Regulatory Knowledge & Support
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:
- Data or biospecimens through intervention or interaction with the individual
- 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.
Quick tool to determine Non-Human Research/QA/QI:
You can use this quick and easy-to-use Non-Human Research Self-Certification Tool to satisfy the requirements for Non-Human Research Determination.
This Self-Certification may not satisfy requirements imposed by other organizations/institutions, sponsors or professional journals.
A full definition to “Human Subjects Research” and examples of studies which require IRB Review can be found under the following Rutgers IRB link:
- Identifying Human Subjects Research
- Defining “Human Subjects Research”
- Types of Studies Which May Require IRB Review
- Studies Which May Not Require IRB Review.
The NIH provides a decision tool to assist with determining if your research involves human subjects. This tool SHOULD NOT be used as the sole determination:
Questions/Need a consultation? Please let us know.
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
Special Considerations may require additional description/information within your IRB Application. It’s beneficial to consider these topics when building your protocol so you can develop a compliance plan of action. Some special consideration topics are:
- Will you collect and store biological samples for your research? If so, you must consider and clearly address in your IRB application:
- Where and how bio-samples will stored, and for how long?
- Did you plan for utilizing an Honest Broker? This person will be a third party who is not a member of the research team.
- The researcher must address whether or not research participants will share in the profits of any commercialization of the knowledge gained from the research. This information will be included in the Consent Form Addendum. This addendum can be found on the HSPP Tool Kit, opening the “Consent Templates” Tab, and scrolling to “Consent Addenda” section for Addendum Consent to Store (Bank) Identifiable Data or Biospecimens Collected in the Main Study for Future Research.
- For additional information please refer to Rutgers IRB HSPP Guidance Topics and open “Registries & Repositories”
- Does your research include vulnerable populations:
- Does your research include Students/Employees? Researchers should consider procedures to reduce the element of coercion or influence when Students/Employees are subjects in research projects. For additional information please refer to Rutgers IRB HSPP Guidance Topics under the tab “Students & Employees As Research Subjects”
- Does your research include Adults Lacking Decisional Capacity? Research should consider appropriate consenting methods for subjects who are cognitively impaired, lack capacity, or suffer a serious or life-threatening disease. For additional information please refer to Rutgers IRB HSPP Guidance Topics under the tab “Surrogate Consent With Adults Lacking Capacity To Consent For Research”
- If your research project includes the participation of populations listed above, the investigator has the obligation to ensure:
- that the study subjects are aware of their research rights (ex: voluntary participation – agreement to participate should be given freely without coercion or undue influence).
- that additional safeguards are in place to protect data and confidentiality of the subjects.
Researchers who have research participants outside of the United States will have to ensure compliance with Rutgers policies for international research and relevant laws of the host country. For more information please visit the HSPP guidance topics under the tab “International Research” tab.
Research involving Multiple Sites
Researchers collaborating with outside institutions should consider the following aspects of multi-site research;
- Data Use- A Data Use Agreement (DUA) is a written contract used to govern the transfer and use of data between organizations. For more information please visit HSPP guidance topics under the tab “Data Use Agreements”.
- Reliance Agreement- A required agreement to set the terms of IRB approval between Rutgers IRB and other institutions. For more information please visit “About Reliance Agreements”.
- Principal Investigator Oversight/Responsibilities- The PI assumes full responsibility for a research project at each performance site, and by each site-specific PI. For more information please visit “Research Roles”.
Utilizing Other Performance Sites
Performance Site approval documentation is required for all research involving any non-Rutgers site which includes systematic participant recruitment, research impacting site staff time, and/or research impacting site financial reimbursement.
Examples of Research Activities Requiring Performance Site Approval: Recruiting on-site, Using hospital staff to provide a service, Using hospital staff as study personnel, Using a room, Using equipment, Accessing medical records (including chart reviews), etc.
For more information please visit the HSPP Tool Kit and open the “Performance Site Approval Forms” Tab.
If your research requires the use of HIPAA Authorization please be sure to follow the instructions outlined in the Rutgers HIPAA Authorization Template. The researcher will have to outline the individual information to be collect and all parties that may have access to the collected data. Templates can be found by visiting the HSPP Tool Kit, clicking the “Consent Templates” Tab and scrolling to “Special Consent Passages”.
Questions/Need a consultation? Please let us know.
Human Subject Project Lifecycle
How We Can Help - NJ ACTS Regulatory Support Office
REGULATORY SUPPORT SERVICES
The NJACTS Regulatory Support office is a centralized resource for all researchers. We bring unique expertise to benefit the entire research team, from research coordinators to Principal Investigators. We can provide knowledgeable guidance and advice with local and federal regulations, and facilitate early engagement and education for stakeholders for the timely and complete submission of necessary applications.
How can we help you?
- Answer general or specific questions about regulatory rules and approval process
- See if your project meets the definition of human subjects research
- Problem-solve on proposed projects, including protocols, consent forms, eIRB, etc.
- Help determine the type of IRB submission required (full board vs. expedited vs. exempt)
- Assist with additional regulatory requirements (i.e. IACUC, Institutional Biosafety, data sharing agreements, material transfer agreements, IND submissions, clinicaltrials.gov, etc.)
- Determination of compliance documents for NJ ACTS Pilot Award Recipients
- Advise on the clinicaltrials.gov (CTG) process
Our consultations are free, and the information you provide is confidential.
You can ask questions, chat with an expert, or request a consultation by phone, email or via Zoom/Webex.
Reach out to us now!
Ask us your questions or request a consult by clicking here: https://redcap.link/m7ip2u8o
One of our regulatory experts will be immediately alerted and will respond within 1 business day!
Regulatory Team Members:
- Anthony Gonzalez, QA/QC Manager, NJACTS
- Farah Anwar, Regulatory Affairs Manager, RBHS CTO