Ethics in R&D

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.

Roche follows strict policies and processes to ensure the safety, well-being and legal rights of people participating in clinical trials. All clinical studies in Roche are conducted in compliance with international guidelines including:

• 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

Each trial must be approved by national regulatory authorities as well as Ethics Committees or local Institutional Review Boards. These boards ensure that proposed trials are acceptable, that participants are fully informed about the benefits and risks related to the trials and that the healthcare professionals who run the trials (investigators) take appropriate actions to protect patients from any harm.

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.

To ensure compliance with these standards, we train, monitor and audit those involved in our clinical trials, including contract research organisations (CROs) that conduct or manage trials on our behalf. We do not perform trials in countries where we do not plan to market the medicine being tested.

During each phase of the clinical trials for a medicine, Roche’s Global Drug Safety Department evaluates the safety and effectiveness to determine the benefit–risk profile of the medicine. If the risk exceeds the patient benefit, then Roche will change the study or halt development of that medicine.

We have clear policies and procedures in place to maintain high ethical standards in our R & D activities, including providing regular ethics training for employees.

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. Employees who encounter an ethical dilemma in their work, and cannot resolve it with their colleagues, can contact our Global Ethics Liaison Office, which then consults both internal and external experts to seek a solution.

The company has established the Roche Science and Ethics Advisory Group (SEAG) to offer advice and counsel on a broad range of ethical matters. The panel meets as needed and is made up of independent internationally-recognised external experts appointed by Roche from the fields of genetics, bioethics, law and sociology, as well as lay members, such as representatives from patient advocacy groups. The panel 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. The SEAG may also meet periodically to discuss 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.