Human Research Protection Program

The purpose of this SOP is to set forth the parameters for the jurisdiction of the Brandeis University Institutional Review Board.

This SOP applies to human subjects research projects conducted under the auspices of Brandeis University.

About Whom

Refers to information the subject discloses about him/herself (including his/her opinions), as opposed to information/facts the subject shares regarding an external topic (such as a program, product or procedures) about which the subject can be considered an expert.

Generalizable Knowledge

Data designed to apply to a population beyond the research subjects themselves and contribute to current academic understanding. Generalizable knowledge generally refers to:

• Dissertation or thesis

• Oral presentations

• Posters at a conference

• Published papers

Projects being conducted solely for a class are not considered generalizable knowledge.

Human Subject

A living individual about whom an investigator conducting research:

• Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens.
• Obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.

Identifiable

The identity of the subject is or may readily be ascertained by the investigator or associated with the information.

Interaction

Communication or interpersonal contact between investigator and subject. 

Intervention

Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject's environment that are performed for research purposes.

Private Information

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.

Research

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

Systematic Investigation

A project that methodically tests (quantitatively or qualitatively) a hypothesis or research question, by gathering and analyzing data with the intention of drawing conclusions. Examples of systematic investigations are:

• Drug trials

• Existing data analysis

• Focus groups

• Interviews

• Participant observation

• Program evaluation

• Questionnaires

• Social or psychological experiments

• Surveys

It is the standard operating procedure of Brandeis University that all human subjects research conducted under its auspices, regardless of funding, be reviewed by Brandeis University Institutional Review Board members (expedited, full review or limited IRB review research) or staff (nonlimited IRB review exempt research).

The Federal Regulations stipulate that all federally funded human subjects research must be conducted under a federalwide assurance or contract entered into by the institution with oversight for the research and the Office of Human Research Protections under the U.S. Department of Health and Human Services. This contract stipulates that all federally funded research conducted under the auspices of that institution will comply with the Federal Regulations. Brandeis University operates under Federalwide Assurance No. FWA00004408.

While the regulations apply only to federally funded research, Brandeis University believes the protection of human subjects in research is vital and has determined that all research conducted under the auspices of the university or by any member of the Brandeis community will be held to the same standards, whether federally funded or not.

Human subjects research conducted under the auspices of Brandeis University, that requires IRB review and approval prior to its initiation, includes that which falls into the following categories:

• Human subjects research conducted by Brandeis University faculty, staff or students.

• Human subjects research performed with or involving the use of facilities or equipment belonging to Brandeis University.

• Human subjects research performed in fulfillment of a Brandeis University degree, such as a thesis or dissertation.