Tutorial Chapter 14: How do researchers protect subject privacy and confidentiality?

Privacy

The issue of protecting a subject’s privacy begins with the recruitment process. The preferred method of recruitment is to disseminate information about the research study to potential subjects and to ask them to contact the investigator if they are interested in participating.

In the interest of respecting individual rights to privacy and confidentiality, it is better to set up these recruitment procedures so interested subjects can identify themselves to investigators rather than investigators obtaining names and addresses from third parties and soliciting participation directly from individuals. Thus names and addresses should not be requested from referral sources unless permission has been given in writing by potential subjects to release their names.

A note of caution: researchers should avoid using their own patients or students as subjects due to the nature of the existing relationship and the unavoidable potential for coercion.

At times, the very fact that a subject is contacted to be in a research project can lead to disclosure of personal information. For example, a reasonable conclusion could be drawn about the health status of a person recruited to participate in a study of potential cures for HIV.

With the advent of computerized medical databases, the potential for invasion of privacy has grown. Having access to medical records does not mean that researchers have the right to use these records for their own purposes. Most hospitals have explicit policies governing the use of computerized records for research purposes. In addition, effective April 14, 2003, most health information in research is now governed by the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) which further restricts the release of medical records.

If the research involves disclosure of sensitive topics (for example, HIV+, drug use, or immigration status) and the data will not be fully anonymous, researchers should consider applying to the US Department of Health and Human Services for a Certificate of Confidentiality which will protect the data from subpoena.

An important piece of relevant Federal legislation that has helped foster individual privacy in a research context is FERPA: The Family Educational Rights and Privacy Act of 1974 (popularly Known as the Buckley Amendment to the General Education Provisions Act) which requires parental permission for access to records or identifiable information of children in public schools. FERPA also prohibits federal agencies from disclosing records without the prior written consent of the person to whom the record pertains.

Confidentiality

Once data have been obtained, researchers are responsible for protecting the subjects’ confidentiality. Identifiers should be removed from data collected as soon as possible and replaced with an anonymous study number.

If identifiers are needed to correlate with follow-up studies, procedures for secure storage and a policy for protecting links between subjects' names and codes and eventual data disposition should be developed.

Confidentiality should also be protected in publications or presentations. Generally, this is accomplished by using aggregate rather than individual data.

If this is not suitable or possible, then subjects should be informed, in both the description of the research and in the consent form, about the lack of confidentiality. If direct quotes are to be used, or audio- or videotapes displayed, specific permission should be incorporated into the consent form through inclusion of an attribution statement.

One common error is to confuse the terms “confidentiality” and “anonymity.”

Questionnaires and surveys containing no identifiers and which are not returned personally and individually by the subject to the researcher generate anonymous data. Data cannot be fully anonymous if the investigator knows the identity of the subject and can match the response to the individual.

These data can only be kept confidential. For example, in most cases subjects who are interviewed individually by the researcher can only be promised that the information collected from them will be kept confidential because the researcher is likely to know their names or would be able to recognize their faces and has recorded their responses.

Further limitations on the guarantee of confidentiality occur when:

• subjects participate in group interviews or focus groups since the researcher cannot guarantee that other members of a group will maintain confidentiality;
• researchers who are mandated reporters are working under circumstances in which they might learn of and need to report to appropriate authorities suspicion of harm to the subject, to children, or to others.

These limitations must be made clear to potential participants in both the recruitment and consent process.

Chapter Review

Question 1

Concerns with privacy begin with the recruitment and selection of subjects.

• True
• False

Question 2

A person with access to medical records through their employment or internship may carry out a study using those records without anyone's approval.

• True
• False

Question 3

There are no circumstances under which the names of potential subjects may be revealed to third parties.

• True
• False

Question 4

Confidentiality may be protected by:

• coding data
• storing data in a secure place
• obtaining a Certificate of Confidentiality
• any of the above

Question 5

Data are anonymous if:

• the researcher does not reveal subjects' names
• names are never known to the researcher
• names are locked in a file

Next Chapter: What are researchers’ obligations when cooperating institutions are involved?