Betty Wilson, MS, CIP

Senior Compliance Specialist

Health Sciences IRB
 IRB approval
 Approved type of consent

 Approved process

 Any change to process, type or

document must be submitted to the IRB
for approval.
 Consent Documents
 Written Consent
 Wavier of Documentation of Consent
 Waiver or Alteration of Consent
 Assent
 Addendums
Waiver or Alteration of Consent
 Must meet all four criteria (typically retrospective chart
review)
(1) The research involves no more than minimal risk to
the subjects
(2) The waiver or alteration will not adversely affect the
rights and welfare of the subjects
(3) The research could not practicably be carried out
without the waiver or alteration
(4) Whenever appropriate, the subjects will be provided
with additional pertinent information after
participation.
Waiver of consent cannot be utilized in FDA regulated research except in accordance with
Emergency Use of a test article FDA 21 CFR 50.23 or planned emergency research FDA
21 CFR 50.24
Waiver of Documentation
 1) That the only record linking the subject and the
research would be the consent document and the
principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked
whether the subject wants documentation linking the
subject with the research, and the subject's wishes will
govern (45CFR 46.117 (c))
OR
 (2) That the research presents no more than minimal risk
of harm to subjects and involves no procedures for which
written consent is normally required outside of the
research context. (45CFR 46.117 (c) and 21CFR 56.109(c)(1))
 Written Consent
 Regulations speak to this consent type first
 Subject signs and Dates
 Person consenting signs the consent
 Witness if the subject cannot read or sign their
name
 Witness signature for VA subjects
 Document the process in source documents
 Subject or representative is given a copy of the
consent
 The process
 Not just the piece of paper
 Document the process
 Provide the paper copy to subject
 Discussion/questions
 Time to consider participation and Read the
consent
 Signing of consent
 Provide a copy for the subject
 May need to discuss again throughout study
 General Considerations
 Use the HS IRB template with University
header and IRB approval box
 Targeted at a 6th grade reading level
 Brief paragraphs
 Section headers to introduce topics
 Simple sentence structure
 Second person tense
 Consider size of font
 General Considerations (cont)
 Limit use of complex terms/provide lay terms
or descriptions
 Sufficient opportunity to consider whether or
not to participate
 Minimize the possibility of coercion
 Cannot appear to waive the subject's legal
rights
 Read the consent as if you are the participant
 Elements of Consent (required element)
 study involves research
 explanation of the purpose of research
 duration of participation (overall and
each visit)
 description of what is involved
(research/non-research)
 reasonably foreseeable risks /discomforts
 Elements cont.
 any benefits (not compensation)
 alternative procedures
 confidentiality
 if injured medical treatment is available/who
pays (greater than minimal risk)
 contact information for questions
 participation is voluntary/no penalty or loss of
benefits/ that the subject may discontinue
participation at any time
Additional requirements (when appropriate )
 any unforeseen risks if the subject becomes
pregnant (subject, embryo or fetus)
 circumstances when the investigator may
terminate a subject’s participation without the
subject's consent.
 whom to contact in the event of a research-
related injury to the subject
 any additional costs
Additional requirements (when appropriate)
 the consequences of a subject's decision to
withdraw subject and any procedures for
orderly termination

 significant new findings developed during the

course of the research which may relate to the
subject's willingness to continue participation
will be provided to the subject.
 Tissue/data bank consents
 Must have required elements
 Consider how long tissue/data will be stored
 Options for participants (genetic testing,
disease process related, etc)
 Future contact
 Results from testing
 Minors
 Children under 18
 Determination of whether a child can provide
assent (age, maturity, psychological state)
 May require more than one type of assent
process
 Written assent
 Waiver of documentation with a note in the
source documents
 A plan to consent for children who turn 18 while
participating
 Cognitively Impaired
 Decisionally -impaired adults or subjects under the
influence of medications, alcohol, severe pain,
degenerative diseases affecting the brain, or have
disabling handicaps.
 Plan to determine competency
 Determination of who may provide consent
 Can the subject provide assent
 Is extra time needed for choosing to participate
 If there is a potential to become competent – consent
 For VA studies please refer to VA policy
 Screening and Flyers
 Recruitment for study via flyer
 Subject calls
 Waiver of documentation of consent
 Any screening questions
 Documentation of the process
 If keeping information for future contact for other
studies
 If keeping information for screen failures
 Faxing consent
 Part of the complete consent process.
 The written consent document may be faxed to
the potential participant for review.
 The participant must be contacted by telephone
to allow the opportunity for questions.
 Once all information has been obtained to the
satisfaction of the participant, the participant
signed and dated consent form may be returned
via fax.
 Telephone Consent
 Written consent: the consent document must
be sent (certified mail or fax) to the potential
participant and then the consent process is
conducted over the telephone with both parties
reviewing the written documentation. The
consent signed by the participant or
participant’s LAR must be received by the study
before enrollment proceeds.

 Waiver of documentation of consent: The

information may be verbally presented to the
potential participant over the telephone.
Who can obtain Consent
 Significant risk, medical treatment studies require
a licensed physician be involved in the consent
process (medical or surgical intervention,
investigational or prescription drugs)
 Significant risk, non-treatment medical studies,
consent may be obtained non-physician PI or
other qualified, active member of the study
personnel
 Minimal risk studies, consent must be obtained by
a qualified, active member of the study personnel
 Consenting personnel must be on the study
 Re-consenting
 Amendment or event requiring re-consenting
 Consider the change
 Consider population that is enrolled
 Consider where subjects are in the study
process
 Describe this for the board
 Re-consent must be completed within 60 days
and IRB notified
 Consent Addendums
 Goes with the consent as an add on form

 Typically for when subjects are beyond

that point in the study or for a sub group

 Describes elements related to the new

information (new test, risks, benefits, etc)
 Other considerations
 Will you want to contact for future research
studies?
 Photo/Video/audio recording hospital release
form
 Withdraw forms