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WHAT IS HUMAN SUBJECTS RESEARCH?

Human subjects research includes any systematic investigation that is designed to develop or contribute to generalizeable (i.e., scholarly) knowledge and which uses living humans or identifiable information about living humans. Some examples of human subjects research projects conducted at the Baptist Health System are:

· drug/device comparison trials

· disease prevention studies

· medical chart review studies


STANDARD DIAGNOSTIC OR THERAPEUTIC PROCEDURES

The distinction between research and treatment can be blurred in patient care settings, as well as in some educational and training settings. An established and accepted diagnostic or therapeutic procedure that is performed only for the benefit of a patient is generally not subject to HRRB review. However, collection of data about a series of such procedures or treatments for dissemination or generalization does constitute research that requires HRRB review. Additionally, if patient care or assignment to intervention is altered for research purposes in any way the activity must be submitted for HRRB review. Also, a diagnostic procedure for research purposes that is added to a standard treatment requires HRRB review.

INNOVATIVE PROCEDURES OR TREATMENTS

Innovations in diagnosis or therapy are not generally subject to HRRB review if they are applied to a patient for the sole purpose of aiding that individual, although such innovations are governed by the appropriate professional ethics (e.g., obtaining informed consent). HRRB review is required when a 'systematic investigation' of such innovations is considered. For example, if a physician plans to collect information about the innovation for scientific purposes or will repeat the innovation in other patients in order to compare it to standard treatment, the physician must receive prior HRRB review.

EMERGENCY USE OF AN INVESTIGATIONAL DRUG OR DEVICE

Nothing in the Baptist Health System policies or Federal regulations is intended to limit the authority of a physician to provide emergency medical care for patients who need such care. The Baptist Health System Human Research Review Board review is not required for emergency use of a test article provided such emergency use is reported to the Human Research Review Board within five (5) working days of the emergency use. When emergency medical care is initiated, the patient may not be considered a research subject. Such emergency care may not be claimed as research, nor may any data regarding such care be included in any report of research activity.

CASE REPORTS

A report on a single case does not usually require prior HRRB approval because it does not usually meet the 'systematic investigation' criteria to be considered research. These are more akin to journalism than to research. However, these projects should follow the same guidelines for the protection of the subject's privacy, dignity, and welfare as they would if they required HRRB review.

What is an Institutional Review Board?

An Institutional Review Board (IRB) is a local committee comprised of clinicians, administrative and support staff, and lay people who review all proposed Baptist Health System human subjects research to ensure that the safety and welfare of subjects are protected. There is one IRB committee at the Baptist Health System that has been named the Human Research Review Board. The Human Research Review Board meets once per month and is supported by staff who are available for consultation on all human subjects research matters. Human Research Review Board staff also are available by appointment to pre-review any human subject research protocol submission to the Human Research Review Board.

Who is Eligible to be a Principal Investigator?

Baptist Health System clinicians, residents, nursing staff, and employees with .5 FTE status or more may serve as Principal Investigator on research protocols involving human subjects.

What Kind of Approval Do I Need to Begin My Human Subjects Research Study?

All human subjects research at the Baptist Health System is to be reviewed by the Human Research Review Board. Depending on the research interventions proposed, you will need Human Research Review Board approval or Exempt From Continuing Review status from the Human Research Review Board. The categories of research and their corresponding levels of review are described in WHAT LEVEL OF REVIEW DO I NEED? You also may need approval from other oversight committees, such as Radiation Safety Committee for protocols involving radiating the subject or Institutional Biosafety Committee for protocol involving genetic therapy and transfer.

How Do I Get Started?

Federal regulations divide human subjects research into three categories, each of which has a corresponding requirement for institutional approval or registration. For an explanation of each, see WHAT LEVEL OF REVIEW DO I NEED? Once you have determined the level of review required, you will need to submit an application for Human Research Review Board Review.

What Do I Need in Order to Submit a Protocol for Human Research Review Board Review?


For all the categories for review, please refer to Appendix I: Submission Instructions.

EXEMPT FROM CONTINUING REVIEW STATUS

To apply for Exempt From Continuing Review Status you must complete and submit to the Human Research Review Board the NEW RESEARCH PROJECT APPLICATION for approval. Request Exempt From Continuing Review Status and include a brief abstract describing your research project. If you will be using a data collection instrument, such as a survey or questionnaire, please attach a copy. There are no submission deadlines for requests for Exempt From Continuing Review Status confirmation.

EXPEDITED REVIEW FOR NEW PROJECT

To apply for Expedited Review, you must submit one complete original copy of the NEW RESEARCH PROJECT application form, the protocol and the informed consent document to the Human Research Review Board office. The fee for review of industry funded or sponsored protocols submitted for expedited review is $750 and is a one-time non-refundable charge. This administrative fee covers initial review, amendments, periodic continuing review, adverse events reports and IND safety letter submissions for the life of the protocol. The fee is due at the time of submission of the protocol. There are no submission deadlines for expedited review, as they are conducted on a continuous basis.

Print out these checklists to refer to when preparing your protocol:

  • "Protocol Preparation Checklist" (Appendix II):
    A list of information that the Human Research Review Board expects to find in a complete protocol.
  • "Consent Form Preparation Checklist" (Appendix III):
    Elements necessary for preparing consent for review.

FULL COMMITTEE REVIEW FOR NEW PROJECT

Print out these checklists to refer to when preparing your protocol:

· "Protocol Preparation Checklist" (Appendix II):
A list of information that the Human Research Review Board committee expects to find in a complete protocol.

· "Consent Form Preparation Checklist" (Appendix III):
Elements necessary for preparing consent for review.

Modifications to Approved Research

Changes in project scope, location, personnel, interventions, or inclusion/exclusion criteria must receive prior approval by the Human Research Review Board. To apply for a modification, you must submit an AMENDMENT TO A PREVIOUSLY APPROVED PROJECT form. Please consult the Human Research Review Board Coordinator to find out if committee deadlines will apply. This is dependent on whether the proposed modification will be reviewed on an Expedited or Full Committee basis.

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