Transcript Slide 1

Is it “Research” ?
If Yes, What Then?
Marianne McGrath, Ph.D., Chair
Institutional Review Board (IRB)
What’s an IRB?
• Because UM-Flint is an institution that receives federal
funding, we are required to have our research reviewed
by an Institutional Review Board (IRB)
• All research in the UM system, federally funded or not,
must be reviewed by one or more UM IRBs
• The main purpose of an IRB is to ensure the ethical
treatment of human participants in research
How is “Research” Defined?
• The federal government defines research
as, “systematic data collection efforts
intended to develop or contribute to
generalizable knowledge.” Examples:
– Presenting the Project/Results at a
Conference
– Writing a Paper That Describes the
Project/Results and Submitting it For
Publication (and it may or may not be
published; the intention was to publish it)
Examples of Non-Research
Projects
• Classroom activities where the results are
limited to class discussion/use
• Program/Department evaluations where the
results will be used only for modification and
improvement of that department
• Any Faculty/Staff/Student Project involving
human “information” that is not intended to be
shared in any public domain
• …All this being said, it’s still vital to consider:
The Participants
Whenever possible, information should be coded with
numbers to protect privacy and confidentiality
The benefits of participating should outweigh any
risks…and the risks should be minimal
If identifiable data are collected (videotapes, etc) it’s best to
consult the IRB for participant agreement forms, etc.
If vulnerable participants are involved (pregnant women,
children, individuals with cognitive impairments,
prisoners) it’s best to consult the IRB for suggestions
about ensuring safe & ethical treatment.
And if Your Project is Research
• {You may present all or parts of it at a
conference, or you may decide to try and
publish it at some point in time.}
• You must submit an application to the IRB.
– Our application/review process is known as
eResearch
eResearch
Michigan Program for Research
Information Management and
Education (MPRIME)
Principal Investigator (PI) /
Study Team Training
eResearch Overview
• What is it?
– eResearch is a Web-based system for submission,
routing, approval, and management of research
information.
– Initially, the system will be used for research involving
human volunteers.
– The system will help the University address its
obligation to conduct human research in accord with
relevant regulations.
– eResearch is a component of the University plan for
Human Research Participant Protection Program
(HRPPP) and is coordinated with the Accreditation
activities.
Benefits
• The application will be prepared by means of a “smart
form.” Built-in logic will guide PIs and SCs to relevant
questions, based on their responses.
• Validation of entered data will improve quality and may
reduce number of changes required after submission.
• Review and approval will be conducted online.
• Email notifications will include hyperlinks to specific
applications; the content of the correspondence will be
maintained on the database for future reference.
• Changes will be logged and time stamped.
To Submit an Application . . .
• The PI (principal investigator) needs to:
– Review information entered by the study
team (can print full application to review)
– Submit application electronically
– Re-submit if changes are required by an
ancillary committee, or an IRB Committee.
• The PI will also need to electronically
submit any adverse events,
amendments, and scheduled continuing
reviews.
New Application: Sections
Required Information
1.
2.
3.
General Project Info
Special Consideration Details
Vulnerable Subjects Details
13.
Compensation
33.
Minors
14.
Experimental Health Care Treatments and
Procedures
34.
Neonates
35.
Pregnant Women and/or Fetuses
15.
Drugs, Biologics, etc.
16.
Devices
36.
Lactating Women
17.
Placebo
37.
Women of Child Bearing Potential
18.
Biological Specimens
38.
Prisoners
19.
Stem Cells
39.
College Students
20.
Genetic Analysis
40.
Impaired Adults
21.
Ionizing Radiation
41.
Subjects Vulnerable to Coercion
22.
Organ/Tissue/Cell Transfer
Committee Details
23.
Gene Transfer
42.
GCRC Resources
24.
Secondary Data Analysis
43.
PRC Information
25.
Protected Health Information (HIPAA)
44.
Supporting Documents
26.
Epidemiology
27.
Deception Research
28.
Internet/Email
29.
Survey Research
30.
International
31.
Watching/Listening to Audiovisual Materials
32.
Data Safety Monitoring Plan
Sponsor Information
Performance Sites
4.
Project Abstract
5.
Research Design
6.
Benefits & Risk to Subjects
7.
Special Considerations
8.
Subject Populations
9.
Exemption
10.
Informed Consent
11.
Subjects
12.
Confidentiality
A Couple of Very Important Points:
1.Research is classified into different
“types,” depending on level of risk to
participant:
– Exempt
– Expedited
– Full Board Review
The Other Point!
• 2. Researchers cannot make this
determination/classification—the IRB
must, according to federal regulations.
eResearch Training
• Practice Lab and Hands-on Training
– These are scheduled throughout the year
• Learning Course
– Self-paced online tutorial available
– Go to eResearch.umich.edu and explore
the options!
In Addition to These Options
• Marianne McGrath is available to answer
questions: [email protected] 7623425
You May Be Asking…
• Why eResearch—why change from our former
procedures and “paper form” to eResearch and
other procedural changes?
• The main reason: Mary Sue Coleman,
President of University of Michigan, wants our
Human Research Participant Protection
Program (HRPPP)—of which IRBs are a vital
part, to be accredited. The eResearch
application incorporates accreditation standards
much more thoroughly than our old form.
Why is Accreditation Important?
• Improves protection programs (IRB functions,
and other aspects of the HRPPP)
• Assists in achieving compliance
• Facilitates research integrity and quality
• Instills confidence in sponsors
• Builds public trust (increased media attention to
violations of ethical treatment, lawsuits, and/or
shut-downs at Johns Hopkins, Iowa, Vermont,
etc.)
Who will Accreditation Affect?
• Generally, the entire UM system
• Specifically, researchers/principal investigators
with research projects currently approved and
those that have expired in the last three years
• Site visitors from the Association for
Accreditation of Human Research Protection
Programs (AAHRPP) will come to our campus
and IRB members and researchers/PIs will be
interviewed
How do researchers/PIs prepare
for Accreditation/Site Visits?
• Complete online training modules for
understanding the ethical treatment of human
participants in research and other issues—
become PEERRS certified:
• PEERRS helps you better understand aspects of
human research such as informed consent, riskbenefit ratio, etc.
• You’ll then better understand the eResearch
application form
http://www.research.umich.edu/training/peerrs.html
You’ll need your “kerberos” password for this and eResearch websites
Preparation for Accreditation
(continued)
• Learn eResearch as soon as possible
– Practice in eResearch “sandbox”
• Go to eresearch.umich.edu and click “Sandbox” on
the left side of the screen, then “Login to Sandbox”
– And the “real” eResearch is available today—
• Go to eresearch.umich.edu and click on Login
Becoming a Well-Informed
Researcher (continued)
• To learn more about non-biomedical
research and IRB review, visit
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
• Read the Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm
• To learn more about Accreditation
http://www.aahrpp.org/www.aspx
UM-Flint IRB Web Site
Please visit the UM-Flint IRB web site for
all questions, concerns, and
information regarding protection
of human subjects in research
http://humansubjects.umflint.edu
Summary & Questions
• Protect and respect human participants and their
information, in all projects, research and
otherwise
• If your project is “research”, understand the
responsibilities of being a researcher/PI or study
team member
• Help UM achieve the goal of accreditation of its
Human Research Participant Program—
including IRBs and research projects
• Questions/Concerns?