Overall, the results presented an answer to the main search question, which addressed two variables regarding the publicly available online reports of the research activities undertaken on humans in Darfur between 2004 and 2012, which are the proportion of mentioning obtaining ethical approval and/or the mention of informed consent. In this section, we are providing a general overview of these results followed by a number of possible explanations to help in understanding them. These possibilities were discussed using the relevant literature, and when possible, by quotes from the studies themselves.
General overview on the findings
In the 68 included studies, the most common methodology was that of household multi-indicator surveys, which were mostly done by the UN agencies and/or other INGOs (51; 75%) and focused on mortality, morbidity and nutrition. They are key elements to planning, implementing and assessing humanitarian interventions in Darfur, although other conditions were also studied like hepatitis, malaria, and HIV/AIDS, and genetics. There was only one retrievable RCT on Darfur refugees in Cairo. This is unsurprising as RCTs generally need more stable settings, as well as technical and logistic requirements that are hard to provide in a conflict setting. Moreover, RCTs are unlikely to be methodologically useful to answer the kinds of research questions raised in conflict settings.
The degree to which household questionnaire-based surveys were so dominant amongst the studies in this review can be used to understand the overall findings. For example, the INGOs may have considered such research activities as ‘low risk’ studies that did not include invasive measures, and therefore ought to be exempted from ethical review. In addition, different agencies may have different policies related to their research practices, including different levels of ethical review depending upon the method and/or risks involved. These hypotheses and possibly others need to be tested in future work.
Mention of ethical review
As none of the CRED studies mentioned their ethical approval status, the following focuses only on the studies retrieved from the online search. The majority of the studies (59; 86.6%) did not report whether they had gained a favourable ethical opinion. This does not necessarily mean that ethical review was not sought or that they did not receive a favourable opinion where one was sought. However, if we assume that the findings from the studies available for review reflect the general picture of all studies conducted in Darfur during the relevant period, we can hypothesise about why the two ethical features (ethical approval and informed consent) were only mentioned so rarely.
These possibilities include the following:
The plausibility of this option is supported by a statement that was found in one of the studies included in this review. The Crude Mortality Survey, led by the WHO and jointly conducted by other UN agencies and the GoS, stated that “WHO guidelines do not require ethical review for retrospective surveys during humanitarian emergencies …” [17].
This statement reflects that at least some of the WHO surveys during emergencies are exempted from ethical review, and this is likely to include the surveys included in this review which were led or actually undertaken by the WHO (7; 10.3%). However, it is not possible to derive a general conclusion from a statement mentioned in one study.
Other possible reasons for exemption from ethical review are provided by MSF’s ethics committee including where the research involves “routine programme implementation and assessment related work” [27]. It is not clear in the guidelines, whether these ‘assessment-related work’ included the collection of personal data and/or biosamples or not. This exemption is unlikely to have been applied in the studies included in this systematic review, whose main inclusion criterion was the prospective collection of personal data and/or biosamples. Moreover, it would be expected than even when these surveys are not done primarily for research purposes may not need ethical approval; yet they would have complied with an essential ethical requirement such as consent.
The majority of these studies (39; 57.4%) were conducted by humanitarian aid agencies. As a part of sharing experiences and lessons learned among these agencies, they could be more interested in sharing their methodologies and findings than sharing other details. Therefore, the published reports would be expected to focus more on the methodological details and results than items related to the ethical issues. However, even if this is true of the studies published in disaster-specific databases where mentioning ethical review or consent is not a requirement for publishing a study report, it should not apply to the one third of studies (26, 34%) that were published in peer-reviewed journals. In the latter, “authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee” [28]. The discrepancy between the 34% of studies that were published in peer-reviewed journals and the 13.2% that mentioned being ethically reviewed suggests that studies were published in peer-reviewed journals without stating their status of ethical approval in the published papers. Further contact with the authors and the journal editors is needed to exclude the possibility that the status of ethical approval was made available to the editors (e.g. in covering letters accompanying a manuscript) but not included in the published articles.
This possibility assumes that the studies done by the organisation were assumed to have been ethically approved, and so the researchers did not have to mention this approval in their published reports. This possibility could be supported by other findings in the study, as one third of the ethically approved studies were either reviewed by the MSF ethics committee or exempted by them as they had met prior established criteria set out in its ethical guidelines. It could be assumed that MSF applies its ethical standards to all its surveys [29]. Moreover, MSF has its own criteria for exempting some of the field research from ethical review [27], which could explain why some of its studies reported ethical review while others did not.
This is an alternative approach to ethical review that is based on ethically reviewing and approving ‘ready-made’ generic study protocols of ‘emergency research’ when the research needed to be conducted in an urgent and timely manner, i.e. it cannot wait for full ethical review. This approach has been suggested for research to be conducted during pandemics [18] and is adopted by the MSF ethics committee in very special circumstances [27]. In the context of this systematic review, this could mean that one or more of the included studies may have been held to be ‘emergency research’ that was a part of wider research whose protocol was previously ethically approved. However, the findings of this systematic review do not provide any evidence of that, as the reviewers did not assess whether these studies met the criteria for exemption stated in the MSF guidelines. We could not find any finding in this review to support this possibility. Additionally, the MSF guidelines clearly states that exemption by MSF Ethics Board “does not exempt MSF to comply with regulatory requirements in the country from where the data originate …” and “local ethical review may still be required.” [28] Moreover, the MSF ERB still requires the ethical approval of the final protocols that used pre-reviewed generic protocols. Thus, the studies under this category should have mention of ethical approval.
At least for the studies retrieved from the CRED search, the patterns and formatting used for reporting were very similar, as though they used a common template. These similarities applied to the methodologies and the reporting of the results. For example, multi-stage cluster sampling was used by almost all of the CRED studies reviewed (137; 99.3%) and more than half of those found online (36; 52.9%). Moreover, many of the reports used exactly the same wording to describe the sampling procedure.
This possibility can also be supported by the finding that the studies conducted by one INGO mentioned ‘Ethical Considerations’ using exactly the same words and structured under exactly the same bullet numbering [8, 9]. This is particularly significant if other INGOs also use a template. Theoretically, changing the template that such organisations use to report their studies may change the extent of inclusion of ethical considerations in future studies. For example, if a template included a section on ‘informed consent’ or ‘ethical approval’, then those using it would be likely to include more details about these aspects.
Discussion of the studies that mention being ethically approved
Given that almost all of the studies included in this review were conducted in the Sudan (apart from the trial that was conducted in Cairo); it would be expected to have them reviewed and approved by a Sudanese ethics committee. The main body responsible for such review is the National Research Ethics Committee, as stated in the Public Health Act [16] and the Sudanese national guidelines [4]. Given the complexity of the setting in which they were conducted, it would be expected that other alternatives would be considered. However, the studies that mention being ethically approved do not have much in common, but they do appear to reflect the general trend of the other studies. One significant exception is that almost all these articles were published in peer-reviewed journals [19,20,21, 29,30,31,32,33,34] (Table 4). Additionally, there are two points worth noting. First, MSF’s procedures on the ethical review of its field surveys [17] were the only INGO ethics-related oversight mechanism mentioned in the studies included in this review. Other NGOs might have their ethics committees and procedures, but they were not mentioned.
Second, there were only two studies ethically approved in Sudan. One was reviewed by a Sudanese university’s ethics committee [19], while the other was the only study that was reviewed and approved by the NREC [21]. Both committees are in Khartoum, not Darfur. The Sudanese research ethics guidelines defines research as “any social science, biomedical, behavioural or epidemiological act that entails systematic collection or analysis of data with the intent to generate new knowledge, in which human being are involved” [4]. With such a broad definition of research, it is reasonable to assume that the studies included in this review would count as research that needs to be ethically reviewed. In addition, all research studies that have non-Sudanese researchers should have been reviewed by the NREC if the Sudanese research ethics guidelines were followed [4, 16]. However, this finding could be for other reasons, such as a lack of ethics review capacity in Darfur, and perhaps Sudan as a whole, as other studies have already concluded [27, 29].
Mention of consent
In the online search, more studies mentioned that they obtained consent (29; 43%) than mentioned that they had been ethically approved (19; 13.2%). More studies in the online search than in the CRED search (17; 12.3%) mentioned obtaining consent. The former finding could be partially explained by the fact that most of the included studies were household-based studies which used similar methodologies that were described in detail and made available to humanitarian aid workers to use [17, 27]. These methodologies are described in common guides used by the researchers in these agencies. These guides usually mention a section on ‘informed consent’ under the ‘methodology’ section, so those who use these templates consider obtaining consent a part of the methodology. This assumption could be supported by the finding that some commonly used template guides mention obtaining consent from participants without mentioning other issues related to ethical review [17, 29]. Therefore, those who follow these guides would only mention what these guides contain, which is consent and not ethical approval.
As might be expected, most participants’ consent was obtained verbally (18; 27%), which is more feasible than obtaining written consent, given the culture of Darfur where people do not like to or cannot sign papers.
The finding that consent was mentioned in more of the online studies than the CRED studies has two possible explanations. First, there is more variation in the studies found in the online search, which included publications in peer-reviewed journals in addition to epidemiological field reports. It is more likely to find consent mentioned in an article published in a peer-reviewed journal than in household surveys that are mainly shared for their epidemiological findings. Second, most of the CRED studies were produced by a relatively limited number of organisations whose main interest is the field-related details, namely the results and survey methods. In contrast, the online studies included studies done for non-humanitarian purposes by non-humanitarian researchers who may follow different reporting formats. Also, the NGOs might have used template guides of survey methodologies that did not include or did not emphasise the mention of consent. For example, consent is built into the first part of the standard survey template and is considered a routine that it is not considered worth mentioning on its own.
The reports that mentioned that informed consent was obtained from participants did not describe how this was achieved. However, there is a point worth noting in relation to the content and structure of the informed consent sheets that were found in a few cases attached to the studies that mentioned obtaining consent from the participants. Despite the variability in the requirements for obtaining consent to be considered ethically valid, there is arguably a common criterion of appropriate disclosure of information to the participant so that she or he is considered ‘informed’. The following examples suggest that this criterion was at least sometimes not met; assuming actual practice was guided by these statements.
Example 1: Consent from a food security and nutritional assessment survey [21]
“Consent: We are conducting a survey on the nutrition and food security of your family. I would like to ask you some questions about your family and we will also weigh and measure your children who are younger than 5 years of age. The survey usually takes about one hour to complete. Any information that you provide will be kept strictly confidential and will not be shown to other people. This is voluntary and you can choose not to answer any or all of the questions if you want; however, we hope that you will participate since your views are important. Do you have any questions? May I begin now? YES______ NO______”
Example 2: Consent from a household health survey [30]
“We are a team from the Sudan Household Health Survey that is concerned with family health and education. We would like to talk to interview you for about 45 minutes. All the information we obtain will remain strictly confidential and your answers will never be identified. During this time, I would like to speak with the household head and all mothers or others who take care of children in the household. MAY I START NOW? If permission is given, begin the interview.”
Finally, most of the CRED studies were produced by a relatively limited number of organisations whose main interest is the field-related details, namely the results and survey methods. In contrast, the online studies included studies done for non-humanitarian purposes by non-humanitarian researchers who may follow different reporting formats. Also, the NGOs might have used template guides of survey methodologies that did not include or did not emphasise the mention of consent. For example, consent is built into the first part of the standard survey template and is considered a routine that it is not considered worth mentioning.
