The October 2013, Version 14 version of the HIPAA Combined Informed Consent/Authorization Template has been posted. What has changed in Version 14?
HIPAA Combined Parental Informed Consent/Authorization Template (October 2013, Version 2) is also now available. This Informed Consent Template should be used when all study participants are under 18 years of age and parent(s)/guardian(s) consent is required. The revisions for Version 2 are consistent with those in the HIPAA Combined Informed Consent/Authorization Template, Version 14. Also available is Version 3 of the Pluripotent Stem Cell Research Informed Consent Template.
All new and revised consent forms are required to be on these templates as of December 1, 2013. Consent forms received after December 1, 2013 on an outdated template will be returned and the application will not be processed until the correct consent forms are submitted.
The Institutional Official who has authority over the JHM Human Subjects Protection Program is the Vice Dean for Clinical Investigation. The current Vice Dean for Clinical Investigation is Dr. Daniel E. Ford.
The Johns Hopkins Medicine Institutional Review Boards (JHM IRBs) are responsible for protecting the rights and welfare of the human subjects of research conducted by faculty and staff at the Institutions. The JHM IRBs review all human subjects research projects conducted by Hopkins faculty and staff. To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for JHM IRB review any human subject research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted.
[ Please Note: Part-time faculty are obliged to obtain JHM IRB approval of all human subjects activities conducted under the auspices of their Hopkins’ appointment ( which means “use of Hopkins’ personnel or space or the use of the faculty appointment in correspondence, agreements with sponsors, etc…”)].
The Institutions operate under Federal-Wide Assurances associated with each of the organizations linked to the JHM IRBs. List of JHM FWAs
For more information on the federal guidelines that determine the kind of research the JHM IRB is required to approve please visit http://www.hhs.gov/ohrp/policy/index.html.