Disclosure of sickle cell disease results to parents /guardians participating in research at Ampath Hemato-oncology clinic in Eldoret Kenya

Abstract

Background: Disclosure is a key process in the management of sickle cell clients. This process if done well results in positive holistic ways of managing clients. However, if not handled well it can affect the client and the entire family both psychologically and emotionally, thus affecting the client's management. There is still an extensive debate regarding when and how to disclose genetic data to research participants in studies with a genetic component. Consequently, researchers and research ethics committee continue to struggle with the questions on whether research protocols should adopt provisions about the return of genetic data and if so, how it should take shape. Disclosure of sickle cell disease results has been ongoing in AMPATH hemato-oncology clinic, however, no specific protocol exist on disclosure of result. Objectives: The objectives were to identify the process of disclosure of sickle cell disease results, to determine the perception on the adequacy of disclosure process and to determine the ethical consideration in the disclosure process. Methods: This was a cross sectional, qualitative study conducted at the AMPATH Hemato-oncology clinic. Key informant interviews and in-depth interviews were conducted. A total of (46) research participants and (5) research staff were interviewed. Results: In view of disclosure process, the World Health Organization (WHO) six-step protocol was not adhered to and thus breach of confidentiality and fairness principles. Results showed that veracity as a principle was not addressed, since there was no specific team assigned to disclose results in the clinic, evidenced by 40/46 participants given results by the doctor alone. Out of 46 participants, 38 reported that they did not get emotional support, thus the principle of non-maleficence was not well addressed. On respect for persons, 36/46 participants reported that disclosure of information was inadequate. Confidentiality was maintained as reported by 44/46 participants and the principle of justice was observed since 40/46 said their children received free medication and showed great improvement. Most staff (3/5) believed breach of disclosure process was due to huge workload. Conclusion: Study results show there was no consensus on who and how to disclose sickle cell disease results at AMPATH hemato-oncology clinic. The six-step WHO protocol was not adhered to and parents/guardians felt that the information given was inadequate. Ethical issues of beneficence, autonomy, veracity, non-maleficence and respect of persons were not well addressed. However, confidentiality was well observed. Recommendation: The AMPATH hemato-oncology clinic should come up with a multi-disciplinary team, which should include a psychological counselor to disclose genetic results. The WHO protocol of disclosure should be incorporated into the standard operation procedures in the department. Ethical considerations on disclosure should also be observed at the hemato-oncology clinic.