The Institutional Review Board (IRB) is the committee designated to review, approve, and monitor biomedical and behavioral research involving human subjects. The role of the IRB is to protect the rights and welfare of the research participant. The IRB must act in compliance with regulations established by the U.S. Food and Drug Administration and the Office for Human Research Protections at the U.S. Department of Health and Human Services.

Contacts

IRBOffice@towerhealth.org   
484-628-5082

Julie Wilberding, PhD, CIP
Director, Human Research Protections
Julie.Wilberding@towerhealth.org 
484-628-5083

Kathryn Nester
IRB Coordinator
Kathryn.Nester@towerhealth.org

Debra Stavarski, PhD, RN, CHRC
System Director, Research Compliance Officer
Debra.Stavarski@towerhealth.org 
484-628-9408

 Important Information:

1. Activities meeting the definition of research and involving human subjects must be submitted to the IRB for review.

2. Definitions:

  • Research: a systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l))
  • Human subjects: a living individual about whom an investigator (whether professional or student) conducting research (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable information or biospecimens. (45 CFR 46.102(e)(1))
  • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or subject’s environment that are performed for research purposes. (45 CFR 46.102(e)(2))
  • Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102(e)(3)).
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). (45 CFR 46.102(4))

3. If a research study is planned, IRB review should be obtained BEFORE initiating the study protocol. 

Prior to submitting a proposal to the IRB, the investigator and study staff must complete the following required education:

1. Citi Program Training:  Note when choosing a learner group, you should choose the group applicable to your primary role in research. If your role in research includes both biomedical and social and behavioral research, please check Biomedical Research.

  • Biomedical Research: is the broad area of science that looks for ways to prevent and treat diseases that cause illness and to develop programs to improve health and wellness. This general field of research includes many areas of both the life and physical sciences. This includes but is not limited to clinical trials, studies that involve behavioral or medical interventions or the development of public health programs. Most researchers at Tower Health will fall into this category. 
  • Social and Behavioral Research: The term “social-behavioral” refers to human motivations, activities, psychological processes and interactions (small groups, families, communities, and whole societies). Social-behavioral research applies the behavioral and social sciences to the study of humans. Such research is commonly conducted in the following academic disciplines: education, sociology, psychology, anthropology, economics, political science, and history. This includes but is not limited to curriculum development, survey research, focus groups and observations of behavior.
  • There are also different Good Clinical Practice Modules for Investigators. Select the most appropriate one applicable to your primary role in research.  New Modules:
    • Clinical Trial Billing Compliance – for researchers involved in research that involves billing.
    • Research Study Design
  • The link is https://www.citiprogram.org/ and the institutional affiliation is Tower Health.

2.  Policies and Procedures Review and Acknowledgement:

Review the following policies and procedures, located in PolicyManager, Sign and date the first page of the policy and procedure as attestation that you read and submit with the IRB Application.  

  • Research Integrity
  • Financial Conflicts of Interest in Research
  • Research Non-Compliance
  • Responsible Conduct of Research 
  • Research Billing                                   
  • Coverage Analysis  

3.  Current signed and dated CV