November 2006

Increased use of the Internet for conducting research (both biomedical and behavioral) presents new challenges and concerns for protecting human subjects.

What are the concerns related to subjects participating in Internet research activities?

One concern specific to Internet usage is the risk related to exposure to certain questions. Although most Internet research is relatively harmless, certain types of questions may illicit an adverse reaction. Since there is usually no contact with participants, it is not likely that the researcher would know about an adverse reaction, much less the extent of the reaction. Generally it is not possible to provide debriefing to participants and if provided, it is difficult to know whether participants accessed the information. Because of these issues, collection of sensitive information may not be appropriate.

Another concern with Internet research is with privacy and confidentiality. Privacy issues include if the activity identifies the participant, and whether the activity is considered private or public. Many Internet activities involve the use of a pseudonym. However, this does not mean the individual is anonymous. Additionally, although most online activity is considered “public”, federal regulations define private information as an individuals’ “reasonable expectation of privacy.” For example, although a chat room may be publicly available, it is not usually expected that conversations in a chat room would be monitored by an investigator and used for research purposes.

Breach of confidentiality is another potential risk to individuals participating in Internet research. Although anonymity is the most protective measure, anonymity is not easy to achieve. For example, data transmitted via email cannot be anonymous without additional steps, as email usually contains the sender’s email address. Investigators wanting to use email as a mode of data transmission must provide an additional third step-- a site that removes the sender’s email address. Anonymity can also be achieved if software is used to store the information in a database that does not include identifiers and/or items that might identify the participant.

Is electronic informed consent possible?

Another issue of concern to Investigators is that of informed consent and documentation of informed consent. Although obtaining informed consent can be achieved through the Internet, documentation of consent can be troublesome since the technology for digital signatures is not yet widely available. One mechanism for obtaining voluntary consent is to present the participant with the required information and then ask them to click on an “I agree” button. This would satisfy the requirements for minimal risk research. Documentation of consent is more problematic. However, not all research needs documentation of informed consent and the IRB can waive this requirement when the research meets waiver requirements. When documentation of consent is required, the participant can sign a downloadable consent form and submit the signed consent to the Investigator. Once received, the investigator can send the participant a password to gain access to the on-line research project.

Use of the Internet is becoming a commonly accepted practice among researchers. Although a challenge, researchers can provide protection to participants while at the same time increase efficiency and gain access to greater numbers of potential participants.

*J. M. Cohen. (2006). Internet research: A brief guide for institutional review boards. In E. A. Bankert and R. J. Amdur (Eds.), Institutional Review Board Management and Function (pp. 394-396). Sudbury, MA: Jones and Bartlett.