Ethical Concerns and the IRB Process In this course, the issue studied was emergency management and trauma centers in the State of Connecticut. By studying this issue, the researcher was exposed to human subjects. Permission to study them had to come from those subjects or those authorized to give consent for those subjects, but the idea of studying humans for a research project also must be addressed by the IRB process. There are some concerns with that, especially where quantitative research into this issue is conducted. The kind of study conducted should, allegedly, regulate whether IRB is necessary, and that have been concerns in the past that the IRB regulations are too strict and that the process is overused. These concerns have come about mostly as an argument regarding what constitutes research into human subjects. Certainly, clinical trials of medications or procedures would be considered human subject research, but the IRB procedure also extended to things like oral histories, surveys, and questionnaires up until recently, when oral histories were excluded (Ritchie & Shopes, 2003).

The regulations for these things are burdensome, and a large number of people want them changed. The main issue is the specific restrictions that are created by the IRB process, and how those regulations go "across the board" and encompass anything and everything that relate in any way to using a human being's information in a study. A literature review analysis does not require an IRB review (Part, 1991; Pope, 2009). However, if surveys or questionnaires are used that is a different story. Technically, the use of these items does mean...

The issue, though, is that these subjects are simply being asked their opinions and are not being used as subjects for the study itself. There must be a distinction made when it comes to using a person as a subject in a study and using a person's opinion as part of a survey that is compiled with other surveys in order to provide a researcher with quantitative information from which to draw conclusions.
Because there are vast differences in using someone for a medical experiment and asking them for information about their medical experiences, the IRB process raises concerns regarding ethics as well as necessity. Is there a need for IRB procedures when a researcher is only taking a survey or providing a questionnaire to be answered? More and more individuals in the medical and academic communities are saying no. This is especially true with social sciences, where people study other people's responses and reactions. That type of study is not focused on medical issues such as medication trials or procedures that can be done. By excluding social science work and research that did not actually use human subjects for anything other than their oral or written responses to questions, it would be much easier for researchers to conduct these types of studies (Ritchie & Shopes, 2003). It would also take less time for the studies to get approved and completed, potentially putting important research out to the public and to other researchers more quickly (Pope, 2009).

Ethically, there is a concern with IRBs. They are designed to ensure that human subjects are treated fairly and safely…