Research Volunteers - Privacy Issues
Make Sure Research Studies Protect Privacy and Confidentiality
Feb 15, 2009
The following article is the third in a series on understanding your rights as a U.S. research volunteer such as the right to privacy, confidentiality, and proper informed consent. The focus of this article is on privacy and confidentiality. Medical researchers are always looking for the right fit between their study and would-be volunteers. As discussed in a previous article on research rights, some research studies pay well to attract volunteers. Should you find yourself signing up for a study, good communication of risks in a research study is essential. People should volunteer for research because it can be good for science, but study volunteers should also be mindful of the basic right to privacy and confidentiality.
Basic Principles
Research has always been conducted under the principle of "do no harm", so the right to privacy and confidentiality is common practice in the research arena. U.S. Federal law (45 CFR 46) also requires privacy during the conduct of a study. The law requires an Institutional Review Board (IRB) to make sure the study has both a built in privacy procedure, and a plan for keeping the information confidential after the study team obtains the information. If these basic procedures are not described in the consent form, then the study volunteer should ask why before signing it. If the consent form does not have any information about privacy, then the form was probably not approved.
Privacy
A privacy protection in this context could mean when a study volunteer visits the study site, the research team has done, and will do, everything to make sure the volunteer's information is invisible to people who do not need to see it. The team should pay close attention to the conditions under which information is released so names and information are kept hidden and quiet to passersby. Research teams sometimes take care of this requirement by asking the volunteers to sign names on little white file folder labels. The study team member removes the label so the next volunteer will be unable to see the name of the previous participant. Research volunteers should understand their specific rights to privacy and should expect it in a research setting.
Confidentiality
Confidentiality in this context could mean the research team has done everything to keep the study volunteer's data hidden after the volunteer leaves the site. Many research teams maintain locked rooms with locked cabinets to store data about their subjects. To extend this protection, only a limited number of keys are distributed, so the files are inaccessible to unauthorized people. Study volunteers are advised to ask about these confidentiality plans to gain an informed stance about participation. After someone takes information from a research participant, then the taker of that information has an obligation to keep it safe and confidential.
U.S. Privacy Rule and Research
The U.S. Privacy rule, known as HIPAA, contains many detailed provisions for privacy. The research portion of HIPAA requires a study volunteer to authorize, in writing, the use of any personal information before it is used. Also, the HIPAA rule dictates very specific rules that researchers must follow in order to protect privacy such as listing the data, the confidentiality and privacy plans, and a time period for keeping the data. Even though the paperwork may be cumbersome the day of the study, a study volunteer should always read every scrap of information concerning privacy, especially HIPAA. The authorization is a key element in the study subject's right to allow or disallow their information to be used. U.S. Hospitals under HIPAA are supposed to give all visitors what is called a "Notice of Privacy Practice" or NPP. In most cases, the NPP is not a substitute for privacy authorizations in research. The best thing to do is ask.
Finally, privacy is the study volunteer's absolute right. Participants in research studies should exercise their right to keep information private. It is okay to ask the study team members if specific information is essential to complete the study. If you are not comfortable providing information in a study, then you have the right to refuse to give it. Work with the study site personnel to make sure you provide what they need to complete their study and still maintain your privacy and confidentiality.
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