The Least You Need to Know About Rules Governing Human Subjects Research

1) Research involving human subjects is regulated in the United States by the Federal  Government. The regulations were imposed primarily in response to a variety of abuses by  researchers and are intended to protect human subjects.  

The history of human subjects research and regulation is long, but the single most important  document for researchers in the United States is The Belmont Report: Ethical Principles and  Guidelines for the Protection of Human Subjects of Research. You can find it at  http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. It’s short and you should read it.  

The Belmont Report identifies three fundamental moral principles that are particularly relevant  to human subjects research.  

A. Respect for persons. This principle requires researchers to (a) honor their subjects’ right  to make their own decisions – their autonomy – and (b) to protect potential subjects who  have a diminished ability to make important decisions.  

B. Beneficence. Beneficence requires researchers to avoid harming human subjects, and that  studies should maximize possible benefits and minimize possible harms to individual  subjects as well as society at large.  

C. Justice. The principle of justice means that the risks and benefits should be spread  equitably across society. It is unfair, for example, if the burden of research is carried by  poor people when everyone, rich and poor, can benefit from the results.  

2) All human subjects research is overseen by the IUB Human Subject Office and must be  reviewed by the IUB Institutional Review Board (IRB).  

A. What counts as human subjects research?  

i. A human subject is any individual about whom a researcher obtains data through  intervention or interaction or identifiable private information. “Intervention and  interaction” can take the form of talking to an individual, studying existing data on an  individual, observing an individual, communicating with an individual via the  Internet, and obtaining data about an individual via a number of other kinds of  interactions.  

ii. Research is defined by the Department of Health and Human Services as “a  systematic investigation, including research development testing and evaluation,  designed to develop or contribute to generalizable knowledge” (45 CFR 46).  

The Least You Need to Know 2  

If you begin a project with the intention of publishing the results, it is almost always  regarded as “research” under this definition. “Publication” is here construed broadly  and includes, e.g., oral presentation at a professional conference.  

B. What is a review? Research projects are reviewed at one of three levels, depending  mostly on the level of potential risk to the human subjects. The categories are:  

i. Exempt – You might think that if a study is “exempt,” it wouldn’t need to be  reviewed. Don’t blame the IRB for stupid terminology; blame the Federal  Government. Think of “exempt review” as “exempt from continuing review.” Exempt  studies require less oversight, do not require an informed consent document, can be  approved relatively quickly, and do not require continuing review. Most qualitative  research qualifies as exempt, but some does not. Note that the IRB, not the researcher,  determines whether a study is exempt. The paperwork for exempt review is less  burdensome than for expedited or full review, but you still have to do the paperwork.  

ii. Expedited – Expedited studies are reviewed frequently by a subset of IRB members  and require more paperwork than exempt research but less than studies that require  full review. Requires continuing review (typically annually).  

iii. Full – Studies requiring full review (as determined by the IRB) are reviewed monthly  by the full board. Requires continuing review (typically annually).  

Needless to say, if you don’t follow the rules, you can get in trouble. For example, if you don’t  follow the rules for your dissertation research, you might not get a degree. But you should also  realize that failure to follow the regulations can have bad results for many other people. In the  

last few years, more than a dozen universities have had all of their human subjects research  suspended by the Federal Government due to violations by a few researchers. You wouldn’t  want to be the cause of that, would you?  

3) You cannot start gathering data until you have received approval from the IRB. No  exceptions. This means you have to budget enough time for an IRB review.  

4) The IRB review process is primarily intended to protect human subjects, but an unintended  consequence is that it forces researchers to think carefully about the moral and logistical  dimensions of their research before they start collecting data. Reviewers often provide helpful  advice on improving research.  

5) The IUB IRB can be reached at  <<Enter your own instituiton's IRB URL>>

The people at the IUB IRB are friendly and helpful. They want to make the review process as  painless as possible. Don’t hesitate to ask them for advice.  

6) A good way to learn more than the least you need to know is to read “Protection of Human  Subjects in Research” or “Protection of Human Subjects in Non-Biomedical Research,”