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Prior to beginning participation in research, participants must give their informed consent. Informed consent is obtained by explaining the nature of the research and participation.

To accomplish this, there are EIGHT REQUIRED ELEMENTS OF INFORMED CONSENT that must be conveyed to participants:

Elements of Consent
  1. A statement that the study involves research. This includes but is not limited to:
    • An explanation of the purposes of the research;
    • The expected duration of the subject’s participation;
    • A description of the procedures to be followed.
  2. A description of any foreseeable risks or discomforts to the subject.
  3. A description of any expected benefits to the subject or to others.
  4. When applicable, a disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
  5. A statement describing how confidentiality of data will be managed.
  6. For research involving more than minimal risk:
    • An explanation as to whether any compensation or medical treatments are available if injury occurs. If these exist, what they consist of, or where further information may be obtained.
  7. A statement that:
    • Participation is voluntary;
    • Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled;
    • The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  8. List of whom to contact with questions about the research, research subjects’ rights, or in the event of a research-related injury to the subject. This includes but is not limited to:
    • Principal Investigator’s contact information;
    • SBER IRB Administrator’s contact information [Dr. Lara Sloboda at the Office of the Institutional Review Board at (617) 627-3417.]

In addition to the eight required elements of informed consent, there are additional elements that may be added to the consent form when necessary. They include:

  • A statement that the particular procedure may involve risks to the subject which are currently unforeseeable;
  • Anticipated circumstances in which the subject’s participation may be terminated by the investigator;
  • Any additional costs to the subject that may result from participation in the research;
  • The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  • A statement that significant new findings developed during the course of the research will be provided to the subject;
  • The approximate number of subjects involved in the study.

Can the informed consent elements or process be altered?

In some cases, some or all of these elements may be waived or altered.

What type of consent should I use?

Please use the flow chart below to determine what type of informed consent is needed.

Examples of Informed Consent Forms

Does your research involve adults or minors? Please see the flowchart below.


 

Adults (age 18+)
 ↓
Literate Illiterate or Diminished
Capacity
Confidentiality or Cultural Concerns
 ↓  ↓  ↓
Standard Written Consent Oral Consent Waiver of Documentation

 

Minors (age 0-17)
 
*Parental Permission is required for all minors under the age of 18.  Additional Assent is required for minors between the ages of 7 years and 17 years.*
 
Age 0-6 years   Age 7-17 years
   ↓
Parental Permission ONLY   Parental Permission AND Assent
 ↓                       ↓                             ↓                           ↓
Literate   Illiterate or
Diminished
Capacity
  Confidentiality or Cultural Concerns   Literate   Illiterate or
Diminished
Capacity
  Confidentiality or Cultural Concerns
 ↓    ↓    ↓  
 
 Written Parental Permission    Oral Parental Permission    Waiver of Documentation of Permission   Written Parental Permission Standard Written Assent    Oral Parental Permission Oral Assent   Waiver of Documentation of Permission AND Waiver of Documentation of Assent

 

What are waivers?   What goes into a consent form?   Consent FAQs