top of page
4.png

HOW IS RESEARCH REGULATED?

Funding Organizations

It is expensive to conduct research, so there are large organizations which give money to researchers so that they can do research. Some of the largest funders include the National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), and the organization that funded this study—the Patient Centered Research Outcomes Institute (PCORI). Other funders include companies that make drugs and other medical devices.

When researchers apply for money, they must explain their plan for research. This includes: 

  • Research risks and benefits

  • Participants’ protection from harm

  • Recruitment goals

  • Language used to explain study to participants

 

Funding organizations will not give money to researchers who do not fully address these points. Also, money is not given to researchers until they have approval from their Institutional Review Board (IRB).

​

​Who is responsible for making sure researchers are acting ethically?

There are several ways that research is  monitored in the United States. Here are some of the  important groups of people who make sure researchers are ethical:

Data Safety and Monitoring Boards

In clinical trials  where researchers test a new medicine or vaccine, a Data Safety and Monitoring Board (DSMB) is required. A DSMB will review clinical trial data to determine if a new drug is working or causing serious harm to participants. You may have heard of studies that were stopped because researchers learned a drug or procedure was never going to work, or because they learned it worked so well that it would be unethical to continue to test it rather than giving it to people in need.  These decisions are made by DSMBs.

​

Institutional Review Board (IRB) Review and Approval

The most important supervision comes from a  group of experts called the IRB.

 

These experts review everything about the study, such as the reason for doing it, the people to be recruited, the study procedures, the ways that information is saved, the surveys or drugs that researchers will use, and researchers’ plans to care for participants. The researchers file paperwork for the IRB to review, and they cannot begin their work until they have full approval from this committee. The committee includes ethics experts as well as researchers and community members. All these people are involved in reviewing the study.

​

​

bottom of page