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103.23 Organization Policy on Credentials of Research Team and Documentation Required from Non-Hopkins IRBs and Study Sites

April 2016

The Organization requires research team members to be qualified to perform the research procedures that they have agreed to perform.  The PI is responsible for assembling a team that has the proper qualifications.  The Organization has policies that govern what procedures individuals are credentialed to perform.  The OHSR works closely with the credentialing offices of the Organization to assure that these policies are followed in the conduct of research.  The Organization also has a policy regarding involvement of fellows in clinical research, and this policy was developed in close consultation with the credentialing offices of the Organization.  Additionally, The Kennedy Krieger Institute has credentialing requirements that apply to research procedures conducts at its facilities.  OHSR and JHM IRB questions regarding credentials will be referred to the appropriate offices for response. 

The Organization requires documentation of IRB/Ethics Board reviews from collaborative institutions and requires that they have appropriate OHRP assurance documents.  Investigators are required to submit approvals from off-site IRBs/Ethics Boards, as well as any required site administrative approval for conduct of research at non-Hopkins facilities.  The JHM IRBs may grant approval with administrative changes for a project that requires this type of additional documentation. 

When the investigator plans to conduct research at any site not under the control of the Organization (e.g. school, nursing home, health care facility, private practice, etc.), the following information must be provided on the application:  site name; site contact information; site permission (if applicable); IRB approval (if applicable). Final approval will not be granted until local site or IRB approval is documented.