Training and Resources in Research Ethics Evaluation

Training and Resources in Research Ethics Evaluation – TRREE is headed by a consortium of interested persons from Northern and Southern countries. It aims to provide basic training, while building capacities, on the ethics of health research involving humans so that research meets highest standards of ethics and promotes the welfare of participants. TRREE achieves this goal primarily by developing a training programme with local collaborators. In its initial stages TRREE focused primarily, but not exclusively, on the needs of African countries.

The training modules are available on a free and open-access basis. Most modules are provided in several languages: English, French, German and Portuguese.

Beside the training modules, TRREE also offers national supplements providing a detailed overview of the national legislation and regulation of health research in several countries from Africa and Europe.

Check TRREE regularly as new national supplements and training modules in new languages are being put online.

Approach

The primary goal of TRREE training modules is to provide training and resources to those who ensure the protection of the rights and interests of individuals and communities serving as participants in health research. The training material is designed for all those involved in collaborative research involving humans including physician-investigators and other researchers, students, research ethics committees and regulatory agencies.

The modules are based on well-established principles of research ethics, as expressed in documents such as the Declaration of Helsinki. Research ethics operates within the universal human rights framework as elaborated in the Universal Declaration of Human Rights (1948), the Convention on the Rights of the Child (1989), and other international human rights instruments. Research on humans often involves risks as well as potential benefits. Research risks are mostly borne by the research participants who therefore deserve to be protected.

Ensuring appropriate protection of research participants while not unduly limiting potentially promising health research requires awareness of local and international guidelines and critical assessment and thinking. Many actors have a collaborative role to play in this and TRREE intends to provide them with a basic training on their specific responsibilities.

Objectives

At the end of Module 1 on the Introduction to Research, participants will:

• be able to identify values and concepts of ethics relevant to the conduct of research involving humans
• be able to identify and consult relevant normative documents
• be able to understand the importance of ethical evaluation in the promotion of the highest ethical standards and the protection of humans who participate in research
• understand the role and mandate of research ethics committees

At the end of Module 2.1 on the Research Ethics Evaluation, participants will:

• understand the role of research ethics committees in the promotion of ethical research and the protection of research participants;
• understand the roles and responsibilities of members of research ethics committees; and
• be able to contribute to research ethics evaluation based on the application of principles of ethics and relevant normative documents.

At the end of Module 3.1 on Informed Consent, all participants will:

• understand the importance of informed consent for participation in research on humans;
• know when the requirement of individual informed consent can be waived

At the end of Module 3.1 on Informed Consent, researchers will:

• know how to seek informed consent from competent potential research participants
• know how to seek informed consent for potential research participants who are unable to give consent;

At the end of Module 3.1 on Informed Consent, researcher ethics committee members will:

• be able to evaluate the informed consent provisions in a study protocol;
• be able to evaluate a consent form.

At the end of Module 3.2 on Good Clinical Practice (GCP), participants will:

• understand the basic elements of clinical research in general and of clinical trials in particular
• understand the basic elements of GCP in clinical trials
• be aware of and understand the technical terms, language and wording standardized by ICH and regulatory bodies in clinical trials
• be able to identify and put in practice the international quality standards required in clinical trials
• understand the roles and responsibilities of the sponsor (including their third party contractors) and investigators involved in clinical trials. For more clarity, some paragraphs have been repeated in different sections
• be familiar with the regulatory authority requirements in the conducting of clinical trials

At the end of Module 3.3 on the Ethical and Human Rights Issues in HIV, participants will have:

• an awareness and an understanding of many key ethical and human rights issues that may arise within HIV vaccine trials,
• knowledge of selected current recommendations aimed at promoting respect for and protecting the rights and welfare of trial participants,
• information about additional resources and where to find them.

Contents

The course is structured in several modules in the following way:

• Module 1 on the Introduction to Research
• Module 2.1 on the Research Ethics Evaluation
• Module 3.1 on Informed Consent
• Module 3.2 on Good Clinical Practice (GCP)
• Module 3.3 on the Ethical and Human Rights Issues in HIV

It is required to have completed the Modules 1, 2.1 and 3.1 prior to start Module 3.2 on GCP.

It is required to have completed the Modules 1 and 2.1 prior to start Module 3.3 on HIV Vaccine Testing

Authors: The list of authors is available on TRREE. It includes a broad numbers of experts from the South and from the North who worked under the coordination of Professor Dominique Sprumont from the Institute of Health Law of the University of Neuchâtel (Switzerland)

Editors: Each Module was edited by a panel of international experts including John Williams, (previously from the World Medical Association), Marie Hirtle (TRREE Manager) and Dr. Jérome Ateudjieu (Division de la recherche opérationnelle en santé, Ministère de la santé publique, Yaoundé/Département des sciences biomédicales, Université de Dschang, Cameroon)

The Swiss Medical Association has accredited the modules as post-graduate and continuing education programme. All the modules are also accredited by the Swiss Association of Pharmacists and the GCP module 3.2 is recognized by the Swiss Drug Agency (Swissmedic) for the GCP training of principal investigators.