Jupiter Medical Center Institutional Review Board (IRB)


Terri Freeman, CPHRM, LHRM, Director of Risk Management/Medical Staff Services, IRB Co-Chairperson
Office: (561) 263-2940
Fax: (561) 263-5788             


Jeanine Secor, RN, BSN, CCRP, Director of Clinical Research
Office: (561) 263-5791
Fax: (561) 263-4149

Michelle Drys, IRB Coordinator
Office: (561) 263-3686

 

Meeting Time, Date & Location

Jupiter Medical Center's IRB meets on the fourth Thursday of the month (third Thursday in November and December), at noon, in the Raso Education Center located on Jupiter Medical Center's campus.


Functions

Federal and state regulations mandate that research involving human participants must be reviewed and approved by an IRB provided for in its assurance with the Office of Human Research Protections and will be subject to continuing review by the IRB. The IRB is responsible for providing guidance and oversight for the human participant protection program and for helping to maintain compliance with applicable laws, regulations and policies. The IRB is responsible for the following oversight functions:

1. Determine what activities constitute human participant research.
2. Review, approve, require modification in (to secure approval), or disapprove all research activities at Jupiter Medical Center prior to the commencement of the research.
3. Require that information given to participants as part of the informed consent is in accordance with appropriate laws and regulations. The IRB may require that additional information be given to the participants when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
4. Require documentation of informed consent or waive documentation in accordance with federal and state laws and regulations.
5. Notify investigators in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
6. Conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year, and have authority to observe or have a third party observe the consent process and the research.
7. Suspend or terminate approval of research that is not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator and the institutional official.
8. The IRB shall also be responsible for reporting to the appropriate institutional official and the FDA, any serious or continuing non-compliance with 21 CFR parts 50 and 56 or the requirements and determinations of the IRB.

 
Information an Investigator must provide the IRB for initial review includes:

  • Professional qualifications (CV, NIH Training, Good Clinical Practice Agreement) to do the research, including the names and description of any necessary support services and facilities.
    •Initial Protocol Review Form
    •Protocol (see Key Elements of a Clinical Research Protocol/Informed Consent and Jupiter Medical Center Checklist for Protocol Review)
    •Title and date of the study
    •Name and address of principal investigator and any co-investigators
    •Site where the study will be performed
    •Purpose of the study, including the benefits expected.
    •Sponsor of the study.
    •Results of previously related research.
    •Subject selection and exclusion criteria.
    •Justification for use of special subject populations (i.e. children).
    •Study design, including as needed a discussion of the research methods, and a description of procedures to be followed.
    •Provisions for managing subject adverse reactions.
  • Informed Consent (see Informed Consent Template, Sample HIPAA Form for Physicians and Patient Bill of Rights).
    •Circumstances surrounding a consent procedure, such as environment, time, condition of the subject, primary language of the subject, and the subject's autonomy.
    •Documentation of informed consent (who will obtain informed consent, provision for a witness as needed, signatures of the subject or the subject's representative, signature of investigator, signature of person obtaining consent, signature of witness, use of short form if needed, providing the subject a copy of the consent information).  A "short form" states that the elements of informed consent have been presented orally to the subject.  When a short form consent document is used, the IRB should review and approve the written summary of the full information to be presented orally to the subject.  A witness is required to attest to the adequacy of the informed consent process and to the subject's voluntary consent.
    •Compensation to the subject for his or her participation.
    •Provisions for protection of the subject's privacy.
    •Extra costs to subject because of his or her participation in the study.
    •Extra costs to third party payers because of subject's participation in the study.