Thrive Research: Guidelines for Reducing Risk Levels

By / Posted on February 24th, 2012

There are different types of research, and some are riskier than others.  Take the study of new medications, for example.  While a medication is tested for safety before people are asked to participate in a study to see how well it works, there might still be unknown risks to taking it and it’s not certain that the medication will be effective.  Some other types of research are very low risk, including studies that learn new things by watching people and asking them about care practices – both of which describe the THRIVE study that is learning about Green House homes and different models of nursing home care. 

To keep risks as small as possible, all research studies must follow guidelines.  Even low risk studies where researchers are simply watching people and asking questions must follow guidelines.  To make sure that researchers follow the guidelines, every study must first be reviewed and approved by an Institutional Review Board (or IRB), sometimes referred to as an ethics committee. 

A few of the rules that must be followed include:

 

  • Respect for people participating in studies.  This means that people must be volunteers and not feel coerced, and must consent (often in writing) to participating.  There are special rules to protect people who have trouble making their own decisions (such as children or people with advanced dementia).  Respect for people participating in studies also includes protecting confidentiality.  For example, researchers aren’t allowed to tell anyone the identity of who participated in a study. 
  • Beneficence.  This fancy word means that there must be a possibility that the research will benefit society, and that it will not harm society or the people participating.  When there are risks to taking part in research, the potential benefits must outweigh the risks.  A good example of beneficence is when a new drug might have some risks and side effects, but might also have the potential to cure cancer, so might be worth the risk.
  • Justice.  Research should benefit as many people as possible.  This means that unless there is a good reason why some people can’t or shouldn’t be in a research study (such as a study about pregnancy which might justifiably exclude men), everyone should have the right to participate in, and possibly benefit from, research.

All research conducted by the THRIVE collaborative has been reviewed and approved by an IRB.  Approval for THRIVE has been pretty easy, as THRIVE is a low risk study. THRIVE is collecting information to learn about existing components of care and resident status, to understand specifically which types of care are better care. We expect to learn ways to improve care, which will benefit all of us.

Questions about THRIVE can be directed to Lauren Cohen (lauren_cohen@unc.edu or 919-843-8874).

The THRIVE research studies are funded by the Robert Wood Johnson Foundation.