Each Informed Consent Form (ICF) document submitted to the Investigational Review Board (IRB) for approval shall encompass the following requisite details:

  • Protocol Title and unique identifying Protocol # 

  • Principal Investigator name and contact information 

  • A statement that the study involves research and an explanation of the research 

  • Expected duration of the subject’s participation 

  • Number of subjects participating in the study 

  • A description of the procedures to be followed 

  • Identification of any procedures which are experimental  

  • Covid-19 processes/procedures, if applicable 

  • A description of any reasonably foreseeable risks or discomforts to the subject  

  • A description of any benefits to the subject or to others which may reasonably be expected from the research 

  • Compensation amount and method of payment  

  • A disclosure of alternative procedures or courses of treatment that may be available to the subject 

  • A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained 

  • A statement that if the records are confidential; the AIRB (Allendale Investigational Review Board) and FDA (Food and Drug Administration) may view those records 

  • If more than minimal risk is anticipated, an explanation as to whether any compensation and medical treatments are available if injury occurs and, if so, what they consist of and a source for further information 

  • Who to contact for further information concerning subject rights (Allendale Investigational Review Board at 860-434-5872 and SubjectRights@allendaleIRB.com) or research related injury (your 24-hour contact number) 

  • A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits and subject’s can discontinue participation at any time 

  • A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time. 

 Additional elements if appropriate are added to the ICF: 

  • A statement that the treatment or procedure may involve risk to the subject (or embryo or fetus if the subject is or may become pregnant) 

  • Reasons why an investigator may terminate a subject without regard to the subject’s consent 

  • Any additional costs to the subject that may result from participation 

  • Consequences of withdrawal 

  • A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided