Section 4: Ethics Assessment Procedures

This section outlines recommendations for best practice in ethics committees, which may be a part of a larger organisation or independent. These recommendations are structured around a series of parameters common to all ethics committees that review R&I activity: composition and expertise; appointment and training; procedures prior to assessment; procedures during assessment; procedures after assessment; supervision; quality assurance (QA); efficiency considerations; organisational and cultural factors. Specific national legislation may also impose additional requirements on ethics committees that go beyond the general recommendations presented here.

Composition and Expertise

  • The appropriate composition of andexpertise within an ethics committee depends on the unit’s goals, the scope of its work and the available resources.
  • The number of members in an ethics committee may depend on any legislative requirements for the size of an ethics committee, the available resources, and the need to include a number of diverse perspectives on research while maintaining a manageable size to allow for fruitful discussion and deliberation.
  • The membership of an ethics committee should be arranged so that it encourages rigorous discussion and evaluation of R&I activity. This is best achieved by a membership that is professional (technically, ethically, and administratively), independent of the researchers and the institutions involved, diverse in backgrounds and expertise, and representative of the communities affected by its decisions.
  • The ethics committee chairperson should possess strong administrative competence, including good interpersonal skills for managing group decisions and good communication skills to convey the ethics committee’s decisions to researchers and supervisors.
  • Those with expertise relevant to theactivity under review should be included among the ethics committee’s members. However, persons without directly relevant expertise should be an equally important section of the membership.
  • ethics committee members should possess the following characteristics:

    • Relevant expertise (professional members) or an informed interest (non-professional members/lay persons, experts from other fields) in the R&I activity under assessment;
    • Good communication skills, both written and interpersonal;
    • An ability to evaluate the benefits, risks, and burdens associated with the specific research projects assessed;
    • An ability to engage in reasoned debate and discussion to reach and accept an balanced view of the research projects assessed;
    • Personal commitment to the goals of EA.
  • Laypersons (i.e., persons without expertise relevant to the R&I activity, including members of the general public) should be included, and there should be a sufficient number of them to ensure that the expert members cannot ignore their views. Lay persons should also only be permitted to serve as ethics committee members for a limited time so that such members continue to provide an ‘outside’ perspective on research. They should be aware that their role is to view the R&I activity both as someone from outside the research community, and as someone belonging to a group of people who may participate in the activity.
  • End users (e.g., patients or elderly), or representatives of end user organisations, should be included
  • Persons with ethical and legal expertise should be included.
  • Ethics committee members with an apparent conflict of interest should not participate in discussions or decisions where that interest may affect their judgement.

Appointment and Training

  • If the ethics committee is embedded in an organisation, the members of this organisation should elect the ethics committee chairperson. The organisation should appoint qualified experts. Members from outside the ethics committtee’s parent organisation (e.g., stakeholder or CSO representatives) should be nominated by their own organisations in a transparent way and selected on the basis of their competency. Lay persons should not exclusively be selected by scientific experts. The chief executive of the organisation should not be a member of the ethics committee.
  • If a newly elected member of the ethics committee is replacing an outgoing member, there should be a transition period in which the new member acts as a regular substitute for the outgoing member and during which knowledge is transferred and training may take place.
  • The chairperson may select temporary or ‘ad hoc’ members in consultation with the ethics committee’s supervisor. Temporary members may be appointed to the ethics committee and treated as advisors to the ethics committee who present their informed opinion of the activity under review, or as temporary members who participate in the ethics committee’s full decision-making process.
  • Ethics training for ethics committee members without ethical expertise could be made more effective by incorporating it into other policies and procedures that require training.
  • EA should be better integrated in political decision-making through education and training in ethical issues for decision makers and by including EA in decision-making procedures.

Procedures prior to assessment

The procedures that take place prior to the EA of R&I activity cover the dissemination of policies and procedures for EA to scientists and others, the actual submission of proposals or requested information to the ethics committee, and the procedures necessary for preparing the descriptions of R&I activity for ethics review. The following procedures are recommended as best practices for all types of ethics committees:

  • Use of a standard application form,including:

    • information on the person responsible for the conduct of the project;
    • a description of the R&I activity including the scientific questions, and the overall aim and purpose of the research/experiment;
    • a detailed presentation of the proposed methodology;
    • the significance of the R&I/R&D activity and expected benefits achieved;
    • documentation describing the procedures for obtaining informed consent;
    • information on the social impact and context of the R&I/R&D activity;
    • information on documentation and data protection and/or how biological material is to be stored; and
    • information on identified stakeholders.
  • Use of self-assessment: The research proposal should include the researchers’ own description and assessment of the ethical considerations.
  • Use of pre-assessment/pre-screening: Pre-assessment or -screening deals with the question of whether the ethical issues of the project have been addressed. They make ethics review both time-effective and enable a thorough EA for R&I activities that require it. The ethics committee will conduct the full assessment of R&I activity where such assessment is needed, e.g. when there is a high-risk project. The pre-assessment will involve:

    • a summary of the case,
    • a reflection on the ethical considerations that the researcher has identified as well as a reflection of how the researcher will deal with them,
    • an analysis of other ethical concerns that the researcher may have not addressed, and
    • the suggestion of a decision (for which the pre-assessor could give reasonable arguments).
  • While the EA of R&I activity is in most cases proactive (i.e. it takes place before the research or innovation is conducted), there are at least two cases where ethics committees should assess on-going projects:

    • An application has already been approved but has undergone essential changes that may affect the risk of harm or other relevant ethical aspects. The researcher (or equivalent agent) should submit a proposal for amending the former application.
    • The application has not undergone ethics review but the researcher (or equivalent agent) identifies ethical issues that ought to undergo ethics review. Here the researcher (or equivalent agent) should submit a new application for ethics review. Any changes to the protocol must go to the ethics committee for approval.

Procedures during assessment

The following general procedures to take place during the EA of R&I activity are recommended as best practices for all types of ethics committees:

  • All ethics committees should have an established decision procedure to promote transparency and to prevent decisions being made on an arbitrary basis. The decision procedure should be documented and made publicly available.
  • The assessment procedure should be designed to ensure that the conducted R&I activity:

    1. protects stakeholders (e.g. individuals participating in research) from undue risk and harm,
    2. ensures that participation in research, trials and similar activities related to the R&I activity is voluntary,
    3. determines whether the research or innovation methods are appropriate, and
    4. aims to increase the awareness of the ethical impact (EI) of R&I.

    Some of these goals can be achieved by using a checklist for relevant and pressing issues.

  • There should be a method for dealing with the issue of weighing the benefits of the research against the risk and harm. However, before weighing the harms against the benefits of the research, it should be considered whether there are ways to redesign the research study or the product to reduce the risk. Such methods should not only consider weighing benefits against harms towards individuals, but also harms against society, the environment and animals.
  • The decision-making procedure should be made public for the sake of transparency, unless prevented by regulatory requirements and/or confidentiality considerations.
  • In cases where the ethics committee finds information lacking, or where they identify ethical issues that can be avoided, they should ask the applicant to revise the application in accordance to their suggestions rather than reject the proposal.
  • The ethics committee should establish mechanisms of communicating their decisions to the researchers.
  • The ethics committee should provide ample motivation for the decisions.
  • The ethics committee should establish procedures for dealing with conflicts of interest within the unit. Researchers should be required to state any potential conflicts of interest.
  • The ethics committee may use ethical checklists in order to comprehensively check for the presence of ethical issues. There should always be a possibility to add new ethical principles and issues to the list. The use of ethical checklists should not preclude open discussion about ethical issues.

Procedures after assessment

The following general procedures after assessment are recommended as best practices for all types of ethics committees in order to deal with communicating the result of the assessment process, the possibility to appeal, and monitoring compliance:

  • The decisions of the ethics committee should be recorded for internal access and for external reference if required by legislation or auditing.
  • After the review/decision, the ethics committee should provide the applicant with a written assessment that explains the reasons for the ethics committee’s decision. If the decision is not unanimous, this should be noted in the decision. The decision may vary depending on whether the assessment is obligatory or non-obligatory. If approval has been given (in the case of an obligatory EA), a favourable report is issued. If minor amendments are necessary, the committee will ask the researcher to submit a revised proposal. Ideally there should be a dialogue between the ethics committee and the submitter of the proposal regarding the ethical issues and how to deal with them. In case of a non-obligatory assessment, the ethics committee will give a recommendation that the R&I activity should either proceed, be revised, or halted.
  • The opportunity to appeal against the decision should be given. The procedure and timeframe for appeals should be specified when the decision is presented.
  • There should be QA monitoring of both whether the researchers followed the ethics committees by either – if it has the resources available to do so or by another organisation (such as a RFO) involved in the research. There should also be QA monitoring of whether the researchers found the ethics committee effective. The ethics committee should oblige researchers to issue annual reports, end-of-study reports and report on adverse events.
  • If decisions (especially binding ones) are to be followed up, there should also be procedures for the measures to take in case of non-compliance.


  • Those responsible for the work performed by an ethics committee have the strongest interest in supervising their work and ensuring that it is of a high quality.
  • ethics committees should be supervised by a high administrative or managerial level of the organisation within which they operate (when they do operate within an organisation).
  • The supervision of ethics committees should not compromise their ability to be independent in their decision-making. Using external auditors and performing QA of the ethics committee’s work are both ways of demonstrating the quality of the ethics committee’s work and that it is fair and unbiased.
  • Policies should be put in place that require the supervisors of ethics committees to take the assessment of the ethics committee into account when deciding on whether to proceed with R&I activity.

Quality Assurance

In EA, QA refers to activities (administrative, procedural or other) undertaken either by ethics assessors themselves or their agents to (systematically) study, evaluate, monitor, or measure and compare with established standards, or make recommendations (for improvement) in relation to the effectiveness of their EA process and procedures. We recommend that ethics committees consider using a modified version of the Plan-Do-Check-Act (PDCA) process1 used in the internationally recognised ISO 9001 ‘Quality Management Systems — Requirements’ standard. Our adapted version that incorporates relevant elements from existing QA of EA practice is presented below:


Establish the objectives of the EA and its processes, and the re- sources needed to deliver results in accordance with ethical requirements and the organisation’s policies. They should develop a QA plan showing:

  1. the objectives of the QA,
  2. the strategy and approach to QA,
  3. the methods/techniques to be used and how performance shall be measured, and
  4. who has the responsibility for QA.


This part envisages the implementation of the QA plan and ensuring that the arrangements therein are followed. This includes support actions, such as:2

  • Determining and providing the persons and resources necessary for establishing, operating, and revising the EA process (while considering the capabilities of, and constraints on, existing internal resources and also what needs to be obtained from external providers).
  • Determining, providing and maintaining the infrastruc- ture and environment necessary for the operation of processes to achieve quality of EA.
  • Ensuring that the resources provided are suitable for the EA performed and are maintained to ensure their continuing fitness for their purpose.
  • Retaining appropriate documented information as evidence of fitness for purpose of the EA process.
  • Ensuring that relevant persons working under the organisation’s control (e.g. ethics assessors, other staff) are aware of:

    1. the quality policy;
    2. relevant quality objectives;
    3. their contribution to the effectiveness of the quality management system, including the benefits of improved performance;
    4. the implications of not conforming with the EA process requirements.
  • Determining the internal and external communications relevant to the EA process (what, when, with whom, how).
  • Maintaining documented information determined by the organisation as being necessary for maintaining the effectiveness and quality of the EA process. This is important for transparency.


This part monitors and (where applicable) measures EA processes and the results against policies, objectives and requirements, and reports the results. Some key questions (based upon and adapted from the EC Better Regulation Guidelines on Evaluation and Fitness Checks)3 that could help assess the quality of EA policy, practice or procedure are outlined below:

  1. What is the current situation?
  2. How effective has the EA policy, practice or procedure been?
  3. How efficient has the EA policy, practice or procedure been?
  4. How relevant is the EA policy, practice or procedure?
  5. How coherent is the EA policy, practice or procedure internally and with other external actions?
  6. What is the European Union added value of EA policy, practice or procedure?


This part involves the review and continuous monitoring and im- provement to improve the performance, adequacy and effectiveness of the EA process. This includes the following type of activities:

  1. Learning from feedback about ethical policy or assessment procedure.
  2. Learning from other organisations.
  3. Revisiting plans, policy documents and the EA process to see if they need updating.
  4. Taking actions on lessons learnt (including from internal and external evaluations/QA exercises).

Efficiency considerations

The recommendations for QA are based on the Plan-Do-Check-Act (PDCA) process described in the ISO 9001 standard. According to this approach, planning for and ensuring efficient use of resources is already part of the QA of a project. The majority of elements relevant to efficiency in the adapted PDCA approach appear in the CHECK stage, and are listed below:

  • To what extent have the objectives been achieved?
  • What have been the (quantitative and qualitative) effects of the EA policy, practice or procedure?
  • To what extent do the observed effects correspond to the objectives?
  • To what extent can these changes/effects be credited to the EA policy, practice or procedure?
  • What factors influenced the achievements observed?
  • To what extent did different factors influence the achievements observed?
  • Did evaluation or review policies/procedures allow for the addressing of things affecting the achievement of the objectives of the EA policy, practice or procedure?
  • To what extent has the EA policy, practice or procedure been cost effective?
  • To what extent are the costs involved justified, given the changes/effects that have been achieved?
  • To what extents are the costs proportionate to the benefits achieved? What factors are influencing any particular discrepancies?
  • What factors influenced the efficiency with which the achievements observed was attained? How affordable were the costs borne by different stakeholder groups, given the benefits they received?

Addressing cultural and organisational factors

  • Cultural factors should only be used to justify stricter requirements than those imposed by national and international laws, and accepted international guidelines on research ethics.
  • ethics committee members with training and experience in applied ethics can assist in identifying and addressing cultural factors that might affect how the general community perceives the research.
  • Legal requirements must take precedence over other considerations in the ethics committee’s organisation and operation.
  • The work of the ethics committee should recognise the goals of the organisation connected with the ethics assessor, without undermining the independence of the ethics committee’s decisions.
  1. Also called the ‘Deming cycle’, this is a widely used process improvement method
  2. This list below is largely based on section 7 of ISO 9001, adapted for use here.
  3. European Commission, “Guidelines on Evaluation and Fitness Checks”, Better Regulation.