Table 2.

Summary of Included Records.

Publication details	Aim	Location	Method of Study	Findings /Ethical Considerations	Conclusions
Peer Reviewed Journal Papers
Patricia Arcega, Chiara Cabantac, Ronald Cruz31 Trends in health research ethics in the Philippines during the American Colonial Period (1898–1946) Developing World Bioeth. 2019; 00:1–6.	To explore trends in health research ethics in the Philippines during the American colonial period (1898-1946).	Philippines	Review of research protocols and clinical trials involving vulnerable human subjects in the Philippines within the American colonization period (1898–1946). Quantitative and qualitative analysis of documents retrieved.	The authors identified 288 documents and 36 of these related to research in prison. These prison studies documented the use of people in prison to test vaccines and to harvest tissues from for medical research. From 1898 to 1946, very few studies mentioned the observance of ethical guidelines or of the informed consent process.	The authors attribute the fact that the consent process is not emphasised in studies and is mostly verbal, and the lack of clearly stated ethical guideline observance to the fact that the Nuremberg Code was not drafted until 1947, after the American colonization period in the Philippines had ended and the study period.
Virginia Dube32 Navigating the Libido Dominandi: Intricate Realities of Forensic Psychiatry Research Ethics in Zimbabwe J Psychiatry 2015, 18:1	To present the inherent ethical issues experienced in conducting forensic psychiatry research in special institutions Zimbabwe.	Zimbabwe	Case study. By examining a particular research study involving forensic psychiatric patients in a maximum-security prison, the author outlines an ethical ‘conundrum’ and considers in detail the ethical issues raised.	Both general psychiatry and forensic psychiatry are driven by the Zimbabwe Mental Health Act of 1996, Zimbabwe Mental Health Regulations of 1999 and the Zimbabwe Mental Health Policy of 2004. Part 3 of the Act addresses forensic psychiatric patients with provisions of a port of entry for the rehabilitation as functional members of society and are admitted in what are called Special Institutions. These institutions are hospitals located within a maximum-security prison where they are subject to the Zimbabwe Prison Act and the Zimbabwe Prison (General) Regulations of 1996. This paper lays bare the many contradictions in such a system and highlights the near impossibility of conducting ethical research in such an environment: ‘The environment is such that the researcher can only congregate with a forensic psychiatric patient for interview provided the researcher has violated all the provisions of the Belmont Report of 1979 … This scenario then calls for collaboration as academia, practice, professional organizations and regulatory bodies to untangle this intricate ethical web.’	The conduct of ethical research into the health of forensic psychiatric patients is very difficult; in Zimbabwe such people are housed in the prison system. The conflicting priorities of the health and custodial systems create tensions and potentially insurmountable difficulties in the conduct of ethical research.
Charles E. Gessert & Catherine McCarty33 Research in Prisons: An Eye for Equity, Ophthalmic Epidemiology 2013, 20:1, 1-3	To consider the issues raised by a study on people in prison published by the journal (Tousignant B, Brian G, Venn B, et al. Optic neuropathy among a prison population in Papua New Guinea)	Papua New Guinea/ worldwide	Editorial/commentary The authors comment on a study on optic neuropathy in people in prison in Papua New Guinea	Epidemiological research is important in documenting health problems, especially in underserved populations. It is particularly important in prisons where those imprisoned are ‘largely invisible’, hidden from the public eye, ‘not only by the walls and barbed wire, but by legal and administrative barriers.’ In some cases, governments do not want additional scrutiny of what occurs in prisons. However, it is important that research is conducted in these settings which have been neglected; people in prison should benefit from research. There must also be adequate protections to ensure they are not being exploited in the process. This is possible and Tousignant’s study is an example of good practice in prison research.	There are two competing concerns with research on people in prison: (1)what steps are necessary to protect them from exploitation (2)what steps are needed to ensure that they are not excluded from participation in research that may be beneficial to them or their peers.
Lyons B34 History, Ethics and the Presidential Commission on Research in Guatemala Public Health Ethics 2014; 7(3) 211–224.	To critique the historical enquiries of the Presidential Commission for the Study of Bioethical Issues which examined research carried out by the US Public Health Service in Guatemala between 1946 and 1948	Guatemala	Commentary The author examines the findings of the ‘Guatemala Commission’, focusing on the prevailing culture of that time.	Between 1945 & 1948, experiments were conducted for national security purposes, and therefore, it was believed by many scientists at that time that the conventional standards of medical ethics could be waived. There was a great public health need for such experiments because the prevalence of sexually transmitted diseases (STDs) was such that the balance of risk and benefit justified the effort, however much it might compromise individual rights. At the time, understanding of the moral norms for research by scientists and others was evolving, and rules and principles were just beginning to be codified. The American Medical Association (AMA) Judicial Council had sided in 1946, with what would soon be the Nuremberg view that voluntary consent to participation in research is essential. Numerous international codes defined ethical standards for human experimentation, most notably the Nuremberg Code, did not command much attention and received very little press coverage. American researchers and physicians apparently found Nuremberg irrelevant to their own work. Key aspects of unethical practice in the studies in Guatemala on people in prison and other vulnerable groups included the lack of consent to participation and overriding utilitarian ethos (sending some men to be killed so that others may live).	The Guatemala Commission ‘seems to have been deficient in its defining of standards, its review of historical data and in its analysis, or at least in its publication of this matter.’ It is important to understand historical misdemeanours/abuses in medical research in context.
Salaam AO & Brown J35 Ethical Dilemmas in Psychological Research with Vulnerable Groups in Africa. Ethics & Behavior 2013; 23:3, 167-178	The aim of the article is to identify key problems and offer a sensible way to conduct ethically sound applied psychological research among vulnerable or marginalized groups in Africa.	Nigeria	Case study The authors examine two research studies, identifying the key ethical challenges in their conduct, discussing these and how they were managed.	Ethical clearance to conduct the study was obtained. Permission was sought from the National Drug Law Enforcement Agencies (NDLEA) in Nigeria in order to gain interview access to drug offenders in their custody. Voluntary participation & informed consent: During the questionnaire distribution, the participants were informed that their participation was voluntary and anonymous. The researcher explained the research’s purpose and aims and ensured that potential participants understood the study had no bearing on the outcome of their cases. Voluntary participation was stressed. In addition, they were told that they could get more information about the study at any time during the data collection; ask questions about the study even after they had completed and returned the questionnaires; leave out questions on the questionnaire they did not feel comfortable completing and the return of a completed questionnaire was their way of consenting to participation in the study, as is common practice elsewhere Risk: Exclusion criteria used included Inmates who might be unfit for an interview due to mental illness, high risk inmates such as those considered to be potentially violent or dangerous, or had previous records of planning/preparing/attempting to abscond or escape, and those deemed ineligible for other reasons at the discretion of the gaoler Anonymity, was ensured through ensuring that no names or other, marks likely to identify the participant appeared on the self-administered questionnaire. A high number of prison inmates who participated in the study were awaiting trial and were reluctant to sign the consent form because of the fear that it would be used to implicate them in their trial Reimbursement: payment or reimbursement in money or in kind is not a problem per se. However, if participants are from financially disadvantaged groups, this could be potentially construed as a form of coercive consent because of their monetary needs: is consent “freely given” if payment is involved? Ethical standards for participation in research demand that the participants should not be coerced and/or unduly influenced by financial, psychological, or other pressures.	Contexts and cultures differ in terms of application of consent seeking procedures and use of rewards as a coercion tool in inducing participation in research more so when carrying out study with vulnerable institutions such as prisons. The challenges should not put researchers off, rather they should think through all aspects carefully. The authors state, ‘it is important to strike a balance between the safety of individuals (both of the researcher and the researched), cultural sensitivities, the socioeconomic realities, and optimal research designs.’
Taborda J & Arboleda-Florez J36 Forensic psychiatry ethics: expert and clinical practices and research on prisoners Rev Bras Psiquiatr. 2006;28(Supl II): S86-92	To review the most relevant ethical issues of the tripartite aspects on which forensic psychiatry is based: expert activity, treatment of the mentally ill in prisons, and research on prisoner subjects.	Brazil	Commentary	Relating to the ethical aspects of research conduct in prisons: Historically, there have been numerous historical abuses involving people in prison in the conduct of profoundly unethical research. This resulted in research in this environment stopping in the 1970s to prevent further abuses. This situation has now improved – people in prison should have the benefits of research. However, there should be ‘the strict observance of universal ethical principles in order to avoid imposing on this highly vulnerable population an onus greater than their sentence’. It is possible to achieve a balance between the need to conduct research in prison settings and the protection of the rights of imprisoned people, particularly if:  -Incentives to participate are avoided.  -Therapeutic research is distinguished from no-therapeutic research.  -Pro-active role of ethics in research committees. The prison setting is unique but there is no prison specific guidance. This is problematic as ‘Merely invoking traditional variables, such as mental competence and the absence of coercion, is insufficient.’ Compensation for study participation which in the community might be regarded as minimal, can, in the prison setting be tantamount to the “buying” of subject compliance, for example the ‘unimaginably minimal recompense’ of better nutrition or transfer to another cell block. Argues for the need for the Ethical Research Committee (ERC) to be pro-active in monitoring study conduct, going beyond reviewing periodic study progress reports to making unannounced onsite inspections.	Bearing in mind the vulnerability of prisoners, deprived of a portion of their autonomy and free will, as well as the fact that they live in an environment that fosters abuse, the ERC should carefully evaluate the following aspects: -the scientific validity of the project; -the qualifications of the researchers; -the estimated risks; -the cost-benefit ratio; -the rules governing the recruitment of subjects; -the guarantee of confidentiality; -the safeguards against the release of confidential data; -any potential conflicts of interest among the researchers. There is a need for prison-specific guidance for the conduct of ethical research.
Tangwa GB37 Research with vulnerable human beings Acta Tropica 2009; 112S S16–S20	To stimulate practical reflection on the possible vulnerabilities of potential research subjects that researchers or investigators need to avoid exploiting rather than on an adequate theoretical treatment of the issue.	LMICs	Commentary	There has been an increase in HIC research on human beings in LMICs, particularly in Sub-Saharan Africa (SSA). Many biomedical research studies in LMICs and particularly in SSA ‘have not been able convincingly to fulfil some of the requirements for ethical conduct of research on human beings, such as the informed consent condition, but have gone ahead, nevertheless.’ Describes the ‘Triple vulnerability’ of many in LMICs - vulnerable as members of economically disadvantaged groups; vulnerable as members of medically disadvantaged groups, bearing a heavy burden of neglected diseases; and vulnerable as members of specific groups such as people in prison. There are particular issues when conducting research in LMICs. For example: -the human rights structures which are central pillars of HIC societies are still to take firm roots in many LMICs. -there is still lack of adequate awareness about what medical research is all about. -‘subtle coercion’ is not yet absent from research -the high burden of disease, combined with poverty and ignorance makes people highly vulnerable to incentives to participate in research.	‘Vulnerability in itself does not imply that no research whatsoever should be carried out with such categories of humans but only that it should be carried out only under very special conditions.’
Zenilman J.39 The Guatemala Sexually Transmitted Disease Studies: What Happened Sexually Transmitted Disease. 2014;40(4):277-9	1. Provide a context for the Guatemala studies’ scientific rationale; 2. Provide a brief overview of the studies that were performed and the populations that were involved; 3. Review the correspondence between key individuals	Guatemala	Commentary The author examines the archives of the study records and data of the USPHS studies on sexually transmitted infections in Guatemala in the 1940s.	Examines the syphilis and other sexually transmitted disease studies conducted in 1946 to 1948 by the US Public Health Service in Guatemala. This data was revealed in 2010 after being hidden for more than 60 years. The studies used many groups who are considered to be vulnerable populations: people in prison, people with mental illness, people with limited literacy and cognition, and commercial sex workers. The key ethical principles that were flouted in these studies include: 1.a lack of respect for individuals’ autonomy, justice, respect for persons, and non-malfeasance. 2.no consent was obtained, either direct or implied, for any of the studies. 3.the studies put the participants’ health at unreasonable risk. 4.the studies’ design and documentation were often faulty. 5.the lack of recognition of participants’ vulnerability.	The vulnerability of groups such as people in prison was not acknowledged by researchers at the time. Many ethical principles now accepted as key in the conduct of research were not adhered to.
International Guidance on conducting Research in Prisons
UNODC HIV in prisons situation and needs assessment toolkit46	To provide information and guidance on conducting situation and needs assessments for the prevention and treatment of HIV infection and tuberculosis (TB) in prisons	Global	Guidance	Provides guidance on the conduct of ethical research in prisons relating to the management of blood borne viruses and TB infection: -Obtain ethics committee approval -All assessments and research involving human participants must be conducted in an ethical manner respecting the dignity, safety and rights of participants, and recognising the safety, security and responsibilities of assessment team members -Guiding ethical consideration in serological and behavioural situation and needs assessments should ensure that the basic human rights of individuals are not violated in the course of the assessment -Explain to respondents the objectives of the assessment; method of assessment; any possible risks of participation; the benefits of participation to themselves, the community and science; and how confidentiality will be maintained. -Participation in the assessment should be completely voluntary, without coercion -The participant’s right to give or withhold consent at any stage of the assessment should be explained to the participants prior to study beginning and during the consenting process -No false expectations should be raised throughout the assessment, -For all KABP survey and focus groups a signed informed consent form is required -Anonymity and confidentiality should be maintained -Anonymity should be maintained and, arrangements should be made to ensure that respondents are not endangered in any way by disclosure of information. -Field worker safety should also be taken into account, considering the particular setting. -All members of the assessment team should sign a confidentiality agreement -The anonymity of serological and behavioural surveys, test results will not be provided to individual participants who might be interested in their results -If participating prisoners want to know their HIV/TB/HBV/HBC serological status, they should be offered an independent and nominative (non-anonymous) test. -A voluntary testing and counselling programme can be linked to the assessment activities in participating prisons. Principal Investigators should consider integrating VCT activity into their assessment protocol.	Although not specific to SSA the presence of UNODC in some SSA country prisons and its focus on HIV&AIDS and TB prevention, treatment care and support including commissioning and funding research in these conditions dictate that all researchers have to abide by these principles when conducting research in prisons