Transcript Human Subjects Research and Scholarly Activity

Human Subjects Research
and Scholarly Activity
Ms. Denise Ball
Associate Director, Office of the Institutional Review
Board for Human Use
Human Subjects Research & the IRB
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Institutional Review Board for Human
Use (IRB) The committee that reviews all UAB
research involving human subjects. The aim of the
IRB review is to protect the rights and welfare of
study participants.
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The IRB review is based on the three ethical
principles described in the Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guid
ance/belmont.htm - April 1979
Belmont Report – Ethical Principles
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Respect for Persons – autonomous agents,
respect people with diminished autonomy or
capacity for decision making.
Beneficence – Risk vs. Benefit - not all risks
physical – risk to reputation, employability,
financial standing, etc.
Justice – Risks and possible benefits of
research to be equally shared by all that may
benefit from the research.
Research
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Research - a systematic
investigation including research
development, testing, and
evaluation; designed to develop or
contribute to generalizable
knowledge. (45 CFR 46)
Human Subject
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A living individual(s) about whom an
investigator (whether professional or student)
conducting research obtains:
(1) data through intervention or interaction
with the individual, or
(2) identifiable private information.
(45 CFR 46)
Definitions 
Intervention: Includes both physical
procedures and manipulation of the subject
or his environment for research purposes.
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Interaction: Includes communication or
interpersonal contact between investigator
and subjects.
Definitions (continued)
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Private Information - Includes information
about behavior that occurs in a context in
which an individual can reasonably expect
that no observation or recording is taking
place, and information which has been
provided for specific purposes by an
individual and which the individual can
reasonably expect will not be made public
(e.g. med record).
Human Subjects - examples
Not only living persons, but also human tissue,
blood samples, diagnostic/pathologic
specimens, study of medical records,
observation of public behavior, and all
questionnaires.
Not Human Subjects Designation
 Cadaveric Materials,
 Cell Lines
Former UCLA exec pleads guilty to body
trafficking – October 17, 2008
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LOS ANGELES (AP) — The former chief of UCLA's
cadaver program pleaded guilty Friday for his role in
selling donated body parts to medical, drug and research
companies in a scheme that netted up to $1 million,
prosecutors said.
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Henry Reid, 58, pleaded guilty in Los Angeles County
Superior Court to one count of conspiracy to commit
grand theft, with a special allegation that he damaged or
destroyed more than $1 million worth of school property,
which refers to the donated bodies.
IRB Application Types
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No Humans – cadaveric/cell lines
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Exemption – little or no risk, no identifiers
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Expedited Review – Minimal Risk (the risk in
daily living)
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Full Review – more than minimal risk vulnerable subject groups, investigational
drugs, investigational devices
Not Human Subjects Designation
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Cell lines, Cadavers, Use of data in which the
participants cannot be linked to data – written
agreement must be in place.
What is de-identified data?
What is anonymized data?
Is there a code/link? If so, who keeps the
code, who has access, will the code be
broken????
Not Human Subjects Designation
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http://www.uab.edu/irb/forms/nhsr.doc
No Human Subjects Training Required
No Protocol Oversight Review by Department
(protocol oversight review is for scientific
integrity/validity)
Need signature of faculty advisor/mentor
No continuing review required
Student may be listed as Principal
Investigator
Exemption Review
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http://www.uab.edu/irb/forms/irb-exemptionreview.doc
Training is required, initial and biennial
continuing
Protocol Oversight Review by Department
Signature of Advisor
Address Informed Consent
Continuing Review/Final Report Required
Student Listed as Principal Investigator
Expedited & Full (convened) Review
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http://www.uab.edu/irb/forms/hsp.doc - the
Human Subjects Protocol
Training is required, initial and biennial
continuing
Protocol Oversight Review by Department
Signature of Advisor
Address Informed Consent
Continuing Review/Final Report Required
Student Listed as Principal Investigator
Expedited & Full (convened) Review
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Full reviews have deadline dates http://main.uab.edu/show.asp?durki=60362
Special Approvals – as applicable
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Hospital, TKC, Children’s, Highlands, etc.
Off-campus locations
International locations – Ethics review locally for
issues of local context
Radiation Safety, Pharmacy, Biosafety
Changes (Amendments) to Approved
Protocols
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If your advisor will add you to an existing,
approved protocol – he/she must submit an
amendment to that protocol.
http://www.uab.edu/irb/forms/project-revisionamendment.doc
Amendment must clearly state the student’s
name and role/duties associated with the
protocol (data collection, data analysis,
informed consent, etc.).
Changes (Amendments) to Approved
Protocols (continued)
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If the students’ work is for a dissertation ir
thesis the name of the thesis should be
included on the amendment form.
Student are required to have human subjects
training.
The IRB may require that the student have a
separate application based on the extent of
the student’s work and independence.
Amendment Form - Example
1. Contact Information
Principal Investigator's Name: Dr. Faculty Member BlazerID: facultymember
E-mail: [email protected]
Contact Person's Name: Ann Assistant BlazerID: aass
E-mail: [email protected]
Telephone: 4-3789 Fax: 4-1301 Campus Address: Old Hillman Building
2. Protocol Identification
Protocol Title: Faculty Member’s Protocol
IRB Protocol Number: F100100100
Current Status of Project (check only one):
Currently in Progress (Number of participants entered:100)
Study has not yet begun (No participants entered)
Closed to participant enrollment (remains active)—
Number of participants on therapy/intervention:
Number of participants in long-term follow-up only:
Closed to participant enrollment (data analysis only)—
Total number of participants enrolled:
Amendment Form - Example
This submission changes the status of this study in the following manner
(check all that apply):
Protocol Revision
Revised Consent Form
Protocol Amendment
Addendum (new) consent form
Study Closed to participant entry Enrollment temporarily suspended by
sponsor
Study Closure
Change in protocol personnel
Other, (specify)
3. Reason for change
Briefly describe, and explain the reason for, the change. If normal, healthy controls
are included, describe in detail how this change will affect those participants.
Include a copy of the protocol and any other documents affected by this change
(e.g., consent form, questionnaire) with all the changes highlighted.
I am requesting that Medical Student, John Doe be added to this protocol. Mr.
Doe will be involved in data collection, data analysis (please be specific) as part
of his MS-2 scholarly activity project. He has completed human subjects
training. Note if you will be using data, obtaining samples, etc or if you plan to
use the information/specimens for a dissertation, you will need to include the
title of the dissertation here as well.
Amendment Form (continued)
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Must be specific to each student’s work
Address applicable items for student’s work
and put n/a if not applicable
Informed Consent
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Informed consent is the cornerstone of research with
people
Informed Consent Document with signatures
Verbal Consent with documentation waived – no
signature
Waiver of Informed Consent
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Minimal risk research
Waiver or alteration will not adversely affect the rights and welfare of
participants
Research could not be practicably be carried out without
waiver/alteration
Additional Information provided when appropriate
For more info – see 45 CFR 46.116
Informed Consent – Essex IRB Study
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578 individuals randomly selected to assess level of
understanding of some commonly used terms in
consent forms
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Results:
A placebo is a small animal like an amoeba.
Double-blind means being blind in both eyes.
Serum is a drug.
An Institutional Review Board is a committee in a
hospital that reviews your medical records to see
whether or not you should be institutionalized.
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Other examples of consent form outtakes...
“The autopsy will have no benefit to you.”
“This page left intestinally blank”
A note about expository writing....
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How to make a peanut butter and jelly
sandwich
How to contact the IRB
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[email protected]
470 Administration Building, 701 20th Street
South
205.934.3789 – phone
205.934.1301 – Fax
http://main.uab.edu/show.asp?durki=30246
or www.uab.edu/irb
Questions?