New Coordinator
Training
Developed and Presented by the Study
Coordinators' Advisory Committee
Study Coordinators' Advisory
Committee
Mission Statement:
The Wayne State University (WSU) Study
Coordinators’ Advisory Committee (SCAC):
Provides guidance, networking, and mentoring to
study coordinators, and
Acts as liaison to the IRB for the WSU research
community to discuss areas of concern regarding
human research.
The committee is open to all who are interested
Resources From the WSU IRB




The Investigator Handbook - comprehensive
document containing everything you need to
know to gain Institutional Review Board (IRB)
approval.
Join the IRB Research Listserv - form
changes, training opportunities, policy changes
and other occasional announcements.
Tools, links, and resource documents
All are at IRB website www.irb.wayne.edu
Key Points

Acronym





IRB: Institutional Review Board
View IRB as a helpful collaborator
No human research activity without IRB
approval
You cannot exempt yourself, all studies must be
reviewed by IRB.
Call if you are unsure if the project requires IRB
review
Contact Information
Institutional Review Board (IRB)
87 E. Canfield, Second Floor
Detroit , MI 48201
(313) 577-1628
www.irb.wayne



Education Coordinator (313) 577-9534
Associate Director (313) 993-7155
Link to SCAC information, membership list , SCAC
Handbook and listserv sign-up at the IRB website:

http://irb.wayne.edu/study_coord_adv_comm.php
Review Process

Review Boards:

Medical (M1, MP2, MP4, & PH1)
MP2 & MP4 - Pediatrics and adults
M1 – adults and VA
PH1- Phase 1clinical trials


Social, Behavioral , Education (B3)
Types of Reviews: Exempt, Expedited, Full Board
No submission deadlines for exempt and expedited
review
 See IRB website for deadlines for full board review

Review Process



IRB is the “Final” step for most protocols.
Some units of WSU and its affiliates require prereview (VAMC, DMC, KCI’s PRMC, Oakwood
& Psychiatry, etc.) before the protocol is
submitted to the WSU IRB
Always check with your institution about other
reviews prior to sendin
IRB Forms
http://irb.wayne.edu/forms-requirements-categories.php
Essential to have the correct version, always download a new copy:
 Medical/Behavioral Protocol Summary Form
 For all expedited and full board Studies
 Appendices-Children, Prisoners, Biological Specimens, etc
 Medical Exempt Protocol Summary Form
 Social, Behavioral , Education Exempt Protocol Summary Form
 HIPAA Summary Form
 Amendment Submission Form
 Continuation Form-submit 7 weeks before expiration.
 Closure Form-Submit when all data collection is done and before
expiration.
 Repeatedly submitting after expiration is considered noncompliance.
Consent Templates












Behavioral Template
Behavioral Assent Template
Medical Template
Parental Permission Template
Parental School Permission Template
Parental School Information Sheet
Humanitarian Use Device Template
Assent Template
Information Sheet
Short Form Consents are available in Arabic, Bengali, Chinese,
Hindi, French, German, Italian, Polish, Russian, Spanish, and
Swahili
Available on IRB website
Do not remove any of the sections unless prompted to do so
Other IRB Forms












Unexpected Problem Form
Unexpected Problem Follow-up Form
Single Time Emergency Use of a Test Article
Coordinating Center Application
Humanitarian Use Device (HUD) Form
Administrative Application
Authorization to Use Another IRB for Protocol Approval
Agreement
Authorization to be the IRB of Record for Collaborating Entity
Data Use Agreement
Additional Key Personnel List
Amendment Forms-4
Continuation Form
Mandatory CITI Training




https://www.citiprogram.org/
Required training must be completed prior to
submitting a new protocol or adding new
personnel.
Renewal at WSU required every 3 years.
Transferable to other institutions that use CITI
program for mandatory education
Additional Training

Offered by the Education Coordinator weekly
(313) 577-9534 (see website for posting:
http://irb.wayne.edu/education.php)


IRB 101, Initial Submissions, Submitting
Continuations and Amendments, Informed
Consent: Highly Recommended
Other Presentations:



Unexpected Problem Reporting
Research Non-Compliance
Others tailored to your needs
The Informed Consent
Process and Options
Informed Consent Process







Must occur before any study procedures are done
Do not rush
Present a summary first to give the potential participant
a basic idea of the study
Present the full consent, reading to the participant if
needed
Allow time for questions
Go over key points in consent again
If requested provide an unsigned copy to take home for
further consideration
Informed Consent Process





Must make sure the participant fully understands
his/her rights and responsibilities
Each page must be initialed by the participant,
parent, and/or legally authorized representative (LAR)
Signatures and printed name with dates are
obtained from the participant or their LAR
Person obtaining consent signs and dates
Witness signs if applicable
Informed Consent Process






If sponsor requires, the PI also signs and dates
consent
Assent required for children 7-17
Refer to IRB Policy on Consent Process
Provide copies of the signed and dated
Informed Consent to the participant
Encourage review of the consent at each visit
Signature page should always be on last page,
with IRB approval stamp box
Informed Consent Process



Informed consent is an ongoing, interactive
process, rather than a one-time information
session
Any changes related to risk & approved by the
IRB must be re-consented.
Both parents must sign if pediatric study is high
risk. (level III)
Documentation

Must include key points of Informed Consent
process
 Was obtained before any study procedures
occurred
 Presented consent
 Time was allowed for questions
 Verbalized understanding
 Other pertinent details (witnesses, LAR, etc.)
 Signed copies given
Informed Consent Options






Written Consent
Parental Permission Form
Assent
Oral Consent
Information Sheet
Waiver of Consent
Assent





Simplified
Used for children under 18 and cognitively
impaired adults
Adult (Parent/LAR)still has to sign full
informed consent or parental permission form
Exception: Mother under 18 can consent for her
child, but not for herself-requires parental
permission
7-12 years oral assent; 13-17 years signed assent
Languages

If planning to enroll non-English speaking
participants: get informed consent document
translated in to language and IRB approved
prior to use
Certified translation or
 Forward and backward translation by two
independent people


If unplanned enrollment-use short form on
website and have translator available for it and
translating English version of consent
HIPAA
Health Insurance Portability and Accountability
Act of 1996 -Purpose
 To
improve portability of and continuity of
health insurance coverage , combat waste, fraud,
and abuse in health insurance and health care
delivery and simplify administration of health
insurance
 The Office of Civil Rights (DHHS) has oversight
 PHI: Protected Health Information: private
health information that is identifiable because it
contains:(name, address, phone, e-mail, MRN,
SS#, Health Insurance #, DL#, unique ID code,
etc.)
The Privacy Rule and HIPAA
 When
medical records, databases, archives, tissues, path
reports, images etc. are accessed for research data
collection purposes, HIPAA rules apply.
 A HIPAA Summary Form must be completed when
this is the case.
 If consent is being obtained, an HIPAA authorization
must also be signed.
 If a waiver of consent is being requested (for
retrospective chart reviews, for example) a waiver of
authorization should be requested.
HIPAA and Research
 PHI
that is USED and DISCLOSED must be clearly
identified on HIPAA Summary Form and HIPAA
Authorization Form and must match.
 The recipients (entities) to which PHI is disclosed must
be clearly identified on both forms.
 A Disclosure occurs when PHI is sent outside of WSU
and its affiliate institutions. (to sponsors, etc.)
 HIPAA Language from sponsor templates must not be
included in informed consent form.
 Authorized members of the institution’s workforce
have access to participant’s records.
HIPAA and Recruitment
into Research
 Someone
with a clinical relationship must first introduce
the study to potential participant, prior to research team
members approaching subject.
 This person does not need to be named as key
personnel on research.
 Mining research records to identify participants to
contact (if PHI is documented) must be covered by a
waiver of authorization(and consent waiver).
 Review of medical records to determine feasibility of
studying certain population does not require waivers
prior to accessing record.
Questions?





Don’t hesitate to call the IRB if you need help
(313) 577-1628
Consult the Investigator Handbook on the IRB website
(www.irb.wayne.edu)
Contact a member of the SCAC
Link to SCAC information, membership list , SCAC
Handbook and listserv
 http://irb.wayne.edu/study_coord_adv_comm.
php
Research Subject Advocate- Office of Research
Compliance-(313)577-9064