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MSU's Human Research Protection Program - Project Path

Explore the elements of Human Research Subject Protection
by

MSU Regulatory Affairs

on 15 January 2016

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Transcript of MSU's Human Research Protection Program - Project Path

H
uman
Ensures all human research at MSU will follow the ethical principles as stated in the Belmont Report and, laws and regulations governing human research, including 45 CFR 46 and all its subparts; The Institutional Official shares responsibility with the MSU HRPP, the IRBs, and researchers for the protection of human research participants.
Olds Hall, 2nd Fl
Institutional Official
Assistant VP for
Regulatory Affairs
Director HRPP
HRL
Manager
IRB Office
Manager
Human Research Liaisons
(Multiple FTE)
IRB Administrators
(Multiple FTE)
Institutional Review Board
(IRB) Committees
SIRB
BIRB
CRIB
WIRB
IRB members meet to review IRB applications. MSU IRBs includes faculty members and graduate students, non-affiliated and non-scientific members. IRB Chairs manage meetings, conduct noncompliance investigations, review unanticipated problems involving risks to subjects or others, and mediate participant complaints.
Reviews studies in the biomedical and clinical departments, with the exception of multi-community research. These colleges include the College of Human Medicine, Nursing, and Osteopathic Medicine.
Reviews non-biomedical human research studies from the non-biomedical or clinical departments.
Review studies typically from Colleges:
Agriculture and Natural Resources,
Arts and Letters,
Education,
Business,
Communication Arts and Sciences,
International Studies and Programs,
James Madison,
Music,
Natural Science,
Social Science,
Plus studies conducted by
Urban Affairs Program,
MSU Libraries,
MSU Museum,
Women’s Resource Center,
Residence Life,
Counseling Center, and
Career Services and Placement.
VPRGS
Dr. Stephen Hsu
J.R. Haywood, PhD
Kristen Burt, JD
Human Research Protection Program
Administrative
Assistance II/S
Student
Employees
Oversees daily operations
Process & perform pre-review of incoming applications, review exempt applications, and coordinate the IRB review process.
Liaisons conduct site visits to investigator labs, offices, or facilities.

They assist investigators after the site visit and perform oversight activities related to FDA regulated studies. Liaisons conduct internal monitoring, and provides outreach and education to investigators.
Provides administrative oversight over the HRPP, including the IRB and HRL offices and directs oversight activities related to clinical research activities as appropriate.
Vice President Research & Graduate Studies
Human Research Liaison
(HRL) Program
Oversees daily operations
Institutional Review Board
(IRB) Office
Visit Us
General concerns, reviews, forms, deadlines and meetings or committee decisions:
Main Office
T: (517)355-2180

Compliance, concerns, or to report a complaint:
Harry McGee, MPH - Chair, SIRB
T: (517)355-2180
Ashir Kumar - Chair, BIRB
T: (517)355-2180
Kristen Burt- Director, Human Research Protection Program
T: (517)884-6020

Subject welfare and the review process
Harry McGee - Chair, SIRB
T: (517)355-2180
Ashir Kumar - Chair, BIRB
T: (517)355-2180

HIPAA Research Privacy Board
Barbara Decker - IRB Administrator III
T: (517)884-6017
Harry McGee - Chair, SIRB
Phone: (517)355-2180
Rebecca Gore - IRB Admin III
Phone: (517)355-2181
Emails: IRB@msu.edu
Ashir Kumar - Chair, BIRB
Phone: (517)355-2180
Barbara Decker - IRB Admin III
Phone: (517)884-6017

Emails: IRB@msu.edu
Ashir Kumar - Chair, BIRB
Phone: (517)355-2180
Barbara Decker - IRB Admin III
Phone: (517)884-6017

Emails: IRB@msu.edu
Questions?
Call Us!
Email: IRB@msu.edu
Your questions & Comments
Email: HRL@ora.msu.edu
Judy McMillan, Manager
Human Research Liaison Program
T: (517)-432-4502

Liaisons
Katy Hunsch
T: (517)355-2180

Jackque Perrin
T: (517)355-2180

Tracy Walker
T: (517)884-0295
Questions? Contact Us!
Reviews biomedical applications for research that will be conducted at two or more partner institutions or multi-community research.
Social Science/Behavioral/Education Institutional Review Board -
Biomedical and Health Institutional Review Board (BIRB) -
The Community Research Institutional Review Board (CRIRB) -
MSU HRPP Manual 4-4
You must create an
IRB Application
online
close
study
Your questions & Comments
Email: HRL@ora.msu.edu
report changes to
the protocol
Start your
research
project!
E: IRB@msu.edu
E: HRL@ora.msu.edu
T: 517-355-2180
Approval
Begin Project Planning
report any unanticipated
event
This is a prezi-presentation.
....Scroll mouse WHEEL to move in
closer or back out.
Exempt
R
P
esearch
rotection
rogram
P
Research in which the only involvement of human participants will be in one or more of the six exempt categories (for HHS) or the four exempt categories (for FDA) is exempt from the human research protection regulations. This means that a research study that is determined to meet the criteria for exempt status by the MSU IRB is exempt from further initial and continuing review by the IRB, with the exception of limited PI required reporting. However, exempt research is not exempt from protection of human participants and application of the ethical principles outlined in the Belmont Report such as informed consent, equitable selection, and risk/benefit assessment.
Exempt
A research study that is determined to meet one or more of nine categories (in HHS & FDA) and is no more than minimal risk can undergo expedited review. These projects are still subject to the regulations for the protection of humans involved in research.

These projects can be reviewed and approved by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB.
The project does not need to be reviewed by the full convened IRB to receive approval. It can be approved between IRB meetings (a faster schedule).
Full Board
Full Board: At MSU, convened meeting dates and deadlines are posted on the human research website. If an initial application is submitted by the submission deadline, it will be placed on the upcoming IRB meeting’s agenda for review.
At MSU, IRB administrators make the determination of exempt status . Processing of applications for exempt status is estimated to take 7-9 working days.
Typically, the submission deadline is approximately 3 weeks before the meeting date.
Review times are estimated to take 4-6 weeks for initial applications, 10-15 2-4 weeks for revision to an approved study, and 3-6 weeks for renewed approval.
How long?
How many days?
Expedited
Contact the HRPP office for assistance.
IRB Office where it is reviewed.
Contact Us
Human research requirements feel like a maze?
We can help.
How to Explore
....Click, Hold, and Pull the screen
...Click an object to get closer.
Take your
IRB is part of MSU's larger Human Research Protection Program.
Responsibilities:
Your project proposal may go to...
IRB make a "determination" on whether your study will ensure participants rights are protected.
Determinations
Part B: Basic Ethical Principles
...Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.

In carrying out the above, the Commission was directed to consider:
(i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
(ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
(iii) appropriate guidelines for the selection of human subjects for participation in such research and
(iv) the nature and definition of informed consent in various research settings.
About Belmont Commission
Type of review will depend upon many factors
Federal Code of Regulations
At MSU, the FDA regulations for the protection of human subjects are applicable when a planned activity is a FDA regulated clinical investigation involving human subjects.

The FDA human subject protection regulations have similarities to the HHS regulations but do have differences, such as the scope of oversight (clinical investigations), provisions for emergency use, and differing informed consent requirements such as inclusion of language regarding FDA access to records and registration on the clinicaltrials.gov website when appropriate.

In addition, the FDA has other regulations that may be applicable to a research activity, such as regulations that apply to the use of investigational new drugs and investigational devices.
FDA
U.S. Food and Drug Administration
The Family Educational Rights and Privacy Act: Federal requirements for the protection of privacy of students’ educational records.
See MSU-specific guidelines at http://goo.gl/Y6xDA
The Protection of Pupil Rights Amendment:
Federal law sets forth additional requirements in elementary and/or secondary public schools when certain activities are conducted (e.g. survey, analysis, physical examinations) or if funded by the Department of Education (e.g. surveys, analysis, or evaluation).
PPRA
The Health Information Portability and Accountability Act:
Federal legal requirements for use or disclosure of protected health information.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
But during the study, don't forget to...
IRB Committee
or request
changes to improve participants' rights.
Once approved you can...
Of course when your project ends.
Let the HRPP office know.
chances
The IRB may ask for more project information,
So it is better to
apply early
, with plenty of time before your planned
start.
This is why....
Different reviews take different amounts of time.
Read exempt categories at http://goo.gl/2ojcw
All based on historical perspective showing a need to protect human research participants.
U.S. Office of Human Research Protection
Click for video info from the
Vulnerable Subjects Discussion (28 min.)
Informed Consent Interview Example (18 min.)
FERPA
HIPAA
HRP staff can direct you to several MSU HIPAA forms. Or download forms at http://HumanResearch.msu.edu
Attention is given to
Vulnerable Subjects - children, prisoners, etc
Subject Selection
specific risk areas
Nuremberg Trials
Stanford Prison Experiment
As well as on-going examples of researchers' poor judgment in regards to treatment of their research subjects.
The committee of volunteers only meets once a month.
Responsibilites
Click an image for details.
At MSU, IRB administrators make the determination of exempt status .

Processing of applications for exempt status is estimated to take 7-9 working days.
How long will it take?
Type of review depends upon the risk to the subjects.
including...
Your application goes to the
Click the NEXT ARROW BELOW
Follow the IRB Application Process
(http://humanresearch.msu.edu)
When assessing subject selection, researchers should consider:
Purpose of research, requirements of proposed study design, and subject population
Recruitment and enrollment procedures
Fairness and equitability of proposed research design
Inclusion and exclusion criteria
Payments to subjects and potential influence
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The informed consent process must:
Allow the prospective participant or representative sufficient opportunity to decide whether or not to participate.
Minimize the possibility for coercion or undue influence.
Include information that is given to the prospective participant or representative in a language understandable to the subject.

The informed consent process cannot include any exculpatory language:
Through which the prospective participant or representative waives or appears to waive any of the participant’s legal rights.
That releases or appears to release the investigator, sponsor, institution, or agent from liability for negligence.
Contacts
Developed by Candace
more human research protection training ideas
at https://sites.google.com/site/indesigns2015/home
Full transcript