Human Subject Approval Institutional Review Board, IRB Biosafety Approval Institutional Biosafety Co

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Human Subject Approval(Institutional Review
Board, IRB)Biosafety Approval(Institutional
Biosafety Committee, IBC)

• Donald E. Mosier
• Chair, IBC
• Member, GCRC Review Committee

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IRB Approval Process

• Determine if Human Subjects Approval is necessary
  (gt 8 weeks prior to submission)
• If YES, submit 17-point IRB form with grant text
• Fulfill NIH TSRI training requirements for Key
  Personnel
• If GCRC (General Clinical Research Center) can
  supply samples, complete their application forms

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ARE YOU CONDUCTING RESEARCH USING HUMAN
SUBJECTS? A human subject is a living
individual about whom an investigator obtains
either (1) data through intervention or
interaction with the individual, or (2)
identifiable private information. Legal
requirements to protect human subjects apply to a
much broader range of research than many
investigators realize, and researchers using
human tissue specimens are often unsure about how
regulations apply to their research. Legal
obligations to protect human subjects apply, for
example, to research that uses Bodily
materials, such as cells, blood or urine,
tissues, organs, hair or nail clippings, even if
you did not collect these materials
Residual diagnostic specimens, including
specimens obtained for routine patient care that
would have been discarded if not used for
research Private information, such as
medical information, that can be readily
identified with individuals, even if the
information was not specifically collected for
the study in question. Research on cell lines or
DNA samples that can be associated with
individuals falls into this category. IF SO, YOU
MUST... Comply with your institutions rules and
the requirements of your Institutional Review
Board (IRB) as well as meeting Federal
requirements (1) in order to carry out your
research.
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Key points

• Any material or information derived from humans
  is likely to require IRB approval
• If you obtain human material from a collaborator,
  both you and the collaborator must have IRB
  approval
• Anonymous samples that are unlinked to an
  individual may be exempt if the IRB agrees

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TSRI Information about Human Subjects Research

• Go to TSRI Website
• Go to Campus Services
• Go to Regulatory Committees
• Go to Institutional Review Board - Human Subjects
  Committee TSRI's Minimum Education Requirement

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Human Subjects Committee TSRI's Minimum
Education Requirement Human Subjects Committee -
Contacts TSRI's Minimum Education Requirement
For Human Subject Research TSRI has implemented
policies and procedures for complying with the
National Institutes of Health mandatory education
requirement relating to research involving human
subjects and specimens. Beginning October 1,
2000, TSRI is requiring that the minimum
education requirement be met prior to the
submission to TSRI's Office of Sponsored Programs
of any grant application or contract proposal
involving human subject research. To access
TSRI's policies, procedures and links to the two
compliance requirement documents, click on the
heading above. Forms For TSRI's Minimum
Education Requirement For Human Subject
Research Identification of Key Personnel Form
Human Subject Research - Minimum Education
Certification Statement TSRI's Requirements And
Forms For Grant Submissions With Human Subject
Protocols Forms For Human Subject Committee
Approval Of Human Subject Protocols Scripps/TSRI
Supplemental Education Seminar Series NIH And
Other Related Links - Resources And Education
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A. THE NIH MANDATED EDUCATION REQUIREMENT APPLIES
TO ALL KEY PERSONNEL PERFORMING RESEARCH
INVOLVING HUMAN SUBJECTS. In order to assure
compliance with the mandated NIH minimum
education requirements relating to human subject
research, TSRI has established a "Minimum
Education Requirement for Human Subject
Research". This requirement applies to all key
personnel participating in the design and conduct
of research on a human subject (human subject
research) under any grant or contract. "Key
Personnel" include all individuals responsible
for the design and conduct of research under a
grant or contract. "Human Subject" means a
living individual about whom an investigator
(whether professional or student) conducting
research obtains (1) data through intervention or
interaction with the individual, or (2)
identifiable private information. Please note
that research using any human specimen, such as
tissue or blood, or any data derived from a human
specimen, may result in that research being
classified as human subject research. If you have
any questions about whether or not a particular
research procedure may be human subject research,
please contact the Scripps Office for the
Protection of Research Subjects (SOPRS) by phone
at [phone] or by email at
hsc_at_scrippsclinic.com.
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TSRI'S MINIMUM EDUCATION REQUIREMENT FOR HUMAN
SUBJECT RESEARCH The TSRI Minimum Education
Requirement for Human Subject Research consists
of completing both of the following (1) The NIH
Investigator Training Module (a computer-based
training program) entitled "Protection of Human
Research Subjects Computer Based Training for
Researchers". (2) Review of the six page
pamphlet published by the NIH entitled "Research
on Human Specimens". TSRI considers completion
of the above materials a minimum requirement and
encourages all investigators to expand the
curriculum through self-study, particularly in
areas where the researcher may be confronted with
a difficult topic, such as consent by a child or
genomic testing, or a special patient population.
The NIH website on bioethics is replete with
resources on a broad range of relevant
topics. The TSRI/Scripps Clinic Human Subjects
Committee has agreed that completion of TSRI's
Minimum Education Requirement for Human Subject
Research also meets the training requirements it
requires investigators to complete before they
can submit protocols for HSC review. (TSRI
investigators who are physicians acting in their
capacity as a physician in performance of an IRB
approved protocol must still meet the training
requirements for physicians.)
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IRB Application

• 17-point narrative must be approved prior to
  grant funding, not submission
• However, prior approval is highly recommended for
  first submissions in case IRG (initial review
  group/study section) has any concerns about human
  subject utilization
• Grant text is required with IRB application

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Any investigator who receives human tissue for
study must have his/her research approved by the
Human Subjects Committee. The Principal
Investigator is the person in whose laboratory
the tissue will be studied. The physician who
obtains the sample should be listed as a
sub-investigator. Use this form for protocols
that propose ONLY to study tissue obtained from
patient samples that would otherwise be
discarded. In addition to this form, the
complete application must include ? A completed
HSC Cover Sheet ? A current copy of any grant
associated with this protocol ? A consent form,
if necessary 2002 17-Point Narrative Form for
Tissue Collection and Study HSC ? New ?
Renewal Date Submitted Title of
Protocol Principal Investigator
Sub-Investigator (s) All sections must
be completed. If not applicable, insert "NA" in
the space provided. 1. RATIONALE AND
PURPOSE Provide a brief explanation, in lay
language, of what you plan to do with the
tissue Why does this project require human
tissue samples? Has this use of human
tissue been described in your current grant
application? ? Yes ? No If no, attach a letter
to the granting agency describing this change in
the proposed use of human subjects.
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2. BACKGROUND OF PROJECT 3. FACILITIES WHERE
STUDY WILL BE CARRIED OUT 4. ESTIMATED
DURATION OF THE STUDY 5. SUBJECT
POPULATION 6. SUBJECT RECRUITMENT Will
advertisements be used? ? YES ? NO Must be
submitted to HSC for approval 7. SOURCE OF
RESEARCH MATERIAL 8. PROJECT PROTOCOL 9. POTENTI
AL RISKS 10. RISK MANAGEMENT PROCEDURES My
laboratory staff has been instructed in biosafety
procedures for safe handling of human
tissues. 11. POTENTIAL BENEFITS
12. RISK-BENEFIT RATIO 13. ALTERNATIVE
TREATMENTS 14. SUBJECT PAYMENT/COSTS 15. INFORM
ED CONSENT 16. CONFIDENTIALITY OF DATA/PRIVACY
OF INDIVIDUALS 17. DISCLOSURE OF FINANCIAL
INTERESTS
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Bloodborne Pathogen Act

• Occupational exposure to bloodborne human
  pathogens (hepatitis B virus, HIV, hepatitis C
  virus, etc.) is regulated by federal, state and
  local laws
• Work with human tissues or fluids must be
  conducted at Biosafety Level 2 http//www.scripps.
  edu/services/biosafety/
• Hepatitis B immunization is mandated

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General Clinical Research Center

• GCRC is an NIH-funded TSRI resource for human
  studies
• GCRC maintains a normal donor pool and provides
  sample collection by trained professionals
• Use of the GCRC requires prior approval of a
  protocol by the IRB (1st) and the GCRC Review
  Committee

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Section E - Human Subjects in NIH grant
application

• Six specific questions must be answered
• Inclusion of women, children, and minorities in
  study population must be addressed
• Training in human research must be documented

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e. Human Subjects We use the General Clinical
Research Center (supported by NIH grant MO1
RR00833) at Scripps as a source of peripheral
blood cells for all of our studies. 1. Blood
donors are all volunteers. All will be healthy,
unmedicated consenting adults. There are no
restrictions for blood donors as to age, sex or
ethnic background, except that children (see
below), mentally disabled individuals and
pregnant women will not be used. Blood will be
obtained by venipuncture from the subjects and
whole blood used for the preparation of PBL. The
composition of the donor pool is given in Table
5A. The ages range between 21-64 years of age.
2. Normal humans contribute whole blood (50-400
ml) for research purposes. The blood is obtained
specifically for this research project. 3.
Consent will be obtained from volunteers before
venipuncture after a brief description of how the
sample is to be used. The Experimental Subjects
Bill of Rights approved by the Scripps Clinic and
Research Foundation Human Subjects Committee will
be explained and signed by each donor. 4.
Volunteers undergoing venipuncture experience
slight discomfort upon needle insertion, drawing
of blood and needle withdrawal. Some bleeding at
the puncture site may follow. No physical risk
to the subject, other than a rare syncopal
attack, is contemplated. No psychological,
social or legal risks are inherent in drawing
blood. 5. Venipuncture will be done following
standard medical practices using sterile
technique and a compression bandage in the area
of blood removal. A record of the donor and
hematocrit result will be kept on file.
Experimental results will not include donor
identification and confidentiality will be
maintained by the Investigator as to identity of
blood donors. 6. There is no direct benefit to
be gained by volunteers. The risk of
venipuncture are small and the benefit of
development of treatments for HIV-1 infection is
so great that the riskbenefit ratio is highly
favorable.
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• Human Subjects (continued)
• Inclusion of women. See targeted enrollment
  plans (p. 40) and genotype coding information
  below. Women are fully represented in the
  Scripps GCRC donor pool.
• Inclusion of children The Scripps Green Hospital
  that houses the GCRC does not provide pediatric
  care. Use of donors under 16 years of age is
  thus prohibited by the IRB because of the absence
  of medical care for any study-related
  complications.
• Inclusion and recruitment of minorities
  Information on the composition of the Scripps
  GCRC donor pool is given below. We have added a
  new collaboration (funded by another grant) with
  Case Western University that will provide PBMC
  samples from a more ethnically diverse
  population. The Scripps GCRC Core Laboratory
  continues to operate an outreach program to
  recruit new donors that reflect the ethnic
  diversity of San Diego County. Demographic
  information is presented on the following page
  (p. 40).
• Training in Research Ethics - All key personnel
  have completed training in the ethics of human
  research. Certification of training is attached.

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Targeted Enrollment Table Is NowAn NIH
Requirement
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Institutional Biosafety Committee Approval

• IBC approval is required for all work involving
  recombinant DNA, infectious pathogens, viral
  vectors, and toxins
• IBC approval is required PRIOR TO review of
  animal protocols involving human or animal
  pathogens
• IBC approval is not required prior to submission
  of NIH grants (except for animal work), but is
  required for AHA and other granting agencies

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To obtain IBC approval

• Complete online biosafety training (general and
  pathogen-specific) http//www.scripps.edu/services
  /biosafety/
• Complete online Registration Documents
• http//www.scripps.edu/services/ehs/bioforms/
• Determine if vaccine is available for human
  pathogens, and TSRI recommendation for vaccination

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Planning Flowchart
Human Subjects YES NO IRB Submission (
GCRC) Human Subject Online Training Biosafety
Online Training IBC Submission Vertebrate
Animals with infectious organisms or vectors
derived from infectious organisms IBC
Submission prior to IACUC submission GRANT
SUBMISSION (e.g., June 1st)
Before April 1st