​Informed Consent
Each potential research subject must be provided with a complete and understandable explanation of the study and an opportunity to have all questions answered. The potential subject should have sufficient opportunity to read the approved Informed Consent (IC) and, if qualified, freely decide to enter the study. In most studies, the potential subject should have the opportunity to take the IC home for further consideration.
Informed consent must be obtained and documented before the initiation of any study-related procedures. Written consent must be obtained from a fully informed subject or, if the Board has determined that it is appropriate, from the subject’s parent/guardian(s) or Legally Authorized Representative (LAR). The informed consent process must be recorded in the source documentation.
It is the investigator's responsibility to explain the role of the IRB to potential subjects. As part of the explanation, the investigator must inform potential subjects that they may contact Schulman by phone or mail with any questions they may have regarding their rights as research subjects or with regard to complaints they may have about the study. Schulman lists a toll free telephone number and address in all Schulman approved informed consent documents.
Please remember that informed consent is an ongoing process. Schulman has the authority to observe the consent process and may request to do so at any time.