Ethical Issues

As part of IR project planning and research implementation, ethical considerations likely to be of concern to Institutional Review Board(s) (IRBs)/Ethics Review Committee(s) (ERCs) must be anticipated, identified and possible solutions clearly articulated. Even though the majority of ethical challenges for IR projects will be context specific, there are some generic issues associated with IR. This includes the need to make a very clear distinction between what is done under routine care and what is being proposed as components of the research study. This is often difficult since IR is conducted within the health system and is expected to provide direct feedback and utilization of the research findings. This distinction also highlights the importance of providing detailed information and justification for the involvement (if any) of health care personnel in IR-related activities.

Another challenge often encountered during the review of IR protocols is the general lack of IR expertise among most IRB/ERC panels. In addition, the protocol review tools/forms (guidelines) are generally designed to assess the quality of more ‘mainstream’ biomedical and clinical research. When such guidelines are used for IR protocols, the outcome may be unfavourable: not necessarily due to quality of proposals, but as a result of inappropriate assessment.

The other most common limitation is failure on the part of the research team to explain sample size calculation for qualitative (or mixed methods) research. This drawback is closely related to the multidisciplinary, and at times, inter-sectorial nature of IR protocols. Delays in the review of such protocols can be minimized by starting with less complex studies and sensitizing ERC/IRC members on the methodologies and expected outcomes applicable in IR. To address these challenges, efforts must be made by the researche team to develop research protocols that identify and propose solutions to ethical issues well before submission to IRB/ERC. It is also prudent for research ethics committees to expand their membership to include key IR expertise in the review panels. In some settings, IRBs have established a parallel review panel and tools for assessing the quality of IR related protocols. Examples of the ethical challenges associated with IR protocols submitted for ethical review are illustrated in table 10.

Research funding agencies require the approval of research protocols by the appropriate ethics review committees before project funds are released. Depending on the circumstances, ethical review may be required from more than one such committee. For example, ethics approval may be required from an institutional as well as a national ethics review committee, or by more than one research or health institution the in case of collaborative projects. The ethics committee(s) will review the study protocol and require full details of the study plan and procedures. The committee(s) will pay particular attention to how consent will be obtained from prospective study participants, and carefully scrutinize all informed consent documents. However, due to the fact that IR is conducted in real-life settings, sometimes certain unforeseen circumstances not considered before the project was presented for ethical review may arise. As a result, any changes in the study, during the project life cycle such as adding new objectives, extending the study catchment area, adding or removing inclusion or exclusion criteria will require additional approval by the ethics committee(s).

This section provides information on the preparation for submission of the study protocol for ethical review. The ethics review process is essential to ensure that the research project will protect research subjects’/participants’ dignity, rights, safety and well-being. Therefore, before initiating a study, written ethical approval of the protocol should be obtained from the appropriate IRBs/ERCs. The team should search from appropriate resources (e.g. institutional websites) to establish the submission requirements, the IRB review process as well as what is involved or the next steps required once the initial ethical approval has been granted. It is the team leader/principal investigator’s responsibility to ensure that the protocol is submitted and also to ensure compliance with the study protocol as agreed by the sponsor and regulatory authority (if appropriate), and as approved by the scientific and ethical committees.

Table 11 outlines the documents generally required to be submitted to ERCs. The researcher should be cognizant that requirements may vary between committees. It is important to check the specific documentation and protocol requirements with the ethics committee(s) to whom you are applying.

The ethical principles of autonomy, risk/beneficence and justice must be observed during the execution of the research project. This section discusses issues regarding seeking informed consent, privacy and confidentiality and ethical issues during project execution.

Informed consent (IC) is recognized as a fundamental ethical requirement for conducting research involving human subjects.⁶ Informed consent ensures that individuals can freely make decisions to participate according to personal interest, values and priorities. IC is more than a contractual obligation and should be understood as a process that begins with the initial contact with the research participant (during the recruitment process), and carries through to the end of participants’ involvement in the project. The establishment of the process requires four basic elements: i) Provision of accurate and appropriate information; ii) Participant’s ability to understand the purpose of the procedures in the research process; iii) participant’s capacity to consent; and iv) voluntary participation and withdrawal.

To have effective informed consent, the full information should be explained in the language of the participants. Furthermore, local/simplified words (i.e. rather than scientific and professional jargon) should be used. The consent form should also include information about the research, the procedure, expected outcomes and potential benefits as well as the consent certificate (see Table 12).

Protecting the anonymity and confidentiality of research participants is another practical component of research ethics. Disclosure of personal information may, in some circumstances, pose a risk of discrimination or prejudice. Research participants should have the right to remain anonymous and to have their rights to privacy and confidentiality respected. Protecting the privacy and confidentiality of participants is the investigator’s responsibility.⁷ Protecting the anonymity and confidentiality of research participants involves adhering to ethical procedures during data collection, storage and analysis, as well as, during any subsequent publication process.

During data collection, the participant should be accorded as much privacy as possible to ensure that the information being provided is not shared with others without the participant’s explicit permission. Unless the respondent gives their permission, at no time should the identity of the respondent be disclosed to any third party during data collection, storage or analysis, or even during dissemination or publication. The identity of the respondents may be associated with anonymous identifiers that cannot be linked to individuals. However, the standard of being anonymous throughout the lifecycle of the study may be a challenge, for example in situations where participants are measured at multiple time points (pre- and post-study) or where content of different databases (e.g. laboratory results and clinical records) need to be linked. Nevertheless, efforts should be made to guarantee the anonymity of all research participants.

Questions of ethics are embedded in every aspect of IR processes and steps. Once the protocol has been reviewed and approved by the ERC(s), the approval certificate informs the team leader/principal investigator of any subsequent steps, which may include a need for regular reviews or follow-up ethical reviews. Whereas in most study designs the original research protocol is followed precisely, in IR the research team continuously monitors and reviews the intervention activities to ensure meaningful and practical outcomes for project planning and execution. During this process, unexpected circumstances may arise leading to changes in the original research plan (in the best interest of the project and/or the participants). In such situations, a number of amendments are likely to be made to the original protocol submitted for ethical review. Therefore, the IR team must inform the ethical committee of any changes to the original research protocol or procedures. For example, during the initial submission of the protocol for ethical review, the research team may indicate that patients will be given daily injections by the nurse in charge of the facility. However, during the research process, the planned administration of daily injections may not be feasible due to unanticipated problems. When such issues arise, the ethics committee must be informed of any proposed change(s) in procedure and those unanticipated problems. The three types of follow-up ethical reviews include periodic, interim and end-of -project (final) ethical reviews:

• Periodic reviews may be requested since most ERCs require follow up to ensure compliance with planned procedure, to evaluate any protocol deviation. Most ethical approvals are given a limited period, commonly one year. However, the frequency and procedures for follow-up and review of operations is on a case-by-case basis.
• Interim ethical review may be needed in special circumstances due to significant changes in the study design or when information used for the original approval of the protocol has changed.
• Final ethical review is a process whereby the project team leader/principal investigator communicates the conclusion of the project to the ERC, through a progress report since last approval, a summary of study results and disseminations plans.