Informed consent documents approved by Schulman include an option for a subject to instruct the study doctor to notify the subject's primary care physician (PCP) or appropriate specialist of the subject's participation in the clinical research study. This option is provided in accordance with the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP) 4.3.3, which states, "It is recommended that the investigator inform the subject's primary physician about the subject's participation in the study if the subject has a primary physician and if the subject agrees to the primary physician being informed."
If a subject opts to have his/her PCP or specialist notified, the investigator should send a letter to the PCP or the appropriate specialist describing the purpose of the study, the length of the study, the randomization plan and a brief summary of the study procedures. The letter should also invite the PCP or specialist to contact the investigator with further questions.
In certain circumstances this option is not included in the informed consent document. If a protocol requires PCP or specialist notification, the subject is not given the option to decline notification. Also, the Board may decide to delete the PCP notification requirement for certain types of studies.