Human Subjects Research Training Requirements

In early October, an announcement was sent regarding the online human subjects training that was started in the fall of 2000 and subsequently completed by all faculty and staff who do human subject research. At the time we announced this requirement in 2000, the Office of Research Integrity (ORI) recommended that certification be valid for three years. We are writing to correct our previous correspondence – ORI withdrew this recommendation and NIH did not adopt this requirement. Accordingly, the online human subjects research training you previously completed will not expire unless we notify you otherwise.

However, all School of Medicine faculty, staff, trainees, students, researchers, administrators, and administrative assistants must complete the Conflict of Interest and Commitment Training Module by December 31, 2003. The training module is available online at https://secure.
lwservers.net. Additional information concerning the Conflict of Interest and Commitment Training Module is available online at: http://www.hopkinsmedicine.org/faculty_staff/ policies/facultypolicies/coi_training_module.html.

For your information, the other training requirements for participation in human subject research are as follows:

• All faculty members must attend the new Course on Research Ethics (C.O.R.E.) or its equivalent by June 30, 2006. The URL is http://www.hopkinscme.org/cme/
  events/core0304.html.
  
• Fellows must meet the C.O.R.E. requirement before the end of their training period.
  
• New faculty, fellows and staff must complete the online human subjects training and COI training before they can begin to participate in human subjects research. This requirement is in addition to the C.O.R.E. requirement.
  

Please see the web site (https://secure.lwservers.net) for other required training modules.

Should you have any questions about these requirements, please contact the Office of Human Subjects Research regulatory team at 5-3008 or via e-mail (ohsceb@jhmi.edu). Thank you for you cooperation.

Changes to IRB Consent Form Template

Earlier this year, a member of the Division of General Internal Medicine conducted focus groups with individuals in the community to discuss the consent form language used in the boilerplate sections of the standard JHM consent document. Not surprisingly, the groups found the boilerplate language difficult to understand. As a result, we have been working on modifications to this section of the form. A new “Combined Informed Consent/Authorization” form is now available on the IRB web site at http://irb.jhmi.edu.

In addition to simplified language, the form contains a new section entitled "What happens to data, tissue, blood and samples that are collected in the study?” This section was developed and approved by Counsel for JHU and JHHS. This provision informs study participants that Hopkins owns the information and material collected during a research study, and if a product or idea is created at some future time through use of that material, individual participants will not receive any financial benefit.

The above paragraph must be included in all IRB approved consent forms. In the event that a potential subject wishes to enroll in a study but does not wish to sign the consent form because of this language, the principal investigator or consent designee may cross out this section and initial and date the action. The participant should initial and date the cross out at the same time. Some commercial sponsors may request inclusion of their commercial language paragraph in a consent form used at Hopkins. Sponsor language may not be substituted without permission from the Counsels. Please direct any sponsor request to use their language on commercialization to a member of the IRB regulatory team for their consideration before modifying the form.

Finally, there is new guidance and a new consent template available for investigators who wish to use Humanitarian Use Devices (HUDs). The guidance is available on the JHM IRB website. At Hopkins, all uses of HUDs require IRB approval before use of the device. Any questions regarding the requirement for submission of HUD use requests to the IRBs should be referred to the IRB regulatory team.

As always, comments and suggestions for future changes in the consent form or guidance materials may be sent to the Office of Human Subjects Research at the following e-mail site: ohsceb@jhmi.edu

Return to top of Human Subjects Research