WAKEMED INSTITUTIONAL REVIEW BOARD (IRB)
PROCEDURE NO. 101 IRB
In an attempt to protect patients and the public, WakeMed through the duly established
Institutional Review Board (IRB) will review, evaluate, modify, approve, and monitor all
research conducted on the premises in accordance with the Department of Food and Drug
Administration (FDA), and other applicable federal and state statues, rules and regulations.
Such assurance is applicable to all activities which, in whole or in part, involve research with
human subjects if:
a) the research is sponsored by the institution, or
b) the research is conducted by or under the direction of an employee
or agent (member of the Medical Staff) or WakeMed, or
c) the research involves the use of this institution’s non-public
information to identify or contact human research subjects or
WakeMed is guided by the ethical principles regarding all research involving human subjects
as set forth in the report of National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research – The Belmont Report1.
It is the policy of the Institutional Review Board of WakeMed that, except for those
categories specifically exempted2 by 45 CFR 46, all research covered by this assurance will
be reviewed and approved by the IRB which has been established under an assurance of
compliance negotiated with Department of Health and Human Services (DHHS). The
involvement of human subjects in research covered by this assurance will not be permitted
until the IRB has reviewed and approved the research protocol and informed consent has
been obtained in accordance with and to the extent required by 45 CFR 46. Certification of
the IRB' review and approval by all DHHS-funded research involving human subjects will be
submitted to DHHS with the application or proposal for funding. Furthermore, the IRB shall
conduct continuing review of research at intervals appropriate to the degree of risk, but not
less than once per year. An IRB that reviews clinical studies subject to 3Parts 50 and 56 of
the FDA regulations must have procedures to notify appropriate institutional officials and the
FDA of IRB-initiated suspension or termination, as stated in 21 CFR 56.113 and
It is the policy of the IRB that unless informed consent has been specifically waived, no
research investigator shall involve any human being as a subject in research unless the
The Belmont Report, Department of Health Education and Welfare, On July 12, 1974, the National Research (Pub. L. 93-
348) was signed into law, thereby creating the National Commission for the Protection of Human Subjects of Biomedical and
Code of Federal Regulations: Title 45 Public Welfare, Part 46 Protection of Human Subjects Revised June 18, 1991, effective
August 19, 1991, - Subpart A -- Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of
Human Research Subjects) Subpart B -- Additional DHHS Protections Pertaining to Research, Development, and Related
Activities Involving Fetuses, Pregnant Women, and Human In vitro Fertilization, Subpart C – Additional DHHS Protection
Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects, Subpart D -- Additional DHHS
Protections for Children Involved as Subjects in research
Food and Drug Administration Human Subject Protections, Part 50 – Protections of Human Subjects (informed consent) Part
56- Institutional Review Boards; FDA Information Sheets September 1998
Procedure No. 101 (con’t)
investigator has obtained the legally effective informed consent of the subject or the
subject's legally authorized representative, in accordance with 21 CFR 50.20. WakeMed
bears full responsibility for complying with federal, state and local laws as they may relate to
research covered by this assurance and acknowledges its responsibility for the performance
of all research involving human subjects.
The Institutional Review Board (IRB) must approve the use of all investigational drugs and
FDA drugs for experimental uses. The IRB shall determine whether research proposals are
compatible with institutional commitments and confirm all applicable laws, regulations and
standards of professional conduct, practice and community attitude. The IRB shall:
a) review and have the authority to approve, require modification in, or disapprove
all research proposals for reasons including but not limited to subject risk,
adequacy of the design, such as hypothesis, methodology, consent form, ethical
considerations, budget, and principal investigator.
b) evaluate on a continual basis, in collaboration with hospital administration, the
safety and effectiveness of ongoing IRB approved research, at intervals
appropriate to the degree of risk involved. As appropriate, Class III device
studies may be reviewed semi-annually; see Procedure 102, IRB Review
Process for Significant Risk and Non-Significant Risk Devices. If an IRB study is
reviewed sooner then the annual renewal date, the earlier date will become the
new annual renewal date. IRB study renewals cannot be effective for more than
one year for any study or six months for appropriate Class III devices as noted
c) suspend and, if appropriate, terminate approval of clinical investigations not
being conducted in accordance with the determinations of the IRB, or when there
is unexpected serious harm to subjects.
d) refer to the Credentials Committee for information regarding approval of
particular projects and protocols for consideration for the credentials files and
privileges for the practitioner involved, as appropriate.
e) establish policies, standards and guidelines for clinical investigations conducted
BOARD COMPOSITION AND FUNCTIONAL GUIDELINES :
The composition and functional guidelines for the IRB of WakeMed are defined in this
procedure and may be amended in accordance with federal, state and local laws and
regulations through the defined process (21 CFR 56.107).
The Board shall be appointed by the Chair of the IRB in consultation with system leadership.
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Procedure No. 101 (con’t)
No member shall be involved in any initial or continuing review of any IRB study in which
he/she has a conflict of interest except to provide information requested by the Board.
The voting members shall include members from the following categories such that broad
representation is assured:
- eligible staff physicians;
- representative from WakeMed Cary Campus
- non-clinical members
- administrative representatives
- clinical representatives
- pharmacy representatives and
- a minimum of one person whose primary concern is not scientific and is not
connected in any way with WakeMed
- Alternates will also be appointed
The Vice President of Legal Services, Director of Medical Records, and a Cardiologist shall
serve as advisors (non-voting) to the Board.
The IRB may call upon advisors as needed to assist in providing opinion on matters in a
specific area of expertise before the IRB. These individuals would not have any voting
privileges on action items for the Board. They could attend meetings, if needed.
IRB MEMBERS TRAINING AND EDUCATION:
All new members are required to take the online web-based training modules on the ethical
use of human subjects at the following two web sites:
National Institute of Health – (NIH) http://cme.nci.nih.gov/
Office for Health and Human Services (OHPR) -- http://ohsr.od.nih.gov/
All new members are required to review the IRB Policy and Procedure manual.
All new or revised IRB procedures will be reviewed with appropriate IRB personnel before
procedures become effective.
Documentation of this training is maintained in the IRB office.
Additional educational information is provided in the IRB meeting notebooks.
IRB MEETING SCHEDULE:
The Board shall meet every second and fourth Wednesday of each month or as need
dictates. A quorum shall consist of 50 percent plus one of the voting members, including at
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Procedure No. 101 (con’t)
least one member whose primary concerns are in non-scientific areas and is not associated
with the WakeMed system (community representative).
IRB SUPPORT STAFF:
IRB Regulatory Specialist (full time) and IRB Regulatory Specialist Assistant (part time)
provide full administrative support to the Board; manage current study files; and are familiar
with the federal regulatory guidelines and regulations for human subjects protection for
REQUIREMENTS FOR IRB MINUTES:
The IRB Regulatory Specialist and Assistant are designated as the Human Protections
Administrator/or Contact Person for the IRB of WakeMed and as such, are responsible for
maintaining the records of all IRB activities, in accordance with 21 CFR 56.115. All initial
and continuing review of studies at convened meetings must include the name and title of
each application, a brief summary given by the presenter, summary of the actions taken,
discussions as they relate to the approval of the applications.
Minutes will be in sufficient detail to show attendance at the meetings; actions taken by the
IRB; the vote on these actions including the number of members voting for, against, or
abstaining; the basis for requiring changes in or disapproving research; and a written
summary of the discussion of opposing issues and their resolution.
The minutes will include applicable regulations to approve research that is of minimal risk or
that will benefit the vulnerable subjects (i.e., Board will determine whether assent is required
and whether the research is of direct benefit to the child according to 45 CFR 46 Subpart D
– Additional DHHS Protections for Children Involved as Subjects in research and pregnant
women according to 45 CFR 46 Subpart B).
The minutes will also include reports of all expedited review approvals, protocol
amendments, investigator’s brochures, revised informed consents, adverse events (at off
site facilities and WakeMed Campus), review of all previously approved studies from the last
meeting, and all continuing education items.
The Board Chair, or designated member, and the Regulatory Specialist (occasionally the
Regulatory Specialist Assistant) will sign the minutes. The full Board will review minutes for
approval at the next IRB meeting.
IRB RECORD KEEPING:
The minutes and agendas for each meeting are to be retained and filed in the WakeMed
IRB office. These files are kept under lock and key when the office is not occupied.
1. Each file shall contain initial submission packet, all intervening correspondence,
approval letters, approved informed consents (if applicable), and renewal
application for continuing review.
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Procedure No. 101 (con’t)
2. The filing system may be accessed through the Regulatory Specialist or the
Regulatory Specialist Assistant and files reviewed in the presence of the
Regulatory Specialist or the Regulatory Specialist Assistant. All retrieved records
must be re-filed by the Regulatory Specialist or the Regulatory Specialist Assistant.
Quarterly the support staff will perform a file audit against the IRB log to assure all
files are present and accounted for.
3. Principal Investigator is responsible for assuring copies of signed consent forms
will be maintained in the subject’s medical records.
4. Closed study files are kept in a locked storage area. Additional storage of files is
kept at an off-site storage vendor.
IRB RECORD RETENTION:
The WakeMed IRB office shall maintain all study records for a period of not less than three
years after completion of the research.
A Faculty Sponsor agrees to abide by the conditions placed upon the research proposal by
IRB REVIEW OF STUDIES CONDUCTED OUTSIDE OF WAKEMED:
When requested, the IRB may review studies involving human subjects conducted outside
WakeMed (i.e., private medical offices/facilities) that require approval by a local IRB. Under
these circumstances, the IRB will require the same adherence to preparation of research
proposals as for studies within WakeMed.
The Board shall report in writing to the Medical Executive Committee4 upon request. These
reports are regularly forwarded to the Medical Executive Committee, attention Brenda
Schwab, Director, Medical Staff Services.
IRB ADMINISTRATIVE FEES:
The WakeMed IRB fee covers all handling of administrative functions: pre-review of the
informed consent to ensure all federal guidelines and requirements are met; copying of all
materials for review by IRB members; amendments to research protocols, investigator’s
brochures and informed consents as needed; review of any adverse event which may occur
during the course of the study; printing and mailing of approval letters; correspondence that
may be required by the study sponsor; investigator’s progress reports and all renewal fees
up to three years after the initial application.
Cost: $1500.00 for each application submission.
Medical Executive Committee is empowered to act for the Staff and to coordinate all activities and policies of
the Staff, it Departments and other clinical units and committees.
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Procedure No. 101 (con’t)
Fees may be waived at the discretion of the IRB Chair. See Criteria for Waiving IRB fees in
IRB Procedure 103.
FEDERAL WIDE ASSURANCE (FWA):
WakeMed’s IRB holds a Federal Wide Assurance. The assurance covers all
federally funded and unfunded human-subject research projects. The assurance
requires that an *Institutional Signatory Official, the Human Protections Administrator
or Human Subjects contact person, and the IRB Chair complete the web-based
Office for Human Research Protections (OHRP) education modules before
submitting the assurance to ensure that these individuals are aware of the
responsibilities that must be fulfilled under the assurance.
The institution holding the FWA is responsible for the protection of human subjects
in all research in which the institute engages, including safeguarding the rights and
welfare of human subjects within its local research context, educating IRB members
of the research community in order to establish and maintain a culture of compliance
with Federal regulations and institutional policies relevant to the protection of human
subjects, and implementing within its local research context appropriate oversight
mechanisms to ensure compliance.
All new and existing Board members and IRB staff are required to complete the
National Institutes of Health web-site training course.
The FWA must be renewed every three years.
*Institutional Signatory Official – West H. Lawson, MD
Human Protection Administrator – Frances A. Whitten
IRB Chair – Miriam P. Rogers, Ed.D, RN, AOCN, CNS
There are two basic approaches for ensuring compliance with human subject
regulations. The Food and Drug Administration (FDA) uses a system of inspections
and audits; the Department of Human and Health Services (DHHS) relies on
assurances of compliance that are negotiated with institutions by the Office for the
Human Research Protections (OHPR).
FDA - regulates the pharmaceutical, biologic, and device industry, whether or
not those substances or devices are used for research purposes as well as
marketing and use of investigational drugs. The FDA regulations provide
administrative action and sanctions for non-compliance [21 CFR 56.120-24].
The FDA monitors IRB compliance through a program of regular on-site
inspections of IRB minutes and records.
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Procedure No. 101 (con’t)
DHHS - requires institutions follow written procedures for ensuring that serious
or continuing noncompliance with the regulations or the requirements or
determinations of the IRB [45 CFR 46.103 (b) (5)] are not allowed.
OHRP - conducts occasional site visits to institutions to assess the adequacy of
their procedures for protecting human research subjects.
NIH - (National Institute of Health) and cooperative group research
organizations, such as the Eastern Cooperative Oncology Group (ECOG),
regularly audit their research performance sites. Audits normally include an
examination of IRB minutes and records of conformance with applicable
regulations. The results of these audits are shared with OHRP and FDA.
CONFLICT OF INTEREST:
This policy applies to all principal investigators, co-investigators, faculty sponsors, and
clinical coordinators (as specified on WakeMed’s Certification/Disclosure form)
undertaking research funded or non-funded at WakeMed or its subsidiaries. Through
this policy, such persons will each be referred to as “Investigator.”
The policy promotes objectivity in research and other sponsored activity by defining
special standards of conduct appropriate for all researchers and staff.
Project – means any internally or externally funded and non-funded research such as
basic, applied, or developmental research.
Significant Financial Interest Relating to the Project - anything of monetary value
from a business entity including salary, payment for services, consulting fee,
honoraria, equity ownership (stocks, options, notes, etc.) and royalty-bearing
intellectual property rights (patents, copyrights, trademarks). Income from equity in an
entity must be aggregated from the investigator, investigator’s spouse and dependent
children. However, a significant interest does not include:
a. Salary, royalties, or other remunerations from WakeMed
b. Income from seminars, lectures, or teaching engagements sponsored by
public or nonprofit entities
c. Income from service on advisory committees or review panels for public or
d. An interest arising solely by reason of investment in a business by a mutual
pension or other institutional investment fund over which the employee
does not have control.
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Procedure No. 101 (con’t)
When an investigator engaging in externally sponsored work has a significant financial
interest in that business.
DISCLOSURE OF SIGNIFICANT FINANCIAL INTEREST:
All investigators (as defined in this policy) shall provide a written disclosure of any
related financial interest to the WakeMed IRB office. This can be accomplished by
forwarding a copy of the Certification/Disclosure Form from the sponsor of the study or
by using the WakeMed Certification/Disclosure Form (Attachment #1).
The following federal regulations govern conduct related to an investigator’s conduct in
carrying out his or her assigned duties for WakeMed.
Title 42 Code of Federal Regulations Part 50 Section 50.604 (Attachment #2)
Title 45 Code of Federal Regulations Part 94 Subtitle A Section 94.4 (Attachment #3)
Title 21 Food and Drug Administration Part 54 Section 54.1 (Attachment #4)
Title 21 Food and Drug Administration Part 54 Section 54.6 (Attachment #5)
Other federal and state laws, rules and regulations may also apply.
CONSEQUENCES FOR VIOLATION OF THIS POLICY:
Final IRB approval cannot be given without the inclusion of this form.
GUIDELINES FOR FEDERAL HEALTH INSURANCE PORTABILITY &
ACCOUNTABILITY ACT (HIPAA):
The Federal Health Insurance Portability & Accountability Act (HIPAA) of 1996 directed
the Department of Heath & Human Services to develop standards to protect the
security, confidentiality and integrity of Protected Health Information (PHI) – any
information created or received by WakeMed that identifies an individual and relates to
the past, present, or future health of that individual.
The principal investigator must provide the following in writing before an authorization
waiver can be considered for approval.
- Why the research cannot practically be conducted without access to PHI;
- How the patients PHI will be protected;
- How and when identifiers will be destroyed, unless there is a health or research
justification for retaining the identifiers or such retention is otherwise required by
- Written assurance that the information will not be reused or disclosed to any
other person or entity – data use agreement must be signed; and
- Waiver of Authorization Request Form (Attachment #6)
The Director of Medical Records will also need the following for consideration:
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- A list of patients’ names and medical record numbers that will need to be
- A copy of the IRB approval letter
- Completed Medical Record Services Request for Records Review Form
All authorization waiver requests will be reviewed and considered for approval by the
OFFICE LOCATION AND HOURS OF OPERATION:
The IRB office is located in Adult Acute Care on the WakeMed Raleigh Campus, first floor
across from Acute Rehab Therapy and Occupational Therapy. The phone number is (919)
350-8795. The hours of operation are 8:00 a.m. until 4:30 p.m. Monday through Friday
except on official holidays.
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