Getting Started

As you prepare to submit a study to the Einstein IRB, or if you are unsure of whether or not you are required to submit your study to the IRB, this page is designed to provide you with the basic keys to help get you started. Familiarizing yourself with these basics will ultimately save you time and reduce effort as you continue on in your project.

What Is Human Subjects Research?

Research involving human subjects means any activity that either:

  • Meets the DHHS definitions of "research" involving a "human subject" or
  • Meets the FDA definitions of "clinical investigation" ("research") involving a "human subject"

DHHS Definitions:

According to DHHS 45 CFR 46.102(d), research is defined as:

  • a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Please note: Activities which meet this definition constitute research per the regulations, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

According to DHHS 45 CFR 46.102(f), a human subject is defined as:

  • a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.
    • "Intervention" as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject?s environment that are performed for research purposes (for example, providing stimuli to gauge a reaction and response)
    • "Interaction" as defined by DHHS regulations means communication or interpersonal contact between investigator and subject (for example, surveys and interviews)
    • "Private information" as defined by DHHS regulations means 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)
    • "Identifiable information" as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information)

FDA Definitions:

According to FDA 21 CFR 56.102(c), Clinical Investigation is defined as:

  • any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part.
    • "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act" means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
    • "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act" means any activity that evaluates the safety or effectiveness of a device. [21 CFR 812.2(a)]
    • Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)]

According to FDA 21 CFR 56.102(e) and 21 CFR 812.3(p), Human Subject is defined as:

  • an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. For research that evaluates the safety or effectiveness of a device, the definition includes a human on whom or on whose specimen an investigational device is used. A subject may be in normal health or may have a medical condition or disease.

Note that the Privacy Rule (HIPAA), including its research provisions, applies to both living and dead people, and the research provisions apply when the DHHS definition of research (45 CFR 46.102(d)) is met.

For our official policy on what constitutes human subjects research at our institution, please download our Human Research Protection Program Policy, available on our Policies and Procedures page. We also suggest looking at OHRP's Decision Chart of Human Subject Research. If you are still unsure if your project meets the definition of research involving human subjects, you may request a consultation with an IRB staff member by emailing us at irb@einsteinmed.org

Is My Study Human Subjects Research?

HHS defines “Human Subject” as meaning a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. While helpful, this definition is sometimes difficult to interpret, and so the Office for Human Research Protections provides decision charts to assist investigators.

Is My Human Subjects Research Eligible for Exemption?

Research may be considered exempt when human participants conform to one of the categories from 46.101(b) of 45 CFR 46. Research may qualify as Exempt if it involves very minimal, or no risk. Projects should not be considered Exempt if they include any degree of deception, involve more than very minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations.

Use this chart first to determine if your research may be exempt:

Chart 02 may refer you to one of the following charts:

**The Einstein IRB does not do exempt determinations under the OHRP categories 7 and 8**

How Do I Submit a Grant Application?

All federal grant applications for Einstein and Montefiore PIs are submitted through Einstein.  At Einstein, grants are prepared and routed for approval through Cayuse. For Cayuse support, please contact your departmental administrator, or the Office of Grant Support.

Does the NIH Single IRB (sIRB) Policy Apply To My Research?

If you are preparing an NIH application and your grant proposes use of a single IRB for non-exempt multi-site research, please complete an IRB Reliance Request Form.

The policy is applicable to new and competing renewal applications/proposals for NIH funding.  It is applicable to NIH-funded multi-site domestic studies involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

If Einstein or Montefiore is being proposed as one of the participating sites in an application by another applicant organization, you should also inform the Einstein IRB as soon as possible by completing an IRB Reliance Request Form.

For more information on fulfilling the requirements of the NIH sIRB Policy, please read the NIH Single IRB Request Process document.

I Have a Protocol Sponsored by Private Industry

The Office of Clinical Trials facilitates the review and negotiation of all clinical trial agreements for protocols sponsored by private industry.

For help with iRIS

The iRIS v11.02 Support page has the latest information to help you navigate the updated interface, as well as links to user guides and manuals. If you have a specific question that you cannot find an answer to, you may contact us via email at iris-support@einsteinmed.org

We are also offering open office hours twice a week. During these office hours you are welcome to come in with any iRIS- or IRB-related questions you may have. Please sign up ahead of time and reserve a date/time using the link below:

IRB Open Office Hours
Sign-up

Are There iRIS User Guides and Tips?

The iRIS v11.02 Support page has the latest information to help you navigate the updated interface, as well as links to user guides and manuals. If you have a specific question that you cannot find an answer to, you may contact us via email at iris-support@einsteinmed.org

We are also offering open office hours twice a week. During these office hours you are welcome to come in with any iRIS- or IRB-related questions you may have. Please sign up ahead of time and reserve a date/time using the link below:

IRB Open Office Hours
Sign-up