December 2012

• 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)."

May 2012

• 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 contact mhallacy@jhsph.edu if you have any questions about clinical trials registration or HIPAA and Research.

April 2012

• 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.

March 2012

• 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.

February 2012

• 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.

May 2012

• 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 contact mhallacy@jhsph.edu if you have any questions about clinical trials registration or HIPAA and Research.

April 2012

• 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.

March 2012

• 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.

February 2012

• 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.

January 2012

• 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.