To detail Cottage Health System Institutional Review Board's (CHS IRB) human subjects research requirements for investigators.
In addition to information contained in the various IRB departmental policies,this policy is designed as a guideline to investigators regarding some of the basic requirements related to human subjects research.
Investigator: An individual conducting research:
- on Cottage Health System patients, and/or
- whose research involves the use of a Cottage Health System facility, and/or
- who conducts research under the purview of the Cottage Health System IRB.
The investigator is responsible for following the study plan outlined in the IRB application while adhering to the Investigator Agreement and Institutional policies.
Researchers wishing to conduct research at a CHS facility or wishing to use the CHS IRB, must first sign and return the Investigator Agreement (attesting to having read all of the reference materials accompanying the Investigator Agreement). (Please refer to policy 8012.01 for more information).
IRB Approval of Research:
Investigators may not use more than one IRB for approval and continuing review of any one given study. Each IRB has its own requests and requirements. Moreover, each IRB has specific consent form criteria. Use of more than one IRB could result in multiple active versions of the consent form (regulations stipulate only one current/IRB-approved version of the consent form may be in use). Principal investigators are responsible for securing CHS IRB approval for research involving human subjects for any of the following:
Studies conducted, in whole or in part, at a Cottage Health System facility, must have the approval of the Cottage Health System IRB.
Studies conducted, supported, or otherwise subject to regulation by any Federal Department or Agency that takes appropriate administrative action to require Institutional Review Board review.
Any clinical investigation involving a test article which must meet the requirements for prior submission to the Food and Drug Administration.
Procedures done within the context of a research study which would not ordinarily be done to meet the needs of the patient, including but not limited to the collection of identifiable private information or the collection of data through intervention or interaction with human subjects; the use of human organs, tissue, or body fluids of individually identifiable human subjects; or the graphic, written, or recorded information derived from individually identifiable human subjects.
Withholding medical treatment for the purpose of a study, e.g., the use of a placebo. (This does not apply to cases covered by the Natural Death Act).
Continuing Education in Research Bioethics:
All investigators are to fulfill minimum education requirements (as nationally mandated for individuals conducting research).
All investigators will receive an initial education packet with their Investigator Agreements.
All investigators are required to complete the CHS Research Training module and associated quiz. A certificate of completion will be provided to them. The certificate is valid for 3 years and may be submitted with subsequent IRB applications in lieu of retaking the training module. Alternatively, certificates from other research training modules (i.e. NIH or CITI) will be accepted as a substitute to the CHS IRB training module.
The IRB will provide ongoing educational opportunities in the form of written materials, presentations, compliance audits, and computer-based training modules. (Please refer to policy 8012.01 and 8012.17 for more information).
Ongoing Communication with the IRB, Institution, and Participants
- The use of investigational drugs shall be in accordance with applicable state and federal laws and regulations, and policies adopted by Cottage Health System and the CHS Pharmacy.
- All changes which occur in the study must be submitted to the IRB for review and approval prior to implementation. This includes all protocol amendments, revisions to the investigator's brochure, consent documents, and any desired recruitment methods. Investigators may not implement any protocol changes without prior IRB review and approval, except when necessary to eliminate apparent immediate hazards to subjects.
- Investigators are required to notify the IRB of any noteworthy events, activities, occurrences, or reports (regulatory or otherwise) that may take place during the course of a study. Reportable events, include, but are not limited to:
- Adverse events (see policy 8012.02);
- Findings from sponsors, monitors, or other reviewers;
- Complaints or concerns from participants;
- Any other unexpected problem or event that may occur.
- It is the Principal Investigator's responsibility to do everything possible to eliminate any confusion, misinformation, stress, physical discomfort, or other harmful consequences the participant may have experienced as a result of his/her participation in the research.
Conflict of Interest:
Investigators are obligated to inform the IRB of any conflict of interest, real or perceived, pertaining to the research to be conducted. Such disclosure is received on the Financial Disclosure Statement included in the IRB application. Conflict of interest must be disclosed on the participant's informed consent document. (Please refer to policy 8012.14 for more information).
Participant Identification Cards:
Investigators involved in research studies providing ongoing drug treatment or the implantation of a medical device will provide research participants with identification cards containing pertinent information regarding their enrollment in a research study (see policy 8010.10). Participants are to be provided with an I.D. card at the time of enrollment and are to be instructed to show the card to other healthcare providers (other physicians caring for the patient) and upon admission to any hospital. The purpose of the card is to alert other individuals providing medical care to the patient of his/her participation in a research study.
- Investigators may develop and supply their own I.D. cards, as long as they meet CHS Office of Research approval.
- Some sponsors provide their own patient ID cards. If so, the investigator may use the cards provided by the sponsor in lieu of those provided by the CHS Office of Research. The investigator shall provide the CHS Office of Research with a sample sponsor's ID card for review.
The original signed consent document, which includes the Experimental Subject's Bill of Rights and the Authorization for Use or Disclosure of Health Information shall be retained by the investigator.
If the patient is admitted to a CHS facility (as part of the protocol intervention or otherwise), a copy of the signed consent form should be placed in the patient's hospital chart at the time of admission. If the patient is admitted to the hospital for any reason other than the research study (i.e. illness secondary to the disease under investigation), the investigator may be asked to provide a copy of the signed consent form for the hospital chart.
Whenever possible, a patient's enrollment in a research study should be noted in the patient's chart each time s/he is admitted to the hospital while the patient is still on study in order to alert other health professionals of specific information which may be important in the care or intervention of the research participant. (Please refer to policy 8012.13 for more information).