During the informed consent process, the investigator or designee must provide each potential research subject with a complete and understandable explanation of the study and an opportunity to have all questions answered. The subject should have sufficient opportunity to read the Schulman approved informed consent document and decide, free of coercion or undue influence, whether he or she wishes to participate in the study. The subject should have the opportunity to take the informed consent document home for further consideration. Informed consent must be obtained and documented before the initiation of any study-related procedures. The written consent document must be signed by a fully informed subject or, if approved by the Board, by the subject's legally authorized representative (LAR).
Please remember that informed consent is an on-going process. Also remember that the Board has the authority to observe the consent process and may request to do so at any time.
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.