|Year : 2021 | Volume
| Issue : 3 | Page : 178-183
Perspectives of buruli ulcer patients toward informed consent – An insight from Nigeria
Ijeoma Angela Meka1, Okezie Obasi Kanu2, Kenneth O Adagba3, Jonah Offor4, Nwamaka R Emodi5, Adebola O Iseoluwa-Adelokiki6, Anthony O Meka7
1 Faculty of Medical Sciences, College of Medicine, University of Nigeria, Ituku/Ozalla Campus, Enugu, Nigeria
2 College of Medicine, University of Lagos, Nigeria
3 National TB & Leprosy Training Centre, Saye, Zaria, Nigeria
4 Cross River State Ministry of Health, Nigeria
5 Anambra State Ministry of Health, Nigeria
6 Ogun State Ministry of Health, Nigeria
7 German Leprosy & Tuberculosis Relief Association, Nigeria
|Date of Submission||13-Apr-2020|
|Date of Acceptance||25-Jun-2020|
|Date of Web Publication||17-Sep-2021|
Dr. Ijeoma Angela Meka
Faculty of Medical Sciences, College of Medicine, University of Nigeria, Ituku-Ozalla Campus, Enugu
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Introduction: Informed consent is a basic ethical requirement in situations involving sharing of patients' data. It supports and upholds the ethical principle of respect for persons and individual autonomy. For Buruli ulcer (BU) patients, associated stigma renders them vulnerable, hence the need for emphasis on additional protection by ensuring obtaining informed consent before third party use of their data. The authors therefore sought to determine willingness of these patients to give informed consent to the third party use of their data before and after treatment. Methodology: This cross-sectional study was carried out between February and August, 2019. The study involved BU patients from three endemic states in Nigeria. Data were collected using pretested, researcher-administered semi-structured questionnaires. Results: A total of 92 respondents participated in the study. The median age was 23.5 years (range 4–74 years) with the age group <15 years being the modal age group 36 (39.13%). About a quarter of the respondents (23.91%) had suffered some form of discrimination in the course of their disease. Majority 86 (93.48%) were favorably disposed to allowing the use of their data for donor drive, policy development, and teaching/training purposes. A significant greater proportion of respondents 90 (97.83%) were willing to give consent for the use of their oral interview as against pictures and videos both in the pre- and post-treatment periods. Conclusion: The present study provides evidence that majority of the respondents were positively inclined to give consent to use of their data by a third party. However, intrusion into privacy and anonymity were major concerns for the respondents.
| Abstract in French|| |
Introduction: Le consentement éclairé est une exigence éthique de base dans les situations impliquant le partage des données des patients. Il soutient et défend le principe éthique du respect des personnes et de l'autonomie individuelle. Pour les patients atteints d'ulcère de Buruli, la stigmatisation associée les rend vulnérables, d'où la nécessité de mettre l'accent sur une protection supplémentaire en garantissant l'obtention d'un consentement éclairé avant l'utilisation par des tiers de leurs données. Les auteurs ont donc cherché à déterminer la volonté de ces patients de consentir en connaissance de cause à l'utilisation de leurs données par des tiers avant et après le traitement. Les méthodes: Cette étude transversale a été réalisée entre février et août 2019. L'étude a porté sur des patients atteints d'ulcère de Buruli provenant de trois États endémiques du Nigéria. Les données ont été recueillies à l'aide de questionnaires semi-structurés prétestés et administrés par des chercheurs. Résultats: Au total, 92 répondants ont participé à l'étude. L'âge médian était de 23,5 ans (de 4 à 74 ans), le groupe d'âge <15 ans étant le groupe d'âge modal 36 (39,13%). Environ un quart des répondants (23,91%) ont subi une forme de discrimination au cours de leur maladie. La majorité 86 (93,48%) étaient favorables à autoriser l'utilisation de leurs données à des fins de mobilisation des donateurs, d'élaboration de politiques et d'enseignement / formation. Une proportion significativement plus élevée de répondants 90 (97,83%) étaient disposés à donner leur consentement pour l'utilisation de leur entretien oral par rapport aux photos et vidéos à la fois avant et après le traitement. Conclusion: La présente étude prouve que la majorité des répondants étaient positivement enclins à consentir à l'utilisation de leurs données par un tiers. Cependant, l'intrusion dans la vie privée et l'anonymat étaient des préoccupations majeures pour les répondants.
Keywords: Anonymity, Buruli ulcer, Informed consent, oral interview, privacyMots-clés: Anonymat, ulcère de Buruli, Consentement éclairé, entretien oral, intimité
|How to cite this article:|
Meka IA, Kanu OO, Adagba KO, Offor J, Emodi NR, Iseoluwa-Adelokiki AO, Meka AO. Perspectives of buruli ulcer patients toward informed consent – An insight from Nigeria. Ann Afr Med 2021;20:178-83
|How to cite this URL:|
Meka IA, Kanu OO, Adagba KO, Offor J, Emodi NR, Iseoluwa-Adelokiki AO, Meka AO. Perspectives of buruli ulcer patients toward informed consent – An insight from Nigeria. Ann Afr Med [serial online] 2021 [cited 2021 Dec 6];20:178-83. Available from: https://www.annalsafrmed.org/text.asp?2021/20/3/184/326192
| Introduction|| |
The ethical principle of autonomy requires that individuals are given the opportunity to make voluntary and informed decision about whether or not to accept medical care, participate in a research and take decisions on matters pertaining to him/her as an individual. Informed consent thus upholds respect for patients' dignity and the right to make autonomous voluntary decisions as voluntary decision process is one of the three components of a valid informed consent. This autonomy and voluntariness ought to be respected and upheld regardless of the type of medical condition of the patient. Certain medical conditions are known to predispose a patient to stigmatization and this stigma mostly leave the patient vulnerable. The act of providing the opportunity for the patient to give voluntary consent helps to protect the vulnerable patient as he is assured of continued care whether or not he consents to participate. It equally protects his dignity as he sees that his choices and preferences are respected. The assurance of continued care regardless of whether or not the individual participates in research helps to buttress voluntariness of participation and hence is a prerequisite component of the informed consent document as stipulated in the Nigerian National Code of Health Research Ethics.
Stigmatized neglected tropical diseases (NTDs) remain one group of diseases which leave the patients vulnerable majorly due to the associated stigma., One such disease is Buruli ulcer (BU) caused by Mycobacterium ulcerans. It is an emerging NTD endemic in Nigeria, but its severity and magnitude is still underestimated. Although the actual worldwide disease burden is still not clear, in the past decade more than 42,000 cases have been reported worldwide, and a crude prevalence of 18.7/100,000 reported in Nigeria. Globally, it has been rated as the third most common mycobacteriosis after tuberculosis and leprosy. This infection is a flesh-eating disease presenting with destruction of skin and soft tissue and causing large unsightly ulcers. These ulcers are usually the cause of the associated stigma. Indeed, a recent study in Nigeria has recorded a high level of social stigma toward individuals with BU. Such individuals may have difficulty to freely interact with others, and also to undertake some income-earning jobs in the community.
Hence, the act of obtaining informed consent from these groups of patients remains an issue of ethical importance which ought to be respected despite their vulnerability. This follows from the consideration that informed consent is meant to protect people from being coerced into decisions that someone else thought were in their–or the state's–best interest.
The use of patients' data by a third party is an issue which should not be taken for granted. The patient ought to be fully aware of who is using the data and for what purpose and hence ought to be given the opportunity to give consent before use of the data. Ultimately, the goal of obtaining informed consent is to provide adequate information to a potential participant in a language he readily understands to enable him make a voluntary decision whether to participate or not.
Indeed, patients' data either in the form of pictures, videos, or oral interviews can be used for research, educational purposes, advocacy, policy drafting, and implementation among other purposes.
Although much has been written about informed consent,,, there is indeed a dearth of data geared toward seeking patients' perspective and inclination in this subject area. This ought not to be considering the currently renewed importance of upholding the patients' dignity in both research and medical practice. The authors therefore sought to determine the perspective and willingness of BU disease patients to give consent to third party use of their data in the form of pictures, videos, and/or oral interviews in the pretreatment and posttreatment periods.
| Methodology|| |
The study was carried out in three BU endemic states in Nigeria; Anambra, Cross River and Ogun, between February and August 2019. These states were purposively selected based on their epidemiological importance to systematic BU Control in Nigeria. They were the first three states where systematic BU Control was scaled up in Nigeria between July 2014 and September 2015. Southern Nigeria is made up of three geopolitical zones; South-East, South-South, and South-West. Anambra is located in the South-East, Cross River in the South-South and Ogun in the South-West geopolitical zones of Nigeria.
The study employed a questionnaire-based cross-sectional comparative study design. The study instrument was a researcher-administered pretested semi-structured questionnaire. The questionnaire was designed by the researchers and pretested using eight patients who were eventually not part of the study population. The pretested questionnaires were assessed for clarity of questions, ease of filling the questionnaires, completeness of data, and appropriateness of response options. Feedback from the pretested questionnaires was used to prepare the final draft which was approved by all authors before use.
Consenting BU cases medically confirmed by quantitative polymerase chain reaction (qPCR) method and enrolled on treatment in the three selected states were recruited as participants in the study. Having been confirmed, they were officially registered into the BU treatment register (BU 02) in respective states which the researchers relied on for participants' identification.
Consenting medically confirmed BU patients in the three selected states of Nigeria.
Non-BU patients, suspected but non qPCR-confirmed BU patients, BU patients not located in the selected states and individuals who declined consent were excluded from the study.
Ethical clearance for the study was obtained from University of Nigeria College of Medicine Research Ethics Committee. Informed consent was obtained from participants (parents or guardians for minors).
This was done using Stata (version 13, StataCorp, College Station, Texas, USA). Frequency tables and cross tabulations were generated for categorical data while continuous data were presented as mean, standard deviations, number, and percentages. Fisher's exact probability and Chi-square tests were used to compare categorical data as appropriate. The significance level was set at 0.05.
| Results|| |
A total of 92 respondents participated in the study. The median age was 23.5 ranging from 4 to 74 years and m: f ratio of 1:1.2. Majority of the respondents 36 (39.13%) were in the age group < 15 years, and the highest educational level for majority 46 (50.00%) was primary education. Pupils and students 52 (56.52%) equally formed majority of the respondents. The details of respondents' demographic characteristics are as shown in [Table 1]. Although there were sex differences between respondents [Figure 1], this was not statistically significant. Nearly a quarter of the respondents 23.91% had suffered some form of discrimination in the course of their disease [Figure 2]. Majority 86 (93.48%) of the respondents were favorably disposed to allowing the use of their data for attracting a donor, policy development, and teaching/training purposes [Table 2]. A statistically significant greater proportion of respondents 90 (97.83%) were willing to give consent for use of their oral interview as against pictures and videos both in the pre- and post-treatment periods [Table 3]. However, willingness to give consent showed no significant relationship with age and sex both in the pretreatment and posttreatment periods [Table 4] and [Table 5]. Invasion into privacy was the major reason given by majority 20 (52.63%) of the respondents for withholding consent [Table 6]. In the same vein, majority 28 (73.68%) of respondents indicated that casting a shadow over their eyes in the case of use of pictures and/or videos will encourage their willingness to give consent [Table 7].
|Figure 2: Respondents who have suffered discrimination in the course of their disease|
Click here to view
|Table 3: Respondents willingness to give informed consent in the pre- and post-treatment period (n=92)|
Click here to view
|Table 7: Measures that can facilitate participants' willingness to give consent (n=38)|
Click here to view
| Discussion|| |
The median age in the present study was 23.5 years with majority in the age group <15 years. This is in agreement with previous studies, done in the field of BU which reported higher incidences in the <15 years of age group in Africa, depicting this age group as being the mostly affected. The reason behind this observation is not yet clear as the epidemiology of BU is still an evolving topic.
BU is one of the stigmatized NTDs hence it is not surprising that nearly a quarter of the respondents indicated having suffered some form of discrimination in the course of the disease. This is in line with the earlier mentioned study also carried out in Southern Nigeria which recorded a high level of social stigma towards individuals with BU. It is largely this stigmatization that renders the patients vulnerable in research and other activities. One major consideration with the involvement of vulnerable groups is protection from harm. This harm may range from the exacerbation of stigma to breach of confidentiality and intrusion into privacy. One form of such advocated protection is to ensure they provide informed consent to the activity they are being involved in.
A person's data may be in the form of medical records, picture, video, or oral interview. Sharing of these data may or may not be in the context of research purposes only. Pictures, videos, or oral interviews may equally be useful in teaching purposes, for policy development or even for funding advocacy. The focus of this study was to determine whether surveyed BU patients were favorably disposed to use of their pictures, videos, and/or oral interviews for any of the aforementioned purposes. As documented earlier, majority were favorably disposed to the use of their data for policy development, attracting a donor, and for teaching purposes. This draws attention to the fact that while we strive to protect, we should at the same time be wary of overprotection. On the other hand, it may seem the purpose for which the data are collected may be a strong factor influencing obtaining informed consent. It is also pertinent to bear in mind that some of the purposes for the collection of these data may ultimately yield interventions to mitigate or reduce the burden of stigma and be beneficial to the affected population.
In both the pre- and post-treatment periods, respondents were significantly more willing to give consent to use of their oral interviews when compared to videos and pictures. When considered together with their reasons for withholding consent, it can be stated that intrusion into privacy is a major limitation. Again, casting a shadow over the eyes was the most common measure to facilitate willingness to give consent. This is not surprising where stigmatization is a major concern for the participants; hence, the preference of oral interviews by majority to videos or pictures which is more likely to reveal their identities.
Hence, in a group of people largely willing to give consent to use of their data for attracting a donor, policy development and teaching purposes, privacy, and anonymity remain challenges. Of course, the privacy considered here is informational privacy aka data privacy which refer to privacy of personal information aimed at ensuring that participants cannot personally be identified through information provided. The right to privacy may equally be said to derive from the principle of autonomy whereby we owe respect to a person's autonomous wishes.
Privacy and anonymity are important and sensitive issues especially when dealing with a stigmatized condition. Ensuring anonymity is indeed another critical way of protecting this group of people from harm as it protects the privacy of the individuals involved.
The concerns of the respondents are certainly not out of place because at the time of data collection, most researchers and investigators promise to maintain anonymity with participants' data typically through the informed consent form, but what happens thereafter may not be under the control of the participant. Breach of privacy and anonymity constitutes harm to the individual, hence violating the ethical principle of nonmaleficence, “do no harm.”
| Conclusion|| |
The present study provides evidence that majority of the respondents were positively inclined to give consent to use of their data by a third party. However, intrusion into privacy and anonymity were major concerns for the respondents. It, therefore, serves as a wake-up call to researchers, investigators and indeed every stakeholder working with this group of individuals to put strong measures in place to ascertain maintenance of privacy and anonymity of data.
Strengths and limitations of study
Inability to get all eligible participants to participate in the study was a limitation. Again, being a cross-sectional study, causality, and trend of results could not be determined. However, the major strength of this study is provision of much needed data to fill the existing literature gap among patients with BU which is an emerging disease condition in Nigeria.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Beauchamp TL, Childress JF. Principles of Biomedical Ethics. 7th
ed.. New York: Oxford University Press; 2013.
Berg JW, Appelbaum PS, Lidz CW, Parker L. Informed Consent: Legal Theory and Clinical Practice. 2nd
ed.. New York: Oxford University Press; 2001.
Millum J, Campbell M, Luna F, Malekzadeh A, Karim QA. Ethical challenges in global health-related stigma research. BMC Med 2019;17:84.
Hofstraat K, van Brakel WH. Social stigma towards neglected tropical diseases: A systematic review. Int Health 2016;8 Suppl 1:i53-70.
Weiss MG. Stigma and the social burden of neglected tropical diseases. PLoS Negl Trop Dis 2008;2:e237.
Ukwaja KN, Meka AO, Chukwuka A, Asiedu KB, Huber KL, Eddyani M, et al
. Buruli ulcer in Nigeria: Results of a pilot case study in three rural districts. Infect Dis Poverty 2016;5:39.
Röltgen K, Pluschke G. Epidemiology and disease burden of Buruli ulcer: A review. Res Rep Trop Med 2015;6:59-73.
Huang GK, Johnson PD. Epidemiology and management of Buruli ulcer. Expert Rev Anti Infect Ther 2014;12:855-65.
Nwafor CC, Meka A, Chukwu JN, Ekeke N, Alphonsus C, Mbah O, et al
. Assessment of community knowledge, attitude, and stigma of Buruli ulcer disease in Southern Nigeria. Afr Health Sci 2019;19:2100-11.
Bester J, Cole CM, Kodish E. The limits of informed consent for an overwhelmed patient: clinicians' role in protecting patients and preventing overwhelm. AMA J Ethics 2016:18 Suppl 9:869-86.
Nijhawan LP, Janodia MD, Muddukrishna BS, Bhat KM, Bairy KL, Udupa N, et al
. Informed consent: Issues and challenges. J Adv Pharm Technol Res 2013;4:134-40.
] [Full text]
Kadam RA. Informed consent process: A step further towards making it meaningful! Perspect Clin Res 2017;8:107-12.
Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol 2008;9:485-93.
Agre P, Rapkin B. Improving informed consent: A comparison of four consent tools. IRB 2003;25:1-7.
German Leprosy and Tuberculosis Relief Association. 2015 Final Report of Nigerian Buruli Ulcer (BU) Scale-up Project Phase 1 (July 2014 – September 2015). Unpublished Data Obtained from German Leprosy and Tuberculosis Relief Association, Enugu, Nigeria on 5 February, 2019.
Yotsu RR, Murase C, Sugawara M, Suzuki K, Nakanaga K, Ishii N, et al
. Revisiting Buruli ulcer. J Dermatol 2015;42 Suppl 11:1033-41.
Calo MR. The boundaries of privacy harm. Indiana Law J 2011;86:1131-62.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]