Research involving people living in low and middle income countries
POSITION STATEMENT AND GUIDANCE NOTES FOR APPLICANTS
Purpose of the position statement
1. The Wellcome Trust has produced this position statement and guidance notes in order to:
• communicate the ethical principles that underlie the Wellcome Trust's funding decisions on research projects that involve people living in low and middle income countries
• provide practical advice and highlight issues for applicants to consider when designing and submitting a research proposal to the Wellcome Trust for funding
• set out the roles and responsibilities of the various parties involved in Wellcome Trust-funded research involving people living in low and middle income countries.
2. The position statement and guidance notes do not form part of the Wellcome Trust's Grant Conditions, but are intended to inform and guide applicants who are applying for Trust funding to support research involving people living in low and middle income countries. Such applicants are advised to demonstrate within their grant applications that they have taken these documents into consideration in developing their research proposal, by referencing them where relevant.
Background
3. The Wellcome Trust is a significant funder of research involving people living in low and middle income countries, with the aim of improving human and animal health. The Wellcome Trust expects all research involving people to be undertaken in accordance with high ethical standards. In a low and middle income country context, the Wellcome Trust aims to fund research that will contribute relevant and sustainable benefits to those communities or regions.
4. In this position statement and the guidance notes, the Wellcome Trust uses the World Bank definitions of low and middle income countries, which are based on gross national income per capita.Lists of applicable countries can be found on the World Bank website.
5. These documents are intended to cover all types of research funded by the Wellcome Trust that require approval by a research ethics committee. This includes biomedical research (e.g. clinical trials, epidemiology and public health research) and social science research. In low and middle income countries the undertaking of such research, particularly medical research and clinical trials, can raise a number of special and sometimes controversial ethical issues.
6. The specific areas covered by the position statement and guidance notes are:
• meeting healthcare needs for low and middle income countries
• selecting research participants
• consent
• standards of care for control groups
• post-trial access to treatments demonstrated to be effective
• confidentiality and data management
7. The Wellcome Trust believes it important to consider its stance in relation to these areas and to make a clear statement of its own position to assist the researchers it funds and the people they work with. This is particularly important as various international guidelines address these issues but sometimes differ in their recommendations and conclusions; there is no one set of guidelines that the Wellcome Trust feels deals with these issues in a way that is consistent with its own approach.
8. In drawing up this position statement and guidance notes, the Wellcome Trust considered the following reports:
• Nuffield Council on Bioethics (NCB) report: 'The Ethics of Research Related to Healthcare in Developing Countries', April 2002.
• The Council for International Organizations of Medical Sciences (CIOMS): 'International Ethical Guidelines for Biomedical Research Involving Human Subjects', September 2002.
• The European Group on Ethics in Science and New Technologies (EGE): 'Opinion on the Ethical Aspects of Clinical Research in Developing Countries', January 2003.
• World Medical Association (WMA): 'Helsinki Declaration', including Notes of Clarification on Paragraph 29 and 30.
9. Initial drafts of this position statement and guidance notes were circulated for comments amongst Wellcome Trust-funded researchers in Kenya, Malawi, South Africa, Thailand and Vietnam. The draft was also put out to consultation amongst the delegates at the Nuffield Council on Bioethics follow up workshop on 'The Ethics of Research Related to Healthcare in Developing Countries'.
10. As part of its strategic planning process, the Wellcome Trust will continue to keep this policy under review.
Additional information
11. The Wellcome Trust supports biomedical research through its various funding streams.
12. The Wellcome Trust also funds international research ethics initiatives and capacity development through its Biomedical Ethics Programme. The aims of this programme are to:
• build the knowledge base by supporting research into the social, ethical, legal and public policy aspects of biomedical research in low and middle income countries
• strengthen research capacity and ethical review committee capacity within low and middle income countries by increasing the number of experts with the experience and training to address ethical questions raised by such research
• encourage application of that research by developing strategies for making research useful to researchers, funders, policy makers and others, including those involved in developing national and international guidelines for the ethical conduct of research.
1. Meeting healthcare needs for low and middle income countries
The position of the Wellcome Trust
The Wellcome Trust considers that all research it funds in low and middle income countries should:
• be responsive to the healthcare priorities or needs within the host country and be relevant to the short- or long-term needs or priorities of the region(s) or population(s) where the research is to be carried out. The research should be sustainable and have local applicability; or
• be research that could have a 'global public benefit' and have potential relevance to the health of humans anywhere in the world.
Guidance notes
Responding to local healthcare needs
Investigators conducting Wellcome Trust-funded research involving people living in low and middle income countries will normally have to demonstrate that their research is responsive to the healthcare needs or priorities within that country. The aim of such research will be to provide relevant and sustainable health benefits to people in those areas where the research is undertaken. Examples include research that addresses diseases that are prominent in low and middle income countries, such as malaria, tuberculosis and HIV/AIDS.
Where research may lead to a new health intervention or treatment, such as a clinical trial for a new drug, such research will be considered by the Wellcome Trust to have local applicability where:
• insofar as it can be estimated, the prospective treatment will or might foreseeably become available to local patients on a sustainable basis
• the prospective treatment will or might foreseeably become affordable locally
• prospective treatments could be delivered within existing structures, or structures that are to be (or could readily be) developed. For example, if a prospective treatment involved administering medication via a particular medical procedure, local healthcare staff would need to have appropriate expertise. If such expertise were neither available nor going to become available in the foreseeable future, careful consideration would need to be given as to how appropriate training should be arranged.
One aspect of making research locally applicable is the subsequent communication of research findings. Thought should be given as to how research results are disseminated, locally and globally. The Wellcome Trust will fund reasonable requests to cover the costs of such activities.
Research that has a 'global public benefit'
The Wellcome Trust will, in special circumstances, fund certain types of basic, non-therapeutic research that involve people living in low and middle income countries but are not obviously or immediately responsive to local health care needs. Such research must be able to demonstrate a potential benefit to the health of people wherever they may live in the world, i.e. the research must have a potential 'global public benefit'.
'Global public benefit' research could include basic research into human biology, human genetic variation and the development of research tools (such as genetic maps or databases). It is usual, in such types of non-therapeutic research, that neither the participants in the research nor anyone of their generation anywhere in the world are likely to directly benefit from the research outcomes. However, subsequent research, using the information created by these types of studies, could have a potential to benefit the health of anyone globally.
The Wellcome Trust believes that people in both high and lower income countries should have the opportunity to participate in such research.
2. Selecting research participants
The position of the Wellcome Trust
The interests of research participants should never be sacrificed for the sake of a scientific goal. The Wellcome Trust considers that people involved in Wellcome Trust-funded research in low and middle income countries should only be chosen to take part in research on the basis of being appropriate individuals to answer the research question.
Participants must not be enrolled in a research project if this would:
• contravene relevant legislation
• contravene binding codes of conduct or guidelines, such as professional guidelines
• go against the clinical judgement of the researcher/treating medical officer.
Guidance notes
In all research involving people, an appropriate balance must be struck between the interests of participants (and, where relevant, the communities to which they belong) and the interests of society or the advance of knowledge. In planning any research a careful risk-benefit assessment should always be carried out so that participants or communities are not exploited or disadvantaged by their inclusion in the research. The risk assessment exercise should compare the degree of risk (if any) to the anticipated benefits of the research.
3. Consent
The position of the Wellcome Trust
The Wellcome Trust expects that people involved in Wellcome Trust-funded research should participate in an appropriate process to give or withhold their individual, informed consent.
Researchers should make themselves aware of special cultural, legal or social considerations in the host country, which may inform the appropriate consent process. In some communities, it may be important to engage in community consultation and/ or seek permission from a community elder before approaching people for their individual consent.
The Wellcome Trust considers, however, that consent from a community elder should never replace the individual consent of a competent adult or appropriate proxy consent, or authorisation with regard to minors and participants with mental incapacity.
Guidance notes
Individual informed consent
All competent adults have a fundamental right to give or withhold consent to participate in research. Principal investigators should pay particular attention to situations where this right might be compromised. One of the requirements of valid consent is that a prospective participant be provided with accurate, relevant and sufficient information on the nature and purpose of the study, the procedures involved, any foreseeable risks associated with participation in the research, and arrangements for post-research access (including options for secondary use of tissue samples and data), where applicable.
Principal investigators should also be aware that the concept of research may not be readily understood and may be confused with direct healthcare provision. The consent-seeking process should be appropriate to the cultural context and to individual needs. Participants should be encouraged to discuss the proposed study and to ask as many questions as they need to in order to understand the implications of enrolment.
When reviewing grant applications, independent referees and Trust Funding Committees might request clarification or information from grant applicants about the proposed consent procedures. In some cases, this could include asking grant applicants to supply them with the proposed consent forms.
Consent forms
A valid consent procedure should involve discussions with prospective participants and an appropriate length of time for them to consider the implications of the information they are receiving. This process is more important than the signing of a consent form, which should only be regarded as evidence that a consent process has been carried out.
Written consent may not always be the most appropriate form of recording consent, for example where participants are visually impaired or illiterate. In such cases, it is recommended that alternative forms of recording consent be used. These could include making a note of verbal consent in a participant’s personalised record or making an audio or video tape.
In some circumstances it might be appropriate to have an independent witness to observe the consent process.
Community consultation
Community consultation or engagement prior to and/or during the course of research studies may be appropriate in many settings. The use of community consultation can play a role in:
• determining the appropriateness of approaching members of a community to participate in research
• designing appropriate consent seeking procedures
• identifying areas of particular concern to the community
• providing feedback of research results to the community.
Consultation may be carried out by various means, including focus groups and public meetings.
Minors: proxy consent
Proxy consent for minors should be in accordance with any host country legislation and, where appropriate, should be obtained from a relevant legal authority: this could be a parent, guardian or others with parental responsibility. It is important to note that the legal age of adulthood in certain low and middle income countries can be different to high income countries. Principal investigators should also be aware of any relevant issues surrounding consent and confidentiality for 'mature' or 'emancipated' minors, who may be able to freely consent to participate in research. Such issues would normally be considered by ethics committees.
Adults with mental incapacity
Subject to relevant ethics committee approval, the Wellcome Trust considers that it is acceptable to enrol in research adults incapable of providing consent if:
• the participation of such adults is necessary to answer the research question
• the participants' interests are safeguarded or promoted
• discussions have been carried out with an appropriate legal authority responsible for the care of a mentally incapacitated adult (where such a body exists)
• the research complies with relevant laws.
Secondary use of tissue samples and data
Where research involves the collection of human tissue, the original consent process should, wherever practicable, include seeking consent for any secondary use of the tissue in subsequent research studies. The Wellcome Trust recognises, however, that in some situations, this may not be possible. In such cases, the Wellcome Trust considers that it is acceptable to use samples/medical data for secondary purposes without returning to the participant for specific consent, if the proposed research:
• complies with relevant national laws
• complies with any binding codes of practice or ethical guidance (such as professional guidelines or licensing regulations)
• is not inconsistent with the original consent as approved by an ethics committee
• uses samples or data which have been anonymised (either fully or, at a minimum, from the researcher's point of view)
• meets policy requirements regarding secondary use as required by the principal investigator's employing institution.
Emergency research
The Wellcome Trust will consider funding emergency research (e.g. accident and emergency research) where the ability of an individual to give consent is compromised or impracticable, provided that the research protocol receives ethics committee approval and complies with all relevant national legislation. It might be appropriate to use measures to inform the general public that these studies are planned or are in progress.
Withdrawal from participation in research
The right to withdraw from ongoing participation in a research study is a fundamental right of any participant.
Researchers need to give careful consideration to the implications of individuals withdrawing their participation from research. The feasibility and implications of withdrawing from research, and the extent to which that applies to the withdrawal of data and samples from a study, need to be clearly covered as part of the consent process.
The Wellcome Trust would consider it appropriate to retain data and samples within a study if they are anonymised, there is no link back to the participant, the risk to the individual of retaining the data is minimal and the withdrawal of the data threatens the integrity of the study.
4. Ethical Review
The position of the Wellcome Trust
The ethical review of a research protocol submitted to the Wellcome Trust is the responsibility of ethics review committees. Wellcome Trust Funding Committees will consider applications for funding before an ethics review is carried out, but the research may not commence until approval has been received from the ethics review committee.
The Wellcome Trust considers that ethical review should be undertaken in all countries where any part of the research is to take place. Where research is undertaken wholly in a low or middle income country and an independent and properly constituted research ethics committee exists in that country, the Wellcome Trust does not require additional review in the UK. If no independent and properly constituted research ethics committee exists in the country where the research is being carried out, review should be sought from an alternative source. The Wellcome Trust considers that it is the responsibility of the employing institution to ensure that it is satisfied with the procedures and quality of the ethical review. Accordingly, principal investigators should be aware of any obligations their own employing institution might place on them regarding ethical review.
The Wellcome Trust reserves the right to refer any application it receives, to any of its funding programmes, regardless of location, to its Standing Advisory Group on Ethics (SAGE) for advice.
The Wellcome Trust will consider providing the actual direct costs of the ethical review process in resource-poor settings. These costs should be included as part of the research application and will be considered on a case-by-case basis.
Guidance notes
The ethical review and approval of research protocols is the sole responsibility of independent ethics committees. The Wellcome Trust considers it the responsibility of research applicants to apply for ethical review; the Wellcome Trust's Grant Conditions state that the researcher's employing institution is responsible for ensuring that ethical approval has been obtained before the commencement of any research.
Applicants for research grants should seek research ethics committee approval in the country(ies) where the research is to be carried out. If the research is carried out wholly overseas, the Wellcome Trust supports review in that country(ies) (i.e. local review) provided it is undertaken by an independent and properly constituted ethics committee and does not require additional review to be undertaken by a UK research ethics committee.
However, it is important for principal investigators to be aware of any obligations their own employing institution might place on them regarding ethical review.This may well require dual (or even multiple) ethics review of the research. For advice see 'Examples of national and international guidance on the composition of research ethics committees', Nuffield Council on Bioethics (NCB) report: 'The Ethics of Research Related to Healthcare in Developing Countries', April 2002.
If UK review is required, it should be carried out, as a matter of routine, by institutional or NHS research ethics committees.
If ethical review is being undertaken by more than one ethics committee, and they have any disagreements, it is anticipated that they should attempt to resolve these through dialogue. The Wellcome Trust, however, will not fund research where there are intractable disagreements between ethics committees. It is the responsibility of principal investigators to inform the Wellcome Trust of any such disagreements.
Procedure if no host country ethics committee exists
Where the host country has no available ethics committees, the Wellcome Trust will accept ethical approval from an alternative source such as an inter-governmental organisation, for example the Science and Ethical Review Group (SERG) at the World Health Organization.
Procedure in case of special ethical concerns
Where an application from any Trust funding programme raises ethical concerns for Trust committee members, referees or staff, the Wellcome Trust reserves the right to refer the research protocol for review by a committee of experts in ethics, research and other relevant fields, for advice. This committee, the Standing Advisory Group on Ethics (SAGE), is convened by the Wellcome Trust on an ad hoc basis. The Group may be supplemented with complementary expertise, according to the particular ethical issues that it is asked to consider.
Funding for ethics review
The Wellcome Trust is prepared to meet the actual direct costs of the ethics review process in resource-poor settings, as part of a grant application. However, this must be done in such a way that there is no risk to the independence of the decision-making process. Such decisions will be made on a case-by-case basis, where an application may request a one-off fee for ethical review. The Wellcome Trust will not consider calculating such payments in terms of a percentage of the total cost of the grant.
Ethics training
It is important that all Wellcome Trust-funded researchers have an understanding of the ethics of research involving people appropriate to their role. The Wellcome Trust strongly encourages all Trust-funded researchers to undergo training in the ethics of research, where necessary. The Wellcome Trust funds regular ethics training workshops in low and middle income countries through its Biomedical Ethics Programme, and is prepared to consider funding attendance at appropriate training courses/workshops as part of a grant for an overseas award.
The use of an independent oversight committee for ethical, legal and social issues
Where research is anticipated to run over a number of years, for example in demographic surveillance studies, researchers may wish to consider the establishment of appropriate mechanisms to monitor and where necessary provide advice on ethical, legal and social issues on an ongoing basis. An example of this would be an oversight committee with members who are independent of the research represented on it. These mechanisms would be additional to ethics review and would provide an additional layer of ethical oversight throughout the lifetime of the research.
5. Collateral benefits
The position of the Wellcome Trust
The Wellcome Trust will consider supporting the provision of collateral benefits as part of a research programme, where they are not of such a degree that they could have an adverse effect on the local research environment or could create an undue influence to participate in research. The nature of any collateral benefits should be fully explained as part of the research proposal.
Guidance notes
Collateral benefits may arise as a by-product of carrying out research, whether or not they are necessary for the research design. Examples include the provision of healthcare benefits to communities during a research study, strengthening local research capacity and providing research-related technical or clinical equipment. Thus, local clinics associated with a research project may benefit from improved diagnostic, medical and scientific expertise.
In some cases, the Wellcome Trust and other agencies (such as the principal investigator's employing institution or other funding agencies collaborating on a project) may decide to support collateral benefits. Care must be taken that such benefits do not:
• adversely affect the local research environment (e.g. by raising expectations that all subsequent research will provide similar benefits)
• amount to coercive or 'undue' influence to participate in a research study.
Where recompense for participating in research is offered, either financial or in kind, it should be set at an appropriate level to cover, for example, reasonable expenses and subsistence costs. Where it is proposed to offer healthcare unrelated to the specific research question, the Wellcome Trust recommends that this should usually be the standard treatment that is available locally.The principal investigator should consider the sustainability of any collateral benefits once the research is over.Details of any such proposals should form part of the grant application and be approved by relevant ethics committees.
6. Standards of care for control groups
The position of the Wellcome Trust
Where a healthcare intervention is being examined as part of research, the Wellcome Trust considers that the standard of healthcare provided to a control group member should be at least equivalent to the best local, currently available and affordable standard of care.
Principal investigators, in consultation with ethics committees, are responsible for determining these healthcare standards, which should be outlined in grant applications, as part of the description of the experimental design.
The Wellcome Trust considers that the use of placebos is only acceptable if:
• there is no reasonably accessible, safe prevention or clinically effective treatment alternative for patients at that particular stage of the disease
• their use is necessary to answer the research question.
Guidance notes
Research that requires the establishment of a control group would typically examine the efficacy of a new health intervention and compare it to existing practice. Such interventions could include a new treatment, diagnostic procedure or preventative measure, such as insecticide-treated mosquito nets to reduce the incidence of malaria.
In this document, the Wellcome Trust considers control groups to include:
• groups who receive no intervention (healthy and non-healthy volunteers)
• groups who continue to receive the same intervention they were already receiving (the 'usual care' group)
• groups who receive an alternative intervention either to the one being tested or the one they were already receiving
• in the context of clinical trials, participants who receive a placebo (either alone in addition to other interventions).
Ethical issues arise where participants in the control group are vulnerable to or suffer from, the condition(s) relevant to the investigation. In such cases, the Wellcome Trust considers that the standard of care ought to:
• be the one that is required to answer the research question
• where relevant, be at least equivalent to the best local, currently available and affordable standard of care
• where relevant, not create an ‘undue influence’ to participate in research.
In some cases, if an intervention or general care is provided to the control group and the participant still needs it beyond the research period, issues of post-research access will need to be considered. This is so particularly where the intervention being tested is not successful and control groups have already started a course of treatment or care which needs to continue beyond the research period. (See post-trial access below.)
Clinical trials
In many cases, the appropriate standard of care for control groups in clinical trials will be locally available treatments (as long as there is no evidence that those treatments are dangerous or would compromise the health of participants). In addition, the use of locally available treatments for control groups will be the most appropriate method to ensure that a research question is relevant and responsive to national, regional or local healthcare needs/priorities and that the research findings can be applied in a sustainable manner. For example, the Wellcome Trust might fund a clinical trial into an HIV therapy, in which control groups did not receive the best globally available standard of care, in order for the research to determine whether a new treatment was an improvement on existing locally available treatments.
7. Post-research access to interventions demonstrated to be effective
The position of the Wellcome Trust
The Wellcome Trust does not fund healthcare per se and considers the financial responsibility of providing successful interventions after research is over to fall outside its remit. It does, however, encourage grant applicants to consider how post-research access could be ensured. This may require the instigation of processes, such as discussions, with different stakeholders prior to the research being carried out.
Where appropriate to its role as funder, the Wellcome Trust may assist with such processes.
Guidance notes
The Wellcome Trust does not fund post-research access to interventions as this:
• does not fall within the Wellcome Trust's remit and area of expertise, which is to fund research with the aim of improving animal or human health
• could divert funds away from supporting valuable research
• could render research prohibitively expensive for the Wellcome Trust.
The Wellcome Trust, however, considers that for some types of research, there should be a reasonable expectation that post-research access to interventions will be provided. This is to ensure:
• that the research has 'local applicability' (to be locally applicable in this context, the treatment must be or could in the foreseeable future become available to the wider community)
• that research participants are not being exploited (in the case of ongoing care for certain individual research participants).
Post-research access: individual research participants
The Wellcome Trust considers that, in some cases, post-research access to interventions ought to be provided to participants; in these cases, the Wellcome Trust may not fund the proposed research until it is satisfied that such provision will be made. Such decisions will depend on various factors including:
• Whether the condition under investigation is chronic or acute. The Wellcome Trust may consider it an ethical requirement to guarantee post-research access to treatments to participants involved in research investigating chronic or progressive conditions.
• The nature of the research question and whether it implies that ongoing care should be provided. Examples could include research not intended to identify a new effective intervention but seeking to understand a condition, or research investigating how a particular treatment affects the progress of a disease.
Post-research access: host country, region, and locality
In order to be locally applicable, any successful interventions arising from Wellcome Trust-funded research should be able to become available to patients in those areas and be deliverable within existing structures (or structures which are to be or could readily be developed).
The Wellcome Trust, however, recognises that in some cases it may be difficult to estimate with any degree of accuracy how financially or logistically feasible it would be for a successful intervention to become available to patients within the host country. The Wellcome Trust will take such difficulties into account when making its funding decision.
Principal investigators should indicate in their application forms whether post-research access needs to be addressed and how this might be achieved. The Wellcome Trust will consider funding requests for activities and processes that relate to ensuring post-research access (e.g. meetings and discussions with relevant health authorities, government bodies, non-governmental organisations, pharmaceutical companies, bilateral organisations or any other appropriate organisation) and will provide assistance to these processes, where appropriate (e.g. in the form of letters of support). Such processes should ideally take place prior to the beginning of research.
Where the issue of post-research access might affect a funding decision, the Wellcome Trust's Funding Committees will assess applications on a case-by-case basis and the Wellcome Trust reserves the right to refer the issue to SAGE for advice (see section 4 above).
8. Compensation for injury
The position of the Wellcome Trust
The Wellcome Trust considers that appropriate compensation arrangements (including insurance or indemnity cover where available) should be in place to cover research participants and/or their dependants against injuries or damage caused as a result of their participation in research.
9. Post-research monitoring
The position of the Wellcome Trust
The Wellcome Trust expects the research protocol to include proposals for any necessary post-research health monitoring related to a volunteer's participation and considers this a responsibility of the principal investigator.
Guidance notes
The Wellcome Trust only provides funds for post-research health monitoring where it is an integral part of the research proposal and informs the research answer. For example, certain long-term drug or vaccine trials may require such monitoring.
In the case of clinical trials, principal investigators will also need to be aware of their responsibility to comply with any requirements on adverse events monitoring.
10. Confidentiality and STEWARDSHIP OF data
The position of the Wellcome Trust
The confidentiality of research participants must be safeguarded, unless appropriate consent has been obtained to disclose information to a third party, or where there is a legal requirement to do so. Mechanisms for safeguarding confidentiality should be sensitive to local norms. Appropriate mechanisms must be in place, prior to research being undertaken, to manage the secure collection, storage, access, and if feasible the withdrawal of data that relates to individual participants.
Guidance notes
Every research participant has a right to confidentiality. The Wellcome Trust recommends that an appropriate organisation (such as an academic institution that can act as a guarantor for the legal and ethical compliance of the research) and individual researchers establish or ascertain that safe mechanisms are in place to ensure that the right to confidentiality is, as a minimum, in line with national/local legislation and has been approved by appropriate ethics committees.
The Wellcome Trust recommends that principal investigators provide an outline of how data will be collected, stored and accessed by any third parties, as part of their application.
These issues need to be clearly dealt with in the consent process. Where research is anticipated to last a number of years, it is recommended that researchers give some consideration to the establishment of an independent oversight committee for the ethical, legal and social issues associated with such research, to advise on issues related to the stewardship of personal data (see section 4).
11. ROLES AND RESPONSIBILITIES
The Wellcome Trust
For the purposes of this position statement, the Wellcome Trust considers its responsibilities as a funder to include:
• managing the process of peer-review of grant applications to ensure that research is of the highest quality
• referring a research protocol to SAGE, where this is considered necessary;
• carrying out site visits, where appropriate
• carrying out outcome evaluations of all Wellcome Trust-funded research.
Principal investigators and their employing institutions
Wellcome Trust awards are mainly made to the employing institution of the principal applicant on a research grant. As a condition of funding any research, that institution must agree to take responsibility for all aspects of the conduct and management of the research. In addition to complying with the Grant Conditions under which a grant is awarded, the Wellcome Trust would normally expect the responsibilities of the principal investigator(s) and their employing institution to include:
• ensuring that the research application has taken into consideration, where appropriate, the guidance outlined in this position statement and guidance notes
• ensuring compliance with the research protocol
• keeping the Wellcome Trust informed of any significant changes to Wellcome Trust-funded research, particularly as it relates to ethical considerations
• obtaining ethics committee approval for the original research protocol, and significant changes that occur subsequently, in the countries where the research is to be carried out
• in the case of dual or multiple review, informing the Wellcome Trust of any intractable disagreements between different ethics committees with regard to proposed research
• ensuring that appropriate compensation arrangements are in place in the event that a participant is injured as a result of the research
• ensuring that an appropriate risk/benefit assessment is carried out so that any risks to participants are proportionate to the possible benefits of the research
• engaging, where appropriate, in processes with relevant stakeholders (for example government ministries or pharmaceutical companies) to try and ensure post-research access to interventions demonstrated to be effective to host communities or populations.