Human Subjects Research Review Committee

Welcome to the home page for the Human Subjects Research Review Committee.Current members of the committee are Robert Baker, David Cotter (Chair), Kenneth DeBono, Dave Hayes and Paul Sorum.

The following forms are available for downloading as Microsoft Word documents in formats for both Macintosh and PC: 

Complete Proposal Application Package (all four of the forms listed below downloaded as one file).   Mac   PC

Guidelines for Faculty and Students Engaged in Human Subjects Research at Union College.   Mac   PC   HTML

Statement of Intention to Engage in Human Subjects Research.   Mac   PC

Statement of Exemption From Human Subjects Review.   Mac   PC

Sample Informed Consent FormMac   PC   HTML

The following links should also be helpful to researchers who plan to conduct research with human subjects. 

1.Code of Federal Regulations, Title 45, Department of Health and Human Services (DHHS), Part 46, Protection of Human Subjects. 

 2 Article 24A of the New York State Public Health Law. 

 3.  IRB Guidebook.

 4.Definitions of human subject and research (From Code of Federal Regulations, Title 45).
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, 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.

Human subject means 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.

Intervention includes 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. 
Interaction includes communication or interpersonal contact between investigator and subject. 
Private information includes 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). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
 

 5. Official Website of the Office of Human Research Protection.

 6. The Nuremberg Code.Developed for the Nuremberg Military Tribunal, it set standards for judging the human experimentation conducted by the Nazis. The Code includes many of the basic principles governing the ethical conduct of research involving human subjects. 

 7. The Belmont Report, which was written by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.The report sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects. Those principles are, respect for persons, beneficence, and justice.They are now accepted as the basic requirements for the ethical conduct of research involving human subjects.