November 30, 2017
The SOM IRB and the JHSPH IRB have agreed on standard Certificate of Confidentiality language for the consent forms for NIH funded studies that collect personal identifiers from participants. This language is shorter than that posted by NIH and has been inserted into our consent templates.
For NIH funded, U.S. based studies that will collect identifiable information, please include this language:
Your study information is protected by a Certificate of Confidentiality. This Certificate allows us, in some cases, to refuse to give out your information even if requested using legal means.
It does not protect information that we have to report by law, such as child abuse or some infectious diseases. The Certificate does not prevent us from disclosing your information if we learn of possible harm to yourself or others, or if you need medical help.
Disclosures that you consent to in this document are not protected. This includes putting research data in the medical record or sharing research data for this study or future research. Disclosures that you make yourself are also not protected.
For NIH funded, international studies that collect identifiers and may bring identifiable data to the U.S., include this language:
This study is protected by a Certificate of Confidentiality that helps keep your information private when stored in the U.S.
Please let us know if you have any questions.
Under NIH’s new policy, all NIH funded studies started or ongoing on or after December 13, 2016, that collect personal identifiers, are deemed to have Certificate of Confidentiality protections. This protection goes with the grant, and investigators are responsible for explaining the extent and limitations of the protections to study participants. We have modified our consent form templates, both oral scripts and consent documents to be signed, to include language that meets NIH requirements. We have tried to make the language as concise as possible. Please be sure to include this language for all studies that fall under this policy.
The IRB has disabled the HIPAA questions in the PHIRST application and will use exclusively the Application for the Disclosure of Protected Health Information available now via link in PHIRST, and on our HIPAA webpage. Please contact the IRB Office at email@example.com if you have questions.”
“Johns Hopkins Medicine has convened a Data Trust Council that is setting policies for the access and use of clinical data from JHH and its affiliates. The Research Data Subcouncil has posted FAQs for all researchers to help them navigate the new procedures for accessing clinical data: see the intranet for more information. Contact the JHSPH IRB office if you have questions.”
Due to the upcoming holidays, IRB-X and IRB-FC will miss a few meeting days. IRB-X will not meet on November 24 and December 29. IRB-FC will not meet on December 28. Please keep this schedule in mind as you prepare your submissions.
On September 16, 2016, NIH issued a requirement that “all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP)….” (See the intranet for more information.) The NIH definition of a clinical trial is, “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” The JHSPH IRB offers access to GCP training through the JHSPH’s CITI training account, which you may access here: https://www.citiprogram.org/. When you log into the CITI site (selecting Johns Hopkins Bloomberg School of Public Health as your institution), select “Add a Course”, then under “Question 2”, select the first Learner Group which offers GCP training.
The IRB office has revised its Research Plan for New Data Collection to include new questions on data confidentiality and security. The questions are more detailed and we hope that it will inform investigators of the high standards of security required for research data. The template also has more space and designated areas for responses; this is an effort to make the finished document easier for reviewers and staff to read. We welcome your comments - please send them to firstname.lastname@example.org. Thank you!
Investigators working with JHH affiliates with studies that involve clinical services must be familiar with the PRA (“Prospective Reimbursement Analysis”) and CRMS (“Clinical Research Management System”) processes that help control the billing procedures for those study services. The SOM Vice Dean for Clinical Investigations has agreed to allow JHSPH investigators to submit these projects through the SOM’s eIRB2 system, which automates the PRA and CRMS processes. Contact the JHSPH IRB Office if you have any questions.
NIH has created a new “human subjects” webpage that links investigators to training and to the Certificates of Confidentiality kiosks. It also helps investigators prepare their “human subjects” sections of their research proposals.
The JHU School of Public Health IRB is posting the PHIRST (Public Health Institutional Review System Tracking) User Guide developed specifically for investigators and study team members using the PHIRST system, our portal for all new human subjects research applications. This manual includes the following topics to get you started:
1. The PHIRST registration process
2. An overview of the submission and review process
3. Basic methods and terms you need to know to create and submit electronic IRB applications
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 email@example.com.
- 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 firstname.lastname@example.org (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.