Protection 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

Balancing Efficiency and the Protection of Research Participants: Canadian Allergy/Asthma Researchers’ Perspectives on the Ethics Review of Multi-Site Health Research

Many studies examining several aspects of multi-institutional research ethics review and the opinions of different stakeholders show the current process to be resource intensive and inefficient. We discuss the experiences and opinions of individual Canadian allergy/asthma researchers engaged in multi-centre research and find that most researchers are dissatisfied, perceive the process as ineffective, and strongly desire some type of reform. These results highlight the tension between efficiency in research ethics review and the effective protection of subjects. Harmonization initiatives and alternate review strategies are being implemented throughout Canada and should help increase efficiency while not compromising the protection of research subjects. With time, evidence gathered from empirical studies that evaluate these new strategies will help determine the effectiveness of the various reform strategies for multi-site ethics review.

Views and Experiences of IRBs concerning Research Integrity

Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards adopt these roles. I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate=55%), and an additional 12 members and administrators. IRBs become involved in a variety of RI problems, broadly defined, and face challenges in deciding how and when to do so. IRBs vary in how they define, discover, and respond to RI problems, and interact with other institutional offices concerning these issues; and what types of RI violations they encountered. While many institutions establish separate Compliance Offices, the boundaries and relationships between these entities and IRBs vary; and many IRBs discover and monitor RI violations, and struggle with how to respond. Larger questions arise of how IRBs decide whether to trust vs. closely monitor individual PIs. IRBs' roles are often indirect, and not fully systematic, raising questions of whether these functions should be enhanced, and if so, to what degree, and how. These areas require heightened investigation and discussion.

Protection of human participants in health research - a comparison of some US Federal Regulations and South African Research Ethics guidelines

In response to criticism of ethical review of a South African clinical trial, we contrast aspects of the United States Common Rule with South African research ethics requirements. In the USA the Common Rule does not apply to all health research and allows many exemptions from ethics review and waivers of informed consent. At a structural level research ethics review in South Africa is in many cases equivalent to the US institutional review board (IRB) and Office for Human Research Protections (OHRP) oversight system, is wider reaching, and has no exclusions.

Evaluating the Risks of Clinical Research

The ethical appropriateness of clinical research depends on protecting participants from excessive risks. Yet no systematic framework has been developed to assess research risks, and as a result, investigators, funders, and review boards rely only on their intuitive judgments. Because intuitive judgments of risk are subject to well-documented cognitive biases, this approach raises concern that research participants are not being adequately protected. To address this situation, we delineate a method called the systematic evaluation of research risks (SERR), which evaluates the risks of research interventions by comparing these interventions with the risks of comparator activities that have been deemed acceptable. This method involves a 4-step process: (1) identify the potential harms posed by the proposed research intervention; (2) categorize the magnitude of the potential harms into 1 of 7 harm levels on a harm scale; (3) quantify or estimate the likelihood of each potential harm; and (4) compare the likelihood of each potential harm from the research intervention with the likelihood of harms of the same magnitude occurring as a result of an appropriate comparator activity. By explicitly delineating, quantifying, and comparing the risks of research interventions with the risks posed by appropriate comparator activities, SERR offers a way to minimize the influence of cognitive biases on the evaluation of research risks and thereby better protect research participants from excessive risks.

Protecting research participants with impaired decision-making capacity

Protecting research participants with impaired decision-making capacity

The Wisdom of Experience: Becoming an Effective Principal Investigator

As an American Cancer Society mentored research scholar recipient, I interviewed 11 experienced principal investigators actively engaged in cancer research with Indigenous peoples throughout the USA to learn helpful skills and advice for someone beginning a research career. Emergent themes provide helpful advice for beginning researchers as well as reminders for experienced investigators. Themes could serve as a catalyst for continued conversations among researchers and include: being a visionary, keeping up with the science, building relationships, protecting research participants and the community, publishing and disseminating, being organized, recognizing opportunity, understanding funders, being budget wise, staying focused, learning from failures, being holistic, being open to learning, having fun, and practicing self-care.

Going Boldly Where No One Has Gone Before? How Confidentiality Risk Aversion is Killing Research on Sensitive Topics

Bernhard and Young (Journal of Academic Ethics, 7, 175-191, 2009) allege that a “myth of confidentiality” plagues research in North America because of the absence of statute-based legal protections and the requirements of some REBs to limit confidentiality “to the extent permitted by law.” In this commentary we describe statute-based protections for research confidentiality available in the United States, clarify the legal situation regarding research confidentiality in Canada, and explain that REBs that “require” confidentiality to be limited by law are imposing a doctrine that is not required by the TCPS and may violate researchers’ academic freedom. The paper laments how excessive REB risk aversion and inaction by the granting agency Presidents has created a situation where some REBs are encouraging researchers to download research risks to research participants and forcing researchers to choose between exposing themselves to the prospect of going to jail to protect confidentiality, watering down their research objectives, or conducting “vanilla” research rather than engaging in controversial and/or sensitive areas of study. The paper urges the granting agency Presidents to seek legislative change to protect research participants who provide information that could cause them harm if their identity were to be revealed.

Informed consent in genomics and genetic research.

There are several features of genetic and genomic research that challenge established norms of informed consent. In this paper, we discuss these challenges, explore specific elements of informed consent for genetic and genomic research conducted in the United States, and consider alternative consent models that have been proposed. All of these models attempt to balance the obligation to respect and protect research participants with the larger social interest in advancing beneficial research as quickly as possible.

Institutional review board challenges related to community-based participatory research on human exposure to environmental toxins: A case study

BackgroundWe report on the challenges of obtaining Institutional Review Board (IRB) coverage for a community-based participatory research (CBPR) environmental justice project, which involved reporting biomonitoring and household exposure results to participants, and included lay participation in research.MethodsWe draw on our experiences guiding a multi-partner CBPR project through university and state Institutional Review Board reviews, and other CBPR colleagues' written accounts and conference presentations and discussions. We also interviewed academics involved in CBPR to learn of their challenges with Institutional Review Boards.ResultsWe found that Institutional Review Boards are generally unfamiliar with CBPR, reluctant to oversee community partners, and resistant to ongoing researcher-participant interaction. Institutional Review Boards sometimes unintentionally violate the very principles of beneficence and justice which they are supposed to uphold. For example, some Institutional Review Boards refuse to allow report-back of individual data to participants, which contradicts the CBPR principles that guide a growing number of projects. This causes significant delays and may divert research and dissemination efforts. Our extensive education of our university Institutional Review Board convinced them to provide human subjects protection coverage for two community-based organizations in our partnership.ConclusionsIRBs and funders should develop clear, routine review guidelines that respect the unique qualities of CBPR, while researchers and community partners can educate IRB staff and board members about the objectives, ethical frameworks, and research methods of CBPR. These strategies can better protect research participants from the harm of unnecessary delays and exclusion from the research process, while facilitating the ethical communication of study results to participants and communities.

PhRMA BioResearch Monitoring Committee Perspective on Acceptable Approaches for Clinical Trial Monitoring

The integrity of clinical research data is critical for making sound regulatory decisions regarding the approval and use of medications. Equally important is the safeguarding of human subjects in clinical trials. A key element in the generation of high-quality data and protection of research participants during clinical research is sponsor monitoring of the clinical investigator site. This article provides the current thinking of the PhRMA BioResearch Monitoring Committee on acceptable approaches to clinical trial monitoring, taking advantage of risk-based decision making and modem technological tools. The intent is to provide flexibility in approaches—given the broad diversity of types of clinical research—while maintaining high standards for quality and integrity. The PhRMA BioResearch Monitoring Committee believes such approaches are applicable to all types of clinical research, regardless of who is sponsoring or conducting the research (industry, academia, or government agency).

All Teachers Are Vulnerable but Especially Gay Teachers: Using Composite Fictions to Protect Research Participants in Pupil—Teacher Sex-Related Research

The ways in which the media searches out, depicts, and writes about teacher—pupil sex-related topics have implications both for researchers working in the area and, sometimes more seriously, for the people who participate in and contribute to that research as respondents. In this article, the authors discuss, and provide an example of, the composite fiction strategy they developed and decided to adopt primarily for purposes of protection when writing up a project that investigated the perceptions and experiences of teachers (and those of members of their families, their friends, and colleagues) who had been accused of sexual abuse of pupils, which they said they had not committed and of which they were eventually cleared.

SHAH AND GRADY RESPOND

Onyeabor's letter highlighted some of the ethical complexities inherent in posttrial access. Although we agree that ethically, individuals benefiting from antiretroviral therapy should continue to receive it, the challenge for all of us involved in the ethical conduct of research is to be clear about how this should occur. Many study participants in developing countries, including those in the studies cited, understandably feel that antiretroviral treatment should be continued for life.1 Yet, in other studies, participants appeared to expect national programs to provide treatment, not necessarily the researchers themselves.2 Similar to other influential ethical guidance documents,3–6 the National Institutes of Health guidelines that apply to the studies in our sample recognize that researchers have an obligation to address the provision of posttrial antiretroviral therapy, but not an obligation to directly provide it.7 Onyeabor seems to suggest that researchers have greater obligations—namely, that researchers should provide posttrial access for participants themselves in recognition of the contributions that participants make to advancing science. Though we agree with Onyeabor that research participants certainly deserve recognition for their contributions, the nature and extent of this recognition might justifiably vary according to the contribution made, and we would argue that participants are owed a fair share of the benefits.8 However, we do not agree that researchers necessarily bear long-term obligations to provide care after their research is over. In conducting research, researchers have many important obligations, including those to maintain scientific integrity and protect research participants. Although the relationship between a researcher and a research participant cannot last forever, researchers' obligations to participants do not end when the last pieces of data are collected. Just as hospital physicians should engage in careful discharge planning when patients are being released from their care, we would argue that researchers have obligations to end their relationships with research participants responsibly. This obligation to help participants transition to local sources of care might increase or decrease in intensity depending on several factors, including the extent of participants' need for assistance and dependence on the researchers, whether local sources of care exist, and how long the research relationship has lasted. More work needs to be done in this area, but we hope the findings from our study help advance a more careful understanding of what it means to conduct and conclude responsible research.

Teacher–student sexual relations: key risks and ethical issues

Researching actual or purported sexual contact between teachers and students raises many difficult ethical issues, questions and dilemmas, which may help to explain why few have ventured into the field. This experientially based paper addresses key problem areas under the headings of: the ethics of researching a sensitive taboo topic; the ethics of challenging normative notions and master narratives around child abuse and protection; obtaining ethical clearance to study teachers, pupils and sex; ethical issues related to giving voice to teachers considered or alleged to have committed sexual offences against students; and ethical issues around the protection and re-presentation of research participants. The paper considers the difficulties faced when seeking to conduct critical transformative ethical ethnographic research which is committed to child protection, whilst challenging practices and legislation which can lead to the perpetration of serious social injustice against teachers.

Nursing students' experiences of being a research participant: Findings from a longitudinal study

the paper reports on a study that highlighted the benefits to nursing students of taking part in research. there is a great deal of literature and ethical guidance to protect research participants who take part in research. However, there is limited empirical evidence regarding the beneficial outcomes of research participation. the findings reported in this paper were part of a qualitative, longitudinal study undertaken in the UK between 2007 and 2009. The study explored the empowerment of nursing students in clinical practice. Thirteen undergraduate nursing students were recruited to the study. Data generation was in the form of annual, individual interviews. Over the course of the study, students were asked about their experiences of participating in the research. Nursing students reported significant benefits as a result of research participation. These were threefold: strengthening self; strengthening knowledge; and strengthening clinical practice. Protection of research participants is crucial, but emphasis on protection obscures the potential benefits that result from being a research participant. researchers who recruit nursing students to educational research must protect them from harm. However, in the process of weighing up risks associated with their educational research, they need to be cognizant of potential benefits that can arise for nursing students when they are asked to participate in nursing research.

Biobanks and the ‘well-being’ of humanity: integrating consent to research with the capability approach

Among the important ethical challenges that biobanks raise, the shortcoming of the traditional acceptation of informed consent is one of the most debated. The protection of research participants’ autonomy is a central theme in current ethical reasoning on biomedical research. In this article, I argue that moral philosophy offers the opportunity to broaden the debate raised by the shortcomings of the established doctrine of informed consent when applied to biobanking activities. The capability approach and deliberative democracy theories are particularly interesting in analyzing biobanks and informed consent because they shift the focus from the relationships patient/physician and participants in research/investigator–the bioethics focus–to the well-being of research participants and their ability to self-determination understood as a mean by which individuals participate in the societal arrangements that underscore biobanks’ regulation, thus fostering the democratic deliberative process. My claim is that many ethical issues raised are better understood and eventually solved if a broader definition of the notion of autonomy as put forth by moral and political theory is integrated in the discourse of biobanking and informed consent. Philosophy is like this: eternally unsettled and only occasionally disturbed by new facts Matt Ridley, Nature via Nurture, p.23

Oral Presentation 19

OBJECTIVES: To investigate qualitative and quantitative variability among local Institutional Review Boards (IRBs) in the approval of research protocols and informed consent documents for a standardized a multicenter study with a common protocol MATERIALS AND METHODS: Descriptive study of the variability of local IRB review and approval process for four multicenter studies with common protocols conducted within the Fellow's Pelvic Research Network (FPRN). The local IRBs follow all applicable federal guidance including the DHHS at 45 CFR Part 46 and the FDA at 21 CFR Part 50 and 56 pertaining to human subjects research and the applicable regulations pertaining to privacy in research under the Health Information Portability and Accountability Act (HIPAA) at 45 CFR Part 160 and 164. RESULTS: Most of the 22 unique network sites (68%) were in academic institutions and (63%) had ABOG-ABU accredited fellowships. The four multicenter network studies included two prospective cohorts, one retrospective review and one retrospective case-control study. Sites participated in 1 (55%), 2 (18%) or 3 (27%) studies. Local IRBs varied in their requirements for identical research study protocols. Many IRBs had varied local requirements regarding standard format and language of consent forms that resulted in most sites (86%) changing consent document prior to IRB submission. Nonetheless, the IRB required changes to 71% of consent documents for the prospective studies. Required changes to consent documents primarily comprised alterations in wording with the intent of improving subject understanding of study risk and privacy safeguards. Thirty-three percent of sites were required to make minor format changes to the common protocol to meet local institution requirements. Despite federal guidelines for review of research, the level of review varied across sites (Table 1). Local IRB's had queries for most (55%) submissions with a significantly more queries for the prospective cohorts compared to retrospective studies [78.6% vs. 35.3% (P = 0.03)]. IRBs required changes to 29% of protocols, but there were no substantive changes made to any protocol. There was considerable variability in time between IRB submission and approval [10 ± 3 days, range 7–12 days for exempt; 22 ± 17 days, range 1–57 days for expedited and 34 ± 32 days, range 13–81 days for full board reviews]. Length of time to approval was longer for prospective than retrospective studies 30 ± 22 vs. 16 ± 15 days but failed to reach significance (P = 0.08). CONCLUSION: We detected considerable variability in local IRB review of standardized multicenter network protocols across a range of minimal-risk study designs. The reasons for this variability may include varied local interpretation in federal guidelines. Reduction in this variability may improve the expediency of multicenter studies while maintaining the highest level of protections for research participants.

Regulating Tissue Research: Do We Need Additional Rules to Protect Research Participants?

This article explores whether additional rules are needed for the regulation of tissue research in Europe. A human rights-based approach (referring to international documents and illustrative examples from national legislation) is taken to address the question: what is so special about tissue, in particular when compared to personal data? The existing regimes in Europe on data protection and clinical trials are presented and examined for their suitability to govern tissue research, taking into account the differences between data and tissue. Six recommendations are outlined, highlighting important points future legislation on tissue research must take into account.

Understanding bureaucracy in health science ethics: toward a better institutional review board.

Research involving human participants continues to grow dramatically, fueled by advances in medical technology, globalization of research, and financial and professional incentives. This creates increasing opportunities for ethical errors with devastating effects. The typical professional and policy response to calamities involving human participants in research is to layer on more ethical guidelines or strictures. We used a recent case-the Johns Hopkins University/Kennedy Kreiger Institute Lead Paint Study-to examine lessons learned since the Tuskegee Syphilis Study about the role of institutionalized science ethics in the protection of human participants in research. We address the role of the institutional review board as the focal point for policy attention.

REPORTING OF INFORMED CONSENT, STANDARD OF CARE AND POST‐TRIAL OBLIGATIONS IN GLOBAL RANDOMIZED INTERVENTION TRIALS: A SYSTEMATIC SURVEY OF REGISTERED TRIALS

Ethical guidelines are designed to ensure benefits, protection and respect of participants in clinical research. Clinical trials must now be registered on open-access databases and provide details on ethical considerations. This systematic survey aimed to determine the extent to which recently registered clinical trials report the use of standard of care and post-trial obligations in trial registries, and whether trial characteristics vary according to setting. We selected global randomized trials registered on http://www.clinicaltrials.gov and http://www.controlled-trials.com. We searched for intervention trials of HIV/AIDS, malaria, and tuberculosis from 9 October 2004, the date of the most recent version of the Helsinki Declaration, to 10 April 2007. We collected data from 312 trials. Fifty-eight percent (58%, 95% CI = 53 to 64) of trial protocols report informed consent. Fifty-eight percent (58%, 95% CI = 53 to 64) of trials report active controls. Almost no trials (1%, 95% CI = 0.5 to 3) mention post-trial provisions. Most trials measure surrogate outcomes. Twenty percent (20%, 95% CI = 16 to 25) of trials measure patient-important outcomes, such as death; and the odds that these outcomes are in a low income country are five times greater than for a developed country (odds ratio (OR) 5.03, 95% CI = 2.70 to 9.35, p = < 0.001). Pharmaceutical companies are involved in 28% (CI = 23 to 33) of trials and measure surrogate outcomes more often than nonpharmaceutical companies (OR 2.45, 95% CI = 1.18 to 5.09, p = 0.31). We found a large discrepancy in the quality of reporting and approaches used in trials in developing settings compared to wealthier settings.