Informed Consents (ICs) approved by Schulman generally 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.
If a subject opts to have his or her PCP/specialist notified, the investigator must send a letter to the PCP or the appropriate specialist. It is recommended that the letter describe the purpose of the study, the length of the study, the randomization schema and a brief summary of the study procedures. The letter should also invite the PCP/specialist to contact the investigator with further questions.
In certain circumstances this option is not included in the consent. If a protocol requires PCP notification, the subject is not given the option to decline notification. Studies in which a direct benefit is not anticipated (e.g., Phase I healthy volunteer studies), this notification is not required by the Board. Also, the Board may decide to remove the PCP notification option for certain types of studies.