Issues to be considered when reviewing research proposals
- Does the research need to be conducted in the particular country under consideration?
- Can the purpose of the research be justified? Is the proposed research relevant to national priorities for healthcare-related research? If the research is not relevant to the national priorities, is it nevertheless justified?
- Have the criteria for selecting the study population been outlined? Have any issues related to the gender of the study population been considered?
- Is the funding which has been allocated sufficient to complete the project?
- If favourable, could the results be implemented, either now or in the foreseeable future? If not, does the research have any beneficial secondary or indirect effects
(e.g. the development of expertise in research)?
- Is the researcher undertaking the research appropriately qualified and does he or she have the relevant experience?
- Is the researcher available for the duration of the study?
Are the staff supporting the research and the facilities available, including technical facilities, adequate?
- Is this the first time this type of research has been conducted? If not, has the scientific value of undertaking the research been justified?
- Is the research design appropriate? Is it likely to yield an unambiguous answer to the research questions which have been posed?
- Is it possible for the quality control of data and analysis to be achieved?
Has consideration been given to issues associated with bio-safety and good manufacturing practice?
- Can the diagnostic, therapeutic and preventative interventions be handled safely?
- Is a control group being used in the research? If so, have details been included in the proposal of the treatment that will be given?
- Will there be any form of follow-up for participants in research? If so, have details of this been provided?
Has the research received appropriate scientific review?
Has the project been given approval by an ethics review committee in the host/sponsoring country?
Have any efforts been made to consult with the relevant communities during the course of designing the research? Have details been given of the measures to be used to recruit prospective participants in research?
Has consideration been given to who will benefit from the research?
Has consideration been given to the risks involved in undertaking the research? Have measures been taken to minimise risks to participants? Is there adequate provision for monitoring the data collected to ensure the safety of subjects?
Have details been given of the information that will be made available to prospective participants? Is this appropriate and complete? Is it in a language and at a levei of complexity appropriate to prospective participants in research?
Have details been given of the procedure that will be used to obtain assent at the level of institutions and communities, where appropriate?
Have details been given of the procedure that will be used to obtain consent from individual participants? Is it appropriate to ask participants to sign a consent form? If not, how will their consent be recorded? Where verbal consent to research is anticipated, is there an appropriate process for witnessing the consent?
Have provisions been made for receiving and responding to queries and complaints from participants in research or their representatives during the course of a research project?
Have details been given of who will be given access to the personal data of the participants in research. including medical records and biological samples? Are measures being put in place to maintain confidentiality and are these adequate?
Are the standards of care being proposed acceptable? Are they appropriate for the country in which the research is being conducted?
Are there other research designs which could answer the research question being posed? If so, why has this particular design been proposed?
Is a control arm to be used? If so, has its use been properly justified? If it is being proposed that the control group in the research should receive less than a universal standard of care, has this been justified? Have details been given of how the intervention will be allocated? Have details been included of what information participants in the control group will be given?
Have any plans to withdraw or withhold standard therapies for the purpose of the search been justified?
What standard of care will be provided for participants who develop diseases or conditions other than those being studied? If it is something less than the best intervention available as part of the national public health system, has this been justified?
Will research participants be offered payment, gifts or other inducements in return for their participation? Are these appropriate?
Will there be follow-up and long-term review of the research? If so, have details been given of how this will be carried out?
Have provisions been made for compensation or treatment in the case of death or injury to research participants?
Have researchers endeavoured to secure post-trial access for effective interventions for participants in the trial? If not has the lack of any such arrangements been, justified?
Has consideration been given to the possibility of introducing an intervention shown to be successful to the wider community and maintaining its availability? If it is not thought possible to make the intervention available to some or all of the population in the country in which the research is to be conducted, can the research be justified?
Will regular progress reports be made to the research ethics committee? If so, have details been given of how frequently these will occur? Have details been given of any arrangements that have been made for providing proper documentation to the committee?
Have details been given of how the results of the research will be used? How will the results of the research be disseminated to participants and other interested parties?
Does the research include provisions for the development of expertise in research within the developing country in which it is to be conducted? If not, is the lack of such provisions justified?
Research conducted with vulnerable populations
- Has the inclusion of individuals in research who cannot consent been justified?
- Is the research question posed important to the health and well-being of this vulnerable population?
- Is the research design appropriate?
- Have safeguards been built into the research design to prevent undue coercion or influence of this group?