October 2011

• The IRB Office is posting today a new version of its research plan. The two changes are in response to discussions in the IRB meetings.  Question 4.b.15 (a) and (b) aim to elicit more information about the accuracy and reliability of diagnostic tests.  Question 8.b. seeks more detail about the anticipated frequency and severity of risks of harm to participants or others posed by study procedures.

  The IRB Office is posting today a new Dari translation of the JHSPH HUMAN SUBJECTS RESEARCH ETHICS FIELD TRAINING GUIDE, provided by Linda Bartlett of International Health and the staff of the RAMOS II project in the JHSPH Kabul office.

August 2011

• The IRB will no longer list previously approved study documents in its Progress Report Approval letters. Once study documents, including consent forms, are approved, there is no need to “reapprove” them at continuing review. If a study document is revised, submitted for IRB approval with an Amendment Application, and approved, the Amendment Application Approval Letter will list the newly approved document title and version number. This practice is consistent with the procedures followed at the SOM IRB and WIRB.

July 2011

• The IRB  has posted new Guidelines for Recruitment Material to assist investigators. Please review before submitting study advertisements, flyers or other materials.
• The IRB Office has posted a revised research plan template, version 10. The changes to the template are significant and include revisions to: Section 5, on Data Security and Protection of Subject Confidentiality; Section 7 on Consent Process and Documentation; and Section 15 on Outside Collaborations.  The revisions to the Data Security section bring our questions into alignment with the recently posted Guidance on “Data Security Guidelines for Community-Based Research: A Best Practices Document Prepared by the Ad-Hoc Committee for Data Security, Program for Global Disease Epidemiology and Control, Department of Public Health.” In particular, we are asking investigators about analytic datasets for the first time. In addition, we are asking investigators to provide more information about the languages that will be used in the consent process. Lastly, we are asking for specificity about who is responsible for key aspects of the research activity. Please call the IRB office if you have any questions.

June 2011

• In collaboration with the MPH Office, the IRB Office recently updated the “IRB Office Determination Request forms” that may be used for all student or post-doc initiated projects to obtain a preliminary opinion as to whether a project requires a PHIRST submission and IRB review. Please see the new determination forms here.
• The IRB Office recently convened a meeting of faculty who conduct research in international settings to discuss the challenges of obtaining informed consent.  As a result of this meeting, we have revised our oral consent scripts and have tried to customize them to specific uses. There are templates for minimal risk studies (U.S. and resource-poor sites), collection of sensitive information (U.S.), and collection of information from JH Affiliates and other U.S. covered entities. Please see the new oral consent script templates here.

• The IRB is happy to post a new Swahili translation of its JHSPH HUMAN SUBJECTS RESEARCH ETHICS FIELD TRAINING GUIDE, courtesy of Alison Norris, and translated by Shemsa Mohammed and Amani Kitali, Tanzanian research colleagues.

May 2011

• Investigators who involve Maryland children in their studies must obtain legally effective informed consent from their parent or legal guardian.  “Guardianship” status varies from custodianship (child lives with the adult) to full legal adoption.  Children in a guardianship situation short of full legal adoption are in the State foster care system, and the State must approve their inclusion in research studies.  The IRB is posting a Guidance explaining how to seek that approval, called “Enrolling Maryland Foster Care Children in Research”, and the State-required application form called, “Department of Human Resources Social Services Administration Child Welfare and Policy: Inclusion of Foster Children in Human Subjects Research or Research-related activities.”  Please contact the IRB Director if you have any questions.

• The IRB is adding two items to the list of “Useful Links” to add information about enrolling two vulnerable Maryland populations in human subjects research, children in foster care and prisoners. 
• The IRB has updated the Conflict of Interest (COI) guidance to clarify how investigators should report conflicts associated with specific research applications.  We are also posting the Conflict of Interest Disclosure form on our forms page to facilitate this process.

• The IRB is adding two items to the list of “Useful Links” to add information about enrolling two vulnerable Maryland populations in human subjects research, children in foster care and prisoners. 

• The IRB has updated the Conflict of Interest (COI) guidance to clarify how investigators should report conflicts associated with specific research applications.  We are also posting the Conflict of Interest Disclosure form on our forms page to facilitate this process.

April 2011

• The IRB is posting two new Guidance Documents, one on Monetary and Other Incentives in the Research Context, which clarifies what “payment to participants” is, versus compensation or reimbursement for study-related costs.  The second guidance, Document Submission to the IRB, specifies those documents the PI must submit for IRB review (for example, consent forms, questionnaires that are not “standard”), and those which (like Case Report Forms or MedWatch reports) the IRB does not require, but for which it will provide acknowledgement of receipt.
• 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.

February 2011

• The FDA has added a new requirement to informed consent documents for clinical trials.  By March 7, 2012, the informed consent document for a clinical trial subject to FDA regulation must contain the new agency-supplied statement about the clinical trial registry databank.  The statement reads in part: “A description of this clinical trial will be available on http://www.ClinicalTrials.gov as required by U.S. Law.”  We have modified the JHSPH IRB instructional consent form template to include this language, and encourage all investigators who conduct studies subject to FDA regulation to modify their consent documents to include this required statement.

• Today we are posting a new, simplified Verification of Confidential Nature (VCN) form and process to be used as needed with respect to participant remuneration.  The form no longer requires confirmation by the ORA, thereby saving a step.  Confirmation of grant and budget information will be the PI’s responsibility, as it is for other expenditures.