The primary task of an REC is the ethical review of research protocols and their supporting documents. Approval or disapproval is based on the ethical acceptability of the research, including its social value and scientific validity, an acceptable ratio of potential benefits to risks of harm, the minimization of risks, adequate informed consent procedures (including cultural appropriateness and mechanisms to ensure voluntariness), measures to ensure protection of vulnerable populations, fair procedures for selection of participants, and attention to the impact of research on the communities from which participants will be drawn, both during the research and after it is complete. The review take into account any prior scientific reviews and applicable laws.
Standard 7. Ethical basis for decision-making in research ethics committees
The REC bases its decisions about research that it reviews on a coherent and consistent application of the ethical principles articulated in international guidance documents and human rights instruments, as well as any national laws or policies consistent with those principles. The REC makes clear the specific ethical guidelines on which it relies in making decisions and makes them readily available to researchers and the public. When an REC develops reliance agreements for review of research under its jurisdiction by another REC, it is the responsibility of the delegating REC to assure that the same ethical principles serve as the basis of the other REC's decision-making.
To aid in determining the ethical acceptability of research protocols, an REC may utilize a checklist to ensure that all relevant criteria are considered during review and that, as a general rule, similar protocols are treated similarly. When an REC determines that an approach it has taken on a particular ethical issue in the past is no longer appropriate, it provides an explicit rationale for its change in position. In communicating decisions about particular protocols to researchers, the REC explains its analysis of any significant ethical issues that arose in the review.
As articulated in more detail in international ethics guidelines and the research regulations of a number of jurisdictions, key criteria include, but are not limited to, the following.
1. Scientific design and conduct of the study
Research is ethically acceptable only if it relies on valid scientific methods. Research that is not scientifically valid exposes research participants or their communities to risks of harm without any possibility of benefit. RECs should have documentation from a prior scientific review, or should themselves determine that the research methods are scientifically sound, and should examine the ethical implications of the chosen research design or strategy. Unless already determined by a prior scientific review, RECs should also assess how the study will be conducted, the qualifications of the researcher(s), the adequacy of provisions made for monitoring and auditing, as well as the adequacy of the study site (e.g. availability of qualified staff and appropriate infrastructures).
2. Risks and potential benefits
In ethically acceptable research, risks have been minimized (both by preventing potential harms and minimizing their negative impacts should they occur) and are reasonable in relation to the potential benefits of the study. The nature of the risks may differ according to the type of research to be conducted. REC members should be aware that risks may occur in different dimensions (e.g. physical, social, financial, or psychological), all of which require serious consideration. Further, harm may occur either at an individual level or at the family or population level.
3. Selection of study population and recruitment of research participants
Ethically acceptable research ensures that no group or class of persons bears more than its fair share of the burdens of participation in research. Similarly, no group should be deprived of its fair share of the benefits of research; these benefits include the direct benefits of participation (if any) as well as the new knowledge that the research is designed to yield. Thus, one question for research ethics review to consider is whether the population that will bear the risks of participating in the research is likely to benefit from the knowledge derived from the research. In addition, ethically acceptable research includes recruitment strategies that are balanced and objectively describe the purpose of the research, the risks and potential benefits of participating in the research, and other relevant details.
4. Inducements, financial benefits, and financial costs
It is considered ethically acceptable and appropriate to reimburse individuals for any costs associated with participation in research, including transportation, child care, or lost wages. Many RECs also believe that it is ethically acceptable to compensate participants for their time. However, payments should not be so large, or free medical care or other forms of compensation so extensive, as to induce prospective participants to consent to participate in the research against their better judgement or to compromise their understanding of the research.
5. Protection of research participants' privacy and confidentiality
Invasions of privacy and breaches of confidentiality are disrespectful to participants and can lead to feelings of loss of control or embarrassment, as well as tangible harms such as social stigma, rejection by families or communities, or lost opportunities such as employment or housing. RECs should therefore examine the precautions taken to safeguard participants' privacy and confidentiality.
6. Informed consent process
The ethical foundation of informed consent is the principle of respect for persons. Competent individuals are entitled to choose freely whether to participate in research, and to make decisions based on an adequate understanding of what the research entails. Decisions for children or adults who lack the mental capacity to provide informed consent should be made by an authorized surrogate decision-maker.
RECs should examine the process through which informed consent will occur, as well as the information that will be provided. RECs may waive the requirement of informed consent only when doing so is consistent with international guidelines and national standards.
While informed consent to research is important, the fact that a participant or surrogate may be willing to consent to research does not, in itself, mean that the research is ethically acceptable.
7. Community considerations
Research has impacts not only on the individuals who participate, but also on the communities where the research occurs and/or to whom findings can be linked. Duties to respect and protect communities require examining by the REC and, as far as possible, are aimed at minimizing any negative effects on communities such as stigma or draining of local capacity, and promoting, as relevant, positive effects on communities, including those related to health effects or capacity development. Researchers should actively engage with communities in decision-making about the design and conduct of research (including the informed consent process), while being sensitive to and respecting the communities' cultural, traditional and religious practices.
