IRB News Archives - 2010
- The IRB is posting a new guidance for investigators called ‘What am I agreeing to do when I become a Principal Investigator on a JHSPH IRB protocol?’ We hope this guidance will inform the JHSPH research community, including faculty advisor/PIs, of how the IRB interprets the PI responsibility.
- The IRB now makes house calls. If you’re spending sleepless nights wondering if your study records are up to snuff; if you’ve had an IRB issue that you knew needed your attention but just couldn’t bear to deal with it; if you’re new to JHSPH or human subjects research; or if you’d just like help organizing a vast mound of IRB paperwork, a house call from our outreach team might be the cure.
The new JHSPH Quality Improvement Program (QIP) provides on-going support, including office visits, to help the research community comply with applicable regulations and policies governing human subjects research. We can provide the tools and guidance you may need, including a free regulatory binder to organize important study documents. Contact us to schedule a friendly house call in your office or study center and we’ll write a prescription for your research compliance needs. If we find any thorny problem areas, we’ll help you through the reporting process and with developing a corrective plan. And in a School of Public Health – we all know the value of a little prevention!
Email us at firstname.lastname@example.org or call 410.502.7781 to schedule a house call or phone consultation.
- Starting the week of January 18, the “due” date for new applications which will be reviewed by IRB X (e.g., minimal risk studies) will change. Currently, new applications (presuming they are complete and ready for review) submitted by 3pm Thursday will be put on the following week’s agenda for review. Often, communications between IRB staff and/or primary reviewers and the PI are constricted by this tight timeline, and failure to completely resolve issues or obtain answers to questions in time often causes review of new applications to be either deferred a week or tabled at the meeting. We are moving the deadline for new IRB X applications back 2 working days, to Tuesdays at 3pm, to facilitate these communications with the expectation that this will actually accelerate the time from submission to approval. As always, the responsiveness of the PI to inquiries from the IRB staff and the primary reviewers is critical to the efficiency of this process.
- The IRB Office welcomes Tariq Syed as the new Senior Research Subjects Specialist fpr IRB X. Tariq has a strong background in pharmacology and clinical trials management, and recently completed a Master of Science in Health Sciences, Clinical Research Administration from George Washington University. We feel very fortunate to have him on our team, and invite you to come down and say hello.
- The IRB is posting a new guidance called “Planning Phase Applications” to clarify for investigators the process for those research activities which precede study phases involving human participants.
- The IRB has revised the Progress Report form in three ways: 1) to underline (and make more prominent) the request for submission of a redacted consent form for studies currently enrolling participants; 2) to clarify the sample size report section; and 3) for community based studies, to invite report of findings shared with the local community.
- The IRB is posting two new documents: a revised Research Plan template, and an instructional Research Plan template to help students and investigators understand what the IRB is looking for in a Research Plan. Please review the instructional version, then complete the Research Plan template. We hope the instructional tool will make PI-IRB interactions more efficient
- For research applications which have foreign language consent documents which require special fonts, we have posted a guidance called “Embedding Foreign Language Fonts in Word 2007 Documents.” The IRB cannot print out the documents without the required fonts, so please follow these directions to help us solve this problem.
To increase efficiency, effective July 1, 2010, the IRB Office will no longer stamp or watermark study instruments (questionnaires, interview guides, etc.) with the JHSPH IRB approval logo unless the study sponsor requires it. See the Guidance on Documentation of IRB Approval for more information about what will and won’t be watermarked/stamped. The IRB approval letter lists each approved document, with title and version identifier, so that letter serves as documentation of IRB approval. All study instruments must have version identification for document control purposes.
- We are posting an instructional template for Progress Reports to help investigators understand what information the IRB requires for a study’s continuing review. Please review and let us know if you have questions or comments.
- The JHSPH IRB has in place a reciprocity review agreement with the SOM IRB. Sometimes faculty members with primary appointments at one institution may request review by the IRB at the other institution. The new guidance, “Criteria for Requests for Review under the JHSPH-SOM IRB Reciprocity Agreement” explains how the IRBs will handle those requests.
The IRB Office and the MPH Office have worked together to create new tools to assist students, their advisors and the PIs of their studies, with IRB interactions. A new surveymonkey program will help students determine whether or not to submit one of two new forms to the IRB for pre-screening, the Application for Use of Secondary Data, and the Application to Collect Human Subjects Data. Please see the Student Projects page on this site for more information.
- The IRB is posting new versions of the Research Plan template and the Instructional Research Plan template. We have added language in the Data Security section to emphasize the importance of protecting data in transport, in particular, hard copies of data collection materials, consent materials, or codes linking data to participant identifiers. We have also reworded the Certificate of Confidentiality question to ask about coverage of study data, rather than focusing on the JHSPH PI’s intention to apply for a Certificate.
The JHSPH IRB accepts a variety of certifications of human subjects research ethics training from non-JHSPH investigators. In particular, we accept (and recommend) Family Health International’s recently updated ethics training module (http://www.fhi.org/training/en/RETC2/index.html ), which uses a case study approach.
- The IRB posts today an updated version of its Biospecimens Consent Form Template. This version includes language for NIH funded Genome Wide Association Studies and revised language presenting options for future use available to participants, based on the recent NEJM article about the Havasupai case.
Up until now, the IRB approval letters may list approved consent documents, with both the IRB version number and date and the PI’s version number and date. Often there is confusion as to which version number and/or date on the document that the PI submits to the IRB is the one that should appear in the approval letter. Dates and version numbers may appear in the headers, footers, and often in the title of the document, and they are not always systematically changed over time as amendments are submitted. To simplify matters going forward, the IRB approval letter will list the IRB version number and date which appear in our template header. The version number reflects the sequence of approved documents, starting with “Version 1”). The date correlates with the date that an IRB member signs the review form approving the document. We will not list the investigator’s version number and/or date unless the PI specifically requests that we do so.
- The IRB has updated the guidance on the Fast Track Review Procedure by clarifying that “new items” which qualify for fast track review include new questions or data fields for instruments and recruitment materials already approved by the IRB. It also specifies that revisions to research plans or consent documents require an amendment application.
- The IRB will post samples of well-written research plans on its SharePoint site for JHSPH faculty and students use.
- The IRB convened a group of experienced JHSPH and Jhpiego investigators to discuss with the IRB the ethical issues associated with verbal autopsies, particularly with the dilemma associated with learning about a person’s unnatural demise. This guidance serves as our best effort to address these complex challenges.
- Because the IRB Office has great difficulty inserting our approval logo into pdf documents, we will no longer accept consent document submissions in pdf format. Please submit all consent documents, English and translated versions, in Microsoft Word and leave the header space open for IRB Office use.
- The IRB is posting a resource document listing references for RECs/IRBs involved in international research. The list includes WHO guidelines for ethical standards and operational tools, as well as links to various training options. This page is intended to serve as a convenience for interested parties.