eIRB Now Available for New Protocol Submissions

As you may know, we have developed an informatics tool, eIRB, to support electronic, on-line submission of protocols to the Johns Hopkins Medicine IRBs. Some departments in the School of Medicine are already using eIrb. Effective immediately, all JHU SOM researchers may now use eIRB for new protocol submissions and must use it beginning September 1, 2005.

eIRB is accessible at http://e-irb.jhmi.edu and from a link on the main JHM IRB website (http://irb.jhmi.edu/). Most faculty and staff who do clinical research have already been given access to eIRB. If you find that you cannot gain access to eIRB, email your first and last name and JHED ID (not your password!) to jhmeirb@jhmi.edu and we will set up an account for you. You will receive an email confirming that your account has been set up. The system is fairly self-explanatory, but some orientation is required. We will hold orientation sessions on both the East Baltimore and Bayview campus. For the schedule, go to the JHM IRB website (http://irb.jhmi.edu/), select “Link to eIRB,” and then select “Technical Training.”

Protocols that have been submitted using the paper system will continue to use paper forms for continuing review, to request changes in research plan, report adverse events, etc. We are working on a process that will allow investigators to efficiently enter such protocols already in our system into eIRB.

Our hope is that this new system will improve the IRB’s efficiency and ability to serve the faculty. If you have any questions about eIRB, please contact the Office of Human Subjects Research eIRB Help Desk at 410-955-3008 or via email at jhmeirb@jhmi.edu. Thank you.

Clinical Trial Registration and Publication

Note a recent requirement applicable to clinical trials, and the implications for faculty who wish to publish clinical trial results. The International Committee on Medical Journal Editors (ICMJE) has implemented a policy that requires registration of new clinical trials as a condition of publication. Details about the policy may be found on line at: http://www.icmje.org/clin_trialup.htm The ICMJE does not require clinical trial registration on a particular website. Instead, they have stated requirements for an acceptable registry. The registry must be: electronically searchable and accessible to the public at no charge; open to all registrants and not for profit; and, have a mechanism to ensure the validity of the registration data. Many trials are being listed on the ClinicalTrials.gov website through the Protocol Registration System at http://prsinfo.clinicaltrials.gov

The ClinicalTrials.gov website was initially developed to allow sponsors of multi-center trials to post information on approved research and to allow the public to access information about such research. Many studies conducted at JHMI are already listed on this site because the sponsors of many multi-center clinical trials have registered the trials and listed all study sites. The ICMJE policy extends the obligation to register a trial to any individual conducting a clinical trial who wishes to have results of the trial published. The policy took effect on July 1, 2005. The BSPH is centralizing the registration process for clinical trials, and the Cancer Center will coordinate the process for oncology faculty. After consideration of the number of trials conducted at the SOM, we have decided that investigators, other than oncology faculty, will have the responsibility for determining; 1) whether or not a trial for which they are the investigator/sponsor should be registered and, 2) completing the registration. To register on the ClinicalTrials.gov website, you will need to establish an individual account. Johns Hopkins Medical Institutions should be listed as the organization name. The website directs you through the steps required to register. Registration is required once, but information must be updated on a regular basis. Please take time to review the ICMJE policy and registry websites. It is in your best interest to make sure that your trials are registered with an acceptable trial registry.

Participation of Foster Children in Research Studies

You may have seen recent newspaper articles regarding government investigations of clinical trials that enrolled foster children. We want to make sure that we do the best possible job of responding to such concerns and protecting the rights of children who participate in research. This is a complex area and, while we are formulating our response to these concerns, please do not enroll foster children in any research studies. If you have any foster children enrolled in current studies, or you have a patient who is a foster child and you believe enrollment in a research study would be the best therapeutic option, please contact Barbara Starklauf, Assistant Dean, Office of Human Subjects Research Compliance, by e-mail at bstark@jhmi.edu or by phone at (410) 955-3008. Questions regarding this request to temporarily limit enrollment may be directed to Dr. Michael Klag or to the General Counsels (for JHHS, Joanne Pollak; for JHU, Frederick Savage). Thank you for your cooperation.

International Compilation of Human Subject Research Protections

NIH now has a website that should help facilitate collaborative proposals with institutions outside the United States. Recognizing the continued growth of international research, the Office for Human Research Protections has developed an International Compilation of Human Subject Research Protections. The Compilation lists the laws, regulations, and guidelines of over 50 countries where DHHS funded or supported research is conducted.

The Compilation provides direct web links to each country's Key Organizations and laws, whenever available. OHRP believes this Compilation will help IRBs, researchers, and others to meet regulatory requirements to assure that research studies comply with applicable law.

The Compilation can be accessed on the OHRP website: http://www.hhs.gov/ohrp/
international/index.html#NatlPol . To use the Compilation, go to page 3 and then click on the country of interest.

Return to top of Human Subjects Research