The institution relies on the IRB to make this
assessment due to the complexity of the rules, which necessitates that
investigators communicate initially with the IRB - even if the answer is
subsequently No. Call
the Human Subjects Protection Office (HSPO), at extension 5687 and ask to speak
to or meet personally with an IRB Coordinator.
Also, several decision charts are available to help you prepare for the
questions that will need to be addressed to make the determination.
To review the decision charts go to the Office for
Human Research Protections (OHRP) web site, at
http://www.hhs.gov/ohrp/ ,
or go directly to the charts
at
http://www.hhs.gov/ohrp/humansubjects/guidance/decisioncharts.htm#c1
. These graphic aids are
intended to assist IRBs, institutions, and investigators in the decision-making
process to determine the review requirements for a particular activity.
Several decision charts are available to address a variety of questions,
including: Chart
1) Is an Activity Research
Involving Human Subjects?; Chart
2) Is the Human Subjects Research
Eligible for Exemption (and if so, does a particular exemption apply)?; Chart 8)
May the IRB Review Be Done by Expedited Procedures?; and others.
To find out if anything is needed for your project to
meet federal, state and institutional guidelines, call the HSPO at x5687 to
arrange a discussion with an IRB Coordinator.
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See the
QI/QA Decision Tree to assist you with this question.
Full IRB
Review means the research is reviewed by the IRB at a convened meeting.
Full IRB review is required for all research protocols involving more than minimal risk, such as
research involving invasive procedures, investigational drugs and devices,
multiple blood sample collection, or research that involves vulnerable
populations including subjects under 18 years of age, pregnant subjects, or
special classes of at-risk populations.
Expedited Review – Expedited review means the activity may be
reviewed by one or more designated IRB members, but convened board review is not
required. To qualify for expedited review the research must present no more than
minimal risk to human subjects and involve only non-invasive procedures. In addition, the research must meet one of the specific categories of
activities identified in the regulations as eligible for expedited review.
Examples:
Examples of expedited research
activities include limited blood sample collection, prospective collection of
biological specimens or data by non-invasive means (i.e., buccal or skin swab,
placenta or amniotic fluid at delivery; physical sensors, weighing, ultrasound,
digital recording), routine surveys and questionnaires, and chart reviews.
A complete description of expedited categories is listed in the Expedited
Application Form.
Exempt
Review – Exempt review means that the
activity may be reviewed by one or more designated IRB members to determine if
the research project qualifies for exempt status. Research activities that
qualify for exemption are exempt from compliance with the federal regulations. To
qualify for exempt status the research must have little, if any, associated risk
and fall into one or more of the six exempt categories permitted by the federal
regulations.
Examples of
exempt research activities include research involving the study of existing
data, records or specimens if the sources are publicly available or if the
information is recorded so that subjects cannot be linked directly or through
identifiers, surveys, observations of public behavior, taste and food
quality evaluations. A complete description of exempt categories is listed in
the Exempt Application Form.
An
application for IRB review is required for all research protocols regardless of
the review category. The
application forms are designed according to the type of research to be
conducted. In addition to providing the eligibility criteria
for expedited and exempt research in those application forms, the questions are tailored to help investigators recognize which form is
needed. You may also call the Human Subjects Protection Office for
assistance.
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The average turnaround time for a new application
undergoing full IRB review, from receipt through final approval, is 4-5
weeks. Three weeks of this time involves a pre-review process, meeting
arrangements, and time for board members to prepare prior to the convened IRB
meeting. The length of time after the
meeting will depend on the investigator's ability to address stipulations made
by the IRB, with time allotted for re-review and approval by the original primary
reviewer.
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New research applications are reviewed at
convened meetings held the 1st and 3rd Monday
of each month. Applications are due in the Human Subjects Protection Office 3 weeks
before a specific meeting. See IRB
Schedules for submission deadlines and meeting schedule. A pre-review process is performed at the time
of submission which may require the investigator to make changes to the
application before it is forwarded to the board members for review.
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A regulatory Compliance Fee is accessed to support the activities of the
Human Subjects Protection Office and the Office of Research Affairs. The fee is
based on the type of IRB Review required (e.g. convened "full board" review,
expedited, exemption determination, annual review, amendment, etc.). For a fee
schedule and additional details, see the information on the Office of Research
Affairs website under
Policies and
Guidelines.
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The Modification Request Form should be used for
modifications or changes to existing protocols, procedures, investigators,
recruitment procedures/materials, etc. which must be approved by the COM/HMC
Institutional Review Board (IRB). This form eliminates the need for a
cover letter to accompany a request and helps facilitate IRB review of the
changes for research, decreasing the amount of time and interim
communications necessary to complete the approval process.
The IRB’s Modification Request
Form can be found at www.hmc.psu.edu/irb,
Forms & Instructions, Ongoing Studies.
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On average, 1200 human subject research investigations are ongoing
in the hospital and
college, including clinical investigations and basic science research. Each
year about 400 new proposals are submitted for IRB review.
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For full board and expedited studies, please fill out a
Progress Report Form at the time you wish to close your study.** For
exempt studies, please submit a letter explaining that study activities have
been completed and a statement that the investigator has closed the
protocol.
**Please note: You must continue providing continuation
reviews on your research until ALL data analysis is
completed. For a study in the data analysis phase, C.3. in section VIII of the Progress
Report Form must be completed. A continuing review of a study in this
phase will receive expedited review.
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Investigator Tutorial: Introduction to
Protecting Human Subjects of Research - All faculty, students and staff proposing to
use human participants in research under the auspices of PSHMC/COM are required
to complete the Investigator Introductory Tutorial.
Principles of Informed Consent -
All Principal Investigators conducting human subject research at
Penn State Hershey Medical Center and College of Medicine are required to
complete this informed consent tutorial.
Approvals for use of research
projects including human participants will not be granted until the required training
has been completed.
These tutorials may be accessed under
Educational
Resources.
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Revised: August 17, 2007
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