Research using the Internet has unique characteristics that are not directly addressed by the Federal regulations. Currently, the Internet is used primarily for two research activities – recruitment of participants and survey administration. Most human participants protection issues that arise in conducting research activities on the Internet concern privacy/confidentiality and true informed consent. The ability to consent is difficult to ascertain over the Internet. Generally, this ability is related to age, but may be relevant to other vulnerable populations (e.g., decision ally impaired, incarcerated). Also, email-based activities are far less secure than website-based activities. Software exists to enhance the privacy of both types of activities. The University strongly recommends that researchers work with a vendor that specializes in Internet-based research to minimize risks in these areas.
Internet-based studies may not include minors as participants unless the IRB waives written parental permission and informed consent.
- email addresses of the investigator and IRB Chairperson;
- no claim about the superiority, safety, or effectiveness of procedures, interventions, devices, or any other materials used in research;
- a description of the process for completing the on-line research activity;
- information on subsequent contacts that will be made if the individual agrees to participate;
- no promise of anonymity and why;
- information regarding procedures for protection of information that the subject provides over the Internet;
- a statement that there will be no future email contacts or an opt-out message that permits individuals to have their names removed from any future mailings. If future contacts are planned, the information must state the number and frequency of such contacts;
- instructions to delete the email message that originated the contact
After reading information about the study, the individual must be required click a button either to indicate his or her wish to continue or to leave the site and opt out of participation. After clicking the button, the subject will be taken via a link to the study task. If the individual opts out, clicking the button will exit the site.
Generally, Internet-based surveys do not require written documentation of consent. If the IRB does require such documentation, the following additional procedures must be used:
- The “agree to participate” button must contain a message, or there must be a separate statement right above the button, that indicates that clicking the button means the subject has read the statement, printed a copy for his or her files, and agrees to participate in the study or be considered for recruitment for the study and accepts that personal information will be electronically supplied to the researcher to document his or her participation (such as name, e-mail name, and date).
- There must be a mechanism by which information is returned to the researcher that identifies the person who is participating. This documentation must be kept by the researcher for at least three years beyond the end of the study.
The following apply to all types of study materials:
- Individuals must be able to easily print a readable copy of information about the study and the informed consent documentation (if required) for their own records.
- The printed version of all information must carry the approval date and the date approval expires for the study as determined by the IRB.
- The IRB must be able to access the document on-line before approval will be given.