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General Instructions for Completing IRB Application Forms
The primary concern of the Sparrow Health System Institutional Research Review Committee (the "IRB") is to protect the rights and welfare of human subjects involved in
research, however, it is also concerned with the timely review of research protocols. The
IRB only accepts electronic protocol submissions via IRBNet (www.irbnet.org), under Sparrow Health System IRB. All applications, reporting forms (amendments, adverse events, etc.) and
supporting documents are to be submitted electronically. To facilitate the review of a project, the investigator should adhere to the following guidelines:
Please complete the application in full. Please be sure to answer all questions. The IRB holds the primary investigator responsible
for presenting a clear and concise research proposal. The IRB may postpone consideration of
any application that is incomplete or inaccurate.
When submitting your application(s) electronically, be sure to provide all necessary supporting documentation (consent forms, protocols, abstracts, questionnaires, advertisements, Investigator
Brochure, etc.). IRBNet allows documents to be attached to your submission.
All new applications will be assigned a local IRB reference number. Please include your study title and IRB reference number in all correspondence with this office.
Click here for IRBNet Instructions.
Contract/Financial Arrangements for Research Projects
If your IRB-approved research project requires a contractual arrangement or disbursement
of grant monies to various departments within the Sparrow Health System that will require reimbursement for services rendered to the research study, you should contact:
Larry Rawsthorne, MD
Vice President, Medical Affairs
Sparrow Health System
Phone: 517.364.5904
E-mail: larry.rawsthorne@sparrow.org
Application for Initial Review
The IRB meets the second Monday of each month. In order to be included on the
agenda, a completed application should be submitted electronically to the IRB office fifteen (15) business days prior to the regularly scheduled IRB meeting.
IRRC meeting dates and document submission dates are provided for your convenience.
The principal investigator, or designee, is required to be present on the day the proposal is to be reviewed to give a brief presentation of the study and answer any questions the IRB members
may have. Approximately ten (10) business days prior to the meeting, the IRB office will send the principal investigator an email to confirm required presence at the IRB
meeting, as well as the date, time and location of the meeting.
The IRB strongly recommends that investigators apply for approval at least six (6) weeks prior to
the desired starting date, so that the research is not delayed. Principal Investigators will be notified, via Email, when the IRB Action Letter has been issued. The Email will
inform the principal investigator to access a copy of the Action Letter by logging into IRBNet. For Exempt from Full IRB Review or Expedited status projects, the principal investigator will be
notified as soon as the project has been reviewed. For Full review protocols, the IRB Action Letter will become available after the protocol has been discussed and reviewed following the IRB meeting.
Investigators may begin research activities only after receiving the Formal Approval letter from the IRB.
The Federal regulations charge the IRB with the responsibility and authority to directly observe ongoing research projects and the consenting process, as well as to audit research records where it deems such oversight is necessary.
Obtaining Informed Consent
Informed consent is a process beginning with a description of the study and insurance of participant understanding followed by a signed consent form.
Informed consent must continue throughout the study via a dialogue between the researcher and research participant. Federal regulations and IRB
policies require each participant receive a copy of the signed consent document. The Hospital, along with the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO), requires that all information given to research subjects is in the medical record or research file along with the consent form.
The Consent Form Guidelines and Basic Elements (PDF format) are not exhaustive of required elements of
consent, but are provided for principal investigators and their research
team, to highlight important points of the consent process. The consent
form must include, but need not be restricted to, the statements or
concepts identified in the Basic Elements. (Also see IRB Policies: Elements of
Information for Consent and Obtaining
Informed Consent.)
The Consent Form Template, available at IRBNet, provides a suggested format for the basic elements of consent.
IRB Reporting of Unanticipated Internal Problems and/or Adverse Events.
The principal investigator must submit an IRB Report of Unanticipated Internal Problems and/or Adverse Events to the IRB, within 48 hours of an unanticipated problem or adverse event, if the event is
1) unexpected, and 2) related or possibly related, and 3) serious. The investigator should also report events that, in the judgment of the investigator, alter or potentially alter the risk to human subjects.
IRB Policy: IRB Report of Unexpected Internal Adverse Event (Word Document)
Once received, the IRB Chairperson, or designee, will immediately review the report. If
the IRB Chairperson determines that action may be needed to protect the safety of
research participants due to the nature or frequency of reported adverse event(s),
he/she may take such action upon the recommendation of a physician IRB member
or consultant physician. The adverse event report will be placed on the agenda of the next convened meeting for review and further action, if necessary, by the full Committee.
Incidents of serious medical adverse event(s) must be reported to the Sparrow Hospital’s
Pharmacy and Therapeutic Committee.
Revisions and/or Amendments
The Federal Regulations and IRB policies require the principal investigator to promptly inform the IRB of any amendments or
changes to their research project. To facilitate that process, an Application for Revision and/or Amendment form is available, via IRBNet, to notify the IRB of: 1) any changes in the research
environment or new information indicating greater risk to the human subjects than existed when the protocol was previously reviewed and approved, or 2) any changes or deviations in the protocol, such as changes in the investigative team,
closures to enrollment, or modifications to the protocol or informed consent form that could be considered minor changes (see IRB Policy: Expedited Review of Minor Changes
in a Previously Approved Study).
Any proposed changes in an approved study may not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the human subjects. (see IRRC Policy: Reported Proposed Changes in Research Protocol).
Application for Continuing Review (Renewal)
Federal regulations state that an IRB approval for a research project is valid for a maximum period of one year.
Principal investigators wishing to continue to conduct research beyond the approval period must apply for renewed approval prior to the IRB approval expiration date.
The IRB strongly recommends that principal investigators request continuation at least one (1) month before approval is due to expire.
The IRB will send a renewal reminder letter to the principal investigator approximately sixty (60) days
prior to the approval expiration date for their research project. The Application for Renewal should be submitted, via IRBNet, no later than fifteen (15) business days prior to the IRB monthly
meeting in order to assure the IRB will review the project before the approval is due to lapse.
Failure to Renew/Lapse of IRB Approval
Failure of the principal investigator to submit projects for continuing review prior to the
IRB approval expiration date will result in automatic termination of the IRB approval. If
this occurs, all research recruitment, study interventions and collection of data must cease. The
principal investigator should contact the IRB office immediately for guidance if they believe it
is in the best interest of some or all enrolled participants to continue participating in the research
or interactions.
If the principal investigator plans to continue the research and fails to submit an
application for renewal by the IRB approval expiration date, and there has been
no contact with human subjects during the lapse, then the principal investigator should provide
the IRB with a statement along with a renewal application explaining the reason for the lapse of
approval and written assurance that no contact was made with subjects during this period.
Closure of a Research Project
When the research project is terminated or completed, the IRB requires the principal investigator to promptly notify the IRB by completing the Application for Closure.
At minimum, the Application for Closure should provide the IRB with the following information:
- Reason for the closure or termination (e.g., completed all data collection/analysis, sponsor closed or terminated the study)
- The number of patients enrolled and number of patients that completed the study
- Important study outcomes (if known)
- Unanticipated problems or local adverse events (including hospitalizations and deaths)
- Any complaints concerning the study
Federal regulations stipulate that all research records must be retained (in a secure manner), and accessible by the regulatory agency or IRB
for audit, for a minimum of three years after closure of the study.
HIPAA Patient Use and Disclosure Regulations
Under the new Health Insurance Portability and Accountability Act (HIPAA)
regulations, the IRB has provided investigators with a HIPAA Patient Authorization for Use and Disclosure of Protected Health Information for
Research Purposes form. This HIPAA authorization form must be
utilized in conjunction with the informed consent form when enrolling new
subjects in an approved research project. Research participants should receive a copy of this signed HIPAA form.
For more information on HIPAA requirements for research, click on HIPAA Guidelines.
Note:
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