Building Trust
in Medical Research
Why is there distrust of medical research?
You may have heard stories about people who were part of a medical experiment without knowing it. Some examples include the Tuskegee syphilis study and Puerto Rican birth control study.
When these unethical experiments were revealed, many people demanded change. New laws and rules were put in place to protect patients in the future. Drug makers and other companies in the healthcare industry also took ownership in making ethical changes.
Learn about the history of medical mistrust among people of color and how we plan to educate and include diverse communities to rebuild trust in clinical trials.
Today’s research studies have a strict informed consent process to protect participants in clinical research. More importantly, in today's research, we have a more diverse group of researchers than anytime in medical history.
It can be challenging to find accurate information in today's environment and misinformation is everywhere. Accurate information about medical research is available through the Research Includes Me website and other organizations such as:
- The US National Institutes of Health
- The US National Cancer Institute
- The US National Library of Medicine
- The World Health Organization
Who is looking out for me as I participate in a clinical trial?
There are many people involved in making sure medical research is conducted with the health and safety of participants in mind.
Study Sponsor
The company sponsoring the research study, which is often a pharmaceutical company.
Regulatory
Agency
Regulatory Agency
An agency in every country sets requirements for medical research, and then reviews and approves the protocol that dictates what participants will go through.
Examples are:
- United States: Food and Drug Administration (FDA)
- European Union: European Medicines Agency (EMA)
- Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Institutional
Review Board
Institutional Review Board
A dedicated group of people, separate from the FDA and study sponsor, review and approve the research plan. They also make sure any information provided to participants is correct, complete, and understandable.
Study Team
These are the doctors, nurses, and other staff who participate in a research study. The study team may work with a Community Advisory Board that is made up of people whose backgrounds and cultures are similar to those of the community where the study takes place.
Your Doctor
Your doctor or trusted medical professional who can help you understand a research study and decide if joining is a good idea for you.
How can I be sure my privacy is protected?
In a research study, your identity and any medical information collected is confidential. It is only available to the people and organizations involved in the trial.
For example, before any lab tests can be done on samples taken from your body (like blood or urine), you must be told about it and asked for your permission. Even if you give permission, you can change your mind at any time, for any reason. The samples and data obtained from them are protected and can only be used for research purposes. There are laws in place to prevent it from being shared for other purposes.
Why should I join?
Over the years, we have learned how important it is to have diverse representation in medical research. Research studies need to represent our society in terms of sex, age, race, ethnicity, culture, medical conditions, gender identity, socioeconomic status, environment, disability, and pregnancy or breastfeeding. Including many different types of people and cultures helps researchers to understand how effective and safe a study medicine or treatment is for those who need it.
No matter who or where you are, there may be an opportunity for you to help improve medical care for people like you!
Learn more about the importance of diversity in clinical trials from Dr. Cato T. Laurencin, MD, PhD.
Where do I start?
To see if there are research studies you can participate in, or just to learn more, you can:
Search for available studies on your own. One place to start is ClinicalTrials.gov, which lists research studies that are being done all over the world.
Talk to your doctor. If you are interested in a specific research study, your doctor can reach out to the doctor involved in the study. Your doctor can also search for studies that might be right for you.
Call the hotline or visit the website listed on a research study poster or brochure in your doctor’s office or hospital.
Download the Clinical Trial Fact Sheet to help you get started on your path to learning more about clinical trials!
