Regulatoryscientific

The Regulatory Core offers regulatory and quality assurance support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond. The goal is to provide the NJ ACTS community with the tools, training and support needed to navigate the complex regulatory pathways that accompany translational research.

Is my project "Human Subjects Research"?

Human subjects research may include field work, humanities, social-behavioral, and/or biomedical research. Not all research with human subjects, however, meets the legal and University threshold for requiring IRB review.

To determine if a project qualifies as “human subjects research”, answer questions A & B

A) Does my project involve Human Subjects?
Human subject means a living individual about whom an investigator conducting research obtains:

  1. Data or biospecimens through intervention or interaction with the individual
  2. Identifiable private information

B) Is my project Research?
Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge“. Is it an activity designed to test a hypothesis [and] permit conclusions to be drawn through a formal study plan with a set of procedures to reach an objective? If yes, it is research.

You can use this quick and easy-to-use Human Subjects Determination Tool to help you determine whether your study requires IRB review.

If you require more information than offered by the quick tool, you can find additional guidance on when research requires IRB review:
Am I Doing Human Subjects Research?
Does my study require IRB approval?

You may also call and consult the IRB office

Was this information helpful? Please contact us.

 

Definitions

Living Individual – Data must originate from live people; specimens or information from dead people or cadavers do not count.

About whom – Data are about living individuals (for example, their beliefs, habits, practices, or blood or saliva specimens). You are gathering information about someone not something.

Biospecimens – Data taken from a living body such as saliva, urine, blood, tissues, or cells.

Intervention – The study involves some procedure or action that affects the individuals or their environment to measure “before and after” results (for example a physical procedure such as venipuncture, or manipulations of the subject or the subject’s environment for research purposes)

Interaction – Communication occurs directly with the participant (for example, in person or by phone, email, videoconference, or online survey)

Identifiable private information – You or another member of the research team can easily determine the participant’s identity. Private means that the individual does not reasonably expect information to be made public [for example, a medical record], or observation (in contrast to a public space such as a restaurant or bus), has shared the information for study purposes, and can assume identifiers will not be published without explicit permission.

Before You Start: Special Considerations

Will you be collecting biospecimens for your study?

If so, you must consider and clearly address in your IRB application:

  • Where and how biosamples will stored, and for how long?
  • Will you be using or creating a biobank/repository?
  • Will you be using an honest broker and who will it be?
  • Are you thinking about commercial use? [If so, the consent must address if the subject will/will not share in profit)

Will you access other Electronic Medical Records (EMRs) for your study?

Human Subject Project Lifecycle

I Activities for Preparatory Research
II Feasibility
III Getting Started: Building the IRB Protocol
IV Choose Appropriate IRB Application
V Consider Special Study Requirements
VI Study Personnel and Training
VII Recruitment Materials and Informed Consent Documents
VIII Plan for IRB Review
IX Confidential Disclosure and Clinical Trial Agreements
X Clinical Trials.gov
XI Study Closure and Data Retention

Leadership Team

Céline Gélinas, PhD

Senior Associate Dean for Research, Professor and Chair for Biochemistry and Molecular Biology

Celine Gelinas

Rutgers, Robert Wood Johnson Medical School

gelinas@cabm.rutgers.edu

View Profile >>

Judith Neubauer, PhD

Professor of Medicine, Division of Pulmonary & Critical Care

Judith Neubauer

Rutgers, Robert Wood Johnson Medical School

neubauer@rutgers.edu

View Profile >>