Informed Consent
Informed Consent
 Written, signed consent forms
 Oral consent
 Waiver of documentation of consent
 Assent
 HIPAA Authorization
 Waiver of consent
 Waiver of parental consent
 Passive consent
Elements of Consent
Identify the study as a UW-Madison
research project
Elements of Consent
Provide details as to exactly what
participation will involve
Total time commitment
Location
Description of all procedures that will be
involved
Elements of Consent
Risks
Risk is that which is beyond what participants
experience in their daily lives
Emotional
Breach of confidentiality
Elements of Consent
Benefits
Typically, “there are no direct benefits for
participating in this research”
Elements of Consent
Confidentiality
List all steps that the researcher(s) plan to
take to ensure confidentiality of the data
Encryption
Pseudonyms
Password protected laptop
Anonymous
Elements of Consent
Compensation
Drawings, raffles
Extra credit
Parking pass
Gift cards
If cash is offered– is the amount coercive?
Elements of Consent
Contact Information
Who the participants can contact with questions
Principal Investigator
Student researcher (optional)
IRB office
For international research– a local contact is required
Elements of Consent
A statement that participation is voluntary,
participants can quit/withdraw at any time
and that they can refuse to answer and/or
skip any questions they do no wish to
answer.
The Consent Form Wizard
The IRBs strongly recommend that you
use the Consent Form Wizard to draft
consent documents.
Informed Consent
Examples of parental consent, assent for
minors and oral consent for those aged 10
and under.
Combined Consent and HIPAA
Authorization
 HIPAA regulations define health information as
“any information, whether oral or recorded in any
form or medium that:
Is created or received by a health care provider, health
plan, public health authority, employer, life insurer,
school or university, or healthcare clearinghouse; and
Relates to past, present, or future physical or mental
health or condition of an individual; health care to an
individual; or the past, present, or future payment for the
provision of health care to an individual.
Combined Consent and HIPAA
Authorization
Protected Health Information (PHI)
includes any individually identifiable health
information. Identifiable refers not only to
data that is explicitly linked to a particular
individual. It also includes health
information with data items which
reasonably could be expected to allow
individual identification.
Combined Consent and HIPAA
Authorization


















Names
All geographic subdivisions smaller than a state (up to and including zip codes).
Dates directly related to an individual, including birth date, admission date, date of death.
Phone Numbers
Fax Numbers
E-mail addresses
Social Security Number
Medical Record Numbers
Health Plan Beneficiary Numbers
Account Numbers
Certificate/License Numbers
Vehicle Identifiers, including license plates
Device Identifiers and Serial Numbers
URL’s
IP Numbers
Biometric Identifiers
Full Face Photographic Images
Any other unique identifying code
Combined Consent and HIPAA
Authorization
In order to use PHI in a research study,
the research participant must grant
authorization.
The privacy rule authorization can be
included in the informed consent
document.
The authorization must be written in plain
language and must included all of the
required elements.
Combined Consent and HIPAA
Authorization
 Authorization Elements:
Description of PHI to be used or disclosed.
The name(s) of person(s) authrorized to make the
requested use or disclosure.
The name(s) of persons who may use the PHI or to
whom the covered entity may make the requested
disclosure.
Description of each purpose of the requested use or
disclosure. Researchers should note that this element
must be research study specific, not for future
unspecified research.
Combined Consent and HIPAA
Authorization
 Authorization Elements (Cont.):
Authorization expiration date or event that relates to the
individual or to the purpose of the use or disclosure
(“end of research study” or “none” can be used for
research purposes.
Signature of individual and date.
The individual’s right to revoke the authorization in
writing.
The potential for the PHI to be re-disclosed by the
recipient and no longer protected by the privacy rule
Additional Info
Exculpatory language
Proofread.
Double and triple-check to ensure that the
details in the protocol application match the
details on the consent form.
Signed consent forms should be retained
for 7 years after the end of the study.