Ethics are the moral principles that distinguish between right and wrong. In research, they differentiate between acceptable and unacceptable behaviours on the part of the researcher. Ethical considerations in research form the basis of adherence for the integrity, reliability and validity of the research findings. Some form of ethical review of human research is prevalent in some countries. However, important features of regulations governing the ethical review practice vary significantly. These features include the composition of ethics review committee, protocol review processes, procedures to determine which activity requires what type of review, and so on. As a result, academic journals receive manuscripts with similar types of research having received different levels of ethical reviews. Sometimes some publications get a waiver on the ethical review and journals are responsible for questioning the appropriateness of such wavers or alternative review processes in order to decide whether or not to accept this research.

 

One type of research where such variation in ethical review is prevalent is ‘survey research’. It is defined as research in which a sample of participants is drawn from a larger population and is asked a series of questions related to a topic about which they should have some knowledge or attitude. In healthcare, survey research is conducted for a lot of reasons, viz. research to understand markets, public opinions, hypothetical preferences, or satisfaction with a particular service, to gain insights into the health status of different subgroups of the population or to make conclusions about health-related behaviours, such as diet or exercise, in a community. Surveys may also be used to collect data as part of a clinical trial designed to evaluate the impact of an intervention or interventions on individuals. However, because participants in clinical trials generally receive some form of intervention, this would not be classified as survey research. Rather, in survey research, the only form of intervention or data collection is through questionnaires or interviews, which, in some cases, may provide participants with information they need to understand a topic related to the questions being asked.

Why the ‘ethics review’? The answer is straightforward: because research involving human subjects puts people at risk. The risks may be physical, psychological, social, economic, legal, or dignitary; a single study may also pose more than one type of risk to subjects. Of course, people are exposed to risks all the time, whether it is at work, in the doctor’s office, or driving a car. The difference in research is that people are exposed to risk in large part for the benefit of others, be they other patients, the health system, or society at large. It is this feature of research that drives the need for independent ethics review. While the integrity of researchers remains an important protection for research subjects, researchers themselves may not be in a good position to make the best judgment regarding the ethical acceptability of a research study. Ethics committees ensure that the liberty and welfare interests of research subjects are protected, and that national and international ethical and legal requirements are upheld.

Ethical issues exist in all types of research and they need to be tackled. The most important ethical principles in survey research are protection of research participants (the respondents) and the guiding foundation of “no harm”. Most institutions and organisations have an Institutional Review Board (IRB), which is a panel of people ensuring the safety of human subjects in research, while also making sure the non-violation of human rights. Some common issues in survey research include voluntary participation and informed consent. These principles are followed to guarantee that all respondents are opting to participate in the survey of their own free will and that they are fully informed regarding the procedures of the research project and any potential risks. This is not a major problem in survey research since a cover letter or introductory statement is used to introduce the survey and provide any other information regarding the purpose, sponsorships, potential use of data, and methods of collecting it. Issues of confidentiality are also typically covered in this statement.

Confidentiality and anonymity of the subjects is protected by applying ethical standards. This is the primary ethical issue in survey research, especially if the survey contains sensitive questions. Researchers should not share information between participants and should have procedures in place to protect the data and names of participants. If the research protocol calls for follow up with reminders or additional surveys at a later date, true anonymity may not be possible. However, if possible, identifying information should not even be recorded. Use of encryption technology for internet surveys and numbering of respondent data can help to reduce possible breaches with respect to confidentiality.

Survey research does not deliver any intervention to research participants; thus, there is no risk of physical harm to participating individuals. Thus, we feel that such type of studies should get an ethics review waiver. However, there can be cases where a risk of informational or psychological harms are unavoidable. The situations with greater than minimal risk of informational or psychological harms necessitate institutional ethics overview of the survey research. Furthermore, survey research projects with vulnerable individuals having diminished autonomy should also receive institutional ethics overview. Additionally, the protocol of the research must ensure confidentiality of participant’s personal information along with the data they provide.

About MarksMan Healthcare

MarksMan Healthcare Solutions (ISO 27001:2013) is an International knowledge-based Patient Access Services (PAS) and Medical Communications consulting firm based in India. It specialises in HEOR, PRMA and RWE solutions.

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