PARTNERS HUMAN RESEARCH COMMITTEE

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CONSENT FORMS

  • TEMPLATES
  • TOOLS & TIPS
  • TERMINOLOGY
INSTRUCTIONS
Consent Preparation Worksheet
7/14
Consent Form Reviewer Worksheet and Checklist
11/10
ADULTS or both ADULTS and CHILDREN 14-17

General Consent Form Template
6/14


Drug Trial Consent Form Template
6/14

Spanish General Consent Form Template
5/14


Consent form template for use when the study plan is to enroll only adults or both adults and children. When children age 14-17 are to be enrolled, consent of the parent and assent of the child are documented on this form. When children age 13 or less are to be enrolled, consent of the parent is documented on this form and assent of the child (age 7-13) is documented on the separate Youth Assent Form.

CHILDREN

Parental Consent Form Template
5/14

Spanish Parental Consent Form Template

5/14

Consent form template for use when the study plan is to enroll only children. When children age 14-17 are to be enrolled, consent of the parent and assent of the child are documented on this form. When children age 13 or less are to be enrolled, consent of the parent is documented on this form and assent of the child (age 7-13) is documented on the separate Youth Assent Form.

Assent Form
3/13

Spanish Assent Form
3/13

Assent form for use when the study plan is to enroll children age 7-13. When children age 14-17 are to be enrolled, assent of the child is documented on the General or Parental Consent Form template (see instructions).

BLOOD DRAW

Blood Draw Consent Form (PHI)
2/10

Consent and authorization template for studies limited to blood collection and the use of identifiable health information. Refer to the PHRC HIPAA page for more information.

Blood Draw Consent Form (No PHI)
2/10

Consent form template for studies limited to blood collection where no identifiable health information will be linked by use of a code or other means to the blood sample. Refer to research with de-identified information for more information.

TISSUE BANK

Tissue Bank Consent Form
2/10

Consent form template for studies that involve banking specimens/samples for future use and/or distribution to multiple investigators.

CERTIFICATE OF CONFIDENTIALITY

Consent Form and Authorization for Studies with a Certificate of Confidentiality
5/14

Parental Consent Form and Authorization for Studies with a Certificate of Confidentiality
5/14


Tissue Bank Consent Form and Authorization for Studies with a Certificate of Confidentiality
4/10

Spanish Consent Form and Authorization for Studies with a Certificate of Confidentiality
5/14

A Certificate of Confidentiality is obtained to provide additional privacy/confidentiality protections. For more information, see the NIH web page.

OTHER LANGAUGES

Short Form Consent Documents

The PHRC provides short consent document translations in several commonly understood languages. This abbreviated translation or "short form" (which attests that the elements of consent have been presented orally) may be used to document informed consent in writing. All other translations not provided by the PHRC must be submitted to the PHRC for approval.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TERMINOLOGY
Alternative Lay Language for Medical Terms in Consent Forms (Partners)

Common Language for Risks and Events (DFCI)

Dictionary of Cancer Terms: (NCI)
Drug Risks (Lay Language)
Glossary for Clinical Research Terms (FIRST Clinical Research)
Glossary for Informed Consent (FIRST Clinical Research)
Misunderstood Words in Health Materials (Sharon Nancekivel, Plain Language Consultant)
Plain Language Alternatives for Writers of Patient Information and Consent Materials (about 5th grade reading level) (Sharon Nancekivel, Plain Language Consultant)
WORD: An Online Glossary of Medical Terms for Children and Adolescents