On-line or Internet Based Research

The incidence of on-line or Internet research has increased exponentially over the years, rapidly advancing ahead of efforts to create effective compliance guidelines. Internet communities (such as mailing lists, chat rooms, newsgroups, or discussion boards on websites) are rich sources of qualitative data for researchers. The IRB believes that online and Internet-based research protocols must address potential risks (e.g., violation of privacy, legal risks, and psychosocial stress) and provide the same level of protection as any other types of research involving human participants.

All studies, including those using computer and Internet technologies, must ensure that the procedures fulfill the principles of voluntary participation and informed consent, maintain the confidentiality of information obtained from or about human participants, and adequately address possible risks to participants including psychosocial stress and related risks. Participation by minors must be addressed in the protocol application.

The following guidelines are offered to help researchers plan, propose, and implement on-line or Internet research:

Recruitment:

Online and internet-based procedures for advertising and recruiting study participants (e.g., internet advertising, e-mail solicitation) must follow the IRB guidelines for recruitment that apply to any traditional media, such as newspapers and bulletin boards.

Data Collection:

It is strongly recommended that data collected from human participants over computer networks be transmitted in encrypted format. This helps insure that any data intercepted during transmission cannot be decoded and that individual responses cannot be traced back to an individual respondent. The highest level of data encryption should be employed, within the limits of availability and feasibility. Participants may be required to use a specific type or version of browser software.

Data Storage:

All personal identifying information should be kept separate from the data, and data should be stored in encrypted format. Researchers are advised to use pseudonyms when reporting results.

Observation of Internet activity:

This usually involves such activities as gathering information about the use of the Internet, recording user information or users’ comments. Examples include: participant observation of an on-line discussion group, using "cookies" to track web sites visited, or asking visitors to a web site to provide demographic information. The human subjects issues involved in this type of research generally involve consent/disclosure issues. Investigators need to indicate to the IRB how they intend to obtain the subjects' consent to use this information for research. As with other types of participant observation, investigators generally must disclose their role as researchers to the group participants.

Informed Consent:

For anonymous web-based surveys, participants would still need to be presented with the consent information and level of potential risk as a result of participating in the research, but would be informed that their consent is implied by submitting the completed survey. Other web-based surveys must include "I agree" or "I do not agree" buttons on the website for participants to click their choice of whether or not they consent to participate. A cover letter/consent page should indicate that by clicking on a "I agree" link, subjects are consenting to participate. This page should also include an e-mail address in addition to a telephone number to withdraw consent and remove data, to the extent possible, upon request of the respondent.

Click on the below to download:

Sample web-based survey cover page

E-mail solicitations requesting participation in a study should contain a version of the approved cover letter and consent forms. Participants must be informed that by replying to the e-mail and completing the requested task(s) constitutes consent.

With all of the above cases, researchers must request a Waiver of Written Informed Consent from the IRB, documenting how and why written consent would not be appropriate, and what format will be used to provide consent information to participants.

Confidentiality or Anonymity:

Researchers conducting web-based research should be careful not to make guarantees of confidentiality or anonymity, as the security of online transmissions is in question. Investigators need to address how they intend to assure confidentiality, keeping in mind that the degree of concern over confidentiality is directly related to the sensitivity of the data. Data transmitted via e-mail cannot be anonymous without the use of additional steps. Because respondents' electronic addresses are typically provided when they return such surveys by e-mail, PIs should devise a plan for stripping such information to maintain the confidentiality and anonymity of respondents' names.

The researcher should also state how the confidentiality of the data will be maintained, for instance, when a survey will be posted online through a third party like Survey Monkey or Zoomerang, so that email addresses or web URLs will not be noted by the researcher.

Data submitted over the web can only be anonymous if software is used to store the information directly in a database without identifiers; otherwise identifiers are attached to the data. Web servers automatically store a great deal of personal information about visitors to a web site and that information can be accessed by others.