International Cell Surgical Society

Institutional Review Board
HHS-OMB Number – 0990-0279
IORG0007657

Overview of the IRB in Clinical Studies

The protection of the rights and privacy of human subjects involved in research activities is mandated by federal law. The National Research Act Public Law 99-158, The Health Research Extension Act of 1985, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research provide guidelines for research with human subjects to ensure their protection in the design and conduct of research. These federal regulations require that any institution requesting and receiving funds from a federal department or agency or otherwise dedicated to compliance with these regulations via federal wide assurance (FWA) for research involving human subjects must assure that such research is reviewed and approved by an institutional review board (IRB).

Mission of the ICSS IRB

The ICSS IRB is committed to providing peer review of proposed studies of investigational medical therapies based upon appropriate clinical translation, good patient care and safety. The purpose of this IRB is to evaluate and access potential risk to human subjects.

The mission of the ICSS IRB is patient safety: to maintain an effective Human Research Protection Program to protect the rights and welfare of human participants in research reviewed under the auspices of our IRBs. While discussion of study methodology is allowed, final determination of approval must be based upon entirely upon risk and patient safety.

Approval by the ICSS IRB does not imply the legality of any study. The ICSS strongly recommends that investigators seek the opinion of legal counsel.

Overview of the Review Process (Initial and Continuing Review)

The review process begins with an initial review by the executive director of ICSS to assure that the application is complete. This will include:

1. Completed IRB Study application or Complete Study Protocol
2. Proof of competency of the Principal and any Co-Investigators
   1. CV of all participating scientists and physicians
   2. Copy of the medical license of each physician
3. Informed consent
   1. The participation by human subjects in any study reviewed or approved by the ICSS must be consensual. The ICSS provides that, at the minimum, an informed consent is constituted by two essential elements:
      1. The subject has the information he or she requires to make an effective decision, and
      2. The subject’s participation is not coerced, i.e. his or her consent is voluntary.
   2. Data collection program
      1. Outcome and Safety Measures to be tracked
      2. Frequency of tracking
      3. Patient safety and general enrollment data must be presented to the IRB quarterly
   3. Any marketing materials

If any element is missing, the executive director will inform the applicant(s) of the missing elements needed for meaningful consideration by the IRB.

Upon successful completion of the initial review, the applicant(s) will be informed that the study is ready for review (full or expedited). After the review is conducted, the applicant(s) will receive notification promptly.

If the IRB is unable to provide approval, it will provide details reasons for its decision and, if applicable, information needed for approval.

While the primary focus of the IRB is the safety of the patient and research participants, the IRB is free to inquire into any applicable elements of the study and model.

Eligibility:

The ICSS IRB is open to qualified physicians and researchers. Studies must be legal and considered practice of medicine in the jurisdiction where the treatment is being provided.

Studies must provide the following:

1. Proof of professional qualification for primary investigator and other key individuals engaged in the study,
   1. Physicians
2. Scientific support for the safe use and application of the materials utilized in the study.
3. Specific inclusion and exclusion criteria for study participants.
4. Methodology, including measures and collection and evaluation processes, for the tracking of all outcomes and the reporting of potential complications for all study participants.
5. Informed consent specific to the study.
   1. Including all elements of consent as required by federal regulations
6. Proof of competency of laboratory, clinic or medical facility
7. Investigators must provide to the ICSS the following information:
   1. Current CV
   2. Copy of license to practice medicine
   3. Proof of insurance

The ICSS IRB maintains the right to require additional oversight, such as:

1. Participation in an ICSS approved accreditation or certification programs.
2. Collection and evaluation of patient outcome and complication data.
3. Proof, in the form of statute or advice from competent legal counsel, that the study is considered practice of medicine in the jurisdiction where it will be administered.

Process:

1. Payment for IRB reviews is due upon completion of deliberations. ICSS reserves the right to charge additional fees for protracted deliberations.
2. Applications shall be forwarded to the executive director of ICSS for preliminary review. This review will consist of assuring that all required information is provided. Should any portion of the study be incomplete or lacking, the ICSS will communicate these findings to the applicant.
3. If approved by the executive director of ICSS, the application will be forwarded to the entire IRB for review and deliberation.
4. While discussions and observations about study design are important, the final determination will be based upon the safety profile of the study and whether or not there is sufficient support to evidence that the study will not cause patient harm.

 The IRB may provide one of the following determinations:

1. Approval: Study is approved. IRB may determine review to be conducted more frequently than every 12 months on a case-by-case basis.
2. Conditional Approval: Study is approved given upon any of the following requests from the IRB: various minor revisions, smaller patient size until next review, present more data to justify claims
3. Denial: Study is denied.
4. Conditional Denial: The study is not approved until such a time as the conditions placed upon it by the IRB are successfully met.
5. In the case of denial, conditional denial, and conditional approval, the applicant(s) is (are) allowed additional opportunities to re-submit the study with appropriate changes. ICSS reserves the right to charge additional fees in protracted deliberations as appropriate.
6. Any change to any approved study must be presented, in writing, to the executive director of ICSS to forward on to IRB for review. The executive director and/or chair will make the determination whether the proposed change should be accepted for expedited approval or submitted to the IRB for review.
7. All studies are required to resubmit for continuing review annually, unless the approval period expires beforehand. . ICSS will provide several monthly reminders prior to a study’s expiration. The applicant(s) will be required to submit all required documents for continuing review, including outcomes, complication rates, and adjudications and pay the review charge. Failure to submit the study for review will result in the expiration of approval.

The following are some of the conditions under which the ICSS IRB may revoke approval of any existing study:

1. Violation of the eligibility IRB review and approval.
2. Change of study protocol without IRB notification and approval.
3. Change in regulatory statute or legal status of any study.
4. Unadjudicated severe adverse event(s).
5. Failure to notify IRB of any severe adverse event.
6. Change of status (professional or legal) or qualification of an investigator or other named member of the study team.
7. Failure to report, or provide qualifications for new member of the study team.