Research Activity includes all aspects of the research study, e.g., recruitment methods, consent process, invasive or non-invasive procedures used with the participants, means used to protect privacy and confidentiality (both electronic and traditional), and use of survey or study instruments. In other words, all of the information outlined in the study submission and reviewed and approved by the CHS is considered the “research activity.”

Adverse Event: any harm experienced by a participant (regardless of whether the event was internal (on-site) or external (off-site) and regardless of whether the event meets the FDA definition of “serious adverse event”) which in the opinion of the Investigator are both unexpected and related.

• Unexpected is defined as an event whose specificity and severity are not accurately reflected in the human studies application, protocol, consent form, current investigational brochure or medical device/medication package insert.
• Related to the research procedures is defined as an event which in the opinion of the Investigator, was more likely than not to be caused by the research procedures or if it more likely than not affects the right and welfare of current participants.

 

Serious Adverse Event (SAE): (used interchangeably with Adverse Event (AE) in many settings) is defined as any adverse event occurring that results in any of the following outcomes: death; a life threatening adverse drug experience; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; any important medical event that may not result in death, be life-threatening, or require hospitalization may still be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Unanticipated Problem involving Risks to Participant or Others is a problem that is (1) unforeseen and (2) indicates that participants or others are at increased risk of harm. The majority of the studies reviewed by CHS involve social and behavioral research and thus, these events may be sometimes difficult to determine. As stated above, all problems should be reported to the CHS office for evaluation by the CHS staff, CHS Chair or CHS.

Non-Compliance is a failure to follow the regulations or the requirements or determinations of the CHS.

Serious Non-Compliance is non-compliance that adversely affects the rights and welfare of participants or places participants at increased risk of harm.

Continuing Non-Compliance is a pattern of non-compliance that indicates an unwillingness to comply or a lack of knowledge that may lead to an adverse effect on the rights and welfare of participants or may place participants at an increased risk of harm,. Examples of continuing non-compliance include: repeated instances of allowing a study to expire before it is re-approved; repeated failure to respond to CHS inquiries or requests for documentation; repeated failure to respond to and resolve any study contingencies; or repeated instances of failures to respond to CHS inquiries and contingencies.

The CHS uses the following definitions set forth in DHHS regulations 45 CFR § 46.102 and FDA regulations 21 CFR § 50.3 and 56.102:

Research as defined by DHHS regulations is 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.

Research subject to regulation, and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, such as IND requirements administered by the FDA. It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

Human subject as defined by DHHS regulations means a living individual about whom an Investigator (whether faculty, staff or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Research Involving Human Subjects: means an activity that meets the DHHS definition of “research” and involves “human subjects” as defined by DHHS, or that meets the FDA definition of “research” and involves “human subjects” as defined by the FDA.

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 could 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.

Minimal Risk: The regulatory definition of "minimal risk" is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

For those studies involving clinical investigations, the CHS uses the FDA’s definitions (set forth in 21 CFR § 56.102 (23)) as follows:

Clinical investigation or research defined FDA regulations means any experiment that involves a test article and one or more human subjects, and that either meets the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Federal Food Drug and Cosmetic Act (i.e. 21 U.S.C. 355(i) or 360j(g)), or does not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that meet the provisions of part 58 (i.e. 21 CFR Part 58, “Good Laboratory Practice for Nonclinical Laboratory Studies”), regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous. In addition:

• An experiment is subject to the requirements for prior submission to the FDA under section 505 (i) of the Food, Drug and Cosmetic Act when it involves any use of a drug other than the use of a marketed drug in the course of medical practice.
• An experiment is subject to the requirements for prior submission to the FDA under section 520(g) of the Food, Drug and Cosmetic Act when it involves the evaluation of the safety or effectiveness of a medical device.

Human subject as defined by FDA regulations means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject is also an individual on whose specimens a medical device is used.

Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food and Drug Act or under sections 351 or 354-360F of the Public Health Service Act.

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, where an investigation is conducted by a team, the responsible leader of that team.

Updated: 21-Oct-2009