Irb

University of Maryland, Baltimore
Institutional Review Board
Phone: (410) 706-5037
Fax: (410) 706-4189
Email: [email protected]

NOT HUMAN RESEARCH
DETERMINATION
Date: June 26, 2014
To: Marlene Matarese
RE: HP-00060199

This letter is to acknowledge that the UMB IRB reviewed the information provided and has determined that
the submission does not require IRB review. This determination has been made with the understanding that
the proposed project does not involve a systematic investigation designed to develop or contribute to
generalizable knowledge OR a human participant (see definitions below).
This determination applies only to the activities described in the IRB submission and does not apply should
any changes be made. If changes are made and there are questions about whether these activities are human
subject research in which the organization is engaged, please submit a new request to the IRB for a
determination.
Definitions –
Human Research: Any activity that either:
• Is “Research” as defined by DHHS and involves “Human Subjects” as defined by DHHS (“DHHS
Human Research”); or
• Is “Research” as defined by FDA and involves “Human Subjects” as defined by FDA (“FDA
Human Research”).
Research as Defined by DHHS: A systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Research as Defined by FDA: Any experiment that involves a test article and one or more human
subjects, and that meets any one of the following:
• 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 meaning any use of a drug other
than the use of an approved drug in the course of medical practice;
• 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 meaning any activity that
evaluates the safety or effectiveness of a device; OR
• Any activity 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.
Human Subject as Defined by DHHS: 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) information that is both Private Information and Identifiable Information. For the purpose
of this definition:
• Intervention means 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 means communication or interpersonal contact between investigator and subject.
• Private Information 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 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).
Human Subject as Defined by FDA: An individual who is or becomes a subject in research, either as a
recipient of the test article or as a control. A subject may be either a healthy human or a patient. A human
subject includes an individual on whose specimen (identified or unidentified) a medical device is used.
Please keep a copy of this letter for future reference. If you have any questions, please do not hesitate to
contact the Human Research Protections Office (HRPO) at (410) 706-5037 or [email protected].