Research ethics and refugee health: a review of reported considerations and applications in published refugee health literature, 2015-2018
Emma E. Seagle, Amanda J. Dam, Priti P. Shah, Jessica L. Webster, Drue H. Barrett, Leonard W. Ortmann, Nicole J. Cohen, Nina N. Marano
BMC Conflict and Health, 20 June 2020; 14(39)
Public health investigations, including research, in refugee populations are necessary to inform evidence-based interventions and care. The unique challenges refugees face (displacement, limited political protections, economic hardship) can make them especially vulnerable to harm, burden, or undue influence. Acute survival needs, fear of stigma or persecution, and history of trauma may present challenges to ensuring meaningful informed consent and establishing trust. We examined the recently published literature to understand the application of ethics principles in investigations involving refugees.
We conducted a preliminary review of refugee health literature (research and non-research data collections) published from 2015 through 2018 available in PubMed. Article inclusion criteria were: participants were refugees, topic was health-related, and methods used primary data collection. Information regarding type of investigation, methods, and reported ethics considerations was abstracted.
We examined 288 articles. Results indicated 33% of investigations were conducted before resettlement, during the displacement period (68% of these were in refugee camps). Common topics included mental health (48%) and healthcare access (8%). The majority (87%) of investigations obtained consent. Incentives were provided less frequently (23%). Most authors discussed the ways in which community stakeholders were engaged (91%), yet few noted whether refugee representatives had an opportunity to review investigational protocols (8%). Cultural considerations were generally limited to gender and religious norms, and 13% mentioned providing some form of post-investigation support.
Our analysis is a preliminary assessment of the application of ethics principles reported within the recently published refugee health literature. From this analysis, we have proposed a list of best practices, which include stakeholder engagement, respect for cultural norms, and post-study support. Investigations conducted among refugees require additional diligence to ensure respect for and welfare of the participants. Development of a refugee-specific ethics framework with ethics and refugee health experts that addresses the need for stakeholder involvement, appropriate incentive use, protocol review, and considerations of cultural practices may help guide future investigations in this population.
Barriers to Obtaining Informed Consent on Shortterm Surgical Missions
Urška Čebron, Calum Honeyman, Meklit Berhane, Vinod Patel, Dominique Martin, Mark McGurk
Plastic and Reconstructive Surgery – Global Open: May 2020; 8(5) e2823
Short-term surgical missions (STSMs) enable visiting surgeons to help address inequalities in the provision of surgical care in resource-limited settings. One criticism of STSMs is a failure to obtain informed consent from patients before major surgical interventions. We aim to use collective evidence to establish the barriers to obtaining informed consent on STSMs and in resource-limited settings and suggest practical solutions to overcome them.
A systematic review was performed using PubMed and Web of Science databases and following Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. In addition to the data synthesized from the systematic review, we also include pertinent data from a recent long-term follow-up study in Ethiopia.
Of the 72 records screened, 11 studies were included in our review. The most common barrier to obtaining informed consent was a paternalistic approach to medicine and patient education. Other common barriers were a lack of ethics education among surgeons in low-income and middle-income countries, cultural beliefs toward healthcare, and language barriers between the surgeons and patients. Our experience of a decade of reconstructive surgery missions in Ethiopia corroborates this. In a long-term follow-up study of our head-and-neck patients, informed consent was obtained for 85% (n = 68) of patients over a 14-year period.
This study highlights the main barriers to obtaining informed consent on STSMs and in the resource-limited setting. We propose a checklist that incorporates practical solutions to the most common barriers surgeons will experience, aimed to improve the process of informed consent on STSMs.
From the Lab Bench to the Battlefield: Novel Vaccine Technologies and Informed Consent [BOOK CHAPTER]
Paul Eagan, Sheena M. Eagan
Ethics of Medical Innovation, Experimentation, and Enhancement in Military and Humanitarian Contexts
Springer, 18 March 2020; pp 69-85
Vaccines are a commonly used medical countermeasure against many infectious diseases and represent one of the tools used by militaries to maintain a healthy fighting force. Vaccines also constitute an essential intervention during humanitarian missions where contagious disease outbreaks can be the primary cause of the crisis or a by-product of social upheaval and natural disaster. Though many infectious diseases are recurrent problems and vaccines exist to address the threat, recent outbreaks of H1N1, Ebola, and Zika have brought to the forefront the inherent inadequacies of traditional vaccine development. New technologies such as nucleic acid-based therapies provide some hope for a more rapid and robust response capability. The potential acceleration of the vaccine development pipeline carries both opportunities and potential pitfalls. The use of immune enhancement technologies, experimental immunization protocols or unproven vaccines in military personnel or vulnerable populations during times of crisis brings to the forefront ethical issues concerning the adequacy of informed consent, human experimentation, and free choice. An overview of novel vaccine technologies is followed by an analysis of the ethical issues surrounding informed consent and human experimentation in vulnerable military and civilian populations.
Abstract 391: Variation in Time to Notification After Enrollment in Trials Conducted Under Exception From Informed Consent for Emergency Research [POSTER PRESENTATION]
Graham Nichol, Rui Zhuang, Tom P Aufderheide, Eileen Bulger, Clifton W Callaway, Jim Christenson, Mohamud R Daya, Ahamed H Idris, Peter Kudenchuk, Laurie J Morrison, Martin A Schreiber, George Sopko, Jeremy Sugarman, Christian Vaillancourt, Henry E Wang, Myron Weisfeldt, Susanne May
Circulation, 11 November 2019; 140(supplement 2)
Research in an emergency setting is challenging because the window of opportunity to treat may be short, and preclude time to obtain informed consent from the patient or their representative. Such research can be conducted under exception from informed consent (EFIC) if specific criteria are met. In the United States, this includes notification of an enrolled subject or their representative as soon as feasible after enrollment so that they have autonomy to opt out from ongoing study participation. To date, there is limited empiric information about time to notification (TTN).
To describe variation in TTN among sites participating in randomized trials conducted under exception from informed consent for emergency research.
Notification strategies were determined at each site prior to initiation of subject enrollment, and approved by a local institutional review board or equivalent. TTN was summarized overall, as well as stratified by site and clinical outcome among patients enrolled in multiple trials conducted by the Resuscitation Outcomes Consortium (ROC).
Included were 34,868 patients enrolled in four trials. Of these, 33,805 had with out-of-hospital cardiac arrest; and 1,063 had life-threatening traumatic injury. TTN varied (Table).
There is large variation in TTN in trials conducted under EFIC for emergency research. Early notification is difficult; delayed notification may reduce the autonomy of patients or their representative.
Mention of ethical review and informed consent in the reports of research undertaken during the armed conflict in Darfur : a systematic review
Ghaiath Hussein, Khalifa Elmusharaf
BMC Medical Ethics, 13 June 2019; 20(40)
Armed conflict in Darfur, west Sudan since 2003 has led to the influx of about 100 international humanitarian UN and non-governmental organizations to help the affected population. Many of their humanitarian interventions included the collection of human personal data and/or biosamples, and these activities are often associated with ethical issues. A systematic review was conducted to assess the proportion of publicly available online reports of the research activities undertaken on humans in Darfur between 2004 and 2012 that mention obtaining ethical approval and/or informed consent.
This systematic review is based on a systematic literature search of Complex Emergency Database, ReliefWeb, PubMed), followed by a hand search for the hardcopies of the eligible reports archived in the Centre for Research on the Epidemiology of Disasters (CRED) in Brussels.
The online search showed that out of the 68 eligible studies, 13.2% (9) reported gaining ethical approval and 42.6% (29) that an informed consent was obtained from the participants. The CRED search included 138 eligible reports. None of these reports mentioned gaining ethical approval and 17 (12.3%) mentioned obtaining informed consent from their participants.
The proportion of studies reporting ethical review and informed consent was smaller than might be expected, so we suggest five possible explanations for these findings. This review provides empirical evidence that can help in planning ethical conduct of research in humanitarian settings.
Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception Room Informed Consent for emergency research
Victoria Vorholt, Neal W Dickert
Journal of Medical Ethics, January 2019 – Volume 45 – 1
Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.