11. International collaborative research

11.1 Concerns
As globalisation increases, so does collaborative research. Concerns have been expressed about the ethics of this, particularly of clinical research in developing countries11 and the application of standards of one country in another.31 Coupled to this are the intellectual property rights (IPR) of indigenous peoples (see also 10.5).

11.2 Ethics principles
In international collaborative research, as in any other research, the four principles of ethics apply. These are autonomy, beneficence, non-maleficence, and justice.

11.3 Collaborators
Those taking part in international collaborative research are host country institutions, collaborating country institutions, researchers from both, research participants and their communities.

11.3.1 Prior agreements
Before submission of a collaborative research proposal to a Research Ethics Committee, there shall be clear agreements on all aspects of the research. These include intellectual property sharing, management of the research process, division of responsibilities, finances, spreading of benefits and burdens, and any other appropriate aspects.

11.4 Principles

11.4.1 Commencement of research

1. No research shall be undertaken until Research Ethics Committees of all collaborating institutions have given ethics approval to the research.
   • Before granting ethics approval, such a Research Ethics Committee shall consider whether the study findings can, and will, be incorporated into the local healthcare system.³²
2. No research shall be undertaken after ethics approval of a protocol by a Research Ethics Committee until there is proper informed consent from participants, their families and communities according to local customs. This consent shall:
   • be obtained in a manner that can be understood by the participants;
   • include full disclosure of the aims and methods of the study, benefits and risks, confidentiality methods and commercial implications;
   • be in written or taped form.

11.4.2 Exploitation

1. There shall be no exploitation of one institution by another, nor of any investigator, research participant or community.
2. Intellectual property rights of institutions, investigators, participants and communities shall be respected, shared and acknowledged according to clear agreements before commencement of research.
3. There shall be equitable compensation of institutions, investigators, participants and communities. This shall be beyond pure financial compensation.
4. Institutions and investigators have a moral obligation to assist indigenous peoples, traditional societies and local communities to protect their knowledge and resources.
5. Institutions and investigators have a moral obligation to respect what is sacred and secret by tradition.
6. No research shall be performed in a host country without local research collaboration in the design and conduct of that research.

11.4.3 Justification

1. There must be clear justification of why research is done in a particular country, a particular institution, with a particular investigator, with a particular participant and in a particular community.
2. Unless there are compelling and acceptable reasons, no research shall be done in a host country that could just as easily be done in a collaborating country.
3. There must be clear potential benefit to the community being researched.
4. Those who are involved in international research should have some understanding of, and be sensitive to, the social, economic, and political milieu in which the research is taking place. This will include protection for research participants who are subject to systematic deprivations through poverty and other threats to freedom.³²

11.4.4 Benefit to host country

1. No research shall commence without agreement between the host research institution and the collaborating institution. In this agreement the development of infrastructure and research capacity in the host country should be addressed.
2. Coercion and inducement of research participants is unacceptable.
3. There should be benefit - other than pure financial gain - to a host country community in which research is undertaken, such as access to the best proven prophylactic, diagnostic and therapeutic methods identified by the study.
4. There must be a clear and fair system of compensation for research injury with clear lines of responsibility and guidelines on how to obtain this. GCP Guidelines for South Africa¹⁰ give these.
5. Research findings should be translated into components of accessible care in the community being researched.³²
6. Participants should be provided with care or treatment they would not normally obtain.³²
7. Care must be taken to ensure that existing disparities are not more deeply entrenched by inappropriate deflection of local human or material resources away from the healthcare system towards the research project.³²

11.4.5 General
A clear agreement on the conduct of the collaborative research must be in place before a study begins including data management and research outputs. Before research begins, particular attention should be paid to the following points.

1. The fate of data must be agreed.
2. The fate of any research specimens must be agreed.
3. Publication strategy must be agreed.
4. An ombudsman to settle disputes should be acceptable to all parties.
5. There should be agreement on the nature of all benefits and their distribution.

12. Ethics guidelines for epidemiology

Guidelines for epidemiology have been discussed for 25 years.^33-37 These include guidelines for the selection of study purpose, design and methods, collection of data, interpretation of results and publication of results. However, it has not been common practice to subject studies to ethics review once the collection of data has begun. The great difficulty of ethics monitoring once a study has begun, is that many published transgressions of ethics occur once the data collection has started.

The American College of Epidemiology has listed 11 ethics guidelines for epidemiology that can be placed within the framework suggested by Soskolne:³⁸

1. The professional role of epidemiologists;
2. Minimising risks and protecting the welfare of research participants;
3. Providing benefits;
4. Ensuring an equitable distribution of risks and benefits;
5. Protecting confidentiality and privacy.
6. Obtaining the informed consent of participants:
   • Elements of informed consent;
   • Avoidance of manipulation and coercion;
   • Conditions under which informed consent requirements might be waived.
7. Submitting proposed studies for ethical review;
8. Maintaining public trust:
   • Adhering to the highest scientific standards;
   • Involving community representatives in research.
9. Avoiding conflicts of interest and partiality;
10. Communicating ethical requirements to colleagues, employers, and sponsors and confronting unacceptable conduct;
11. Obligations to communities:
    • Reporting results;
    • Public health advocacy;
    • Respecting cultural diversity.

12.1 'Public' versus 'health'
Resolution of ethical dilemmas in epidemiology revolves around notions of 'public' and 'health'. 'Public' has two categories: the individual as a member of society, and the public as a collective or community. 'Health' may be considered the presence or absence of disease or a continuum of the two. Epidemiology emphasises the individual in both definitions of 'public' and 'health'. However, public health decisions usually emphasise the community. The concern in broad policy decision-making is the trade-off between benefits to the community and risks to the individual.³⁹ Individuals typically fare less well than the community in prevention programs ('the prevention paradox').40 In epidemiology, therefore, there is conflict between autonomy and distributive justice.

It is suggested that a practical approach to ethics in epidemiology would be to follow the general principles outlined in this book especially in Section ¹¹.