Rights Of Research Participants Research Articles

Commentary: Systems, rules and the costs of being ethical - a response to D. Chalmers and to S. Whitney and C. Schneider

Commentary: Systems, rules and the costs of being ethical - a response to D. Chalmers and to S. Whitney and C. Schneider

Viewpoint: How to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond

Viewpoint: How to avoid a dichotomy between autonomy and beneficence: from liberalism to communitarianism and beyond

Conducting Video Research in the Learning Sciences: Guidance on Selection, Analysis, Technology, and Ethics

Focusing on expanding technical capabilities and new collaborative possibilities, we address 4 challenges for scientists who collect and use video records to conduct research in and on complex learning environments: (a) Selection: How can researchers be systematic in deciding which elements of a complex environment or extensive video corpus to select for study? (b) Analysis: What analytical frameworks and practices are appropriate for given research problems? (c) Technology: What technologies are available and what new tools must be developed to support collecting, archiving, analyzing, reporting, and collaboratively sharing video? and (d) Ethics: How can research protocols encourage broad video sharing and reuse while adequately protecting the rights of research participants who are recorded?

Publication ethics

The editor of any medical journal has to be aware of the ethical and legal framework within which medical research is conducted. When research and publications relate to children, then particularly high standards are required in the design, conduct, and reporting of research in order to protect the rights of children and their families. Authors have a number of duties and responsibilities that are mirrored by those of editors and publishers. Of particular importance are the principles of transparency and integrity. Authors should be explicit about who carried out the work and who funded the study. They should declare whether the work has been published before and is not being considered for publication elsewhere. The authors must protect the rights of research participants including their anonymity. Editors and publishers have a duty to ensure high editorial standards and efficient and effective peer review systems. They should follow ethical and responsible publication practices and should safeguard the intellectual property of the authors. This review discusses in detail the duties and responsibilities of authors, editors, and publishers in modern medical publishing.

The roles, Challenges and institutionalization of institutional review boards

Researches involving human participants are expected to be conducted professionally to ensure that the research participants are protected from any likely harm. In this regard, the Institutional Review Board (IRB) of an institution plays a very important role in ensuring the safety and rights of research participants. Though most institutions have an IRB that approves research protocols, official policy that all research must be approved is yet to be institutionalized. In addition, training and re-training of members of IRBs is not given sufficient attention. While noting that the functionality of an IRB is hinged on an efficient secretariat that serves as the clearing house for protocols to be approved, some of our IRBs do not have a working secretariat with dedicated staff. Indeed, there are a number of challenges that are capable of undermining the role of the IRBs. Other challenges in the operationalization of IRBs include: poor mechanisms of monitoring of research, financial constraints, poor data archival systems, lack of a standard operational procedure and guidelines for submission and evaluation of protocols etc. As the IRBs are expected to play important roles in research involving human participants especially in clinical and vaccine trials, this paper highlights the role, challenges and requirements for the institutionalization of IRBs.

Running an ethical trial 60 years after the Nuremberg Code

The Nuremberg Code has served as a foundation for ethical clinical research since its publication 60 years ago. This landmark document, developed in response to the horrors of human experimentation done by Nazi physicians and investigators, focused crucial attention on the fundamental rights of research participants and on the responsibilities of investigators. Although the Nuremberg Code has provided an important framework for discussions on the requirements of ethical clinical research, and has resulted in the development of other initiatives-eg, the Declaration of Helsinki and the Belmont Report-designed to ensure the rights and safety of human beings taking part in medical research, knowledge of both past events and the current complexity of research suggests further improvements are necessary in the existing approaches to human clinical research.

Unintended consequences of human research ethics committees: Au revoir workplace studies?

To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) are in conflict with an important stream of industrial sociological research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a 'good news story' guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences.

Ethical considerations in phenomenological research

Wendy Walker examines some important ethical issues that researchers need to consider before and during phenomenological research. She argues that failure to address such issues means putting at risk the rights of research participants.

The ethics of policy research

English Codes of ethics governing research in social science have tended to focus on the rights of participants in research. This focus is too narrow to be an effective guide for ethical policy research. Some typical problems concern the development of organisational research, research in the public domain, and conflicts between the rights of participants and others. Policy research needs to be guided by standards related to professional practice in policy, public accountability and general principles related to the promotion of welfare.

Confirming comprehension of informed consent as a protection of human subjects

Confirming comprehension of informed consent as a protection of human subjects

How well does South Africa's National Health Act regulate research involving children?

Currently there are no laws in South Africa regulating the rights of research participants. The National Health Act is the first attempt by the legislature to use the law to protect research participants, including children. This article describes the strengths and limitations of the provisions, implications for researchers and research ethics committees, and makes recommendations. Strengths of the Section include that it enables the Minister of Health to issue regulations detailing protections for research participants, it supplements existing law on consent, it introduces the concept of the 'best interests' of the child and it creates procedural safeguards. Limitations of the Section include that it does not set an independent age for consent to research, it focuses on informed consent and not other protections, it is inconsistent with existing or draft legislation and ethical guidelines, and it retains the contested distinction between 'therapeutic' and 'non-therapeutic' research. Poor drafting and inconsistencies also impede interpretation. The implications for researchers are that it facilitates so-called 'non-therapeutic' research on children. However, procedural burdens for obtaining consent are created. Research Ethics Committees (RECs) will have to work with the 'therapeutic' and 'non-therapeutic' distinction as well as new concepts such as 'best interests' of the child, and ensure that consent procedures comply with the Act. We conclude that while the Act is an important development in the law, it is flawed in places. We recommend that amendments be made and that capacity development be provided to stakeholders.

Ethical Challenges of Genomic Epidemiology in Developing Countries

Ethical challenges in genomic epidemiology are the direct result of novel tools used to confront scientific challenges in the field. An orders-of-magnitude increase in scale of genetic data collection has created the need for establishing diffuse international partnerships, sometimes across developed- and developing-world countries, with ramifications for assigning research ownership, distributing intellectual property rights, and encouraging capacity-building. Meanwhile, the fact that genomic epidemiological research is so far upstream in the pipeline of therapy development has implications for the privacy rights of research participants and for a rigorous definition of valid informed consent, particularly in resource-poor settings. From these scientific underpinnings, we distill out two main categories of ethical issues: (1) How should researchers ensure that the subjects of research are appropriately protected? and (2) What is the structure of an equitable and fair system for distributing the financial and scientific rewards of research? We attempt to delineate the contours of specific problems in each category and propose steps toward solutions with reference to a particular project, known as gMap.net, that focuses on genomic epidemiological studies of malaria.

Institutional research responsibilities and needed infrastructure.

To describe research grantee institutions' responsibilities to the funding agencies, research participants, and investigators, and the infrastructure and resources necessary for successful completion of funded research projects. Grants management includes investigator access to institutional and school infrastructure and resources, oversight and monitoring of the implementation of the research, and strategies to maximize research yield while stretching research dollars. Grantee institutions are responsible for overseeing the conduct of research, protecting rights of research participants, safety of study personnel, monitoring conflict of interest, fiscal management, access to data, and disseminating study findings. Central and school departments that provide needed services are important infrastructure supports. In addition to research space and investigator time, senior research mentors and research administrators are the most valuable resources for research success.

The Concept of informed consent in qualitative research

Informed consent is an essential part of all research endeavors that involve human participants. The human rights of research participants must be protected. It is incumbent upon the qualitative researcher to provide a dynamic informed consent when study outcomes change. The violation of privacy is more apt to occur with in-depth interviews, which has implications for researchers to protect human rights throughout data collection, analysis, and dissemination.

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.

Critiquing the ethical aspects of research

This article concentrates on critically evaluating the ethical aspects of published research. It accepts the rights of research participants and suggests measures for their protection. Questions, which uncover the ethical dimensions of published research, are suggested and issues of particular concern to health-care practitioners, students and researchers are explored.

Role of the research ethics committee

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

Conventional consent with opting in versus simplified consent with opting out: An exploratory trial for studies that do not increase patient risk

Objective: The objective of this study was to assess a modified consent procedure allowed under federal regulations and developed for studies, particularly clinical trials, that are judged by the Institutional Review Board to reduce or have no effect on patient risk. Study design: This was a randomized trial of a conventional consent procedure that required parental signature to give consent (opting in) after a comprehensive disclosure of the rights of participants in research versus a modified consent procedure that required parental signature to refuse consent (opting out) after specific disclosures appropriate when risk is not increased. Consent was sought for a trial of primary follow-up care for disadvantaged infants at high risk, a trial judged by our Institutional Review Board to increase access to care for both groups. A blinded assessor interviewed mothers within 24 hours of the consent decision. Results: Among the 44 mothers interviewed, the modified consent group scored higher than the conventional consent group in recall and understanding of study purpose and methods (47% vs 30%; p < 0.02). Other comparisons provided no evidence that the modified consent procedure was less desirable. Virtually all mothers reported satisfaction. Conclusions: The modified approach may improve communication and facilitate studies judged by the Institutional Review Board to be risk-neutral or risk-reducing. Further evaluation of a modified consent procedure for such studies is warranted. (J Pediatr 1998;132:606-11)

Justifications and procedures for implementing Institutional Review boards in business organizations

The present paper describes a number of ethical quandaries facing the implementors of motivational interventions in organizational settings. A critical analysis of the traditional solutions to these issues within the organizational literature finds them lacking for want of considering unwitting cognitive biases and self presentational doublespeak, both of which may result in the rights of research participants being underprotected. The establishment of an Institutional Review process, loosely analogized from the biomedical and behavioral science research traditions, is suggested as a means of protecting the rights of research participants as well as humanizing future motivational interventions.

Ethical Considerations in Family Therapy Research

In this article, significant ethical issues that arise in the conduct of family therapy research are considered and four major areas are emphasized: (a) the researcher's responsibility to protect the rights of research participants, (b) confidentiality and informed consent, (c) the researcher's values, and (d) methodology. In each area, parallels are drawn between the ethical issues facing family clinicians and those facing family researchers.