Choosing to volunteer for a research study is an important decision. There are risks and benefits to every study.  Being informed can help you make the decision that is best for you.  Before you decide to participate, you should understand the rights and protections you have as a volunteer.

The Research Code of Ethics

Researchers are trained in a code of ethics inspired in part by an important document called the Belmont Report. The Belmont Report was published in 1979, partly as a response to ethical mistakes in the Tuskegee Syphilis Trial.  It establishes 3 ethical principles for research involving human volunteers:

• Respect for persons: People should enter research voluntarily and with information!
• Beneficence: Do no harm, maximize benefits, and minimize risks to participants
• Justice: All persons should be treated equally, and research should not primarily benefit or burden people based on race, gender, ability to pay, or other factors.

All researchers must make sure that their studies are designed with these principles in mind.  Before a study even begins, it must pass very strict assessment by a committee called an Institutional Review Board (IRB). This committee can be made up of scientists, community members, and even faith leaders. The IRB makes sure that the rights of participants are protected by assessing all the plans and documents for the study. 

Learning from History

Throughout history, there have been many abuses and mistakes in medical research.  There are many cases where medical research was conducted at the expense of people in racial minority groups or in vulnerable groups like children, the poor, or prisoners. Today, many federal laws and international guidelines have been written to protect participants from these abuses and to make sure that research is conducted ethically, fairly, and respectfully.

Case Study: Henrietta Lacks

In 1951, Henrietta Lacks went to Johns Hopkins Hospital with a complaint of vaginal bleeding. Upon examination, the doctor discovered she had a malignant tumor on her cervix.  The cells from her biopsy were sent to Dr. George Gey’s lab, where he had been collecting cells from cervical cancer patients. To his surprise, these cells did not die like the other samples he had—but instead multiplied! These cells are still used today to study the effects of all kinds of drugs, therapies, and toxins on cancer cells and have played a crucial role in research.

What went wrong?

At the time that Henrietta Lacks sought treatment, there were no regulated practices for getting informed consent from patients.  She was not aware that her tissue would be taken and used for research. Researchers should have told Henrietta Lacks about their intentions with her tissue sample and made sure that she agreed.

Today, federal law requires that researchers obtain informed consent in order to use your samples for research. The Henrietta Lacks case raised important concerns about consent, privacy, and the responsibility of researchers to communicate with participants. 

Researchers at UNC are committed to earning the respect and trust of the local and global community. That means making sure that we inform you, the participant, about every part of the research process and your rights.  We work to protect your information and your privacy.  Learn more by reading our Participant Bill of Rights.