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All research conducted at Sparrow Health System involving human subjects or human materials must
have prior approval by the IRRC. This includes, but is not limited to, investigations conducted
by Sparrow Health System medical/clinical staff, faculty and students at MSU* or other
institutions, and others interested in research. The type of IRRC review required
(exempt, expedited, or full board), depends upon the classification of the research proposal
and on the levels of risk to subjects.
Under our Assurance, an Institutional Review Board (IRB)
was created at Sparrow Health System and is known as the Institutional Research Review Committee
(IRRC). The IRRC is charged with reviewing and approving each research project involving
human subjects or materials of human origin before it is implemented. The
IRRC routinely updates the Medical Staff Executive Committee regarding the status of research
projects involving human subjects being conducted at Sparrow.
*All Michigan State University faculty and/or students wishing to conduct research at a
Sparrow Health System facility must obtain MSU BIRB approval as well as IRRC approval.
See IRB Reliance Review Process.
Institutional Review Boards (IRB)
Federal regulations and hospital bylaws require that all research projects involving human subjects and materials of human origin be reviewed and approved by the Hospital's Institutional Review Board before initiation to protect the rights and welfare of human subjects.
The Institutional Review Board's primary responsibility is to promote an ethical and safe research environment and protect the rights and welfare of the human subjects.
IRBs are required to review and approve protocols against the following criteria according to
federal regulations at 45 CFR 46 (http://hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm) and 21 CFR 56
(http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html):
- Procedures and research design do not
unnecessarily expose subjects to risks.
- Risks to subjects are minimized and are
reasonable in relationship to anticipated benefits.
- Selection of subjects are equitable, taking
into account special problems of research involving vulnerable
populations (e.g. pregnant women, children/minors, prisoners,
handicapped persons, etc.). See IRRC Policies Protecting Minors in
Research and Incompetent Persons in Research.
- Informed consent is sought from each subject or
authorized representative and documented. See IRRC Policy Obtaining
Informed Consent.
- The consent form must conform to the standards
presented in the IRRC Policy Elements of Information of Consent as well
as the Guidelines and Basic Elements and Consent Template.
- Where appropriate, adequate provisions are in
place to monitor the collected data to ensure safety of subjects.
- Privacy is protected and data confidentiality is
maintained.
See IRRC Policy Storage of Informed Consent.
The Office of Human Research Protection (OHRP) can be accessed on the web at:
(http://www.hhs.gov/ohrp/) this site offers a link to the FDA Code of Federal
Regulations governing IRBs.
Sparrow Health System's IRB
Sparrow Health System has one IRB, the Institutional Research Review Committee (IRRC). The IRRC reviews applications for research involving human subjects in keeping with ethical principles
and the U.S. Department of Health and Human Services regulations for the Protection of Human Subjects.
The IRRC is a multidisciplinary standing review committee comprised of:
- Members of the Sparrow Health System Medical
Staff
- Representatives from Michigan State University
College of Human Medicine and Osteopathic Medicine
- Representatives from the Sparrow Health System
Administration and Nursing Services
- At least one member not affiliated with the
Sparrow Health System
- At least one member whose primary concerns are
in nonscientific areas
- Community representatives including, but
not limited to, an attorney, a clergyman, and ethicist and/or
social scientist.
Collaborative Research Agreements
SHS/MSU IRB Reliance Agreement
The IRB Reliance
is an agreement between Sparrow Hospital's IRRC and Michigan State
University's Committee on Research Involving Human Subjects (UCRIHS)
which allows an MSU-paid faculty/staff member, intending to conduct
research at a Sparrow facility, to have a research project undergo
IRB review through UCRIHS, with the IRRC accepting the review of the
lead institution. See IRB Reliance Review Process.
SHS/MSU IRB Collaborative Authorization Agreement
The SHS/MSU IRB collaborative Authorization Agreement, with MSU's Community Research Institutional Review Board (CRIRB), provides CRIRB review of collaborative, multi-community research projects,
with IRRC appointed member representation on this committee.
Michigan Cancer Research Consortium's OCIRB Agreement
The SHS contractual agreement with the Michigan Cancer Research Consortium's Oncology Central IRB (OCIRB) provides for OCIRB review of MCRC research projects for the Sparrow Regional Cancer Center.
The IRRC provides appointed member representation on the OCIRB.
Definitions
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which
is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR 46.102(d)
Human subject is defined as a living individual(s) 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. 45 CFR 46.102(f)
For projects to which FDA regulations and policies apply:
Clinical investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under
section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act,
but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
The term does not include experiments that are subject to the provisions of part 58 of this chapter, regarding non-clinical laboratory studies. 21 CFR 50.3(c)
Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.
Examples of research with human subjects
- Research conducted or supported by a federal
department or agency
- Research that is neither conducted nor
supported by a federal department or agency, but is subject to
regulation
- Interviews
- Telephone or mail surveys
- Behavioral or education testing
- Observation of individual or group behavior
- Collection of blood or other biological samples
- Existing data (i.e., surveys, biological
materials and medical records)
Information included on the IRRC Website:
Overview of the IRRC, including the mission statement.
Applications for IRRC review, forms for renewal and amendments with
general instructions, including information regarding study closure, unanticipated problems and adverse events. Also provided are Informed Consent Guidelines and Basic Information as well as a template.
SHS/MSU IRB Reliance review process and application form, including a link to the MSU UCRIHS Website.
Human Subjects Training Requirements. Links to the required human subjects training tutorials are provided on the new application and renewal forms. The following sites are available for researchers at no charge:
http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp
http://www.hhs.gov/ohrp/education/index.html#materials
http://www.humanresearch.msu.edu/training/training_index.htm
Federal Regulations and Guidelines for IRBs. Links to useful information provided by the DHHS Office of Human Research Protections and the FDA information Websites.
IRRC Policies and Procedures. Detailed listing of the IRRC policies and procedures for research involving human subjects conducted at Sparrow Health System facilities.
HIPAA Guidelines and Sparrow HIPAA Use and Disclosure Authorization Form.
IRRC Meeting Dates an Submission Deadlines. The IRRC meets the second Monday of every month.
Contact Information
Investigators and participants are encouraged to contact the IRB office with any questions, concerns or suggestions.
Investigators do not need to schedule an appointment to speak with an IRB staff member regarding any questions they may have regarding the IRB, the SHS/MSU IRB Reliance Agreement, MSU CRIRB
Collaborative Agreement, or the MCRC OCIRB.
The IRB Chairperson is available, by appointment only, to meet with investigators, research staff, medical
residents and fellows, or participants. To schedule an appointment, contact the IRB office at 517.364.2150 or send an Email to irrc@sparrow.org.
If you have any concerns or complaints about a specific research study at Sparrow Health System facilities,
please contact George S. Abela, MD at 517.364.2150 or send an email to irrc@sparrow.org
IRRC Contact Information
IRRC Chair: George S. Abela, MD
IRB Administrator: Marion Parrish
Office of Research Oversight and Compliance
Sparrow Health System
1215 E Michigan Avenue
(PO Box 30480)
Lansing, MI 48909-7980
Phone: 517.364.2157
Fax: 517.364.2763
Email: irrc@sparrow.org
Website: www.sparrow.org/irrc/research.asp
Office Hours
Monday - Friday 7:30am - 5:00pm
Office is closed for all hospital
holidays.
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