Ethical Standards

Clinical research and development use cutting-edge science. We are unlikely to find important new treatments for serious diseases without exploring the boundaries of current scientific and medical knowledge. Inevitably, concerns are raised about new research methods and technologies as they emerge. Roche is fully committed to applying the principles, regulations and guidelines in place to ensure that healthcare companies carry out their research to high ethical standards, and to ensure that volunteers and patients involved are at minimal risk. Maintaining a high degree of transparency about the research we carry out and the results it produces helps answer any questions raised and alleviate concerns. Our policy is to:

• Comply fully with all established ethical, legal and regulatory requirements
• Demonstrate our compliance with these principles and requirements
• Maintain a structured programme of peer review to ensure high ethical standards in our clinical trials and other development activities
• Contribute to the development of new standards and guidelines as appropriate by actively supporting academic, governmental or industry working groups.

All Roche-sponsored research and development is carried out in accordance with a range of principles and standards. These include:

• The Declaration of Helsinki, a statement of ethical principles developed by the World Medical Association to guide physicians and others involved in medical research in humans
• The ICH (International Conference on Harmonization) and national Good Clinical Practice (GCP) guidelines, which protect patient rights and safety.

Based on these guidelines, we have developed internal policies and a global position statement on clinical research. This is made available to every employee, and commits us to a comprehensive range of measures to ensure high ethical conduct.

Our clinical trial registry provides information about all trials Roche conducts with patients and contains a database of key results from completed trials.

We run a comprehensive internal education programme to regularly remind our employees of our values and ethical standards. This helps ensure that our employees address ethical issues and uphold our values as part of their normal work. Our values clearly define how our business should be run, helping to reassure and motivate our employees.

Our employees will sometimes encounter ethical issues they cannot resolve themselves as they carry out research in new areas of science and technology. We have a systematic framework for discussing and resolving such ethical issues which follows a three-step approach:

• Employees and teams who encounter ethical concerns they cannot resolve themselves or by discussion with their team can contact the Global Ethics Liaison, a central source of advice;
• If this does not resolve the issue, it is escalated to an internal committee of experts in the area of concern;
• Cases not resolved internally are referred to our Clinical Research Ethics Advisory Group (see below), a panel of independent advisers. The internal committee will consider their advice and decide on a final position.

More detail is available in the Roche Framework for Discussing and Resolving Ethical Issues in Clinical Research.

The Clinical Research Ethics Advisory Group (CREAG) is a panel of independent, external advisers that helps Roche to resolve ethical issues related to research in humans. It includes internationally-recognised experts in bioethics, law, and medicine, and non-specialists such as patient group representatives. The committee is made up of members from different continents to prevent cultural bias, and to ensure its advice is comprehensive and relevant to all situations that arise.

Periodically, the CREAG also discusses ethical issues in the wider health arena with Roche, to keep us up to date and to act as a sounding board for any internal debates that may benefit from an independent opinion.

Bioprospecting is a term for the collection and analysis of natural materials as potential sources of new medicines.

Many communities have used natural resources in their traditional medicines for generations. We recognise that these communities have the right to maintain access to such resources, and that their knowledge should be respected. It is also critical that resources are conserved and that the biological diversity surrounding them is not damaged when they are collected.

Roche does not carry out any activities of this type, nor do we have any plans to. Should this change in the future, we will abide by the 1992 UN Convention on Biological Diversity. This addresses issues relating to conservation and equal access to resources.

More details of our position on these issues can be found in our Global Statement on Biodiversity.