How do I submit to the IRB?

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EXTERNALLY FUNDED CLINICAL TRIALS

  • Study Definition
  • To-Do Check List of Requirements
  • Forms
  • Who do I contact?
  • Study Definition:

    These types of studies consist of the following:

    • Designed and sponsored by an external company/institution with external funding in which SLUHN is a participating site, regardless of design (e.g. interventional/therapeutic versus observational/non-therapeutic).
    • Designed and carried out by SLUHN employees with external funding source (e.g. industry funding support, grants, etc.), regardless of design (e.g. interventional/therapeutic versus observational/non-therapeutic).
  • To-Do Checklist of Requirements:

    • Develop a Billing Coverage Analysis (BCA) if qualifying clinical trial (e.g. interventional therapeutic trials), or a Cost Analysis if observational study.
    • Develop budget based on BCA/Cost Analysis and obtain funding sponsor approval.
    • Work with SLUHN legal counsel to review and execute Clinical Trial Agreement (CTA) and/or any other contractual agreements (e.g. Business Associates Agreement, Facility Use Agreement, etc.).
    • Complete Finance Approval Form and send to SLUHN Business Office for review and approval.
    • Obtain research contract account from Accounts Payable.
    • Develop Informed Consent Form(s) in SLUHN template and obtain sponsor approval prior to IRB submission
    • Complete the Initial IRB Application and all other required documents, and submit along with the finalized ICF(s) to the IRB for review and approval
    • Complete all required essential regulatory documents (e.g. FDA Form 1572, Investigator Financial Disclosure Forms, signed and dated CVs and Medical Licenses, Delegation of Authority Logs, etc.).
  • Forms:
    **Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

    • Initial IRB Application
    • Clinical Trial Protocol
    • Investigator Brochure/Device Brochure or Package Insert (if research involves a drug or device)
    • Copy of the FDA IND/IDE Approval Letter (if applicable)
    • Informed Consent Form(s) or Child Assent/Parental Permission Form (if study involved minors)
    • Patient Materials (e.g. Questionnaires, diaries, phone scripts, etc.)
    • Advertisements (if applicable)
    • FCOI Disclosure for all listed personnel
    • FCOI NIH Tutorial Certificate for all listed personnel
    • CITI training for all listed personnel
    • New Study Feasibility Form (CTO trials only)
  • Who do I Contact?

    Tracy Butryn, MS, CCRP, CHRC Network Director of Clinical Trials and Research
    (484-526-5190, Tracy.Butryn@sluhn.org)

INTERNALLY SUPPORTED INTERVENTIONAL STUDIES

  • Study Definition
  • To-Do Check List of Requirements
  • Forms
  • Who do I contact?
  • Study Definition:

    These types of studies consist of the following:

    • Designed and carried out by SLUHN employees with no external funding source.
    • Determination of cause-and-effect relationships between a treatment/intervention and an outcome.
    • Assignment of participants to treatment and control groups (randomized controlled trial) or to treatment and comparison groups with no random assignment (quasi experiment).
  • To-Do Checklist of Requirements:

    • Complete CITI training, Good Clinical Practice (GCP) module (http://www.citiprogram.org).
      • This training is required of all study personnel, regardless of their role in the study.
      • If you previously completed this training:
        • At SLUHN: Your certificate is good for 4 years.
        • At a non-SLUHN institution: Your current certificate of completion will be considered—however, you are encouraged to retake the course through SLUHN if you are nearing the 4-year expiration date.
      • If this is your first time taking the course, please register and enter St. Luke’s Information. When searching for institutional affiliation, type in “St. Luke's Hospital & Health Network - Bethlehem, PA”.
      • You are only required to complete the GCP module (course #2).
      • Print your certificate and forward via interoffice mail to Jayne Silva, IRB and Research Institute Administrative Coordinator.
    • Complete the brief NIH Conflict of Interest (COI) tutorial
      • This training is required of all study personnel, regardless of their role in the study.
      • After viewing slideshow, print certificate on last page of PowerPoint and forward to Jayne Silva.
      • This tutorial is good for 4 years.
    • Complete the Financial Conflict of Interest (FCOI) form and return to Manny Changalis, Department of Medical Affairs.
      • This form is required of all study personnel, regardless of their role in the study.
      • The FCOI form must be completed annually.
    • Complete the required IRB forms for interventional studies and submit to Jayne Silva (East Wing, 2nd Floor, next to the chapel) for IRB review and approval.
  • Forms:
    **Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

  • Who do I Contact?

    Jill Stoltzfus, PhD, Research Institute Director
    (484-526-4942, Jill.Stoltzfus@sluhn.org)

PROSPECTIVE NON-INTERVENTIONAL or SURVEY STUDIES

  • Study Definition
  • To-Do Check List of Requirements
  • Forms
  • Who do I contact?
  • Study Definition:

    These types of studies consist of the following:

    • Cohort studies with no treatment/intervention (e.g., following a group of elderly patients over time to determine quality of life).
    • Surveys/interviews to determine outcomes such as level of pain, patient satisfaction, etc., that do NOT include a treatment/intervention as part of the study design.
  • To-Do Checklist of Requirements:

    • Complete CITI training, Good Clinical Practice (GCP) module.
      • This training is required of all study personnel, regardless of their role in the study.
      • If you previously completed this training:
        • At SLUHN: Your certificate is good for 4 years.
        • At a non-SLUHN institution: Your current certificate of completion will be considered—however, you are encouraged to retake the course through SLUHN if you are nearing the 4-year expiration date.
      • If this is your first time taking the course, please register and enter St. Luke’s Information. When searching for institutional affiliation, type in “St. Luke's Hospital & Health Network - Bethlehem, PA”.
      • You are only required to complete the GCP module (course #2).
      • Print your certificate and forward via interoffice mail to Jayne Silva, IRB and Research Institute Administrative Coordinator.
    • Complete the brief NIH Conflict of Interest (COI) tutorial
      • This training is required of all study personnel, regardless of their role in the study.
      • After viewing slideshow, print certificate on last page of PowerPoint and forward to Jayne Silva.
      • This tutorial is good for 4 years.
    • Complete the Financial Conflict of Interest (FCOI) form and return to Manny Changalis, Department of Medical Affairs.
      • This form is required of all study personnel, regardless of their role in the study.
      • The FCOI form must be completed annually.
    • Complete the required IRB forms for interventional studies and submit to Jayne Silva (East Wing, 2nd Floor, next to the chapel) for IRB review and approval.
  • Forms:
    **Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

  • Who do I Contact?

    Jill Stoltzfus, PhD, Research Institute Director
    (484-526-4942, Jill.Stoltzfus@sluhn.org)

RETROSPECTIVE CHART REVIEWS

  • Study Definition
  • To-Do Check List of Requirements
  • Forms
  • Who do I contact?
  • Study Definition:

    These types of studies consist of the following:

    • Retrospective cohort study [i.e., tracking patient outcomes based on exposure versus non-exposure to selected risk factors (cohort of interest)]
    • Retrospective case-control study [i.e., determining whether certain risk factors predict/contribute to disease (cases) versus no disease (controls)]
    • Other types of retrospective review of patient data (e.g., descriptive outcomes analysis)
  • To-Do Checklist of Requirements:

    • Complete CITI training, Good Clinical Practice (GCP) module.
      • This training is required of all study personnel, regardless of their role in the study.
      • If you previously completed this training:
        • At SLUHN: Your certificate is good for 4 years.
        • At a non-SLUHN institution: Your current certificate of completion will be considered—however, you are encouraged to retake the course through SLUHN if you are nearing the 4-year expiration date.
      • If this is your first time taking the course, please register and enter St. Luke’s Information. When searching for institutional affiliation, type in “St. Luke's Hospital & Health Network - Bethlehem, PA”.
      • You are only required to complete the GCP module (course #2).
      • Print your certificate and forward via interoffice mail to Jayne Silva, IRB and Research Institute Administrative Coordinator.
    • Complete the brief NIH Conflict of Interest (COI) tutorial
      • This training is required of all study personnel, regardless of their role in the study.
      • After viewing slideshow, print certificate on last page of PowerPoint and forward to Jayne Silva.
      • This tutorial is good for 4 years.
    • Complete the Financial Conflict of Interest (FCOI) form and return to Manny Changalis, Department of Medical Affairs.
      • This form is required of all study personnel, regardless of their role in the study.
      • The FCOI form must be completed annually.
    • Complete the required IRB forms for interventional studies and submit to Jayne Silva (East Wing, 2nd Floor, next to the chapel) for IRB review and approval.
  • Forms:
    **Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

  • Who do I Contact?

    Jill Stoltzfus, PhD, Research Institute Director
    (484-526-4942, Jill.Stoltzfus@sluhn.org)

EXEMPT STUDIES

  • Study Definition
  • To-Do Check List of Requirements
  • Forms
  • Who do I contact?
  • Study Definition:

    These types of studies consist of the following:

    The “Common Rule” (45 CFR 46 subpart A) defines a number of research activities that may be exempt from its purview, unless otherwise specified by Department or Agency heads.

    Exempt research has very little, if any, associated risk. Corresponding research activities, as defined by 45 CFR 46.101(b), include six exempt categories:

    • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
      • research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
    • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
      • information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
      • any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
    • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
      • the human subjects are elected or appointed public officials or candidates for public office; or
      • Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
    • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
    • Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
      • public benefit or service programs;
      • procedures for obtaining benefits or services under those programs;
      • possible changes in or alternatives to those programs or procedures; or
      • possible changes in methods or levels of payment for benefits or services under those programs.
    • Taste and food quality evaluation and consumer acceptance studies:
      • if wholesome foods without additives are consumed; or
      • if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

    SLUHN policy allows the IRB to disallow exemptions that are allowable under federal law. Only the IRB Chair or IRB Chair designee may determine whether a submitted research project meets the requirements for exemption from IRB review.

    If the research project does not meet criteria for exemption, the Principal Investigator will be notified, and the project will require resubmission for either expedited review or review by the full IRB.

    Research that does not qualify for IRB exemption at SLUHN includes the following project subtypes / subject populations:
    • Prisoners
    • Pregnant women
    • In vitro fertilization
    • Use of deception
    • Fetuses
    • Decisionally impaired subjects
    • Use of school records of identifiable students or interviewing instructors about specific students
    • Survey or interview procedures with children (participants under the age of 18 years)
    • Observation of public behavior when the investigator(s) participates in the activities being observed
    • Collected data that include protected health or medical information when there is a direct or indirect link that would identify the participant
    • Sensitive aspects of the participant’s own behavior, such as illegal conduct, drug use, sexual behavior or use of alcohol
    • FDA-sponsored research except in emergency circumstances
  • To-Do Checklist of Requirements:

    • Complete CITI training, Good Clinical Practice (GCP) module.
      • This training is required of all study personnel, regardless of their role in the study.
      • If you previously completed this training:
        • At SLUHN: Your certificate is good for 4 years.
        • At a non-SLUHN institution: Your current certificate of completion will be considered—however, you are encouraged to retake the course through SLUHN if you are nearing the 4-year expiration date.
      • If this is your first time taking the course, please register and enter St. Luke’s Information. When searching for institutional affiliation, type in “St. Luke's Hospital & Health Network - Bethlehem, PA”.
      • You are only required to complete the GCP module (course #2).
      • Print your certificate and forward via interoffice mail to Jayne Silva, IRB and Research Institute Administrative Coordinator.
    • Complete the brief NIH Conflict of Interest (COI) tutorial
      • This training is required of all study personnel, regardless of their role in the study.
      • After viewing slideshow, print certificate on last page of PowerPoint and forward to Jayne Silva.
      • This tutorial is good for 4 years.
    • Complete the Financial Conflict of Interest (FCOI) form and return to Manny Changalis, Department of Medical Affairs.
      • This form is required of all study personnel, regardless of their role in the study.
      • The FCOI form must be completed annually.
    • Complete the required IRB forms for interventional studies and submit to Jayne Silva (East Wing, 2nd Floor, next to the chapel) for IRB review and approval.
  • Forms:
    **Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

  • Who do I Contact?

    Jayne Silva, IRB and Research Institute Administrative Coordinator
    (484-526-6742, Jayne.Silva@sluhn.org)