CONSENT
FORMS

  • TEMPLATES
  • TOOLS & TIPS
  • TERMINOLOGY
  • ASK AN EDITOR
  • TRAINING
INSTRUCTIONS
Consent Preparation Worksheet
1/09 NEW
Instructions for Preparing Research Consent Forms
6/07
Consent Form Reviewer Worksheet and Checklist
12/08 UPDATED
ADULTS or both ADULTS and CHILDREN 14-17

General Consent Form Template
12/08
UPDATED

Drug Trial Consent Form Template
12/08
NEW

Spanish Consent Form Template
11/05


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
12/08
UPDATED

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.

Youth Assent Form
8/98

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)
12/08
UPDATED

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)
12/08
UPDATED

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 REPOSITORY

Tissue Repository Consent Form
11/05

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
12/08
UPDATED

Parental Consent Form and Authorization for Studies with a Certificate of Confidentiality
12/08 UPDATED

Spanish Consent Form and Authorization for Studies with a Certificate of Confidentiality
4/03

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

 

 

 

 

 

 

 

 

 

 

 

 

ASK AN EDITOR

Have questions about writing or editing a consent document? Email Ann Ogletree for help.

SUGGESTIONS
The consent editing team is always open to suggestions. Are there new descriptions of procedures, risks, or other consent elements that you would like available in plain language? Please let us know! Email Ann Ogletree with suggestions.

 

A CONSENT WRITER'S WORKSHOP

Plain Language and Informed Consent

Can you write a consent form at the 8th-Grade reading level? Yes, you can! Invest some time and get some hands-on training by attending a "Plain Language" research consent form writing workshop. These sessions are designed for any research community members who write or edit consent forms. Ann Ogletree, Sr. Human Research Specialist and Consent Editor, will be presenting.

To register, email aogletree@partners.org, and specify which dates work for you. Include your phone number, please. Feel free to attend at either campus. Seating is limited to 14 at each session, so please list all possible dates. Note: There will be no workshops in May.

DATE TIME LOCATION
June 11, 2009 1:00pm-4:00pm MGH Yawkey Center, Room 4-820
June 17, 2009 9:30am-12:30pm BWH One Brigham Circle, Room 4-002G
July 14, 2009 1:30pm-4:30pm BWH One Brigham Circle, Room 4-002G
July 17, 2009 9:30am-12:30pm MGH Yawkey Center, Room 10-640
August 3, 2009 1:30pm-4:30pm MGH Yawkey Center, Room 4-820
August 20, 2009 1:30pm-4:30pm BWH One Brigham Circle, Room 4-002G