Title: IRB APPROVAL It is what you need and what you want!
1IRB APPROVALIt is what you need and what you
want!
IRB
- Ken Kepler, MSESS
- Institutional Review Boards
- University of Florida
He takes guarding humans very seriously.
2The History
- The Tuskegee Syphilis Study
- 1932 - 1972
- Nazi War Crimes of a Medical Nature
- 1942 - 1946
- Willowbrook State School
- 1956 - 1970s
- The Jewish Chronic Disease Study
- 1963
3Tuskegee Syphilis Study
- 400 African Americans
- 40 years of monitoring
- Denied cure
4Nazi War Crimes of a Medical Nature
- Altitude
- Hypothermia
- Potability of sea water
- TB
- Insemination
- Sterilization
5Jewish Chronic Disease Study
- Injected live cancer cells
- Patients were not told
- They are going to die anyways
6Willowbrook State School
- Infected with Hepatitis C
- Natural disease progression
- Coercion
- They are going to get it anyways
7Guidelines Ethical Considerations
- Nuremberg Code
- Voluntary consent is essential
- Research should be beneficial to society
- The experiment should avoid unnecessary suffering
and injury
8Guidelines Ethical Considerations
- Declaration of Helsinki
- More specific guidance
- Duty to protect life, health, privacy and dignity
- Emphasized subject understanding
9Belmont Report1979
- Respect for Persons
- Informed Consent
- Privacy and Confidentiality
- Nazis, Jewish Chronic Disease, Tea Room
- Beneficence
- Risk/Benefit Analysis
- Scientific Merit
- Tuskegee, Nazis
- Justice
- Review of subject selection
- Tuskegee, Willow brook
10Federal Regulations
- Federal Policy adopted in 1981
- Common Rule (1991)
- DHHS Regulations for the Protection of Research
Subjects - 45 CFR 46, Subpart A
11Who is Covered?
- Dept. of Agriculture
- Dept. of Energy
- Dept. of Commerce
- Dept. of HUD
- Dept. of Justice
- Dept. of Defense
- Dept. of Education
- Dept. of Veterans Affairs
- Dept. of HHS
- Dept. of Transportation
- NSF
- NASA
- EPA
- CIA
12Responsibilities in Research
- Institutional Responsibilities
- Federal Wide Assurance
- IRB Responsibilities
- IRB review
- Investigator Responsibilities
13IRB Responsibilities
- 4 IRBs
- Review all proposed human subject research at
the University of Florida - Federal regulations and guidance
- Authority to approve, request modification in,
and/or disapprove research
14Investigator Responsibilities
- Investigators have the primary responsibility
for protecting the rights and welfare of human
research subjects and are responsible for
complying with all applicable provisions of their
institution's Assurance.
15Investigator Responsibilities
- Investigators are expected to be knowledgeable
about the requirements of the Federal
regulations, applicable state law, their
institution's Assurance, and institutional
policies and procedures for the protection of
human subjects.
16Do you need IRB approval for your new study?
- All research that involves intervention/interactio
n with human subjects or their identifiable
protected health information must be reviewed by
the IRB BEFORE it is conducted.
17Types of research that require IRB approval
- Therapeutic/Clinical research
- Surveys
- Chart reviews
- Studies involving tissues
- Published quality assurance research
- Exempt research
18IRB approval NOT required
- Decedent research
- Case Reports
- Designed to contribute to generalized knowledge,
but not a systemic investigation. - Quality Assurance
- Systemic investigation , but does not contribute
to generalized knowledge. - Note intent to publish
19So you need IRB approval Now What?
- Visit our website
- www.irb.ufl.edu
- See the required reading
- Belmont report
- FWA
- CFR
- http//irb.ufl.edu/education/trainingreq.htm
20Note the deadlines
http//irb.ufl.edu/irb01/deadlines.htm
21FORMS
22FORMSYou must download and use the most current
forms!!
- All paperwork must be typed
- All submissions must be signed by the PI
- All supporting documentation must be attached
- Protocol, grants, brochures, advertisements,
questionnaires, surveys, data collection forms
etc. - Once complete- you must submit with original
signatures and 4 photocopies of EVERYTHING.
23FORMSYou must download and use the most current
forms!!
- Paperwork should be complete and correct at the
time of submission. - Prior to submission- be intimately familiar with
all IRB requirements. - That is why you are here
- Attach a separate cover letter if you need to
provide additional information.
24IRB
25Forms for New Studies
- First determine if your study is
- Exempt
- Expedited
- Full Board
26Forms for New Studies
- Exempt
- Exemptions are determined by the IRB (reviewed by
a single member). - A study is exempt unless otherwise required by
OHRP or FDA if the only involvement of the human
subject will be in one or more of the six
categories described in 45 CFR 46. - See the GUIDELINES FOR EXEMPT AND EXPEDITED
SUBMISSIONS form on the website. - http//irb.ufl.edu/docs/op-expedite-exempt20studi
es.doc
27Exempt Studies
- IRB determined, and falls into one of the
following six categories and involve minimal risk - 1. Research conducted in established or commonly
accepted educational settings, involving normal
educational practices. - 2. Research involving the use of educational
tests, surveys, procedures, interviews or
observation of public behavior UNLESS - - There are links, AND
- Disclosure puts subject at risk
28Exempt Studies
- 3. Research involving the same as 2 for public
officials or candidates, or if federal statutes
require without exception that the
confidentiality of the personally identifiable
information will be maintained. - 4. Research involving the collection or study of
existing data, documents, records, pathological
specimens or diagnostic specimens, if these
sources are publicly available, or if the
information is recorded by the investigator in
such a manner that subjects can not be
identified, directly or through identifiers
linked to the subject.
29Exempt Studies
- 5. Research and demonstration projects which are
conducted by or subject to the approval of the
department or agency heads, which are designed to
study, evaluate or otherwise examine - 1. Public benefits or service programs
- 2. Procedures for obtaining benefits, or
services under those programs - 3. Possible changes in, or alternatives to those
programs or procedures - 4. Possible changes in methods or levels of
payments for benefits or services under those
programs.
30Exempt Studies
- 6. Taste and food quality evaluations and
consumer acceptance studies if - 1. Wholesome foods without additives is consumed
- 2. A food is consumed, that it contains a food
ingredient at or below the level found to be
safe.
31Forms for New Studies
- If you meet the criteria for exempt fill out the
INTRODUCTORY QUESTIONAIRE- EXEMPT STUDIES - http//irb.ufl.edu/docs/IQ-short.doc
32Forms for New Studies
- Expedited Review
- Reviewed by a single member of the IRB.
- A shorter turn around time (3-4 weeks).
- Must fit into one of 9 Federally defined
categories 45 CFR 46 - See also the GUIDELINES FOR EXEMPT AND EXPEDITED
SUBMISSIONS - http//irb.ufl.edu/docs/op-expedite-exempt20studi
es.doc
33Forms for New Studies
- Expedited Review- Category 5 is the most common.
- 5. Research involving materials (data, documents,
records, or specimens) that have been collected
or will be collected solely for non-research
purposes (such as medical treatment or
diagnosis). Note Some research in this category
may be exempt from the HHS regulations for the
protection of human subjects. 45 CFR
46.101b4. This listing refers only to
research that is not exempt.
34Forms for New Studies
- Expedited Review
- If you meet the criteria for expedited review you
will need the INTRODUCTORY QUESTIONAIRE and
PROTOCOL forms. - http//irb.ufl.edu/docs/frm-iq.doc
- http//irb.ufl.edu/docs/frm-prot.doc
- Use the PROTOCOL TEMPLATE GUIDELINES
- http//irb.ufl.edu/docs/prot20temp20guidelines2
0v01.22.04.doc
35Forms for New Studies
- Full Board Reviews
- Generally involves greater than minimal risk to
the participants. - Do not fit the criteria for exempt or expedited
- Forms for full board are the same as expedited-
INTRODUCTORY QUESTIONAIRE and PROTOCOL
36Forms for New Studies
INFORMED CONSENT
- Both Expedited and Full Board reviews require
INFORMED CONSENT. - Unless you request
- Waiver of Informed Consent
- Waiver of Documentation of Informed Consent
- Modification of Informed Consent
37Forms for New Studies
INFORMED CONSENT
- See Section III of the Introductory
Questionnaire- check the correct box - Must meet specific criteria (45 CFR 46 116 and
117) - See the INFORMED CONSENT INSTRUCTIONS
- http//irb.ufl.edu/docs/icf-instruct.doc
38Forms for New Studies
INFORMED CONSENT
- Informed Consent with HIPAA
- Has additional information that covers PHI
- http//irb.ufl.edu/docs/HIPAA/ICF-with-HIPAA-auth.
doc - Informed Consent without HIPAA
- http//irb.ufl.edu/docs/frm-icf.doc
39Forms for New Studies
HIPAA or NO HIPAA
- If you are collecting, creating or using health
information you must use the HIPAA version of the
INFORMED CONSENT form. - You may submit a REQUEST FOR WAIVER OF
AUTHORIZATION to recruit and/or enroll if- - your study is Exempt
- If you have a WAIVER OF CONSENT
- if you have a WAIVER OF DOCUMENTATION OF CONSENT
- http//irb.ufl.edu/docs/HIPAA/authorization-waiver
.doc
40Forms for Existing Studies
- CONTINUING REVIEW/STUDY CLOSURE form
- Studies reviewed annually unless specified by the
board - Make sure the of patients flow from year to
year - An IRB closed study officially starts the record
keeping clock - IRB- 3 years
- HIPAA- 6 years
- Treatment records- 8 years
- http//irb.ufl.edu/docs/frm-cr.doc
41Forms for Existing Studies
- When closing your study dont forget
- The Cumulative Adverse Events Table
- http//irb.ufl.edu/docs/AETable.doc
42Forms for Existing Studies
- Revising your study??
- Any change including an increase in the of
subjects is a revision - DO NOT implement the changes until the revision
is approved. - Complete the REVISION MEMO
- include all paperwork affected by the revision
- http//irb.ufl.edu/docs/frm-rev.doc
43Other Forms
- The IRB wants an explicit change-
- Complete the Explicit Change form.
- http//irb.ufl.edu/docs/frm-explicit.doc
- The IRB has tabled your project-
- Fill out the Tabled Submission Response Form
- http//irb.ufl.edu/docs/frm-tabled.doc
44Other Forms
- Emergency Use
- The investigator, with the concurrence of another
physician, believes the situation necessitates
the use of a test article - The subject and/or legally authorized
representative is unable to communicate consent - There is insufficient time to obtain consent and
- No alternative exists that will provide an equal
or better chance of saving the subject's life. - http//irb.ufl.edu/docs/frm-emergnew.doc
45Other Forms
- Temporary Transfer of Study Responsibility
- Temporary PI must be on the existing IQ
- http//irb.ufl.edu/docs/frm-transfer.doc
- Unaffiliated Investigator Agreement
- http//irb.ufl.edu/docs/frm-uia.doc
46Standardized IRB Text
- Blood draw risk
- Employee subjects
- MRI
- Placebo / randomization
- Reproduction Risks (pregnancy)
- Storage of tissue
- Student subjects
- Videotaping of subjects
47Questions?