Journal of Empirical Research on Human Research Ethics
Dados do Periódico
| Tipo | JOURNAL |
|---|---|
| Editora | Sage |
| ISSN | 1556-2646 / 1556-2654 |
| Scopus | 17800156703 |
| Wikidata | Q6295148 |
| OpenAlex | S57033397 |
| MAG | 57033397 |
| Site | http://www.sagepub.com/journals/Journal202321/title |
| Total de publicações | 906 |
| Período coberto | 2006 - 2026 |
| País | US |
| Idioma | EN |
| Indexação | Scopus |
| Citada por | 1.520 |
| Fator de impacto | 0.624 |
| SJR | 0.444 (Q2) |
| SNIP | 0.817 |
| CiteScore | 3.5 |
| Índice h | 14 |
| Índice i10 | 29 |
| Média de citações em 2 anos | 0.013 |
| Participação feminina na autoria | 50.0% |
This journal publishes empirical research on human research ethics. While ethics are crucial in anthropological fieldwork, the journal's focus is on the empirical study of research ethics itself, which is a broader methodological and philosophical area with only loose intersections with social anthropology. It receives a score of 2
Communication · Education · Law · Medicine (miscellaneous) · Social Psychology · Academic integrity and plagiarism · Artificial Intelligence in Healthcare and Education · Big Data and Digital Economy · Biomedical Ethics and Regulation · BRCA gene mutations in cancer
Impact of Institutional Review Board Type and Food and Drug Administration Diversity Action Plan Draft Guidance on Demographics of Participants Enrolled Clinical Trials Conducted from 2020 to 2024
We assessed participant representation in phase 3 clinical trials registered on clinicaltrials.gov that were conducted in the U.S. between 2020 and 2024. From the 211 clinical trials analyzed, most relied on commercial IRBs (23.2%). Most of the trials in the “unknown” category were sponsored by pharmaceutical companies which likely relied on commercial IRBs. Trials relying on commercial and other/unknown IRBs had the least Black (10.4 −12.1%) and…
Beyond Methodology
Reflexivity is often framed in qualitative research methods literature as a means of enhancing methodological rigour and research quality. However, less attention has been paid to whether research that meets such standards is also ethically responsive to the needs of participants and communities. In this paper, I critically examine the role of reflexivity in advancing ethical research practices, particularly in studies involving marginalised grou…
Commentary on “Ethics as if Your Life Depended on It”
Pearce proposes lessening restrictions on drug access while increasing transparency and democratizing governance, on the grounds that this would both respect autonomy and rebalance risk-related tradeoffs to a more socially optimal position. I raise some questions about whether, and in what respects, democratization is the answer to these problems
Bridging the Gap
BackgroundClinical trials are vital for advancing medical knowledge, yet engaging diverse populations-those under-represented due to race, age, income, education, geography, sexual orientation, or gender identity-remains a challenge, limiting research generalizability.MethodsThis study used a literature review and semi-structured interviews with participants from diverse backgrounds recruited on LinkedIn. A demographic survey was conducted via Qu…
An Experimental Analysis of Research Assent in Children
An International Delphi Study on the Challenges of Self-Experimentation for Medical Research Ethics
Self-experimentation is a research practice that might advance scientific progress and benefit populations worldwide. However, it also carries risks, both in terms of potential harm to researchers and the possibility of undermining research. This study seeks to explore expert perspectives on self-experimentation, examining its potential benefits and risks, identifying areas of consensus and divergence, and highlighting key themes to inform debate…
Ethical Issues on the Secondary Use of Human Biological Samples
Human biological samples are a valuable source of information that may aid in the generation of new knowledge. However, the use of human biological samples for research poses various ethical, legal and social issues (ELSI). We performed a scoping review to identify the ethical issues surrounding the use of human biological samples for research. We developed a search string strategy to identify literature in PubMed, Scopus, Web of Science, and Goo…
Ethical Opinions in Research Ethics Committees
Research ethics committees occupy a central position in scientific governance, yet the literature reveals a persistent gap in structured, theoretically grounded guidelines for drafting ethical opinions. Opinions are frequently characterised by insufficient substantiation and communicative opacity, eroding researcher trust and institutional legitimacy. This study provides an integrated framework for the production of quality ethical opinions. A na…
Attitudes of Longitudinal Study Participants and Members of the Public Towards Data Sharing for Secondary Research
Most research funders and journals now require researchers to make their data available for sharing. There is a growing body of literature on research participants’ attitudes towards health data sharing, but less evidence regarding views of participants taking part in longitudinal studies, clinical trials or public health research. 1,664 respondents from the UK (participants in longitudinal studies ALSPAC and ACONF and members of Patient and Publ…
Reactions to Trauma-Related Research and Motivations for Participation among Korean College Students with Trauma Experiences
Trauma-related research is essential for advancing knowledge, yet ethical concerns persist regarding participant distress. Using a mixed-methods approach, this study examined reactions to trauma-related research and motivations for future participation among Korean college students. Participants ( N = 138) completed measures of trauma exposure, PTSD symptoms, perceived understanding of informed consent, and reactions to research participation. Qu…
Ethics as if Your Life Depended on It
PurposeThis Commentary examines whether current ethics approval systems for medical research, grounded in the Belmont Report's principles of respect for persons, beneficence, and justice, paradoxically result in preventable deaths by delaying patient access to experimental therapies and proposes a framework for democratizing ethics oversight while maintaining safety.FindingsPeer-reviewed evidence demonstrates that ethics delays impose mortality c…
When Artificial Intelligence Enters the Research Process
The rapid integration of generative artificial intelligence (AI) into academic and professional workflows is reshaping human participants research. While prior discourse has focused largely on AI-assisted writing and analysis, less attention has been given to its influence on data generation and integrity. This invited commentary examines emerging risks associated with generative AI use by researchers and participants, including data fabrication …
Ethical Challenges Posed by HIV-Vaccine Induced Seropositivity for the Informed Consent Process and HIV Testing Practices in Maputo City, Mozambique
Mozambique has a robust HIV control program and currently conducts HIV vaccine trials. One measure of a vaccine's success is development of antibodies, the vaccine-induced seropositivity(VISP). This study assesses the understanding and practices regarding VISP from trial participants and healthcare providers, as well as ethical challenges encountered during the informed consent. We conducted in-depth, semi-structured interviews using open and clo…
Trainee Perspectives on the Fogarty African Bioethics Consortium Postdoctoral Fellowship Program
There is a growing demand for postdoctoral bioethics training in Africa, driven by the significant rise in graduate programs offered by universities. This study sought to evaluate the Fogarty African Bioethics Consortium Post-Doctoral Fellowship program and to explore the experiences and perspectives of its trainees as well as the program's impact on their careers in their home countries. This study adopted an exploratory qualitative design invol…
Impacts of Responsible Conduct of Research Education on the Career and Practice of Graduating Fellows
This study investigates the impact of the Fogarty/NIH-funded Responsible Conduct of Research (RCR) Education Fellowship Program on scientists’ RCR activities and practices by following up on 110 of 117 fellows who graduated from the program. The results suggest that the program played a crucial role in promoting RCR activities among the fellows, leading to positive outcomes such as publications in research ethics (64%), attendance of RCR conferen…
Gaps and Opportunities in Responsible and Ethical Conduct of Research Training
Training in responsible and ethical conduct of research (RECR) is essential for fostering a strong research culture. We surveyed faculty, students, and research staff at R1/R2 and primarily undergraduate institutions (PUIs) to assess practices in mentoring, administrative support, grant writing, and project management. While many institutions provide formal education in research ethics and grant writing, major gaps persist in mentoring, grant imp…
A 360 Degree Qualitative Ethical Assessment of Reporting Patient Reported Outcomes
While guidelines exist for returning genetic, biomarker, and radiologic research results, there is little guidance regarding the return of patient-reported outcome (PRO) research results. As a supplement to an ongoing trial of palliative care for Parkinson's disease, we conducted thirty qualitative, semi-structured interviews of persons with Parkinson's disease, their carepartners, community neurologists, primary care physicians, and researchers …
Determining Ethical Incentives in Biomedical HIV Research
Incentives are crucial for recruiting and retaining participants in research studies, yet researchers and regulators often struggle to determine appropriate incentives due to ethical concerns and a lack of clear guidelines. We conducted interviews and focus groups with three stakeholder groups-biomedical HIV researchers (n = 12), institutional review board (IRB) members (n = 12), and people living with HIV (PLWH) (n = 69)-to explore their perspec…
Artificial Intelligence in Human Participant Research
The rapid integration of artificial intelligence (AI) into research presents emerging ethical and governance challenges for institutions overseeing human research. While existing frameworks provide general protections, they offer limited guidance for addressing AI-specific risks related to informed consent, transparency, data privacy, and fairness. This commentary synthesizes key ethical concerns associated with AI-enabled research and examines s…
Survey of the Current status and Challenges of Centralized Review in Multicenter Research in Japan
Centralized review can streamline multicenter research by shortening timelines, harmonizing decisions, and reducing administrative burden. However, adoption in Japan remains limited because many committees operate independently and regulations are complex. We conducted a questionnaire survey of 27 institutions in the Shizuoka Clinical Trials Network. For centralized review, we assessed feasibility, prior requests, and implementation experience. T…
Governance Structures for Health Research Ethics in the Eastern Mediterranean Region
IntroductionThis work aimed at mapping research ethics governance at EMR countries.MethodsThe study used two tools shared with Eastern Mediterranean Region (EMR) countries. The first enquired about legal provisions and regulatory frameworks, as well as Research Ethics Committee (REC) composition, resources, procedures. The second covered ethical oversight of clinical trials (CTs), including coordination of ethical reviews.ResultsMost respondents …
Community Perspectives on Ethical Considerations in Clinical Research
The study explored community perspectives on ethical considerations in clinical research, focusing on the ESRIFAL trial conducted in Cameroon. The hermeneutic phenomenological approach was used to analyze and interpret the data. Participants were selected by systematic sampling. In-depth interviews were used to gather data from the participants. Some findings revealed that while ethical principles such as informed consent are highly recommended i…
Navigating Ethical Dilemmas in Qualitative Research with Vulnerable Groups in Indonesia
This article discusses strategies for ethical research practices, drawing on the experiences of researchers working with victims of abuse, sexual violence, inter-religious conflict, terrorist convicts, and their children. The research employs qualitative methods with data collection techniques interviews, observations, and focus group discussions, while reflecting on researchers' positionality and ethical responsibilities. Two complementary frame…
Decision Letters from a Kyrgyz Research Ethics Committee (2018–2022)
Research Ethics Committees (RECs) safeguard participants, yet little is known about how their decisions are communicated to study investigators in low- and middle-income countries (LMICs). We analysed 138 decision letters from a public-health REC in Kyrgyzstan (2018-2022) using descriptive statistics and documentary review. REC panel consisted predominantly of clinical and biomedical experts, with identifying data missing for 51% ( n = 506/991) o…
Optimizing Pathways for Common Issues in Administrative Review of Submission Materials of Investigator-Initiated Clinical Trials
This study evaluates the quality and efficiency of administrative review for investigator-initiated trials (IITs) at a leading tertiary hospital in Shandong Province, China. We conducted a retrospective empirical comparative analysis using feedback reports issued by the Clinical Research Management Office. A total of 151 reports from 2022 were compared with 162 reports from September 2023 to August 2024, after targeted improvement measures were i…
Enacting Research Ethics in Partnerships with Indigenous Communities in Canada
Two studies conducted through community-campus partnerships demonstrated emerging frameworks for ethical conduct of research involving Indigenous peoples in Canada. Both projects involved multiple Indigenous community partners whose interests in promoting children's development and fathers' involvement motivated the projects. The Indigenous projects were conceived within a broader social agenda of restorative justice and self-determination of Ind…
Community-Based Participatory Research (Cbpr) with Indigenous Communities
The health disparities between Indigenous and non-Indigenous peoples in Canada continue to grow despite an expanding body of research that attempts to address these inequalities, including increased attention from the field of health geography. Here, we draw upon a case study of our own community-based approach to health research with Anishinabe communities in northern Ontario as a means of advocating the growth of such participatory approaches. …
The Challenges of Collaboration for Academic and Community Partners in a Research Partnership
The philosophical underpinning of Community-Engaged Research (CEnR) entails a collaborative partnership between academic researchers and the community. The Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion of the collaboration between academic researchers and the community. In CPBR, the goal is for community partners to…
Do Incentives Exert Undue Influence on Survey Participation? Experimental Evidence
MONETARY INCENTIVES ARE INCREASINGLY used to help motivate survey participation. Research Ethics Committees have begun to ask whether, and under what conditions, the use of monetary incentives to induce participation might be coercive. The article reports research from an online vignette-based study bearing on this question, concluding that at present the evidence suggests that larger incentives do not induce research participants to accept highe…
Normal Misbehavior
Those concerned with protecting the Integrity of science generally focus on the serious but rare infractions of falsification, fabrication, and plagiarism (FFP). While the violations of FFP are clear threats to the quality of scientific work and public trust in science, are they the behaviors that researchers themselves find most troubling? Noticing that scientists seldom are asked to report their perceptions of the behaviors that pose problems f…
If Ethics Committees were Designed for Ethnography
WHERE DID THE ETHICS REVIEW PROCESS go wrong for qualitative research, and how can we make it right, or at least better? This paper begins with an excerpt from an ethnography of attempting to attend an ethics review-related workshop, which exemplifies that the ethics-review process is based on epistemological assumptions aligned with positivistic research, and does not fit the qualitative research process. We suggest that a new format for ethics …
Research with Aboriginal Peoples
Recent ethics guidelines and policies are changing the way health research is understood, governed, and practiced among Aboriginal communities in Canada. This provides a unique opportunity to examine the meanings and uses of such guidelines by Aboriginal communities themselves. This qualitative study, conducted in Labrador, Canada, with the Innu, Inuit, and Inuit-Metis, examined how communities and researchers collaborate in a co-learning environ…
Photovoice as a Community-Based Participatory Research Method among Women Living with HIV/Aids
Photovoice is a method in which participants use photography to identify, express, and disseminate their experiences. We conducted photovoice projects with women living with HIV/AIDS (N=21) to explore opportunities and challenges associated with the method. Photovoice provided a means to achieve two key principles of ethical public health practice: It gives participants opportunities to define their health priorities, and facilitates participant …
What Scientists Want from Their Research Ethics Committee
Whereas investigators have directed considerable criticism against Institutional Review Boards (IRBs), the desirable characteristics of IRBs have not previously been empirically determined. A sample of 886 experienced biomedical and social and behavioral scientists rated 45 descriptors of IRB actions and functions as to their importance. Predictions derived from organizational justice research findings in other work settings were generally borne …
Scientists' Perceptions of Organizational Justice and Self-Reported Misbehaviors
Policymakers concerned about maintaining the integrity of science have recently expanded their attention from a focus on misbehaving individuals to characteristics of the environments in which scientists work. Little empirical evidence exists about the role of organizational justice in promoting or hindering scientific integrity. Our findings indicate that when scientists believe they are being treated unfairly they are more likely to behave in w…
Researchers' Perspectives on Collective/Community Co-Authorship in Community-Based Participatory Indigenous Research
Ethical tensions exist regarding the value and practice of acknowledging Indigenous contributions in community-based participatory research (CBPR). Semistructured phone interviews with researchers documented their perspectives on authorship in the scholarly dissemination of their community-based participatory Indigenous research. Thematic analysis resulted in four key ideas: (1) current practices regarding methods of acknowledging community contr…
Ethical Issues in Research on Sensitive Topics
While many studies ask participants to disclose sensitive information or to participate in emotionally arousing tasks, little is known about participants' subjective experiences of discomfort and benefit. Ethics review committees, therefore, have little information about participant experiences to guide their informed decision-making. We asked undergraduate females about their experiences in a study that included an experimental session, intervie…
Human Subjects Protections in Community-Engaged Research
In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such a…
Human Research Ethics Committees
Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was di…
Ethics Regulation in Social Computing Research
The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insight…
What Is “Publicly Available Data”? Exploring Blurred Public–Private Boundaries and Ethical Practices Through a Case Study on Instagram
This article adds to the literature on ethics in digital research by problematizing simple understandings of what constitutes "publicly available data," thereby complicating common "consent waiver" approaches. Based on our recent study of representations of family life on Instagram, a platform with a distinct visual premise, we discuss the ethical challenges we encountered and our practices for moving forward. We ground this in Lauren Berlant's c…
Developing a Participatory Aboriginal Health Research Project
Community-based research methods were used in a study of health needs with the Wikwemikong Unceded Indian Reserve, Ontario, Canada based on critical theory, Indigenous teachings and participatory action research (PAR). The process of developing the project led to the elucidation of eight key principles deemed necessary for the development of a project that is both culturally and community appropriate: partnership, empowerment, community control, …
Increasing Research Literacy in Minority Communities
The community alliance for Research Empowering Social Change (CARES) is an academic-community research partnership designed to: (1) train community members about evidence based public health, (2) increase community members' scientific literacy, and (3) develop the infrastructure for community-based participatory research so that local stakeholders can examine and address racial/ethnic health disparities in their communities. Nineteen community me…
The Ethics of Using Artificial Intelligence in Qualitative Research
Artificial Intelligence (AI) and other large language models are rapidly infiltrating the world of education and educational research. These new technological developments raise questions about use and ethics throughout the world of educational research, particularly for qualitative methods given the philosophical and structural foundations of its associated designs. This paper seeks to interrogate the perceived ethics around the use of AI in qua…
A New Era of Indigenous Research
Indigenous communities across Canada have established principles to guide ethical research within their respective communities. Thorough cataloging and description of these would inform university research ethics boards, researchers, and scholars and facilitate meaningful research that respects Indigenous-defined ethical values. A scoping study was conducted of all relevant peer-reviewed literature and public-facing Indigenous research ethical gu…
Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth
This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational, and voluntary self-consent. Sixty sexually active SGMY (ages 14-17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian perm…
Opportunities, Ethical Challenges, and Lessons Learned from Working with Peer Research Assistants in a Multi-Method HIV Community-Based Research Study in Ontario, Canada
We discuss ethical challenges and opportunities experienced by peer research assistants (PRAs) in a multi-method HIV community-based research study in Ontario, Canada. We review lessons learned and best practices based on our experience conducting a qualitative investigation of research priorities with diverse women living with HIV (WLWH) and implementation of a cross-sectional survey with African, Caribbean, and Black WLWH. While some opportunit…
Relationships between Community-Based Processes for Research Ethics Review and Institution-Based IRBs
Community groups are implementing research ethics review processes to determine whether and how research is conducted in their communities. We report on a survey of 109 of these community-based review processes about their relationships with institution based research ethics boards (I-REBs). Ninety-two percent reported that studies they review were also reviewed by an I-REB. Over half characterized their relationship with I-REBs positively. Those…
Sharing Data and Results in Ethnographic Research
RESEARCHERS RECENTLY HAVE argued that offering to share research results with study participants should be an "ethical imperative." This article considers that suggestion in light of the practice of ethnographic, particularly anthropological, research. Sharing results is discussed in relation to several issues, e.g., whether it occurs during or after completion of a project, whether the research is long-term, the complexities involved in depositi…
Seeking Ways to Inform the Uninformed
Participants often do not read consent forms in social science research. This is not surprising, especially for online studies, given they do not typically offer greater risk than what is encountered in daily life. However, if no one is reading, are participants really informed? This study used previous research to craft experimentally manipulated consent forms utilizing different visual presentations (e.g., greater use of line spacing, bullets, …
Reply from Editor
Cognitive Interviewing as a Tool for Improving the Informed Consent Process
Consent materials often contain complex information, legalese, and other features that render them difficult to comprehend in such a way that consent is truly informed. I propose that researchers adapt cognitive interviewing, normally used for the pretesting of survey questionnaires, to evaluate the understandability of consent materials and the way which subjects use this information to make decisions regarding participation. Cognitive interview…
The Evolution of Best Ethical Practices in Human Research
Ideally, best practices in human research would evolve quickly in the wake of new ethical challenges, but in reality such challenges sometimes evoke Procrustean new oversight requirements that benefit neither human subjects nor science. The rapid advance of new topics, methods and ethical challenges in human research inevitably raises questions about the appropriateness of time-honored research practices, and about the most intelligent applicatio…
Informed Consent in International Health Research
Informed consent is universally recognized as a central component of ethical conduct in scientific research. Investigators working with diverse populations throughout the world face myriad challenges. The application of standards for informed consent can be daunting for researchers when they face the pragmatic constraints of the field and the reality of cultural beliefs about consent that may be in direct conflict with regulatory requirements. Th…
Normal Misbehavior
Those concerned with protecting the Integrity of science generally focus on the serious but rare infractions of falsification, fabrication, and plagiarism (FFP). While the violations of FFP are clear threats to the quality of scientific work and public trust in science, are they the behaviors that researchers themselves find most troubling? Noticing that scientists seldom are asked to report their perceptions of the behaviors that pose problems f…
Scientists' Perceptions of Organizational Justice and Self-Reported Misbehaviors
Policymakers concerned about maintaining the integrity of science have recently expanded their attention from a focus on misbehaving individuals to characteristics of the environments in which scientists work. Little empirical evidence exists about the role of organizational justice in promoting or hindering scientific integrity. Our findings indicate that when scientists believe they are being treated unfairly they are more likely to behave in w…
U. S. Health Researchers Review Their Ethics Review Boards
Virtually all research involving human subjects in the United States must be reviewed by an institutional review board, a form of research ethics review board. This article reports the results of qualitative research on how investigators regard this regulatory regime. Interviews were conducted with forty investigators conducting health-related research. Most respondents shared the regulations' goals, but doubted that the regulations, as implement…
Resisting Power and Influence
THIS IS A CASE STUDY based on the author's experience while serving as an ethics committee (IRB) chair in New York City. It addresses the issues of power and coercion as they apply to the human research participants protection process. It primarily focuses on the power imbalance that can exist between research participants and their IRB advocates on the one hand and the research institutions, funding agencies, and investigators with their unlimit…
A Needs Assessment to Build International Research Ethics Capacity
INTERNATIONAL COLLABORATORS IN BIOMEDICAL sciences face ethical challenges in the design, review, and conduct of research. Challenges include differences in research ethics capacity, cultural differences in interpretation and application of ethical principles, and cooperation between ethics review boards at collaborating institutions. Indiana University School of Medicine (Indianapolis, USA) and Moi University Faculty of Health Sciences (Eldoret,…
The Ethics in Human Research Ethics
False, but common, assumptions about dilemmas in moral reasoning and the so-called fact/value dichotomy can impede the prosecution JERHRE's prime aim: Facilitating ethical problem solving in human research. Research ethics, and the development of moral science, demand better assumptions about ordinary everyday problem solving morality and the deep-seated connectedness of facts and values
Anthropological Research in Light of Research-Ethics Review
DESPITE CLAIMS THAT RESEARCH-ETHICS review is changing or discouraging social research, there are no studies that have tested this assumption. Examining Canadian Master's theses in anthropology between 1995 and 2004, this paper explores the extent to which the theses represent a change in number, topic, or methodology in relation to formal ethicsreview guidelines that came into force in Canada in 2001. ProQuest Digital Dissertations reveals that …
Ethical Issues in Trauma-Related Research
Ethical decision-making about trauma-related studies requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: Benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so…
Essentials of the Disclosure Review Process
Many researchers need to make arrangements to share de-identified electronic data files. However, the ways in which respondent identity may be protected are not well understood or are assumed to be the special province of large statistical agencies or specialized statisticians. Approaches to data sharing and protecting respondent identity have been pioneered by federal agencies which gather data vital to political and economic decision making. Th…
The Importance of Story-Telling
AN ORAL TRADITION AND STORY TELLING CULTURE are still central to aboriginal personal and community identity, and provide major means of remembering and conveying personal and community experience with university researchers. These stories describe stark accounts of betrayal and upset, as well as descriptions of positive experiences. They provide dramatic reminders to researchers of the importance of respectful and collaborative relationships with…
Introduction
THIS SPECIAL SECTION OF JERHRE is in response to the needs of institutions to develop advanced data sharing capabilities. On October 1, 2003, the National Institutes of Health (NIH) initiated a requirement that investigator-initiated proposals for grants with direct costs over $500,000 in any year incorporate plans to accommodate sharing research data. The requirement stipulates that such plans describe the procedures through which shared data wo…
Solving Problems of Disclosure Risk While Retaining Key Analytic Uses of Publicly Released Microdata
MEASURES USED TO PROTECT SUBJECTS in publicly distributed microdata files often have a significant negative impact on key analytic uses of the data. For example, it may be important to analyze subpopulations within a data file such as racial minorities, yet these subjects may present the greatest disclosure risk because their records tend to stand out or be unique. Files or records that are linkable create another type of disclosure risk-common e…
Solving Problems of Disclosure Risk in an Academic Setting
THE HEALTH AND RETIREMENT STUDY collects a vast amount of information about a sample of the U.S. population over age 50 from biennial interviews, supplemental questionnaires, and through linkages with administrative data including Social Security earnings and benefits records and Medicare claims records. To h onor i ts p ledge to t he r espondents that their data will be kept confidential, but at the same time meet its objective of providing usef…
Empirical Research to Evaluate Ethics Committees' Burdensome and Perhaps Unproductive Policies and Practices
THE U.S. SYSTEM FOR THE PROTECTION of human research subjects, particularly its ethics committee or Institutional Review Board (IRB) component, is excessively burdened. Many commentators, myself included, are concerned that, as a consequence of these excessive burdens, the IRB is losing its effectiveness in safeguarding the rights and welfare of human subjects. I believe that IRBs devote too much time doing work that simply does not need to be do…
Women's Autonomy and Informed Consent in Microbicides Clinical Trials
ACHIEVING RESPECT FOR PERSONS is problematic in settings with concepts of autonomy that differ from Western values. For international research, women's autonomy to consent to participation is an increasingly contentious issue. We present data from ancillary studies conducted in preparation for a clinical trial testing the safety and efficacy of topical microbicides, used to prevent HIV infection. These ancillary studies were conducted in seven co…
The Ethics of Paying Drug Users Who Participate in Research
The payment of research participants raises ethical and empirical questions that have special importance in addictions research involving drug-dependent participants. Despite a now large literature on human subjects payment, what is still needed is practical guidance for investigators and ethics committees. This paper reviews the literature on: Current payment practices and guidelines; defining features of undue and due incentives and fair reimbu…
A Review of Paying Research Participants
Current regulatory guidelines require the ethical review committee to consider one question when evaluating payment: Is the payment to the participant undue or coercive? Although this is a seemingly simple question, determining appropriate payment involves a series of complex issues. There is limited empirical knowledge to assist with this determination and little consensus on which elements of a study should be considered in making these decisio…
Using Formative Research to Develop a Context-Specific Approach to Informed Consent for Clinical Trials
PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild transmission of HIV during breastfeeding, formative research was conducted to explore the community's underst…
Ethical Issues in Registry Research
RESEARCH BASED ON REGISTRY STUDIES involves significant ethical issues. Using detailed information about one registry concerning in-hospital resuscitation, we present issues concerning informed consent, access to identifiable medical information, and benefit for participants. In addition, multiple methodological difficulties have indirect implications for the ethical conduct of registry research, including consensus about variable definitions, va…
Empirical Research on IRBs and Methodologies Usually Associated with Minimal Risk
Sharing Data and Results in Ethnographic Research
RESEARCHERS RECENTLY HAVE argued that offering to share research results with study participants should be an "ethical imperative." This article considers that suggestion in light of the practice of ethnographic, particularly anthropological, research. Sharing results is discussed in relation to several issues, e.g., whether it occurs during or after completion of a project, whether the research is long-term, the complexities involved in depositi…