If the only involvement of a County facility in a project is in the initial identification and recruitment of subjects, is IRB approval required?
All organized recruitment of potential research subjects at Bureau facilities must be reviewed. Organized recruitment would include contacting patients whose names have been extracted from medical records; stationing recruiters in clinic waiting rooms or other hospital areas; posting flyers or handing out recruiting leaflets on site. This is in contrast to an individual physician informing a patient during a clinical interaction about a research study that is available at another institution. As long as only descriptive information is given to the patient ( i.e., a summary of the research and the name and phone number of the physician conducting the trial), without any implied endorsement of the research, this interaction is considered to be a clinical referral, not organized recruitment.
Related Questions
- Does the educational facility have to wait for the executive county superintendent’s approval on the Emergent Hiring form before the district may permit the employee to start working?
- For collaborative research at the 3T MRI Facility in Newark, is IRB approval from both the Rutgers and UMDNJ IRBs required?
- Must investigators obtain IRB approval before involving human subjects in nonexempt research?
