Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

Kolman, J. M.; Wray, Nelda P.; Ashton, Carol M.; Wenner, Danielle M.; Jarman, Anna F.; Brody, Baruch A.

doi:10.1111/j.1748-720x.2012.00649.x

Cited by 7 publications

(4 citation statements)

References 19 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…With regard to a court subpoena requiring a researcher to disclose identifiable information about research participants, regulations protecting the confidentiality of participants' data and regulations granting subpoena authority for judicial purposes are not, in any E R H E R H & obvious way, harmonized across or even within relevant national jurisdictions. 31 Researchers can fight subpoenas to protect research participants but, at the same time, are cautioned not to guarantee in the consent form that participants' identifiable or sensitive information is protected from government inquiry. Not even the National Institutes of Health's Certificate of Confidentiality is ironclad in practice.…”

Section: Psychological Risks To Patients and Bystandersmentioning

confidence: 99%

Ethical Considerations When Using a Mobile Eye Tracker in a Patient‐Facing Area: Lessons from an Intensive Care Unit Observational Protocol

Larsen

Kolman

Masud

et al. 2020

Ethics & Human Research

Self Cite

View full text Add to dashboard Cite

This article describes the process of designing, approving, and conducting an investigator-initiated protocol to use an eye-tracking device in a health care setting. Participants wore the device, which resembles eyeglasses, in a front-facing manner in an intensive care unit for the study of personnel gaze patterns, producing a visual record of workflow. While the data of interest for our study was not specifically the health information protected by the privacy rule of the Health Insurance Portability and Accountability Act (HIPAA), a wide variety of such data was captured by the eye-tracking device, and the prospective consent of all people who might have been incidentally videotaped was not feasible. The protocol therefore required attention to unique ethical considerations-including consent, privacy and confidentiality, HIPAA compliance, institutional liability, and the use of secondary data. The richness of eye-tracker data suggests various beneficial applications in health care occupational research and quality improvement. Therefore, sharing our study's successful design and execution, including proactive researcher-institutional review board communication, can inform and encourage similarly valuable, ethical, and innovative audiovisual research techniques. KEYWORDS human subjects research, mobile eye tracker, HIPAA Privacy Rule, audiovisual research, intensive care units, patient rights, health personnel

show abstract

Section: Psychological Risks To Patients and Bystandersmentioning

confidence: 99%

Ethical Considerations When Using a Mobile Eye Tracker in a Patient‐Facing Area: Lessons from an Intensive Care Unit Observational Protocol

Larsen

Kolman

Masud

et al. 2020

Ethics & Human Research

Self Cite

View full text Add to dashboard Cite

show abstract

“…It may, for example, be difficult to determine whether an injury is a direct result of research participation (Steinbrook, 2006) or a result of underlying vulnerability or morbidity. The type and amount of compensation provided is also often a subject of debate and varying guidance internationally (Kolman et al, 2012). Bavdekar and Thatte (2009) recommend that compensation be based on the participant's age, years of productive life remaining, and need for medical care resulting from the injury.…”

Section: Abstract: Concern Has Been Voiced In Thementioning

confidence: 99%

“…Kachedwa, 2009). The opposing opinion to the provision of compensation for research-related injury, adopted primarily in the United States, is that sponsors, institutions, and investigators should not be obliged to provide compensation because participants are aware of the risks when they voluntarily agree to participate (Bavdekar & Thatte, 2009;Cleaton-Jones et al, 2006;Kolman et al, 2012;Mastroianni, 2008;Resnik, 2006;Steinbrook, 2006;Thatte, Kulkarni-Munshi, & Kalekar, 2009;Vasgird, 2006). Recently, however, the U.S. Presidential Commission for the Study of Bioethics tabled its 2011 report and acknowledged that the United States ''lacks a comprehensive system'' (Gutman & Wagner, 2011, p. 1) for dealing with research-related injury.…”

Section: Abstract: Concern Has Been Voiced In Thementioning

confidence: 99%

Compensation for Research-Related Injury in NIH-Sponsored HIV/AIDS Clinical Trials in Africa

Mamotte

Wassenaar

Singh

2013

Journal of Empirical Research on Human Research Ethics

View full text Add to dashboard Cite

Concern has been voiced in the research ethics literature that under U.S. federal regulations U.S. sponsors, particularly the NIH, are not required to provide compensation for the treatment of research-related injury for trial participants or to allow grant funds to be used by investigators for appropriate insurance. This is problematic in developing country contexts because most participants are unlikely to have health insurance, resulting in overburdened and under-resourced health systems in many developing countries being responsible for providing care and treatment for research-related injury. This study provides preliminary insight into how respondent principal investigators of NIH-sponsored HIV/AIDS clinical trials in Africa and African research ethics committees deal with compensation for research-related injury. The majority of PIs surveyed provided free treatment for research-related injury, but few provided other forms of financial reparation to participants. The study also found that half of the PIs surveyed indicated that NIH funds were used for compensation, highlighting a contradiction between literature and practice. The majority of REC chairs surveyed indicated that their RECs routinely reviewed compensation plans for research-related injury and that their ethics application forms specifically requested information on compensation. Findings from one southern African country revealed that NIH funds were not used to provide treatment and/or financial reparation for research-related injury. Instead, PIs from this country relied on the government or the individual research participant (and/or their medical aid/health insurer) to cover the costs of research-related injury. The findings are discussed in the light of the recent (December 2011) U.S. Presidential Commission for the Study of Bioethics report which recommends that research participants are morally entitled to compensation for research-related injury.

show abstract

“…The most commonly cited document is Emanuel, Wendler, and Grady’s “An ethical framework for biomedical ethics” [ 2 ]. Some sources mistakenly perceive this literature as a “coalescence of current standards in a single source” [ 3 ]. If we look at Emanuel, Wendler, and Grady’s article, there are clear indications that though the various guidelines were consulted, the aim of the article is to produce a “broader, systematic, and comprehensive framework” precisely because for them, existing guidelines are neither systematic nor comprehensive enough [ 2 ].…”

Section: Introductionmentioning

confidence: 99%

What do international ethics guidelines say in terms of the scope of medical research ethics?

2016

View full text Add to dashboard Cite

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus (or lack thereof). In this manuscript, we attempted to do just that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus (i.e., consensus of at least 3 of the 5 ethics guidelines). Of the 12 clusters (Basic Principles; Research Collaboration; Social Value; Scientific Validity; Participant Selection; Favorable Benefit/Risk Ratio; Independent Review; Informed Consent; Respect for Participants; Publication and Registration; Regulatory Sanctions; and Justified Research on the Vulnerable Population), Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0106-4) contains supplementary material, which is available to authorized users.

show abstract

Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions

Cited by 7 publications

References 19 publications

Ethical Considerations When Using a Mobile Eye Tracker in a Patient‐Facing Area: Lessons from an Intensive Care Unit Observational Protocol

Ethical Considerations When Using a Mobile Eye Tracker in a Patient‐Facing Area: Lessons from an Intensive Care Unit Observational Protocol

Compensation for Research-Related Injury in NIH-Sponsored HIV/AIDS Clinical Trials in Africa

What do international ethics guidelines say in terms of the scope of medical research ethics?

Contact Info

Product

Resources

About