As technology increases the World Wide Web has become a potential way to recruit participants. Although websites use a different medium than traditional print or broadcast advertisements to recruit participants, the requirements remain the same. When information posted on a clinical trial website goes beyond directory listings with basic descriptive information it becomes part of the informed consent process and requires IRB review and approval.

The Office of Human Research Protections (OHRP) has issued guidance to institutional review boards (IRBs) for reviewing information provided on clinical trial websites, please visit http://www.hhs.gov/ohrp/policy/clinicaltrials.html for specific details.

When is IRB Review of Clinical Trial Websites Not Required?

If the website only includes the following basic descriptive information:

- study title
- purpose of the study
- protocol summary
- basic eligibility criteria
- study site location(s), and
- how to contact the study site for further information.

Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) ClinicalTrials.gov website, the NIH National Cancer Institute’s cancer clinical trials listing (Physician Data Query [PDQ]), and the government-sponsored AIDS Clinical Trials Information Service (ACTIS).

When is IRB Review of Clinical Trial Websites Required?

If a clinical trial website has information that exceeds the basic descriptive information listed above it is considered part of the informed consent process and falls under the Wayne State University Human Investigation Committee (HIC) policy Advertising for Research Participants (http://www.hic.wayne.edu/hicpol/advertis.htm).

Websites/advertisements to recruit participants should be limited to the information the prospective participants need to determine their eligibility and interest. Websites should include the following:

- study title
- study site location(s),
- the name of the investigator
- purpose of the study
- protocol summary
- basic eligibility criteria
- potential risks/benefits
- time or other commitment
- compensation (if applicable)
- solicitation of identifiable information (if applicable)
- how to contact the study site for further information

The HIC requires a final copy of printed website to evaluate the content, relative size of type used, and graphics.

The information presented in the website should not imply a certainty of favorable outcome or benefits beyond what is outlined in the informed consent and protocol. No claims should be made that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. The terms “new treatment”, “new medication” or “new drug” should not be used without explaining that the test article is investigational.

Monetary and non-monetary incentives (e.g., access to services or programs) can create undue influence on a potential participant’s decision about research participation. Websites may state that the participants will be paid, but should not emphasize the payment or the amount to be paid.

Informed consent must be obtained for the collection of any information about the respondent unless the IRB has determined that the informed consent requirement can be waived.

IRB Guidance

As with the review of all recruitment materials, IRBs should pay particular attention to risk and potential benefit information to ensure it is presented in a balanced and fair manner. The information presented should not mislead, for example, by promising benefits or implying a benefit beyond that potentially provided by the research.

IRBs reviewing clinical trial websites also should assess the types of incentives, if any, are being offered to prospective participants. IRBs must ensure that the clinical trial website makes clear that participation in a trial is voluntary, and that incentives for participation are not so great that they compromise a prospective participant’s assessment of the risks or affect the voluntariness of his or her choices.

Some clinical trial websites ask viewers to answer questions regarding eligibility for a specific clinical trial. If identifiable private information is collected via the clinical trial website, the IRB should review plans for protecting the confidentiality of that information. The IRB should ensure that the website clearly explains how identifiable private information might be used

The HIC adheres to their policy for advertising and will review the final copy of printed website/advertisements to evaluate the content, relative size of type used, and graphics. Any changes to design or content of the website must be submitted to the HIC as amendment. If a clinical investigator wishes to use a website as a source of study recruitment after a study has received IRB approval, an amendment must be filed.

If you have further questions you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu.

–Patti Webber, HIC