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eOPC Updates

eOPC Updates

If you have any questions, please contact the Office of Policy Coordination at policy@jhmi.edu or (410) 516-5560. 

May 5, 2008

Conflict of Interest Statement in Human Subjects Consent Forms

The Office of Policy Coordination (OPC) and the JHU Institutional Review Board (IRB) have adopted a standard template for conflict of interest disclosure language in the consent form for human subjects research.  OPC will no longer require that the specific details of the conflict be included in the disclosure statement.  Instead, a general disclosure statement will be assigned. 

The following disclosure language is used in all consent forms for studies involving a conflict of interest.

A conflict of interest occurs when a researcher or Johns Hopkins has a financial or other interest that might affect the researcher’s judgment when conducting a research study. In some situations, the result of a study might lead to a financial gain for the investigator(s) and/or Johns Hopkins.

One or more of the investigators working in this research study [and Johns Hopkins*] has a financial conflict of interest in connection with the study.

If you have any questions about this conflict of interest, please talk to [name and telephone number of non-conflicted individual]. This person is a member of the study team, but does not have a conflict of interest related to the study. You can also call the Office of Policy Coordination (410-516-5560) for more information. The Office of Policy Coordination manages conflicts of interest.


*to be taken out when not applicable

April 15, 2008

In our continuing efforts to improve eOPC, the following changes have been made:

UpdateImpact to eOPC
The Confidential Disclosure Agreement (CDA) question has been removed from the disclosure form. 

eOPC will no longer collect or manage disclosures for CDAs that involve no time commitment or remuneration. Please feel free to contact OPC to discuss implications of signing a CDA or refer to our website for CDA guidance.  All previous CDA answers have been archived.

If you are making a time commitment to consult for an outside organization or are receiving remuneration in connection with a CDA, you must submit a disclosure of the commitment or remuneration.

The spouse/domestic partner/minor dependant question on the first page of the disclosure form has been changed from a Yes/No question to a free text box. In addition, an important notice has been added to the top of the page defining “you” in the disclosure questions as including the user and the user’s spouse, domestic partner, and/or minor dependents.

Details of disclosures involving a spouse, domestic partner, and/or minor dependent can now be provided in question 6 on the first page of the smart form.  All information provided in the old Spouse/Domestic Section 6.0 has been condensed into the new free text field on page 1.
The start and end dates for outside services have been removed from all sections of the disclosure form and will no longer be collected or used for reporting in eOPC.Users are no longer required to enter term start and end dates for the services being disclosed. Instead, any service selected on the first page of the disclosure form will be considered current. Therefore, when a service terminates, users must return to eOPC and amend their disclosure and deselect the service on the form. For instructions on How to Submit an Amendment, visit our website.
A new question has been added to the “Prepare Amendment” activity.When preparing an amendment, users are asked why they are submitting an amendment. Users can pick from a list of reasons or provide another explanation. This information will allow OPC staff to more efficiently review and process amendments.
The instructions at the top of the first page of the disclosure form have been updated to change depending on whether the user is submitting a “new disclosure” or an “amendment”.The instructions presented to users on the form are more customized; they are now based on the type of disclosure being submitted.  Users are no longer able to select a different company when submitting an amendment.

 
 
 
 
 

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