Archive for the ‘2016 FABTP Articles’ Category


A case study of researchers’ knowledge and opinions about the ethical review process for research in Botswana

Monday, November 7th, 2016

Abstract Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

Silent voices: Current and future roles of African research ethics committee administrators

Thursday, November 3rd, 2016

Efforts to strengthen the capacity of research ethics committees in Africa to date have largely targeted their chairs and members, neglecting an explicit focus on research ethics committee administrators, who often manage the reviews and the review committees. The concept of an administrator as a key role player in research ethics review in Africa is only now emerging. No empirical studies have been conducted to describe their position, roles, and responsibilities or their potential to affect positively the quality and responsiveness of ethics review. This questionnaire-based study found that research ethics committee administrators vary greatly in expertise and responsibilities, identifies the administrators’ potential to improve research ethics review performance in Africa, and outlines specific requirements to realize this potential.

Implementing Community Engagement for Combination Prevention: Lessons Learnt From the First Year of the HPTN 071 (PopART) Community-Randomized Study

Thursday, November 3rd, 2016

Small is beautiful: demystifying and simplifying standard operating procedures: a model from the ethics review and consultancy committee of the Cameroon Bioethics Initiative

Thursday, September 29th, 2016

Ethical challenges in designing and conducting medicine quality surveys

Wednesday, April 27th, 2016

Objectives

 

To identify and discuss the main ethical challenges related to the conduct of surveys and make suggestions on how to address them.

Method

 

Most evidence-based information regarding medicine quality derives from surveys. However, existing research ethical guidelines do not provide specific guidance for medicine quality surveys. Hence, those conducting surveys are often left wondering how to judge what counts as best practice. A list of the main ethical challenges in the design and conduct of surveys is presented.

Results and conclusions

 

It is vital that the design and conduct of medicine quality surveys uphold moral and ethical obligations and analyse the ethical implications and consequences of such work. These are: impact on the local availability of and access to medicines; the confidentiality and privacy of the surveyors and the surveyed; questions as to whether outlet staff personnel should be told they are part of a survey; the need of ethical and regulatory approvals; and how the findings should be disseminated. Medicine quality surveys should ideally be conducted in partnership with the relevant national Medicine Regulatory Authorities. An international, but contextually sensitive, model of good ethical practice for such surveys is needed.

Obtaining informed consent for genomics research in Africa: analysis of H3Africa consent documents

Friday, April 22nd, 2016

BACKGROUND:

The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium.

METHODS:

A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of test results.

RESULTS:

Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results.

CONCLUSION:

H3Africa research makes use of three consent models-specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa.