Medical - Consent

• Consent forms
     Templates
     Samples - minimal risk research
• Assent
     Templates
     Parental permission
     Child assent requirements
• Informed Consent Checklist - IRB Members use this when reviewing consent forms.
    We hope this information helps investigators understand what the IRB looks for in a consent form.
• Consent terms
      Glossary of lay terms
      Full consent
      Waiver or alteration
      Waiver of documentation
• Vulnerable classes of participant
• General Requirements for Informed Consent
• Non-English speaking participants
      Translating the consent document
      Short form consent process

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Consent Forms

Templates
The following links will open different templates for the standard informed consent for both Stanford University and for the VA:

• Stanford University Consent (HIPAA Authorization not included) rev 7/23/09
  
• Stanford University Consent (includes HIPAA) rev 12/17/09
• Stanford Minimal Risk Consent (e.g., for blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions; HIPAA Authorization not included) rev 7/15/08
• Stanford HIPAA Authorization rev 12/17/09
  
  
  
• VA Palo Alto Health Care System Consent (VA HIPAA Authorization not included) rev 9/24/08
• VA Palo Alto Health Care System Consent (includes HIPAA) rev 9/24/08
• VA Minimal Risk Consent(e.g., for blood draws, data collection, leftover specimens, interviews, surveys, behavioral interventions; includes HIPAA) rev 7/2/09
• VA HIPAA Authorization rev 7/10/09
• VAPAHCS 10-1086 (Required Header and Footer for VA Consent Forms)

Samples - minimal risk research
These are examples of Stanford University consent forms (including HIPAA) for minimal risk research, for studies involving only:

• Blood draws
• Data collection
• Use of leftover specimens

In constructing your consent form, you will need to cover the topics included in the template. In addition, specific consent language is also included for particular types of research (Magnetic Resonance Imaging or Tissue Banking, for example) or for particular populations of subjects (children, or women of child-bearing age, for example). These templates may be edited or expanded as necessary for your particular protocol.

Per California privacy laws, the Stanford and VA consent form templates have been updated. For Stanford and VA studies, the HIPAA Authorization must meet the following requirements:
1) The Authorization must be written in a type face no smaller than 14 point font.
2) The Authorization language must be clearly separate from any other language on the same page, or it must exist as a separate document from the consent form.
3) A separate signature is required, which serves no other purpose than to execute the Authorization.
4) The Authorization must state the end date to the use and disclosure of information - see the Stanford or VA template as appropriate, for instruction on the end date.

Assent
Parental permission: When children are included as research subjects, in most circumstances parental permission must be obtained (see Parental Permission and IRB Guidance For Investigators on Consent for Protocols Involving Children and Consenting Minors).

Child assent: When children are included as research subjects, their assent must generally be obtained. See IRB Guidance For Investigators on Consent for Protocols Involving Children and Consenting Minors and Additional Protections for Inclusion of Children in Research - OHRP and FDA.

• Assent Form Template

Consent Terms
The IRB has provided a Glossary of Lay Terms for Use in Preparing Consent Forms. The glossary will open in a separate browser window.

Full consent: Written, signed consent should always be sought unless there are compelling reasons to seek an alteration or waiver of consent or waiver of documentation (e.g., signature) (see below).

Waiver or Alteration: The criteria for a waiver or alteration of consent are explained in the guidance Regulations for Waiver or Alteration of Consent Requirements.
Alteration or waiver of consent is not allowed for protocols subject to FDA regulations (unless the emergency exception applies -- See the guidance on Emergency Use of a Test Article and Chapter 5.8 of the STANFORD HRPP).

Waiver of Documentation: The criteria for waiver of documentation are explained in the guidance Regulations for Waiver or Alteration of Consent Requirements.


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Vulnerable classes of participants
For guidance on requirements for vulnerable subjects (i.e., children, prisoners, pregnant women, neonates, fetuses), see Guidances and HRPP Policies.

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Non-English speaking participants
Stanford University is located in a very culturally diverse region of California.  Investigators are encouraged to recruit and include all segments of our community in research, including individuals whose primary language is not English.

Participants who do not speak English should be presented with a consent document written in a language understandable to them.

Written consent documents should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent.  The Stanford HRPP and OHRP strongly encourage the use of a full consent form translated into the participant’s language whenever possible. 

When all of the participants in a study (i.e., the target population) are anticipated to be non-English speaking, a full translated consent is strongly encouraged.
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Translating the consent document:
When research is being conducted in a language other than English, it is important that consent forms be translated accurately. Procedures for ensuring accurate translation should be described. For further information, contact Translation Services at Stanford Hospital and Clinics at (650) 724-8735 or Interpreter Services at Lucile Packard Children’s Hospital at (650) 497-8371.

See Short Form Consent Process page for translated short form consent templates.