Question

How is ethics committees’ work important to the research in a healthcare setting?

How will this information have an impact toward future organizational direction?

250 word answer.

Answer 1

Importance

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

Research ethics committees review proposed studies with human participants to ensure that they conform to internationally and locally accepted ethical guidelines, monitor studies once they have begun and, where rel-
evant, take part in follow-up action and surveillance after the end of the research. Committees have the authority to approve, reject or stop studies or require modifi cations to research protocols. They may also perform other
functions, such as setting policies or off ering opinions on ongoing ethical issues in research.
Review by a research ethics committee is required by international ethical standards governing research involving human participants, as well as by
local law in many jurisdictions. In international cooperative research, review may be required by the laws of the country in which the research is being
sponsored, even if it is not required by the host country’s own laws. Review is also essential if the researchers intend to publish the results of their inves-
tigation, as most medical journals will not publish the results of research that has not received the approval of a research ethics committee.
The main responsibility of a research ethics committee is to protect potential participants in the research, but it must also take into account potential risks
and benefi ts for the community in which the research will be carried out. Its ultimate goal is to promote high ethical standards in research for health.

Importance in future

Identifying risks
This is first and foremost a task for the investigator, who must specify the nature, characteristics and scale of the risks in the research proto-col submitted to the research ethics committee. The committee should
carefully consider the description of risks contained in the protocol, but it should not assume that this description is necessarily accurate or complete. This is particularly true with respect to social risks, which may stem from local conditions or attitudes of which the investigators
and sponsors may not be aware.

Identification of the expected benefits

Medical research involves diff erent types of interventions.

• Interventions that hold out the prospect of a direct diagnostic, thera-peutic or preventive benefi t for the individual participants. Some ethical guidance documents state that these types of interventions should not be provided in the context of research unless there is a reasonable basis for expecting that they will be “at least as advan-tageous to the individual subject ... as any available alternative”

(CIOMS Guideline 8).

• Interventions that do not hold out the prospect of direct benefi t forthe subject, but are expected to produce scientifi c information that may benefi t society in the future. The risks presented by such inter-ventions must be “reasonable in relation to the importance of the Knowledge to be gained

These two types of benefi ts must be clearly distinguished from benefi ts (“perks”) participants may receive in exchange for their partici-pation, such as payments for time spent participating in the study.

While study participants may value these perks, the research ethics committees should not consider them “benefi ts” of the study for the purposes of the risk/benefi t assessment.

Evaluation of the risk/benefit ratio

Any type of research must be preceded by a scrupulous evaluation of the relationship between the risks and the potential benefi ts for the participants and/or their communities. This evaluation requires a thorough and up-to-date knowledge of the scientifi c literature.

Comparison of the risks and benefi ts of research must avoid two pitfalls :

• underestimating the risks and/or overestimating the potential benefi ts,

either of which can result in exposing participants to unjustified harm

• overestimating the risks and/or underestimating the potential ben-efi ts, thereby holding back potentially benefi cial research.