How do I submit to the IRB

EXTERNALLY FUNDED CLINICAL TRIALS

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 Check List 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?

Jennifer Sisler, BSN, RN, Sr. Network Director, Clinical Trials and Research
(484-526-5190, Jennifer.Sisler@sluhn.org)

INTERNALLY SUPPORTED INTERVENTIONAL STUDIES

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 Check List of Requirements

Prior to engaging in any Research at St. Luke’s University Health Network, each Investigator/Key personnel must:

Complete Financial Conflict of Interest (FCOI) Training presented by the NIH Office of Extramural Research every 4 years.
Submit FCOI form annually.
Complete CITI Good Clinical Practice (GCP) module every 3 years.
Complete CITI Human Subjects Research (HSR) Biomedical Researchers module once.

Please see the links and details below:

FCOI Training presented by the NIH Office of Extramural Research
- http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
- Please date and print the certificate on last page of PowerPoint tutorial and forward to IRB office annually.
Please complete the attached FCOI form and forward to IRB coordinator annually
Good Clinical Practice (GCP) course through CITI: www.citiprogram.org
- You are only required to do the GCP module.
- Please print/forward certificate to an IRB office.
Human Subject Research (HSR) through CITI: www.citiprogram.org
- You are only required to do the Biomedical Researcher module under HSR.
- Please print/forward certificate to an IRB office.
- There is no expiration for this certificate.

If you have never done CITI courses before, please register and enter St. Luke’s information. When searching for our affiliation, type in exactly “St. Luke's Hospital & Health Network - Bethlehem, PA”.

If you have completed the GCP training 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 3-years.

All certificates/forms can be emailed to Jayne.Silva@sluhn.org or Mayra.Estremera@sluhn.org.

Forms

**Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

Initial IRB Application
Study protocol
Appropriate Informed Consent Form(s):
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)
Signed letter of support from department (for unfunded studies only)

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

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 Check List of Requirements

Prior to engaging in any Research at St. Luke’s University Health Network, each Investigator/Key personnel must:

Complete Financial Conflict of Interest (FCOI) Training presented by the NIH Office of Extramural Research every 4 years.
Submit FCOI form annually.
Complete CITI Good Clinical Practice (GCP) module every 3 years.
Complete CITI Human Subjects Research (HSR) Biomedical Researchers module once.

Please see the links and details below:

FCOI Training presented by the NIH Office of Extramural Research
- http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
- Please date and print the certificate on last page of PowerPoint tutorial and forward to IRB Office.
Please complete the attached FCOI form and forward to IRB Office annually
Good Clinical Practice (GCP) course through CITI: www.citiprogram.org
- You are only required to do the GCP module.
- Please print/forward certificate to the IRB Office.
Human Subject Research (HSR) through CITI: www.citiprogram.org
- You are only required to do the Biomedical Researcher module under HSR.
- Please print/forward certificate to the IRB Office.
- There is no expiration for this certificate.

All certificates/forms can be emailed to Jayne.Silva@sluhn.org or Mayra.Estremera@sluhn.org.

Forms

**Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

Initial IRB Application
Study protocol
Informed Consent Form or Child Assent/Parental Permission Form (if study involved minors)
Exemption Request Form
Patient Materials (e.g. Questionnaires, diaries, phone scripts, etc.)
Advertisements (if applicable)
Signed letter of support from department (for unfunded studies only)

Who do I contact?

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

RETROSPECTIVE CHART REVIEWS

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 Check List of Requirements

Prior to engaging in any Research at St. Luke’s University Health Network, each Investigator/Key personnel must:

Complete Financial Conflict of Interest (FCOI) Training presented by the NIH Office of Extramural Research every 4 years.
Submit FCOI form annually.
Complete CITI Good Clinical Practice (GCP) module every 3 years.
Complete CITI Human Subjects Research (HSR) Biomedical Researchers module once.

Please see the links and details below:

FCOI Training presented by the NIH Office of Extramural Research
- http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
- Please date and print the certificate on last page of PowerPoint tutorial and forward to IRB Office.
Please complete the attached FCOI form and forward to IRB Office annually
Good Clinical Practice (GCP) course through CITI: www.citiprogram.org
- You are only required to do the GCP module.
- Please print/forward certificate to the IRB Office.
Human Subject Research (HSR) through CITI: www.citiprogram.org
- You are only required to do the Biomedical Researcher module under HSR.
- Please print/forward certificate to the IRB Office.
- There is no expiration for this certificate.

All certificates/forms can be emailed to Jayne.Silva@sluhn.org or Mayra.Estremera@sluhn.org.

Forms

**Please refer to the “IRB Submission Checklist” for a full listing of submission forms**

Request for Patient Data (to obtain patient data from the SLUHN data warehouse)
Initial IRB Application
Exemption request form
Study protocol
Signed letter of support from department (for unfunded studies only)

Who do I contact?

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

EXEMPT STUDIES

Study Definition

Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review. Please check those items that apply to your research. These categories are taken from 45 CFR 46.104(d)

Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact student’s opportunity to learn required educational content or the assessment of educators who provide instruction, 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. The exemption may only be used for studies about normal educational practices.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, as long as one of the following criteria is met:

the information is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, AND the IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).

NOTE: Audio and/or recording is now included in this exemption.

NOTE: Surveys also cannot include collection of biospecimens or interventions, as those additional activities would disqualify the research from this category.

NOTE: In order for research subject to paragraphs (i) and (ii) to apply, the investigator(s) must not participate in the activities being observed and educational tests. Surveys or interviews of children do not qualify for exemption.

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii)
Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, AND an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).

NOTE: For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

NOTE: If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, IF at least one of the following criteria is met:

The identifiable private information or identifiable biospecimens are publicly available;
Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

NOTE: In order to meet this category, tissue and/or data no longer needs to exist at the time the research is proposed to the IRB as previously required by the pre-2018 rule. The data can be collected prospectively and still be used for exempt research under this Category.

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including 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.

Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

NOTE: Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

NOTE: In order to meet this category, the research must: 1) be conducted pursuant to specific federal statutory authority; 2) not involve significant physical invasions or intrusions upon the privacy interests of participant; 3) have authorization or concurrence by the funding agency.

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.

To-Do Check List of Requirements

Prior to engaging in any Research at St. Luke’s University Health Network, each Investigator/Key personnel must:

Complete Financial Conflict of Interest (FCOI) Training presented by the NIH Office of Extramural Research every 4 years.
Submit FCOI form annually.
Complete CITI Good Clinical Practice (GCP) module every 3 years.
Complete CITI Human Subjects Research (HSR) Biomedical Researchers module once.

Please see the links and details below:

FCOI Training presented by the NIH Office of Extramural Research
- http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm
- Please date and print the certificate on last page of PowerPoint tutorial and forward to IRB Office.
Please complete the attached FCOI form and forward to IRB Office annually
Good Clinical Practice (GCP) course through CITI: www.citiprogram.org
- You are only required to do the GCP module.
- Please print/forward certificate to the IRB Office.
Human Subject Research (HSR) through CITI: www.citiprogram.org
- You are only required to do the Biomedical Researcher module under HSR.
- Please print/forward certificate to the IRB Office.
- There is no expiration for this certificate.