned in 54.6% of the misconduct definitions, followed by unethical publication practices (36.4%), conflict of interest mismanagement (36.4%), unethical peer review (31.8%), misconduct related to misconduct investigations (27.3%), poor record keeping (27.3%), other deception (27.3%), serious deviations (22.7%), violating confidentiality (22.7%), and human or animal research violations (22.7%). Having a national policy was positively associated with research and development funding ranking and intensiveness. To promote integrity in international research collaborations, countries should seek to harmonize and clarify misconduct definitions and develop procedures for adjudicating conflicts when harmonization does not occur.