Table 1 Description of the octagon framework as applied to the research ethics system at an institution

1

Basic values and identity

•Formulation of organization's vision and mission

Documents that describe reasons for the establishment of the organization, objectives the organization wishes to achieve in research ethics in the future (vision), and contribution the organization wishes to make in research ethics (mission).

•Organization's vision and mission are documented in writing, are known and accepted by all members of staff.

•Formulation of relevant strategies

•The organization has devised strategies that have been documented and which are clearly linked to the organization's vision

2

Structure and organization of activities

•Application of a clear division of duties and responsibilities for research ethics

Duties and responsibilities are allocated and coordinated; democratic rules are applied and these rules manifest in the organization's constitution or strategic plan or rules and regulations; decision-makers can be held responsible for their decisions and actions.

•Management and staff know the duties, responsibilities and powers they have for research ethics

•Application of democratic rules

•Transparent routines and systems for approval of accounts and reports, and for scrutiny of decisions made

•These systems include participation of both men and women.

3

Implementation of activities / Production

•Planning for the implementation of activities for research ethics

What are the research ethics outputs the organization has identified and can the organization describe its research ethics activities in the form of operational plans? Are the plans useful for the implementation of research ethics activities?

•Operational plans that are actually used by management and results achieved have been documented.

•Follow-up and learning from work done

•Systems for regular follow-up and for making good use of experience gained.

4

Relevance

•Content of research ethics activities corresponds with the vision/mission

Whether the organization’s research ethics activities in their content and methods correspond to its goal and vision/mission.

•Activities of the organization actually correspond to its vision/mission

•Working methods correspond with the vision/mission

5

Right skills in relation to activities / Competence

•Professional qualifications and experience of the staff

Whether the organization has a recruitment strategy and selects personnel in accordance with existing, documented criteria for research ethics.

•Job descriptions for all posts, and staff in place that fully meet the criteria of the job descriptions.

•Ability of management

•The staff regards management as legitimate and gives management its active support.

6

Systems for financing and administration

•Administration of financial resources

Sources of finance for research ethics, whether financial resources are sufficient for planned activities and whether there are plans to reduce dependence on external grants. Examine routines for systematic documentation of activities

•Guaranteed financing and several sources of funds for research ethics.

•Administrative routines

•Efficient administrative systems in which documents are filed systematically

7

Target groups

•Support and acceptance by target groups; dialogue with target groups on research ethics

Whether the organization encourages the continuous and broad participation of the target groups in its research ethics activities.

•Organization has documented how the target groups are defined.

•Target groups are clearly involved in activities.

•Legitimacy for its work, and active participation in networks

8

Working environment

•Government rules / regulatory environment for research ethics

What is the legal context in which the organization operates, and what rules or framework does the government have regarding research ethics.

•Activities are in line with the government's vision and policy statements of multilateral organizations e.g. the World Health Organization

•Influence on national health research system

•Plays a leadership role at national level