Question

In this journal, reflect on the knowledge you have gained in this course and how you envision using this information moving forward as a more informed consumer of data. Also reflect on how you envision using this information as researcher in your future career in the healthcare professions. As an informed consumer, consider the role of the IRB in healthcare research.

• How has your understanding of statistics evolved since the beginning of the course?
• What are the next questions you want to find answers to now?
• How will the knowledge you have gained in this course inform your personal and professional life?
• How might you apply what you have learned about critically reading research articles in the future?
• What is the purpose of the IRB? Why is it important to have regulations surrounding research involving human subjects?

Answer 1

The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implications. The Board will also include at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB has several consultants who advise the Board and are periodically involved in protocol review.

Independent review of clinical research by an IRB is required for US studies funded by the Department of Health and Human Services (DHHS) and other US federal agencies, as well as for research testing interventions such as drugs, biologics, and devices that are under the jurisdiction of the US Food and Drug Administration (FDA).

One-third of articles still do not mention IRB approval. Mention varied by country and was associated with biomedical research and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards.

The IRB must approve each proposal and certify that the research will be conducted in accordance with the law and protect subjects from harm. An IRB consists of a group of scholars from various departments who are mandated to review proposals to ensure that they comply with ethical guidelines and write a summary of proposed risks to subjects.

• Following these procedures provides research subjects protection from harm that might result from their participation in research.

• Complying with these procedures (e.g., IRB review, informed consent, confidentiality concerns) improves the overall quality of the research we conduct and the data used in the analysis.

• Consideration of the confidentiality and human subject issues and compliance with the rules will allow us to continue to conduct difficult research on important societal problems and to provide a scientifically informed basis for making important public policy decisions.

• The codes of conduct and ethical standards of our profession to which we adhere require the dutiful protection of human research subjects and confidentiality.

• Many of these concepts have longstanding associations with other fundamental aspects of our society (e.g., belief in individual rights, representative government), and fulfilling our obligations defines us as a society and a nation.