--Open, balanced, two-way communication between investigators is, in general, mutually beneficial and fosters the advancement of science.

--The acknowledgment of contradictory findings or models is beneficial to individuals not directly in a field. Ideally, the open exchange of ideas and reagents can allow the contradictory findings to be resolved or understood.

--Detailed collaborative agreements are advantageous to all parties involved.

--Agreements to publish coordinately can sometimes be beneficial to both parties.

--All plasmids, reagents, gene-targeted mice, assays and protocols published by investigators at the NIH must be made available to other researchers when practical, provided the requestor outside of the NIH agrees to and signs the appropriate Material Transfer Agreement (MTA) required.

--All correspondence regarding the distribution of reagents should be kept.

For clinical issues:

--When potentially eligible research subjects may be impaired in their ability to give informed consent, it is important to be aware of the process for consent and the requirements for involving the IRB in approving the consent process to be used for enrollment of such subjects.

--There is a need for additional safeguards in the study design and consent process, and particular regulations that apply to protect the rights and welfare of special populations, such as children, prisoners, pregnant women, and mentally disabled persons, if such subjects may be eligible to enroll in a study. There is also the potential in all studies that subjects with economic or educational disadvantages may be vulnerable to coercion or undue influence.

--The Institutional Review Board (IRB) will provide guidance to the investigators during the review of the clinical protocol for the overall consent process before the protocol is approved. However, the IRB might need to be consulted even after the protocol consent is approved if unanticipated situations arise when considering enrollment of subjects who may be impaired in the ability to give consent.