Introduction to Research Ethics Evaluation

Research ethics evaluation is a process by which a group of people representing different perspectives meet to review the ethical acceptability of a research project.

The process used to conduct the evaluation involves 2 steps:
  1. Ethical deliberation: This refers to the reflection and discussion process that allows each member of the committee to express their own perspectives about the research project. When different principles of ethics and concepts appear relevant but lead to contradictory courses of action, a significant amount of deliberation may be needed to come to a satisfactory resolution.

  2. Decision-making: After deliberating, the committee must reach a decision about the protocol being reviewed. Ideally, the committee will come to a consensus about how to resolve any ethical issues that is acceptable to all members. The committee’s decision should be justified and communicated in writing to promote a common understanding of any issues raised.
Why research ethics evaluation is important

During the twentieth century, in response to multiple problems and scandals, there was a significant shift with respect to who would bear responsibility for assessing the ethical acceptability of research projects. Independent and multi-disciplinary ethics committees became responsible. Importantly, these committees had public representation. In practice, this meant that doctors would no longer make this assessment alone; the public was recognised as having important views on the acceptability of research projects.

RECs conduct ethics evaluation of research protocols. Research ethics evaluation is important because it ensures that a given project is ethically acceptable and properly protects participants. In the context of externally sponsored research that is conducted in developing countries, RECs also play an important role in ensuring that ‘research has been properly planned, taking into account the local context, and effectively reviewed on scientific and ethical grounds’.

In short, RECs ensure that the project is consent-worthy before any potential research participants are invited to participate.

Role and mandate of research ethics committees (RECs)

The primary role of RECs is to ensure the well-being, safety and protection of research participants. This involves working with researchers to ensure that research meets the highest standards. RECs ensure the protection of research participants by accomplishing a combination of the following activities:

  • Ethics review and positive opinion before the research starts.
  • The continuing review of ongoing research.
  • The active promotion of principles of ethics through education and training.
Authority of RECs

Generally, RECs can come to the decision that a given project:

  • is acceptable as presented,
  • needs to be modified as per the REC’s comments before it can be accepted,
  • requires more information to make a decision, or
  • is unacceptable in its current form.

Typically, clinical trials need to receive several levels of approval, including regulatory approval, institutional approval and REC positive opinion. REC opinions can be binding or advisory:

  • The opinion of a REC is binding if a positive REC opinion is required and a negative opinion cannot be overridden by regulatory or institutional authorities.
  • REC opinion will be advisory if they can be overturned by higher authorities, such as hospital administrators or ministry of health officials.

Ideally, a regulatory or institutional authority would consider itself bound by a negative REC opinion.

The REC’s opinion is fundamental to the ethics review process. In some countries a proposal needs to receive ethics positive opinion before proceeding to other regulatory bodies for medicinal product registration, medicine importation, and/or a clinical trial approval certificate.

Whether a REC opinion is binding or advisory depends on applicable regulations and if there is a requirement for ethics approval. Requirements for ethics approval may not necessarily exist in the country hosting the research; a requirement may exist in the country sponsoring the research, or in the country where the clinical trial data will be submitted in support of a submission for market approval of the experimental medicine.