IRB News Archives
The IRB is happy to post a new Khmer (Cambodian) of its Field Training Guide. Please let us know if you have other translations available to post
- To all investigators whose studies may be affected by the government shutdown: Please let us know if you need help with research stoppages, review deadline problems, or other IRB related complications to your work.
- The JHSPH IRB is launching a new web-based module series called “QUALITY IMPROVEMENT THROUGH SELF-ASSESSMENT.” This series is designed to help human subjects research investigators meet their commitment to comply with legal, regulatory, and institutional requirements by monitoring their own research studies. It’s public, and we are not collecting identifiers from the users. We’d appreciate feedback from you; please direct questions/comments/suggestions to our Quality Improvement Specialist at firstname.lastname@example.org.
- The JHSPH IRB has revised the Investigational Drug Data Sheet (IDDS) required for research applications that involve Investigational New Drug Applications. The instruction section is simpler and the form incorporates a more detailed protocol section to collect site specific information. Please feel free to contact the IRB office if you have any questions.
- We have updated our CITI FAQs to help you understand the new compliance training requirements.
- The JHSPH IRB has updated its requirements for human subjects research ethics training for JHSPH faculty, staff, and students engaged in human subjects research. Certification of completion of CITI training must be renewed every 5 years. Certain specialized research requirements have been added for investigators conducting clinical trials, working on Native American reservations, using Protected Health Information (PHI), and/or funded by the Department of the Navy. Training requirements for non-JHSPH collaborators have not changed. The IRB has updated its website to more fully explain its requirements and CITI course offerings under the CITI training link.
- The HIPAA page on our website has been updated to include information about how to obtain a limited data set containing PHI from the Johns Hopkins Health System. Investigators must complete a Questionnaire to Obtain Business Associate Agreement (BA) and/or Data Use Agreement (DUA) from JH HIPAA Covered Entity. The revised HIPAA Privacy Authorization and Waivers Guidance explains the requirements.
- All PHIRST users will note a change to the New Application process starting January 24, 2013. After a Principal Investigator (PI) completes the application and clicks “Finish” at the end, there is a new step to complete before submission. The PI must perform a new activity called “Request Study Team Participation.” This activity will send an email to all study team members (every co-investigator, student investigator, and study contact) listed in the application requesting them to agree or decline their proposed roles in the study. When a person agrees, they will affirm adherence to principles of research ethics and the obligation to disclose any conflicts of interest with the study. Once all study team members have agreed to participate, the PI will be able to access the “Submit” activity and will be able to submit the New Application. If you have questions or problems with this process, please contact email@example.com.
- The IRB has revised its Student Investigator Policy 103.02 to make clear that JHSPH faculty may not serve as Principal Investigator for undergraduate students. It also has clarified the Conflict of Interest Policy for IRB Members, Policy No. 111.11. Click here for updated policies.
- The IRB has revised the research plan to incorporate new questions about HIPAA (Question 3.e.), data custody (Questions 5.d. and 16.b.), and incidental findings for future research using biospecimens (Question 18.f.). The instructional template update will follow. Click here for forms.
- To help investigators understand what the IRB members look for when reviewing a human subjects research application (or related submission), we are posting a tool that demonstrates the connection between the requirements of research ethics and the evaluation of a research application: “Framework for Analyzing the Ethics of a Human Subjects Research Study (for IRB Members)."
- The IRB has worked with the Research Compliance Officer to simplify HIPAA forms and provide Guidance on Clinical Trials Registration and Protected Health Information (HIPAA). We have posted new a HIPAA Authorization Form and a new Application for Waiver of HIPAA Privacy Authorization form. In addition, we have revised our Policy No. 103.25 on Clinical Trials Registration. Please firstname.lastname@example.org if you have any questions about clinical trials registration or HIPAA and Research.
- The IRB Office has updated the IRB Office Determination Request Form: Secondary Data Analysis and the IRB Office Determination Request Form: Primary Data Collection that students or post-docs may use to request the IRB’s preliminary opinion on whether their projects require IRB review.
- In an effort to make it easier to add/delete co-investigators, study team members, and study team members, the IRB is posting today a new form, “Administrative Amendment Application for Change to Study Personnel.” We have updated the Investigator Agreement Form which needs to be signed by the person being added to the study. Changes to the Principal Investigator of a study will still require review by a Chair, so continue using the revised Amendment Application for that purpose. For convenience sake, we are posting a new Guidance: Study Roles and JHSPH Requirements on the Amendment page to help you manage your personnel-related submissions. We are also posting a new Guidance on Document Control and Naming Conventions for Study Documents to help with creating distinct names for different versions of study associated documents. Please delete old versions of our forms from your hard drive, and only use the most current versions.
- The IRB recently completed a successful audit by the Food and Drug Administration (FDA). One of the things we learned is that the number of studies falling under FDA jurisdiction is limited to studies involving IND or IDE submissions, or a change of labeling for approved drugs or medical devices. We also learned that the consent forms for all FDA regulated studies must inform the participant, no matter where the study takes place, that the FDA may see study records. These consent forms must also include a statement that the study, and its results, will be posted on www.clinicaltrials.gov. Today we are posting a revised instructional template for our consent document which includes both these statements.
- The IRB is happy to post a new Nepali translation of its Field Training Guide. Please let us know if you have other translations available to post
- The IRB Office was recently audited by the FDA for compliance with the human subjects research protections regulations associated with clinical investigations. As a result of this audit, which went very well, two of our policies have been revised to provide greater detail about how the IRB assesses risk in studies which pose more than minimal risk to participants, and also more detail about what the IRB considers at its initial review of a new application (Policies 111.01 and 111.10) We post all our policies, so feel free to review them.
The IRB Office has updated its page on “Resources for IRBs/RECs Involved in International Research” by replacing the first item with the link to the recently published World Health Organization guide for Research Ethics Committees, “Standards and Operational Guidance for Ethics Review of Health – Related Research with Human Participants.” This tool may be useful for people trying to establish RECs, or upgrading existing RECs.
Happy New Year! The IRB has revised the Consent Documents page to, we hope, make it easier for you to find the appropriate template for your particular study. We have also added new language about incidental findings associated with imaging studies conducted at JHU facilities. Please include this language in studies involving such procedures.