October 2003 One of the challenges facing JHU investigators today is to provide patients with the best possible health care and to inform them of current research projects without violating federal regulations. Generally, all communications that might be construed as “advertising” and are used to recruit participants for studies are subject to JHM IRB review. However, departmental lists of studies open for enrollment are acceptable and not subject to JHM IRB review, so long as they do not cross the boundary between “permitted information” and “advertising.” This notice intends to clarify what options clinical departments may choose in their efforts to notify visitors of current research. Clinical departments may distribute to visitors information about the department’s current JHM IRB approved studies that are open for enrollment. Such departmental lists will not constitute “advertising” and will not need JHM IRB review if they include only the following information: - the study title,
- the PI’s name, and
- study contact information.
Furthermore, no list provided to a patient may be “customized” to correlate with that individual patient’s medical condition unless it is provided by the treating physician to his or her patient.
If a clinical department would like to prepare a more comprehensive list of studies in greater detail than permitted above, it may submit that list to JHM IRB for review and approval. For example, a department may wish to provide a description of studies that is more understandable to the lay person, along with the title, contact information and, possibly, enrollment criteria. The JHM IRB will review the material to ensure that it is consistent with the protocols, not coercive, and does not state or imply a favorable outcome beyond that which is outlined in the protocol or consent form.
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