Research Ethics

Research on sexual violence is fraught with ethical and methodological challenges due to its sensitive nature. This paper describes the ethical and methodological challenges encountered in planning and conducting two exploratory studies on sexual violence that included in-depth interviews of eight female adolescent rape survivors in Ibadan and four married women in Lagos Nigeria who were raped, forced to perform sexual acts and sexually deprived. The first challenge encountered was an Institutional Review Board (IRB) requirement to obtain parental permission from adolescents, when such a requirement may place the adolescent at risk if a parent was a perpetrator of sexual violence. Using arguments emphasizing the Council for International Organization for Medical Sciences guidelines helped convince the IRB to provide a waiver of parental consent. Second, the privacy required to conduct in-depth interviews for rape survivors was difficult to achieve because five of the rape survivors were apprentices who work in public settings which are typically used to conduct business in the informal sector. To overcome this challenge, interviews were conducted in safe locations, investigator's offices and homes of survivors. The culture of silence associated with sexual violence posed a challenge because it encourages perpetration of violence with impunity causing rape survivors to suffer in silence. None of the affected adolescents had sought judicial redress for rape despite availability of stringent punishment for this behaviour. Referral information was provided on where survivors could seek care. Interviews with the women could not be recorded on audio-tapes because of concerns that their partners might identify their voices from the tapes and punish them for this. Although research on sexual violence poses ethical and methodological challenges, it is not only desirable but also feasible to conduct such research in ways that ensure safety of participants.

Background: Previous studies have found lapses in ethical safeguards for subjects of critical-care research.

Objective: To assess recently published empiric critical-care research conducted in the United States for the reporting of research protections as they relate to informed consent and surrogate decision-making. Methods: Systematic review of a sample of empiric critical-care research studies published between 2000 and 2004.

Results: Of 51 studies reviewed, consent was reported as having been obtained in 44. Assessment of subjects' decision-making capacity was noted in 35% of studies. Assessments of subjects' capacity was less likely to be reported in studies in which researchers accepted consent from either subjects or from third parties, compared to studies with only subjects' consent (P=0.042). Five studies did not report securing Institutional Review Board approval.

Conclusion: Lapses in the reporting of critical-care research are prevalent.

Used wisely the concepts of race and ethnicity in research have great potential, but used unwisely they can do immense damage. We need to consider the potential issues that might require a change of emphasis or application of ethics in a multi-ethnic society.

Doing no harm (non-maleficence) is the most important ethical pillar in the ethnicity and health field. Ethnic differences can be used in damaging ways. Without the ethic of beneficence in place it is better not to draw attention to ethnic differences.

Respect is the pre-condition for autonomy. Autonomy of ethnic minority populations to live in their own traditional way is not easy to achieve in multi-ethnic societies. There are difficult issues in multi-ethnic societies that require great sensitivity to create a sense of fairness and justice. Justice is the core value that underpins equity. There is a deep paradox – to promote equality, we may need to treat people and groups unequally.

Ethical codes need to be modified to emphasize the importance of including ethnic minority populations in research and not bypassing them, as has been happening. It is correct, for example, that potential research participants' personal details are guarded. If such a person, however, does not read it may be unethical to send written information about a project. It may be more ethical to tele phone or even call at the doorstep of such a person.

The history of racism in research is worrying, not least the fear that it might return. We need a governing code of conduct. Ethical research can help ethnic minority groups to move from the shadows of society and participate in a vibrant, healthy, multi-ethnic society.

There is a growing interest in researching the plight, health, and social care needs of forced migrants and the complex ethical issues related to researching this vulnerable group. Conducting health and social care research with forced migrants is a sensitive and complex issue and can place emotional demands on contributors, requiring high ethical and moral standards which safeguard participants, researchers and the integrity of the study. Researchers and those who review research need to be sensitive to the needs, privacy and fears of participants. In addition to the medical and personal benefits that can be obtained from undertaking research with forced migrants, there comes the risk of stigmatization, exploitation and harm. This paper identifies some, but by no means all, key ethical issues confronting researchers, these dilemmas include the complex issues of language and translation, immigration status, contextual issues, lack of familiarity with the research process, issues of informed consent and safeguarding anonymity. Confidentiality, sensitivity to cultural traditions and values, and avoiding re-traumatization also need to be considered as this knowledge can minimize research risks and protect the rights and welfare of research participants. This paper will draw upon experience of working with refugees and asylum seekers for many years and from experience gained from small-scale qualitative research undertaken with Somali and Ethiopian forced migrants. It argues for the need for a consistent, robust, ethical framework to ensure that the ‘researcher’ does not inadvertently ‘do harm’ by infringing on the security, privacy and well-being of the subjects of the research. This paper in turn adds to the knowledge base on good practice and research ethics and is hoped that it will provide useful guidance for those undertaking the ethical review for this type of research.

This study appeared in full in the last issue of Research Ethics Review (2007; 3 (4): 130). Claire, a physiotherapist, wishes to investigate the effects of ‘sports drinks’ on local primary school children who are keen to take part. She plans to use a Multistage Fitness Test in which the children will be asked to run from one designated point to another in time with recorded sounds. Each child will be asked to take the test twice. On the first occasion no sports drink will be given. The drink will be administered before the children take the test for the second time.

This paper focuses on the REC and its political context to clarify the process of ethical review. The examples initially considered are taken from a Research Ethics Review editorial to develop the social explanation of the membership and function of a research ethics committee. It is suggested that the management and administration of medical matters are not always best understood solely in medical terms. The conclusion of the paper is that the larger political relationships determine the membership and function of the research ethics committee. The REC is defined as the political mechanism for formally socializing medical research and its lay members as similarly socializing the REC.

This paper reviews some of the ethical issues associated with the administration of long and intrusive questionnaires and interview schedules, particularly to people whose mental health is compromized. The author argues that this approach to research is potentially abusive and challenges its acceptance as the best method of obtaining relevant data. Recommendations focus on collaboration between the National Research Ethics Service, patient representatives and the research community in order to develop more humane approaches to help understand the needs of vulnerable patients.

Deficiencies or unclear statements in consent forms used for research with human participants may lead to publicly-funded research data being unsuitable for sharing with other researchers. Long-term data use is encouraged or required by many of the UK research councils and other funding bodies. Researchers may fail to address long-term use and sharing of data when obtaining informed consent and when arranging to keep data obtained from participants confidential. Sharing data should not compromise confidentiality if care is taken to anonymize information where this is needed or has been explicitly requested. Whilst researchers should consider all potential uses of their research data in confidentiality and consent agreements, research ethics committees can provide better guidance by pointing out to researchers that long-term use, preservation and sharing of research data should be taken into account when informing participants and obtaining their consent.