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Research Process Guide

Step 7: Considering Ethical Issues in Research with Human Subjects - Institutional Review Board (IRB)

Due to historically unethical and cruel practices in research, in particular those in the last century and a half, including but not limited to Nazi experiments during World War II, the Tuskeegee Syphilis Experiment, Willowbrook, and the Stanford Prison Experiment), the international research community put in place a series of rules and policies that are mandatory for researchers to adhere to so that human subjects are never again unethically treated. The Nuremberg Code (1947), Declaration of Helsinki (1964), National Research Act (1974), Belmont Report (1979), and European Charter of Fundamental Rights (1999) are all historical research policies in direct reaction to abusive and unethical research practices using human subjects. Most recently, the Institutional Review Board (IRB) was born out of the ever-advancing protections of human subjects over the last century. Founded on the guiding principles of respect for persons, beneficence and justice, the IRB is a system of checks and balances to ensure that human subjects are ethically treated (Bouma et al., 2012).

As a researcher, there are important ethical considerations you are required to take into consideration as you are design your study (Buoma et al., 2012; Miles et al., 2018):

  1. Treat your research subjects with respect and dignity including:
    • Personal information and privacy
    • Free and informed consent
    • Respect for vulnerable persons
    • Respect for privacy and confidentiality
    • Respect for justice and inclusiveness
  2. Research must be based on knowledge of work by others in the fields and be conducted by persons qualified to do the work and ensure the safety of participants.
  3. The potential benefits of research must substantially outweigh the potential harm to participants.
  4. Participants must be able to make a voluntary, informed decision to participate. With informed consent, and freedom to withdraw.
  5. Research is conducted openly and the researcher is accountable to both the participants and the community in the research.


What role does IRB play in your research and planning? Great question.

Every institution has a panel of academics and researchers who are responsible for holding each researcher accountable for the above ethical considerations. For dissertation, post-doc, institutional, or any other empirical inquiry using human subjects, the Institutional Review Board (IRB) must approve all aspects of your proposed research. Once you have discussed your research with your dissertation advisor and put together your research proposal and all research protocols (traditionally these are included in Chapter 1-Chapter 3 of your dissertation), you will have to submit your research proposal to Kean University's IRB.

IRB members review all assigned research protocols to ensure that:

  1. Risks to subjects are minimized
  2. Risks to subjects are reasonable in relation to anticipated benefits
  3. Selection of subjects is equitable
  4. Informed consent is properly obtained from all prospective subjects and documented
  5. Subject’s privacy and confidentiality are protected


Anyone who intends to complete research using human subjects must not only apply to the IRB but also complete CITI training before conducting their research. Ask your advisor or instructor about CITI training, which is available through Kean University’s IRB website.

Use your Kean University credentials to sign up and sign in to CITI. You will complete particular training modules and then receive a certificate of completion. This certificate will be a mandatory component of your IRB application.

IRB Resources: https://www.kean.edu/offices/research-and-sponsored-programs/irb-research-compliance

References

Bouma, G. D., Ling, R., & Wilkinson, L. (2012). The research process (2nd Canadian ed.). Oxford University Press.

Miles, M. B., Huberman, A. M., & Saldaña, J. (2018). Qualitative data analysis: A methods sourcebook. Sage.