Investigators & Research Staff

Announcements

Mandatory Clinical Trials Registration Information FDA/ICMJE

Effective March 7, 2012, the FDA has mandated the following language in all consent documents for Phase II or III controlled clinical trials with FDA oversight, or controlled trials with health outcomes of an FDA regulated device:

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

The HIC has incorporated this language into our informed consent and compound authorization templates, available on the forms page, available on the forms page.

Please also note: Registration of clinical trials is now also a requirement of ICMJE for manuscripts submitted to biomedical journals.

(For more information on registering clinical trials, including whether your trial must be registered, see the YCCI webpage, see the YCCI webpage or contact YCCI at 203.785.3482)

Effective January 18, 2012, the HRPP has revised our procedure for Certificates of Confidentiality. Revisions to the procedure, found here, include the following:

• We added the CDC as a possible source for CoCs in the “Application to the US Dept of Health…” section.
• We revamped the procedure to add the IRB approval section. This section includes major changes:
• The Committee may decide not to approve a study until the CoC has been obtained.
• If the study is approved and a CoC is to be applied for, the IRB will check with the PI after 2 months. If no application has been made, the PI will be considered non-compliant and will be referred to the Compliance Manager.
• For current studies, if no CoC is in place at renewal, the IRB will either defer renewal (and all activity must stop) or the renewal period will be shortened, pending receipt of the CoC.
• In the “Informing Subjects” section, two changes:
• When the CoC has been received, the PI does not need to inform subjects who are no longer enrolled in the study.
• If the study will begin before the CoC has been obtained, the proper language for the consent form has been changed to, “ We will apply for”, rather than “We have applied for”, to more accurately inform subjects.

HIC Signatures and Approval Marks:

Please note that some documents reviewed and approved by the Yale IRBs will no longer be signed by the IRB reviewer and/or stamped with approval marks. Sophisticated role based security within the eIRB system permits only duly authorized individuals to generate IRB approvals. The authenticity of the IRB approver is based on his/her role and individual identification and password. Dates of review and approval are “date stamped” and archived, thereby negating the need for hand stamping or signing of documents. These changes apply to protocol submissions sent to the IRB either electronically or via paper and are effective March 18, 2011.

Documents reviewed by the IRB that will continue to have approval notations and validation dates applied include:

• Consent, Assent, Permission and Compound Authorization Forms, Information Sheets
• Other documents used for or to ensure continuing informed consent such as addenda or letters from clinician/researchers explaining new risks
• Yale IRB Application Forms/Protocols

Documents that will no longer be signed or receiving approval notations include:

• IRB Letters of approval, acknowledgement or those requesting revisions
• Reapproval/Request for Continuing Review Forms
• Requests to close a study
• Recruitment advertisements and flyers
• Amendment Request forms
• Research Authorization or Other HIPAA Forms
• Sponsor Protocols
• Questionnaires/assessments

Yale University investigators and research staff are responsible for ensuring that research is designed and conducted ethically and with integrity. Their distinctive roles in the performance of research position them as gatekeepers for ensuring that the rights and interests of Yale’s research volunteers are protected and upheld.

To fulfill these unique responsibilities, investigators and research staff must understand the underlying concepts and principles of human research protection; providing benefit and minimizing risk of harm, respect for persons and equitable recruitment. Investigators and research staff should use the information and tools located in this section to stay current with Yale’s human research protection policies and requirements, including IRB procedures, forms and educational offerings.

Investigators are encouraged to contact the IRB for assistance in developing protocol applications. IRB members and staff can assist in crafting protocol applications to address such issues as conflict of interest, community partnerships, development of repositories, and research with vulnerable populations. Early consultation can increase the efficiency of protocol review.

For information concerning Yale IRB timelines, view the 2010-2011 Human Investigation Committee schedules. For information concerning Yale IRB review fees, view the Fee Schedule for IRB Review.