Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-9

Title 9:

Use of the Internet for Recruitment and/or Research Data Collection

Effective Date:

06-21-06

Revision History:

12-06-04

Objective

To describe the issues involved in using the Internet for research purposes, including recruitment and research data collection.

Description

The Internet is now widely used for both the recruitment of research subjects and research data collection (i.e. electronic surveys and/or questionnaires). Both uses present unique issues to the investigator and to the IRB.

  1. Recruitment Using the Internet:

    Direct advertising for study subjects is the start of the informed consent and subject selection process and must have prior IRB review and approval. Unlike print media or television/radio media, which is passive, recruitment involving the Internet can be passive or active.

    Passive electronic recruitment involves advertisements that are simply electronic versions of printed media advertisements, residing on a website or functioning as a pop-up window ad when visiting a particular web site. These advertisements must be reviewed and approved by the IRB. A mock-up of the Internet advertisement may be presented to the IRB for review and comment, prior to incurring programming costs to actually produce the advertisement. Once the IRB notes that the mock-up is ‘approvable’ and the final Internet ad is produced, the IRB must review and issue final approval on that Internet ad (while it is still hosted on a dummy or inactive website) prior to going ‘live’. For more specific information about recruitment and the review of advertisements, including statements to avoid and information to include, please see VCU IRB WPP XVII-2 Subject Recruitment and Compensation.

    Recruitment tools that use email or other electronic solicitations (such as instant messaging or text messaging) to reach ‘potential’ research subjects are examples of Active electronic recruitment methods. This type of method requires that any list of email addresses gathered be obtained from public sources or with documented permission of the list owner. The following guidelines pertain to these recruitment methods:

    1. Electronic invitations (by email, instant messaging, or text messaging) must allow for the recipient to ‘opt out’ of any future contact regarding the research project simply by the click of a button and/or typing in the email address/text or instant address. The recipient must not be asked for a reason or for their name or other contact information. It is reasonable and prudent to inform anyone using the ‘opt out’ feature of the approximate time that it will take for contact to the terminated.
    2. Electronic invitations that allow the recipient to open a website (by hyperlink or other) must be presented to the IRB will the full text illustration of the website and it’s functions (additional hyperlinks, audio, video, etc.). All hyperlinks must be approved/accepted by the IRB.
    3. Electronic invitations that allow the recipient to complete the informed consent process (as approved by the IRB) and proceed to any research data collection tools (such as surveys or other data collection instruments, as approved by the IRB) must include technology to ensure that the research subject is not contacted again with the request to participate.
    4. Other general concerns that the IRB may address:
      1. Recipients of electronic invitations to research (depending upon the nature of the research) may need to be informed of how their electronic address was obtained and any permission obtained prior to the contact.
      2. If the research involves a sensitive subject or issues of confidentiality, the use of an email address, or other electronic address, may be denied by the IRB due to risks of privacy and confidentiality.
      3. If electronic recruitment is the only method of recruitment used, could the equitability of subject selection be a concern?

    It is important to note that while printed media advertisements are not interactive, electronic advertisements may have this functionality. In the case of an interactive advertisement, care should be taken to diagram the interaction (including buttons that may be selected for more information and windows that will allow for additional information to be presented to the viewer of the advertisement). As a reminder, all information that can be directly linked from the electronic advertisement must be approved by the IRB. Care should be taken to present all hyper linked sites to the IRB with the advertisement. Certain hyper linked sites may contain information that is not related to the research (such as a link to the current weather statistics, etc.). Investigators are advised to INCLUDE information about these hyperlinks as well, even though the information is seemingly not part of the recruitment process.

  2. Research Data Collection Using the Internet:

    Research data collection using the Internet may also be conducted using passive or active methods.

    1. Passive Data Collection: Data mining, sorting through data to identify patterns and establish relationships, is a term that does not necessarily pertain only to Internet research; however, research involving the observation and reporting of on-line behavior is sometimes called data mining. When the research involves the passive observation of online behavior, the IRB will take every effort to ensure the protection of human subjects who participate in on-line communities (such as cancer support groups, etc.) and do not intend or agree (in advance) for their on-line discussions to be used for research purposes. The IRB provides the following guidance to investigators planning to observe and report on online behavior:
      1. Just because a researcher comes across a support group's conversation online doesn't give him the automatic right to conduct research on that conversation. Technology alone (access) cannot be used as a legitimate justification for use of the information as if it were intended to be public.
      2. As most on-line groups allow persons to join and not participate, the investigator should not attempt to justify not obtaining permission because of concern that the investigator’s presence will affect the behavior. Permissions must be obtained from the list/group/community manager, and an announcement should be made to the list/group/community that an observation is taking place for research purposes, (after IRB approval and PRIOR to collecting ANY research data).
      3. Informed consent/permissions will not be waived by the IRB due to concerns that permissions would not be granted by the community. However, it may be appropriate for the investigator to request a waiver of signed/documented informed consent may be requested.
      4. Procedures must be in place to verify that research participants are adults.
      5. If the community disclosed to the members that the on-line forum or discussion group may be part of a research project, the IRB may still require additional permissions and/or informed consent (depending on the sensitivity of the research/discussion, clarity of such prior disclosure, and confidentiality/anonymity of subjects.
    2. Active Data Collection: A second form of Internet research involves active data collection via direct email, web surveys, or other electronic instruments. The Internet is a non secured medium, as data in transit is vulnerable. Therefore, Internet data collection is rarely private, anonymous, or even confidential. The potential source of risk is harm resulting from breach of confidentiality and is accentuated if the research involves data that places subjects at risk of criminal or civil liability or could damage their financial standing, employability, insurability, or reputation. The IRB has provided the following guidance and procedures for research that involves Internet data collection:
      1. An Internet consent document should be written like a cover letter and should include all the elements of a regular signed consent, as appropriate. The consent line should say, “By completing the survey, you are agreeing to participate in the research.” Web based surveys should allow for a click button to agree or not agree. Online consent may not be appropriate for studies involving highly sensitive information.
      2. There are various protocols for transmitting data securely over the Internet (Secure Sockets Layer or SSL connections and Secure HTTP or S-HTTP). Both SSL and S-HTTP can work independently or together. The investigator must describe the technology chosen for implementation of the research and justify the plan in based upon the sensitivity of the research.
      3. For sensitive data transmissions, the investigator should use a disclosure in the consent process, such as: “This research involves the transmission of data over the internet. Although every reasonable effort has been taken to ensure the effective use of available technology, confidentiality during the actual Internet communication procedure cannot be guaranteed.”
      4. An alternative means for completing the survey should be offered where appropriate (such as printing the survey and mailing it in).
      5. Survey instruments should be designed in such as way that allows participants to skip questions or provide a response such as “I choose not to answer.”
      6. At the end of a survey, there should be one button to submit the data and another button to discard the data. The purpose of these buttons is to ensure that a subject may withdraw at any time and to help them understand that if they do withdraw, even after completing the survey, their data can be discarded prior to transmission to the researcher.
  3. Additional Considerations:
    1. As compensation for participants, consider using gift certificates from online retailers (and displaying the unique certificate redemption number to subjects after they complete the survey), in lieu of requiring identifiable information in order to mail out compensation.
    2. Investigators working with children online are subject to the Children’s Online Privacy Protection Act (COPPA) [http://www.ftc.gov/ogc/coppa1.htm] in addition to human subject regulations. Investigators must not collect personal information from a minor without verifiable parental consent.
    3. As appropriate, technology may be used to help screen out minors, such as software that checks for Internet Monitoring software or Adult Check systems.

Responsibility

It is the responsibility of the investigator to ensure that these guidelines are followed as the research is planned and the responsibility of the IRB to ensure their enforcement in the review of the research.

References

John M. Grohol, Psy.D. (August 5, 2003 Internet Publication): Dr. Grohol's Psych Central - When is it Ethical to Research Online? Date Accessed: November 2, 2004.

Federal Trade Commission Children's Online Privacy Protection Act of 1998 Title XIII – Children’s Online Privacy Protection Date Accessed: November 2, 2004.

VCU IRB WPP XVII-2 Subject Recruitment and Compensation