Participants in human subject studies frequently express concern about the physical, psychological, social, economic, health, and privacy risks brought by the methods and procedures of the research. For instance, subjects often worry about privacy, personal dignity, costs, damage to employability, guilt, health, and other negative consequences that may diminish their opportunities or well-being. Biomedical research is one sensitive field where concerns over who should bear the cost of harm resulting directly from the research are frequent (White, 2020). Participants have also expressed concerns over people authorized to access their data or how researchers will conceal their identity.
The informed consent process can alleviate the concerns because it demonstrates respect for participants and transparency. A consent form is written in a language understood by subjects to eliminate the possibility of coercion or undue influence (Manti & Licari, 2018). Therefore, the information provided to participants during the process allows them to make informed decisions and gain confidence in the research.
The informed consent document is an effective educational tool and a contract. It is based on ethically sound approach, including information on the research risks, to protect the subjects (White, 2020). However, mistrust or unconsciousness about the participants’ culture and social and economic well-being could trigger a negative response to a researcher. Researchers who appear unfriendly, not hospitable, time poorly, or lack the skills to approach participants properly can also create doubt or concerns over the research. Therefore, researchers should learn about their subjects’ cultural aspects, welfare, lifestyle, and opinion to determine the best approach.
Assuring participants that their personal information will be protected is a fundamental way to make them believe their rights are protected. It includes making the process transparent by revealing the research benefits, risks, uses of their data, and the freedom to withdraw consent and seek clarification whenever an issue arises (White, 2020). Observing ethical principles during the research also helps assure the subjects their dignity and rights are protected.
References
Manti, S., & Licari, A. (2018). How to obtain informed consent for research.Breathe (Sheff), 14(2), 145–152. Web.
White, M. (2020). Why human subjects research protection is important. The Ochssner Journal, 20(1), 16–33. Web.