Research studies aim to generate measurable and testable data, and on certain occasions, humans are a major factor in achieving this. In mostly medical studies where biological samples are required and accessed via minimally invasive techniques, procedural principles (ethical standards) have been put in place to safeguard the health and safety of human participants.
Ethics represents the tether between researcher obligations and research participant rights. These principles act as a balance between researcher and participant interactions, while also serving as the researcher’s anchor to morality and procedural integrity.
When human subject research is pursued, a miniature ecosystem is formed between an Institutional Review Board (IRB), the researcher/research institution and the research participant. The IRB being the most important element in the equation is according to the FDA responsible for reviewing and monitoring biomedical research involving human subjects. It has the authority to approve, request modifications to, or disapprove research in accordance with extant country regulations, which in Nigeria is the purview of the National Health Research Ethics Committee (NHREC), which stands as the United States’ Food and Drug Administration (FDA) equivalent.
When reviewing research applications for ethics approval, one of the many roles of the IRB is to ensure sufficient enrollment so that participants or volunteers are not placed under potential risk for a research that cannot be completed. It also ensures that the investigators, particularly the recruiters, have full knowledge of the cultures, and social issues peculiar to a population. Language, for instance, is a major barrier to research when researchers or recruiters conduct recruitment beyond their geographic location of origin.
One way 54gene is fulfilling these IRB expectations, is by hiring recruiters native to a vicinity. These recruiters speak the local language fluently, can communicate with people across all social strata, are aware of sacred customs, and can put to rest the major concerns and misconceptions people may have about the research project. That way, communication is seamless and precise, saving time and preventing ambiguity on the part of the potential recruit.
Privacy and transparency are the foundation of research participant recruitment. The first step in this process is identifying the most suitable candidates for a project and then approaching them. Techniques when approaching possible candidates differ on a case by case basis, depending on what is most effective, but can include formal letters, flyers, emails, social media sites or even informal personal conversations.
Once a potential candidate has been approached, the next step is gaining their consent to participate. This process requires that details and technicalities of the specific research project are explicitly spelled out, in writing and in person, in order to avoid confusion, ambiguity or unwarranted expectations by the participants.
Although the content of any consent material may vary with the nature of a study, one rule is universal – the language must be simple enough that even a child could understand. There cannot be any technical or scientific jargon, as the end goal of the consenting process is that the participant has enough information to make an informed decision to participate in the research or not. 54gene ensures that consenting participants sign approved consent forms in triplicate to ensure the researchers and the participants have copies for future reference and protection.
A few ethical considerations come into play when assembling recruitment material. These include, but are not limited to the following:
- The unbiased presentation of the study: In no instance should the project be made to seem more attractive or beneficial than it actually is, as this may mislead the potential participant. Also, a clear statement indicating that the project is being conducted for research purposes must be included to quash all misconceptions of the study being a treatment for a patient’s condition or disease.
- Accurate and clear description of the study: Information such as eligibility requirements (age, sex, health status), location, purpose of study, risks, benefits and compensation plans, or time commitments, need to be explicated and thoroughly detailed.
- Lack of undue influence: Participation in research is voluntary and must be of the individual’s freewill. As such, any coercive measures such as reaching out to someone with considerable influence over your potential participant, or giving little time to decide, may cause undue pressure that could cloud their judgement, and be seen as a violation of research ethics principles.
All positively appealing conducts and methods of approach fall under the term ‘Recruitment etiquette’. Just as normal etiquette comprises the customs or rules governing behavior regarded as correct or acceptable in social life, ‘Recruitment etiquette’ is used to emphasize on the importance of reciprocal respect for individuals and self-awareness on the part of the recruiter (Gyure et al., 2014). Studies have shown that the manner in which people are approached affects or determines their willingness to participate in research.
As enrollment for human research subjects within a variety of settings can present difficulties that may not generally be foreseen by investigators, the principle of ‘beneficence’ calls for scientists or investigators to decrease hurt, amplify potential benefits, and secure the welfare of participants.
An important thing to note, is that participants have the right to give consent to participate, withdraw from, or decline to partake in research projects. They have the option to stop individual data or recognizable information from being shared, as well as to seek out their wellbeing and security. At whatever point required, the privacy of their information is of paramount priority, and should not be exposed to unnecessary levels of risk.
The ethical principles of research strive for honesty in all scientific communications, objectivity, integrity, transparency, accountability, confidentiality and competency, but no principle is as important as the protection of human subjects.