Knowledge vs Ethics in Clinical Research in Resource-Poor Settings

Abstract

"How does one balance the roles of a clinical caregiver and researcher, especially when these may be in conflict? In this study, the researchers were mostly clinicians whose primary responsibility was patient care. Shouldn’t the basic principles of clinical ethics of beneficence, non maleficence and patient autonomy apply in these settings too? Aren’t these also ethical principles guiding research? If one accepts this, then, in view of the long-term nature of the follow-up and the implications of not intervening, the women should have been consulted at every stage in decision-making regarding their care, regardless of their initial consent to be part of the study. In this particular case, the initial consent also seems to have glossed over several important facts well known to the researchers at that time, such as the lesions’ potential to progress to invasive cancer. Patient autonomy cannot be overridden even if the clinician believes in good faith that what s/he is doing is best for the patient – though even this does not seem to have been the case here. Also, the least the clinicians could have done was to expedite treatment for these women once they developed carcinoma. That they failed to do so reveals a total lack of concern for the women in the study as compared to the research outcomes. Then, what about public health ethics? How does one strike a balance between clinician and public health researcher? What if, truly, this study had uncovered a different pattern of progression of dysplasias in south Asian women? Would it then have been justified in its design and methodology? Would the larger good of understanding cervical dysplasia in south Asian women to benefit women in the future have been justification enough for following up women with dysplasia in this study without intervention? I do not think so. Even if the study were justified in terms of the larger public good, adequate safeguards should have been built in, so that women in this study also received the benefits of existing and emerging knowledge, whether from this study or elsewhere. Interim monitoring of results, terminating the study in the face of the results of the other study, expediting treatment for women whose dysplasias progressed in severity - all of these should have been necessarily built into the study."(pg 52)