Internet-Based Human Subjects Research

Computer and internet-based research protocols must address the same risks (e.g., violation of privacy, legal risks, and psychosocial stress) and provide the same level of protection as 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.
- Adequately address possible risks to participants.
Recruitment
One-way ads that do not involve direct communication with potential subjects (i.e. paid Facebook Ads), are reviewed according to existing IRB review policies. See IRBNET Library: Appendix 1a_ Basic Protocol Format and Reference 7 - Recruitment Flyer Template V.2.doc.
Recruitment material should include:
- Principal Investigator's contact information.
- Purpose of research.
- Inclusion/exclusion criteria in summary form.
- A brief list of procedures involved.
- Details on how to enroll, including time as well as other required commitments (number of visits, total duration during follow-up visits, etc.).
- Location of research and contact person for further information.
Database Storage and Disposal Recommendations

Informed Consent in Internet-Based Research
Electronic Data Collection
Research involving the collection of data about people from medical records, through social media or networking sites involves the same considerations as any other research with human participants.
These considerations include:
- Determining an appropriate and effective informed consent process;
- Assuring that participation is voluntary;
- Protecting privacy and confidentiality of individuals and the data collected;
- Minimizing risks and maximizing benefits; and
- Assuring equitable selection of participants.
However, with the dynamic and evolving nature of norms and technologies in social media use, translating these principles into real practice can be challenging.
On-line research id different geographical areas adds an additional level of complexity (researcher located in one area, participants in another (or multiple locations) and the data is stored in another location.
COPPA regulations
Researchers should take steps to authenticate online research participants.
All surveys conducted at Florida Atlantic should preferably be conducted using Qualtrics or REDCap. If researchers are interested in using other survey software OIT should review the software data security and purchasing process to assure they are following the appropriate university channels.
The Florida Atlantic - HIPAA website provides information and guidance on the policies, procedures and forms related to HIPAA compliance at Florida Atlantic: www.fau.edu/hipaa/
Encryption: strongly recommended for PHI data.
When to use Qualtrics or Redcap?

Florida Atlantic now maintains a license for Qualtrics to conduct online surveys. All administrators, faculty, staff, and students have access to use the software using their Florida Atlantic Net ID and password. All surveys conducted at Florida Atlantic should now be conducted using Qualtrics at the site below. Qualtrics is a very common tool to conduct surveys, but is less secure. It CANNOT be used to collect PHI.
Surveys conducted at Florida Atlantic require the approval of a dean or vice president, with certain limited exceptions. In addition, the survey will also need approval of the university's survey research committee, led by the Assistant Vice Provost for Institutional Effectiveness & Analysis. Requests for such approval can be submitted to the committee by submitting a ticket using the Submit a Request button.
Surveys must also comply with the university policy on the administration of surveys and questionnaires.
If you have any questions related to creating a Qualtrics account and using this site please contact John Cahill at jcahill@fau.edu or by phone at 561-297-0244.
Source: helpdesk.fau.edu

REDCap is a secure Research Electronic Data Capture service provided by the Office of Information Technology (OIT). Sponsored by the Division of Research, REDCap provides electronic data capture services to researchers, faculty, employees and students. REDCap is the choice recommended for electronic capture of PHI. Redcap is less common, but it is the secure alternative to collect PHI.
Studies requiring IRB approval will typically need to submit data collection instrumentation as part of the approval process. Florida Atlantic – Office of Information Technology encourages users planning on using REDCap to design their instruments prior to requesting IRB approval as instrumentation changes typically do require re-authorization.
If a study meets the requirements for IRB review and approval such approval must be granted prior to the research project being published in REDCap. It is the responsibility to the researcher to obtain any and all approvals.
For more information about RedCap visit here.