IMPORTANT HIPAA CHANGES
Effective September 23, 2013, changes to HIPAA go into effect. Note below changes that are specific to researchers. More information is available on the HIPAA website
We have posted a new version of our compound authorization form template, with revised instructions. There are NO changes to the content of template.
Record reviews of individuals deceased more than 50 years no longer require authorization or waiver
Authorizations can be combined for multiple studies, including banking or future unspecified research, as long as: it is clear if any research-related treatments are contingent on signing the RAF and there is a way to authorize the additional uses or activities separately (e.g. check boxes for banking)
Unallowable access or disclosure is considered a reportable breach unless a risk assessment determines that there is a low probability that the PHI has been “compromised”.
We have 60 days to investigate and notify patients.
Report all incidents immediately to either a supervisor or to a Privacy Officer or call the incident reporting line 203-627-4665
HIC Protocol Submissions for Full Board Review (6/26/12)
New protocols and amendments to approved protocols requiring full board review will undergo regulatory review by HIC staff and will be scheduled to a meeting when the review process is complete. Protocols submitted in a timely manner for annual renewal will be scheduled to a meeting within 30 days prior to expiration.
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 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:
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:
Documents that will no longer be signed or receiving approval notations include:
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.