PM 08-01-07-aa

new textClinical Trial is Approved by an Institutional Review Board (IRB)

Informed Consent Form

An "informed consent form" is a document that describes the rights of the clinical trial participant, includes details about the study (such as, purpose, duration, required procedures, risks, expected benefits and contact information), and is signed by the participant. Federal regulations require that IRBs must approve all informed consent forms; therefore, a copy of the informed consent form is acceptable proof that an IRB reviewed and approved the clinical trial.

Informed Consent Form Not Available

If an informed consent form is not available, accept an official letter from the administrator of the clinical trial. The letter must contain the name and location of the clinical trial, name of the disease or condition, and the name and contact information of the administrator. Use the information provided to locate the clinical trial in the ClinicalTrials.gov website. If the clinical trial appears on this website you may assume an IRB approved the study.

Clinical Trial Involves a Rare Disease or Condition

Review the documentation to determine if the study involves a rare disease or condition. Some commonly known rare diseases are Lou Gehrig's disease (amyotrophic lateral sclerosis), Crohn's disease, cystic fibrosis, cystinosis, Duchenne muscular dystrophy, Huntington's disease, and Tourette syndrome. The clinical trial meets the requirement if the documentation lists one of these diseases, or indicates that the study involves a rare disease or condition as defined in the "Orphan Drug Act".