Our Quality Improvement Specialist, in conjunction with her School of Medicine counterparts, has posted tools to help you set up your regulatory research binders: Regulatory Binder Tabs for Hard Copy Binders and Regulatory Documents Binder Tab Topics for Electronic Storage. We hope they will be useful for you.
- Because the holidays this year fall on Board meeting days, a few of the meetings will be cancelled. IRB-X will not meet on November 26, December 24 or December 31. IRB-FC will not meet on November 25 or December 30. Please keep this schedule in mind as you prepare your submissions.
- Please note there will NOT be a meeting for IRB-X on September 3, 2015.
- Please note there will NOT be a meeting for IRB-FC on August 26, 2015.
- The IRB has revised its Amendment Application process. The old “Administrative Amendment for Changes to Study Personnel” has been updated and broadened in scope to include some other minor changes. Please use the “Administrative Amendment for Minor Changes to Research” for changes to personnel, funding, contact information on study documents and other minor changes. All other changes to research should be submitted to the IRB using the Amendment Application. A new guidance called “Submitting Research Changes to the IRB” replaces the old “Fast Track Procedure” guidance and intends to assist you with the amendment process.
- On January 25, 2015, NIH implemented a new Genomic Data Sharing Policy that changes requirements for proposals involving large-scale human or non-human genomic data as well as the use of these data for future research. NIH expects investigators to provide basic plans for following this policy in the “Genomic Data Sharing Plan” located in the “Resource Sharing Plan” section of funding applications and proposals. This section for human subjects research proposals must include: how data will be de-identified, how consent will be obtained, and how the consent language will be written to permit broad sharing and future research.
- De-identified data, and the tools needed to interpret them (protocols, instruments), are expected to be deposited in NIH-designated data repositories on a timely basis and broadly available for use in future research. Researchers who are likely to submit such proposals must anticipate these requirements in their submissions. If you plan to submit a proposal that requires a Genomic Data Sharing Plan, please contact your departmental administrator and/or JHU ORA point of contact as soon as you are aware so there is adequate time to meet the requirements.
- More information and guidance will be forthcoming. Until then, if you have any questions, please contact the JHSPH IRB Office at firstname.lastname@example.org.
- Because the holidays this year fall on meeting days, we will miss a number of meeting days. IRB-X will not meet on November 27, December 25 and January 1. IRB-FC will not meet on December 24 and December 31. Please keep this schedule in mind as you prepare your submissions.
- The IRB has updated its information about human subjects research conducted in collaboration with the Baltimore City Health Department (BCHD) and the Maryland State Department of Health and Mental Hygiene (DHMH). Please review it if you work with the DHMH or City or County Health Departments in the State of Maryland.
- Please note there will NOT be a meeting for IRBX on July 3, 2014.
- The Pan American Health Organization has published a research ethics casebook in Spanish for use in ethics training. We are posting the link on our page called “IRBs/RECs involved in international research.” Please share it with your colleagues.
- As internet research opportunities expand, investigators and the IRB will continue to address the related ethical issues. We have posted on our website the DHHS “Secretary’s Advisory Committee on Human Research Protections” (SACHRP) guidance “Considerations and Recommendations Concerning Internet Research,” and the slides from a webinar on “Conducting Internet Research” provided by the federal Office of Human Subjects Protections (OHRP), and will refer to these resources when reviewing internet studies.
- The U.S. Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) have joined forces and created an interactive training video for clinical and behavioral researchers on protecting human subjects and research integrity. It might be useful. Here’s the link to the tool, called “The Research Clinic.”
- The IRB has modified its research plan and is posting TWO new documents: one is a new Research Plan for Secondary Data Analysis of Existing Data/Specimens, and the second one is a revised Research Plan for New Data Collection. We have tried to improve the logical flow of the documents, and to separate out the sections that are specific to certain types of studies. We have also tried to improve the descriptions of the information we need to complete our reviews to reduce the amount of back-and-forth with investigators. We welcome feedback, so please send your comments to email@example.com (our new IRB office email address). PLEASE DELETE ALL EARLIER RESEARCH PLAN TEMPLATES FROM YOUR COMPUTERS AND USE THE NEW VERSIONS. Thank you.
- The IRB is posting guidance on internet research written by the DHHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). Investigators proposing such research should review its recommendations. It is also posting the President’s Bioethics Commission report on Ethical Management of Secondary and Incidental Findings.
- The IRB is posting a new Data Security Guide created by Darren Lacey, Chief Information Security Officer and Director of IT Compliance for JHU and JHM. The guide is for investigators using clinical data, especially those using 500 or more medical records. All investigators who will use Protected Health Information (PHI) should review and follow.