WHAT IS AN IRB AND WHY SHOULD I
CARE?
B E T H TA R A B A N
RESEARCH INTEGRIT Y OFFICE
IRB--DEFINITION
An Institutional Review Board is a committee
whose primary responsibility is to protect
rights and welfare of human research
participants.
IRB review is required for all federallyfunded research involving human
participants. The procedures for research
review are set out in the Code of Federal
Regulations (CFR).
IRB DEFINITION--CONTINUED
Most institutions (including TTUHSC) have
elected to abide by the CFR regulations
for human research review even for
research that is not federally funded.
The FDA also requires IRB review and
approval of research for any research
involving a drug, a biologic or a medical
device.
FEDERAL REGULATIONS--GENERAL
Biomedical IRBs are regulated by two groups:
Department of Health & Human Services (DHHS)—
Office of Human Research Protection (OHRP)
DHHS rules for IRBs can be found in 45 CFR 46 and
subparts B,C, and D which offer special
protections for pregnant women,
fetuses/neonates, prisoners and children
And by the
Food and Drug Administration (FDA)
FDA rules can be found in 21 CFR 50 and 21 CFR
56
THE “COMMON RULE” (45 CFR 46)
 The Common Rule is a federal policy regarding Human subjects
Protection that applies to 17 Federal agencies and offices that have
signed the agreement and is enforced by OHRP
The main elements of the Common rule include requirements for:
1. Assuring compliance by research institutions
2. Researchers’ obtaining and documenting informed consent
3. Institutional Review Board (IRB) membership, function,
operations, review of research, and record keeping
 The Common Rule includes additional protections for certain
vulnerable research subjects
• Subpart B-Pregnant women and fetuses
• Subpart C- Prisoners
• Subpart D- children
FEDERAL REGULATIONS--CONTINUED
Failure to follow either the DHHS
regulations or the FDA regulations
can result in penalties for individual
researchers and for the institutions
themselves—a single rogue
researcher can halt ALL HUMAN
RESEARCH at an institution!
WHAT IS RESEARCH?
Research is defined as any systematic
investigation, including research
development, testing, and evaluation,
designed to develop or contribute to
generalizable knowledge.
Source: 45 CFR 46.102(2)
WHAT IS HUMAN RESEARCH
Human subjects are defined as living individuals
about whom an investigator conducting
research obtains
1) Data through intervention or interaction with
the individual or
2) Identifiable private information
Source: 45 CFR 46.102(f)
SO, IS THIS RESEARCH OR NOT??
When in doubt,
Contact your local IRB Administrator
Lubbock—Karen Douglas—806-743-4753
Amarillo—Kathy Thomas—806-354-5419
OR
Check the very cool decision trees at the OHRP
website:
http://www.hhs.gov/ohrp/policy/checklists/decision
charts.html
OK, IT’S HUMAN RESEARCH, I NEED IRB
APPROVAL. NOW WHAT?
Training requirements for ALL study personnel involved in
human research at TTUHSC :
CITI Biomedical Investigator Course
(13 modules) Retraining required every 3 years
CITI Financial Conflicts of Interest Course
(2 modules) Retraining required every 4 years
www.citiprogram.org
I FINISHED CITI. NOW CAN I SUBMIT MY
PROJECT?
Not yet. First, you need to get access to the iRIS
program—this is an internet based program through
which all communication TO and FROM the IRB takes
place.
Obtain iRIS access by clicking the “Request a New
Account” button at the iRIS website:
www.sobmrimedris.ttuhsc.edu
Training specific to using iRIS can be arranged through
the IRB office.
A LITTLE MORE ON CITI
Registering at www.citiprogram.org is pretty simple.
However, if you would like step-by-step
instructions, with pictures, you can find answers
at the CITI Support Center.
Here is the link to the “How do I enroll in a CITI
course for the first time?” instructions (updated
1/24/14)
http://citiprogram.desk.com/customer/portal/arti
cles/163300-how-do-i-enroll-in-a-citi-course-forthe-first-time-
I HAVE CITI AND IRIS.
Can I send my study for IRB review NOW?
Almost! You are SO CLOSE! Do you have
an up-to-date financial disclosure form
on file?
YES, goshdarnit—and believe me, that’s not the
word I was really thinking!!
OK. You can submit your research project
for IRB review now.
IRB COMPOSITION
Federal regulations govern IRB composition:
At
At
At
At
least 5 members
least one “scientist” member
least one “non-scientist” member
least one member who is otherwise unaffiliated with the
institution
At least one member who is considered a “participant
advocate.”
Diversity regarding gender, background, etc. to represent
the types of research reviewed
TTUHSC IRB COMPOSITION
TTUHSC has 2 IRBs
(Lubbock/Odessa/Midland and
Amarillo/Dallas/Abilene)
Most IRB members are TTUHSC
faculty
The members spend, on average 4-6
hours per month preparing for and
attending the IRB meeting
Current list of members available on
IRB website:
www.ttuhsc.edu/research/hrpo/IRB
IRB REGULATIONS—RESEARCH APPROVAL
• Risks to subjects are minimized
• Risks are reasonable in relation to potential
benefits
• Selection of subjects is equitable
• Informed consent will be sought and
documented for each subject
• Ongoing monitoring will occur to ensure subject
safety
• Adequate provisions exist to protect privacy
• Special safeguards are in place for vulnerable
subjects
WHAT IS THE IRB LOOKING FOR?
TTUHSC IRB reviewers are looking for:
1) Protection of subject safety and wellbeing)
1a) Scientific validity of the research
project
1b) Qualification of investigators to
conduct research
1c) Adherence with federal regulations and
TTUHSC policies.
TYPES OF IRB REVIEW
Exempt projects
Expedited
Full Board review
IRB REVIEW--EXEMPT PROJECTS
Exempt studies are “exempt” from the federal regulations
Generally, these are:
a) studies that are done as part of normal classroom
procedures for which you don’t collect any identifying
information
b) surveys or questionnaires of adults in which you don’t get
any identifying information and don’t ask any sensitive
questions or
c) retrospective research in which all of the data are already
in existence and you won’t be recording any identifying
information.
A-HA! MY STUDY IS EXEMPT FROM IRB REVIEW, SO I DON’T
HAVE TO SUBMIT ANYTHING TO YOU, RIGHT?
~~WRONG~~
The federal regulations say that the
investigator can not be the one to decide if
a project is exempt.
TTUHSC has decided that the IRBs will make
that decision.
SUBMITTING AN EXEMPT STUDY
If it’s a retrospective chart review, you need to submit:
Your IRB application
Your protocol
Be sure in your protocol to clearly state the following two things:
1) The data are all in existence AS OF THE DATE of the IRB
application. Often people will say something like, “Medical records
dated 1/1/2003 through 12/31/2013 will be examined” The
important part is that the end date is from a time BEFORE your
submit your IRB application
2) You will not be recording any identifiable information—this
includes DATES associated with the patient
Your data collection sheet
A HIPAA Waiver of Authorization form (allows you access to medical
records for research purposes)
SUBMITTING AN EXEMPT STUDY--CONTINUED
If it’s an anonymous survey, you need
to submit:
Your IRB application
Your protocol
Your survey (or a link to the survey if
it’s web-based)
Any flyers or letters that you’ll be using
to recruit respondents
MY STUDY ISN’T EXEMPT—WHAT
ELSE COULD IT BE?
Your study might meet criteria to be expedited. This
means that the study can be reviewed by one or
two experienced IRB reviewers and you don’t have
to worry about deadlines or meeting dates.
Expedited studies are always minimal risk studies-no investigational drugs, no protected
populations, no very sick people and no highly
sensitive procedures.
EXPEDITED REVIEWS
Note that an “expedited” review doesn’t
necessarily mean a “quick” review.
Regulations require that an expedited review
be given the same scrutiny that a submission
to the full board would receive.
An expedited reviewer can APPROVE or REQUIRE
MODIFICATIONS to a study but can not
disapprove a study.
MY STUDY IS NEITHER EXEMPT OR
EXPEDITED
In this case, your study will require Full Board
review. You will need to submit all required
materials by the deadline date. You can find all
IRB deadline dates and IRB meeting dates on
the TTUHSC IRB website:
www.ttuhsc.edu/research/hrpo/irb.
The Full Board reviews proposed research that is
greater than minimal risk, uses vulnerable
populations, has any unapproved drugs or
devices, deception of subjects, surveys with
sensitive questions or any other project that
doesn’t quite meet the definition for expedited
review.
SUBMISSION REQUIREMENTS FOR A FULL
BOARD REVIEW:
Complete IRB application form
Protocol
Informed consent and HIPAA Authorization form
Recruiting materials
Letters of support from collaborating sites
Data collection forms
Grant applications
All surveys, questionnaires, videotapes, etc.
For investigational drug or device studies, we also need
IND or IDE number from the FDA
Investigator’s brochure
Documentation of approval by other committees (Radiation Safety;
Institutional Biohazard Committee; Conflict of Interest Committee)
IRB REVIEW—FULL BOARD
Two (or more) reviewers will be assigned to read and review all of
the materials you’ve submitted. Prior to the meeting, the
PRIMARY reviewer will write an objective summary of your project
and both reviewers will add a subjective review of the project
All of the other IRB members will have access to the materials in
iRIS and they, too, can add information (subjective or objective)
to the review.
At the IRB meeting, the primary and secondary reviewers will
present the study along with their recommendations about what
should happen to the study.
Principal investigators may ask or be asked to attend the IRB
meeting at which their study is presented.
FULL BOARD REVIEW--CONTINUED
The members will discuss the study and then vote on it. The Board
can vote to:
APPROVE the study as it is
REQUEST ADDITIONAL INFORMATION prior to approval or
DISAPPROVE the study.
You will receive an e-mail through iRIS, usually within 24 hours of
the IRB meeting, telling you the outcome of the review.
If the Board requests additional information, the email will provide
detailed STIPULATIONS—things that need to be addressed prior
to approval. You have 30 days to respond to the stipulations.
FULL BOARD REVIEW--CONTINUED
If the Board disapproves the study, you will
be provided written notification of the
reason for the disapproval. You can
request reconsideration within 10 days of
receiving the notice. If, after
reconsideration, the Board still
disapproves the project there will be no
further activity—TTUHSC officials can
not approve research that has been
disapproved by the IRB (45 CFR
46.112)
THEY ASKED FOR ADDITIONAL INFORMATION AND I
ANSWERED THEM—NOW WHAT?
Depending on how many stipulations you had and the
nature of the stipulations, either one IRB member or
the Full Board will review your responses. If
everything has been adequately addressed, your
informed consent and HIPAA documents will be
stamped and you will get an official Approval Letter
from the IRB.
Once you have that approval letter in your hand (AND
NOT BEFORE!!) you are ready to start your study.
USING PHI IN RESEARCH
Protected health information (PHI) is
any information, including demographic
information, that is transmitted or
maintained in any medium
(electronically, on paper, or via the
spoken word) that is created or received
by a health care provider…that relates to
or describes the past, present, or future
physical or mental health or condition of
an individual… and that can be used to
identify the individual.
IDENTIFIABLE PHI
Names
Medical Record Numbers
Geographic subdivisions smaller than a State
Dates (except year) directly related to an
individual including
Date of birth
Admission date, discharge date, date of
death
All ages over 89, including dates and
year
Telephone numbers, fax numbers,
E-mail addresses, internet URLs, IP addresses
Social security numbers
Account numbers, Certificate/license numbers
License plate numbers/VIN numbers
Device identifiers and serial numbers, Finger and voice prints,
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
SO, WHAT DO I HAVE TO DO?
If you need PHI to do your research (and most biomedical research does), you MUST
do one of two things:
1 Obtain written authorization from your potential participants allowing you to access
their medical record for research purposes. Can generally be done as part of the
informed consent process
Or
2) Ask for (and be approved for) a WAIVER OF AUTHORIZATION.
You must attest that:
•
there is minimal risk to the privacy of the research participants (generally
because you will not be recording any personally identifiable information);
•
you will not reuse or disclose any of the PHI that you access;
•
the research could not practicably be conducted without access to PHI; and
•
the research could not practicably be conducted without the waiver of authorization.
ANYTHING ELSE?
If you want to make ANY CHANGES* to your
study from what the IRB originally
approved, you must submit a
Change/Request Amendment to the IRB
(through iRIS). You can’t actually make
the change until you get the amendment
approved.
* Yes, we do mean ANY changes—changes in study personnel,
changes in methodology, changes in where data are stored,
ANYTHING that is different from what you originally said in the
protocol.
ANYTHING ELSE—PART 2
The IRB also wants to know about any*
unexpected events—anything that didn’t
go according to plan
The IRB requires ongoing progress reports.
The IRB will determine the frequency, but
regulations require continuing review at
least once every 365 days.
* Yes, ANY…no unexpected event is too
minor…
ANYTHING ELSE—PART 3
Clinical Trial Registration:
If you are conducting a clinical trial, the project MUST
be registered at ClinicalTrials.gov prior to enrolling your
first subject.
Also, the FDA mandates specific language in the consent
document regarding ClinicalTrials.gov registration.
For more information, see
http://prsinfo.clinicaltrials.gov; or
www.icmje.org/clintrialup.htm or
www.fda.gov/cder/guidance/4856fnl.htm
ANYTHING ELSE—PART 4
Unanticipated events that occur during the study
need to be reported to the IRB—PROMPTLY.
Unanticipated event types:
1) Protocol deviations (affect one participant—don’t
increase risk of study)
2) Unanticipated Problems Involving Risks to Subjects or
Others (Affect the conduct of the study more generally—
bigger deal)
3) Serious Adverse Events (defined elsewhere)
4) Unanticipated Adverse Device Effects
IS THIS ALL REALLY AS COMPLICATED
AS IT SOUNDS?
Nah, not at all. The Office of Research and IRB really DO
want to help you get your research done. Come and talk
to us.
OR
Check the IRB website:
www.ttuhsc.edu/research/hrpo/irb
OR
Check the OHRP website:
http://www.hhs.gov/ohrp
TO SUMMARIZE:
If you are going to do research with people, an IRB
will be involved.
You will ALWAYS be better off asking questions first.
The primary goal is always protection of participants,
but institutional, state and federal policies and
regulations also have to be followed.