Human Subjects Research Meeting Requirements - Darden College ...

HUMAN SUBJECTS
RESEARCH AT ODU:
NUTS AND BOLTS
Dr. Stacie Raymer
Dept. of Communication
Disorders & Special Education
DCOE Rep to University IRB

HUMAN SUBJECTS RESEARCH DEFINED
•Any “systematic investigation” asking
humans to perform tests or tasks in
order to contribute to “generalizable
knowledge”
•Requires Informed Consent
•Some Exemption categories exist

WHY
• Famous documented cases where humans were
abused in the context of research
• Nuremberg Code (1948): following abuses that went
on by German physicians during WWII
• Belmont Report (1974) : following abuses in US
e.g., Tuskegee airmen study, stuttering study
Respect for Persons
Beneficence
Justice

VERY IMPORTANT
•Federal regulations and State codes
•All human subjects research must
be approved before conducting the
study
•Failure to do so places
the investigator and the
institution at great risk

WHO REVIEWS THE RESEARCH
•IRB = Institutional Review Board
University committee
Reviews all full submissions
Reviews exempt submissions with Federal
funding/support
•Human Subjects Committee
College committee
Reviews only exempt submissions

EXEMPT OR FULL REVIEW
Full review unless meet one of
exemption categories:
**6.1 Educational settings
**6.2 Anonymous low-risk tests, surveys, public
behaviors
•6.3 Elected officials and candidates for office
**6.4 Existing data, de-identified
•6.5 Not applicable to universities
•6.6 Taste and food quality/consumer studies

FORMS AND INFORMATION AT ODU
•Office of Research
•http://www.odu.edu/ao/research/compliance
/humans.shtml
IRB Deadlines:
•Submission: 2 nd Monday of month
•Meeting: 3 rd Thursday of month
•Recommend investigator or a
representative attend the meeting

FULL SUBMISSION
• Human Subjects Research Review Application Form
• Informed Consent Document
• Human subjects training certificate (CITI)
If applicable:
• Informed Consent Document for Parents
• Assent Form (for children)
• Cover Letter
• Tests and Protocols for the project
• Send all pdf files electronically and signed hard copy
- to Adam Rubenstein in Office of Research

FULL SUBMISSION: COMMON ISSUES
• RPI: Responsible Project Investigator
Faculty or staff member at ODU
*Include this phrase in the consent form, too
e.g. Anastasia Raymer, Responsible Project
Investigator, Professor, Dept of Communication
Disorders & Special Education
• Co-Investigators:
All people involved in the project should be named
in the application and on the consent form –
whether collecting data, analyzing data, planning
and interpreting results of study

FULL SUBMISSION: COMMON ISSUES
DATES OF RESEARCH
•Full submissions: 1 year approval
Dates: Fill in the full year
3a. Date you wish to start research
(MM/DD/YY): ______/______/______
3b. Date you plan to end research
(MM/DD/YY): ______/______/_____ (End date
for data collection and analysis)
•Progress report due by 1 yr anniversary

FULL SUBMISSION: COMMON ISSUES
DATES OF RESEARCH
•Exempt research: approved for life of the
project
•If any changes are made, must notify
committee for re-approval
•Allow plenty of time for the approval process –
ODU is very efficient, but you never know if
there will be an issue to slow you down

FULL SUBMISSION: COMMON ISSUES
CHILDREN IN RESEARCH
•Children,

FULL SUBMISSION: COMMON ISSUES
COMPENSATION
•OK to give class credit or reasonable
compensation
•Do not make it coercive
•Use procedures to avoid coercion if planning
research in your own classroom

FULL SUBMISSION: COMMON ISSUES
RISKS & BENEFITS
•Most studies have at least some risk –
e.g., release of confidential information
• Yet don’t overstate the risks
•Class credit or a payment is not a benefit
•OK to say there is no direct benefit
•Talk about potential benefit, if there is one

FULL SUBMISSION: COMMON ISSUES
ANONYMITY
•Anonymous and Confidential are different
•Much research involves confidential data as
you work directly with the pt
• Describe procedures to safeguard
data/separate data from the name
of pt

HUMAN SUBJECTS TRAINING
• All RPIs and graduate students completing research
projects/dissertations must complete CITI
(Collaborative Institutional Training Initiative) training
annually: Human subjects research (Social/Behavioral
Research) course - link on Office of Research page
• HIPAA training (if applicable): complete CITI modules
for Health Information Privacy and Security
• CITI Responsible Conduct of Research (RCR) modules:
not the same as Human Subjects Training; optional for
RPI but required for all graduate students in first year;
does not have to be renewed

FULL SUBMISSION: CONSENT FORMS
•Use second person language: You will….
•If Parent Permission form, use appropriate
language – Your child will….
•Assent form for children: keep it simple
•Some studies with teachers and children
might require three different forms for all
participants involved: teachers, parents,
children

FULL SUBMISSION: CONSENT FORMS
Description of the study
•Use common language; avoid jargon
•Avoid making description too wordy, yet
explain what the participant is asked to do
•Do not use biasing language
•State how much time commitment is required
•State how many other participants are part of
the study
•Note whether any recordings will take place

FULL SUBMISSION: CONSENT FORM
•Exclusionary Criteria: Actually inclusionary and
exclusionary criteria
•Risks/Benefits/Costs/Payments: same
wording here as in application
•Signatures: remove if not applicable
Subject's Printed Name & Signature
Date
Parent / Legally Authorized Representative’s
Printed Name & Signature (If applicable)
Witness' Printed Name & Signature (if applicable)
Date
Date

REVISIONS AFTER THE MEETING
•There will be revisions – there
always are!
•Revise documents and send signed
hard copy directly to George
Maihafer

EXPEDITED REVIEW
•If minor changes to already approved project
•If approved at another institution
•Provide cover letter and other materials
describing changes or prior approval process
•Send signed hard copy to IRB chair:
Dr. George Maihafer

PROGRESS REPORT
•Human subjects Research Progress Report
form
•Due by the anniversary date of approval
•Must maintain continuing approval, even if
only analyzing data or writing manuscript
•Keep accurate tally of number of pts enrolled
in each year
•RPI CITI training up-to-date

ADVERSE EVENTS
•Any illness, injury experienced by a research
participant during the time of enrollment
•Can occur during the study
•Also includes illness or injury
outside the time of the study in
ongoing studies
•Unexpected: not listed as a risk on the
consent form
•Serious AE: results in death, life threatening
situation, hospitalization, significant
disability, birth defect

ADVERSE EVENTS
•All AEs must be reported to IRB
•Serious or Unexpected AEs must be reported
within 5 days
•Neither serious nor unexpected: must be
reported within 1 month
•Use Adverse Event Reporting form
•Serious AEs (expected or unexpected) require
doctor’s opinion and signature
Send in form and resend once
doctor’s signature obtained

CLOSE OUT REPORT
•Human Subjects Research Close-Out Report
form
•Required for Full submissions, not exempt
•Send signed hard copy to Adam Rubenstein