Determination of Human Subjects Research and Guide

Standard Operating Policy
Institutional Review Board
Owner: Vice President of Academic Affairs
Author: CSS IRB 
Contact: irb@css.edu
Effective Date: 10/8/2021

1.Policy

All The College of St. Scholastica (CSS) faculty, students, and staff involved in activities that fall under the federal definitions of Human Subjects Research are required to comply with federal and state laws as well as CSS IRB policies and procedures for the protection of human research subjects. This policy outlines the process to follow if an investigator is unsure if the research is human subjects research as defined by the regulations and CSS IRB policy.

2.Purpose

This SOP serves to clarify types of activities that are determined to be Human Subjects Research in order to assist the CSS IRB and investigators if they are unsure if the proposed research is human subjects research as defined by the regulations and CSS IRB policy.

3.DHHS Definitions 45 CFR 46.102(l)

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or 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. For example, some demonstration and service programs may include research activities.

Not Human Research 45 CFR 46.102(l)(i) For purposes of this part, the following activities are deemed not to be research:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health  signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Human subject (45 CFR 46.102(e)(1)) means a living individual about whom an investigator (whether professional or student) conducting research:

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

Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.

An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

4.Food and Drug Definitions

Research Clinical investigation activities that include:

1. Use of a drug other than the use of a FDA approved drug in the course of medical practice (21 CFR 312.3(b)).
2. Use of a medical device other than the use of an FDA approved medical device in the course of medical practice (Food, Drug and Cosmetic Act 530(g)(3)( a)(i)).
3. Gathering data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, certain dietary supplements, an infant formula, a food or color additive, a drug, biologic or medical device for human use, or an electronic product. (21 CFR 50.1 (a)).

Human Subject
Human subject means an individual who is or becomes a participant in a clinical investigation, either as a recipient of the test article or as a control. A subject may be in normal health or may have a medical condition or disease. The FDA has another caveat: for research subject to FDA device regulations, subject means a human on whose specimen an investigational device is used or as a control (21 CFR 50.3(g))

5.Additional Definitions

IRBNet The electronic IRB management system.

Systematic Investigation Systematic means using a careful system or method. In other words, systematic research is formal and planned, rather than haphazard and done randomly. Here are some suggestions what a systematic investigation may include:

• The activity attempts to answer research questions (in some research, this would be a hypothesis);
• The activity is methodologically driven, i.e., it collects data or information in an organized and consistent way;
• Data or information collected is analyzed in some way, be it quantitative or qualitative data analysis;
• Conclusions are drawn from the results.

Generalizable Knowledge To be considered “generalizable knowledge” the activity would include the following concepts:

• The information gained is intended to contribute to a theoretical framework of an established body of knowledge.
• Results are expected to be generalized to a larger population beyond the site or population studied.
• Results are intended to be replicated in other settings.
• The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study.
• Most academic institutions consider a thesis or dissertation to be generalizable knowledge (relevant only if it includes human research).

6.The CSS IRB has developed the following guidelines to assist Investigators in determining which activities are subject to IRB review.

1. Any activity that qualifies as Research (as defined above) and includes one or more Human Subjects (as defined above) must be reviewed and approved (or declared exempt) by the IRB prior to the commencement of the study.
2. Human Subject Research activities must be reviewed by the IRB irrespective of funding.

7.Determination if an Activity is Considered Research Involving Humans

Only activities that meet the definition of human subjects research require submission to the IRB for a review and approval or for a determination of exemption. However, there are many situations where it may be unclear whether or not the proposed activities meet the definition of research and if it does, whether or not it involves human subjects. Requests for the IRB to make a determination as to whether or not an activity meets the definition of human subjects research should be submitted via the IRBNet system. The IRB Chair or designee will determine if the study meets the definition of human subjects research. Upon conducting its preliminary review, the IRB will confirm that the study either does or does not meet the definition. If the study meets the definition the review will move forward. The IRB will notify the investigator of its determination.

References:

21 CFR 56.102

45 CFR 46.102

Purdue University https://www.irb.purdue.edu/docs/new/sops-web.pdf University of Massachusetts – Amherst

 https://www.umass.edu/research/guidance/determining-whether-irb-review-required-activity

IRB EasyEd. Definition of Human Subjects Research. Volume 2 Number 4 and Addendum. ©2017 Apex Ethical

CSS IRB - HUMAN RESEARCH DETERMINATION GUIDE

The purpose of this worksheet is to provide support for individuals in determining whether an activity is Human Research or how it is regulated. This worksheet is to be used. It does not need to be completed or retained.

1. Research as Defined by DHHS Regulations¹ (Check if “Yes”.)

• Is the activity an investigation? (Investigation: A searching inquiry for facts; detailed or careful examination.)
• Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.)
• Is the systematic investigation designed to develop or contribute to knowledge? (Designed: observable behaviors used to develop or contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.)
• Is the knowledge the systematic investigation is designed to develop or contribute generalizable? (Generalizable: Universally or widely applicable.)

2. Human Subject Under DHHS Regulations (Check if “Yes”.)

• Is the investigator conducting the Research gathering data about living individuals?

3. Human Subject Under DHHS Regulations (Check if “Yes”.)

• Will the investigator gather that data through either of the following mechanisms (specify which mechanism(s) apply):
  • Physical procedures or manipulations of those individuals or their environment for research purposes (“intervention”).
  • Communication or interpersonal contact with the individuals. ("interaction”).

4. Human Subject Under DHHS Regulations (Check if “Yes”.)

• Will the investigator gather data that is either? Specify which category(s) apply if yes:
  • The data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place (i.e. “Private information”).
  • Individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will NOT be made public, such as a medical record (i.e. “Private information”).
• Can the individuals’ identities be readily ascertained or associated with the information by the investigator (i.e. “Identifiable information”)?

If all items are checked under 1, 2, and 3 or 1, 2, and 4, the activity is Human Research under DHHS regulations.

5. Human Subject Under FDA Regulations (Check if “Yes”.)

• Does the activity involve any of the following? (Check all that apply)
  • In the United States: The use of a drug in one or more persons other than use of an approved
    drug in the course of medical practice.
  • In the United States: The use of a device in one or more persons that evaluates the safety or
    effectiveness of that device.
  • Data regarding subjects or control subjects submitted to or held for inspection by FDA.
  • Data regarding the use of a device on human specimens (identified or unidentified) submitted
    to or held for inspection by FDA.

If “Yes”, the activity is Human Research under FDA regulations.

If the activity is Human Research under DHHS regulations or under FDA regulations, it is Human
Research under institutional policy.

Engagement Determination (Complete if the activity is Human Research. (Check if “Yes”)

• The institution is engaged in Human Research.