What is an IRB and Why Should I Care?

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What is an IRB and Why Should I Care?

• Beth Taraban
• Research Integrity Office

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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 federally-funded
  research involving human participants. The
  procedures for research review are set out in the
  Code of Federal Regulations (CFR).

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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.

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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

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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
• Assuring compliance by research institutions
• Researchers obtaining and documenting informed
  consent
• 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

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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
  themselvesa single rogue researcher can halt ALL
  HUMAN RESEARCH at an institution!

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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)

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What is human research

• Human subjects are defined as living
  individuals about whom an investigator conducting
  research obtains
• Data through intervention or interaction with the
  individual or
• Identifiable private information
• Source 45 CFR 46.102(f)

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So, is this research or not??

• When in doubt,
• Contact your local IRB Administrator
• LubbockKaren Douglas806-743-4753
• AmarilloKathy Thomas806-354-5419
• OR
• Check the very cool decision trees at the OHRP
  website
• http//www.hhs.gov/ohrp/policy/checklists/decision
  charts.html

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OK, its 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

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I finished CITI. Now CAN I SUBMIT MY PROJECT?

• Not yet. First, you need to get access to the
  iRIS programthis 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.

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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/articl
  es/163300-how-do-i-enroll-in-a-citi-course-for-the
  -first-time-

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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, goshdarnitand believe me, thats not the
  word I was really thinking!!
• OK. You can submit your research project for IRB
  review now.

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IRB Composition

• Federal regulations govern IRB composition
• At least 5 members
• At least one scientist member
• At least one non-scientist member
• At 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

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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

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IRB regulationsResearch 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

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What is the IRB looking for?

• TTUHSC IRB reviewers are looking for
• Protection of subject safety and well- being)
• 1a) Scientific validity of the research
  project
• 1b) Qualification of investigators to conduct
  research
• 1c) Adherence with federal regulations and
  TTUHSC policies.

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Types of IRB review

• Exempt projects
• Expedited
• Full Board review

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IRB Review--Exempt Projects

• Exempt studies are exempt from the federal
  regulations Generally, these are
• studies that are done as part of normal classroom
  procedures for which you dont collect any
  identifying information
• surveys or questionnaires of adults in which you
  dont get any identifying information and dont
  ask any sensitive questions or
• retrospective research in which all of the data
  are already in existence and you wont be
  recording any identifying information.

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A-ha! My study is EXEMPT from IRB review, so I
dont 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.

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Submitting an exempt study

• If its 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
  informationthis 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)

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Submitting an exempt study--continued

• If its an anonymous survey, you need to submit
• Your IRB application
• Your protocol
• Your survey (or a link to the survey if its
  web-based)
• Any flyers or letters that youll be using to
  recruit respondents

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My study isnt exemptwhat 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 dont
  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.

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Expedited reviews

• Note that an expedited review doesnt
  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.

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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 doesnt quite
  meet the definition for expedited review.

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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
• Investigators brochure
• Documentation of approval by other committees
  (Radiation Safety Institutional Biohazard
  Committee Conflict of Interest Committee)

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IRB ReviewFull Board

• Two (or more) reviewers will be assigned to read
  and review all of the materials youve 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.

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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 STIPULATIONSthings
  that need to be addressed prior to approval.
  You have 30 days to respond to the stipulations.

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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
  activityTTUHSC officials can not approve
  research that has been disapproved by the IRB
  (45 CFR 46.112)

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They asked for additional information and I
answered themNow 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.

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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 providerthat 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.
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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
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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.

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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 cant actually make the
  change until you get the amendment approved.
• Yes, we do mean ANY changeschanges in study
  personnel, changes in methodology, changes in
  where data are stored, ANYTHING that is different
  from what you originally said in the protocol.

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Anything elsepart 2

• The IRB also wants to know about any unexpected
  eventsanything that didnt 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, ANYno unexpected event is too minor

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Anything elsepart 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 

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Anything ElsePart 4

• Unanticipated events that occur during the study
  need to be reported to the IRBPROMPTLY.
• Unanticipated event types
• Protocol deviations (affect one participantdont
  increase risk of study)
• 2) Unanticipated Problems Involving Risks to
  Subjects or Others (Affect the conduct of the
  study more generallybigger deal)
• 3) Serious Adverse Events (defined elsewhere)
• 4) Unanticipated Adverse Device Effects

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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/researc
  h/hrpo/irb
• OR
• Check the OHRP website
• http//www.hhs.gov/ohrp

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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.