Worcester State University

Human Subjects

All grant proposals that include human subjects must comply with the Worcester State Policy for the Human Subjects Review Board, prior to the submission of the proposal.


If you are planning on submitting to a Federal Funding Agency, a special internal review and Federal Assurance Number is required. Please contact Linda Crocker (508-929-8976) as soon as possible, as this review will add significant time to your proposal preparation.


The Human Subjects Review Board website contains all the information needed to submit your project/protocol for review.



Worcester State uses IRBNet.org, the online submission program. Please note that among the documents on the HSRB website you will find a document called “Application Process Pointers and Reminders.  This document is useful with the process of using IRBNet.


If you have any questions, please contact Marc Wagoner, chair of the Human Subjects Review Board, mwagoner@worcester.edu


[From the Worcester State Human Subjects Review Board (HSRB), Guidelines for Research With Human Subjects (Including College Policy and Procedures for Obtaining Approval)]

The Code of Federal Regulations (Title 45 CFR) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or to contribute to generalizable knowledge”. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. The use of human subjects in research is governed by Federal and State laws. Consequently, all research involving human subjects must be reviewed by an Human Subjects Review Board (HSRB) to ensure compliance with these regulations. This policy outlines these regulations, which apply to all Worcester State faculty, staff and students, whether their research is conducted on or off the Worcester State campus. The policy also applies to visitors and users of the campus or any off-campus Worcester State facilities.


The purpose of the HSRB review is to assure protection of the rights and welfare of human subjects in research. No evaluation is made of the content or scientific merit of the project, unless subjects are found to be “at risk”, at which time the risk/benefit ratio of the project will be evaluated. The HSRB review focuses on such issues as risk to subjects, voluntary participation, informed consent, and confidentiality. The guidelines in this policy pertain only to the use of human subjects, however, and do not address compliance with other Federally-mandated regulations, for example, those that govern animal subjects, recombinant DNA, and radioisotopes. Any investigator who wishes to employ such methods in his or her research should contact the office of the Vice President for Academic Affairs. Reports of violations of this policy or complaints from research participants will be brought before the HSRB at a convened meeting, and appropriate action taken (see Section 13).


According to the Code of Federal Regulations (Title 45 CFR; Part 46 Protection of Human Subjects) human subjects approval for research activities is mandatory if these activities meet either of the following conditions:

There is an interaction or intervention with a living person that
  would not be occurring or would be occurring in some other
  fashion if not for this research
. Interaction includes any form of
  communication or interpersonal contact between investigator and
  participant. Intervention includes both physical procedures by which
  data are collected and manipulations of the participant or the
  participant’s environment that are performed for research purposes.

Identifiable private data/information will be obtained in a form
  associable with the individual
. Private information includes a) any
  information about a person that occurs in a context in which the
  individual can reasonably expect that no observation or recording is
  taking place, and b) 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).
  Private information must be individually identifiable (e.g., the
  identity of the subject may be directly or indirectly associated with
  the information) in order for the acquisition of such information to  
  constitute research involving human subjects.

Please note that under Federal regulations the HSRB cannot
  approve research projects that have already been implemented (i.e.
  after the research has begun or has been completed) without
  previous HSRB approval. Performing research with human
  subjects without HSRB approval is illegal, and may jeopardize
  federal funding to the College. Safeguarding the rights and welfare of
  human subjects in any research activity is the responsibility of the
  researchers. It is the policy of the College that no activity falling
  under the Federal definition of research with human subjects be  
  undertaken until those activities have been reviewed and approved 
  according to the procedures established by the College’s Human
  Subjects Review Board.

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