Research Involving Human Subjects
Changes to human subjects research regulations went into effect January 21, 2019. Please refer to the applicable policy below. Learn more
For Research Approved PRIOR to January 21, 2019
Charles River Campus IRB
Policies and Procedures
Title: Research Involving Human Subjects
Date: May 31, 2016
Purpose
The purposes of this policy are to define activities that are subject to review and approval by the Charles River Campus (CRC) IRB and to outline the ethical obligations and legal requirements that must be followed by the IRB, investigators, students, and staff when reviewing and conducting human subjects research.
Definitions
Department of Health and Human Services (DHHS) Definitions:
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject: A living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, OR
- Identifiable private information.
Intervention: 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: Communication or interpersonal contact between investigator and subject.
Note: This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction.
Private information: 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, student records, employee file, etc.)
Individually Identifiable: The identity of the subject is or may readily be ascertained by the investigator or associated with the information
Food and Drug Administration (FDA) Definitions:
Clinical Investigation*: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit
* The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for FDA purposes
Human subject: An individual who is or becomes a participant 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
Test Article: Any drug (including a 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 act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n)
Medical Device Definitions:
Investigation: A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device
Subject: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease
Policy
Boston University is committed to conducting human subjects research following the ethical principles as outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The basic ethical principles are:
- respect for persons,
- beneficence, and
- justice.
All individuals (IRB, investigators, students, and staff) involved in conducting human subjects research must adhere to these principles.
The CRC IRB is established in compliance with regulations of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), as well as other applicable federal regulations, and state and local laws. This includes the following. This list is not all inclusive and may change depending on current funding sources:
- Office for Human Subjects Research (OHRP)
- Food and Drug Administration (FDA)
- Department of Defense (DOD)
- Department of Education (DOE)
- State and local laws
Human subjects research being conducted by members (faculty, students, or employees) of Boston University’s Charles River Campus must be reviewed and approved by the CRC IRB. The CRC IRB adheres to the DHHS and FDA definitions when determining if research activities are human subjects research.
The CRC IRB has the authority to approve, require modifications to secure approval, and to disapprove research activities being conducted by members of Boston University’s Charles River Campus. Officials of Boston University cannot approve research that has not been approved by the CRC IRB.
The CRC IRB does not have oversight over research conducted by members when they are acting independently of their official BU roles and responsibilities. This research will be determined to be independent of their official roles and responsibilities and not subject to IRB review if:
- The research is conducted on their own time and not reimbursed by Boston University or through Boston University accounts
- The research is conducted without the use of Boston University space, materials, supplies, or secretarial/staff support
- Any research publications, reports, or presentations will not list the member’s position and affiliation with Boston University
Investigators are responsible for determining if research projects involve human subjects and therefore require review by the CRC IRB. If an investigator is unsure if a project is human subjects research, he/she should contact the IRB for consultation. The IRB Director or IRB Analysts have the authority to make the determination of whether a research project meets the definition of human subjects research. Investigators who would like a written determination about whether the project is human subjects research can contact the IRB office with this request.
Classroom Protocols
Classroom activities are not considered to be human subjects research as there is no intent to develop or contribute to generalizable knowledge and they are being conducted for educational purposes only. The CRC IRB will consider these activities to be educational and not subject to IRB review when the following criteria are true:
- The classroom activity is not designed to develop or contribute to generalizable knowledge. The only purpose of the activity is to teach research methodology
- Activities are not considered to be generalizable because either:
- The results of the activity will not leave the classroom (e.g. the data/results will NOT be published or presented at meetings) OR
- The activity involves collecting data from or about a company, organization, or agency and the data/results will only be shared with that 4 company, organization, or agency to be used internally for the purpose of quality assurance or quality improvement
- The activity is limited to surveys/questionnaires, interviews, observations of public behavior, conducting non-invasive biomechanical measurements (e.g. placing sensors on the skin), or standard educational exercises directly related to the class assignment for the official Boston University course.
It is the responsibility of the faculty member to determine if the assignment meets the criteria above. If the faculty member is unsure if the activity meets the criteria, he/she should contact the IRB for consultation
Examples of studies that generally require IRB Review (this list is considered to be guidance and is not all-inclusive):
- Pilot studies that involve human subjects
- Master’s theses
- Dissertations
- Use of identifiable information from medical records, student records, employment records, or other private sources,
- Research studies that collect data about human subjects through interaction or intervention with subjects, such as surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc.
- Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.
Examples of studies that generally do NOT require IRB Review (this list is considered to be guidance and is not all-inclusive):
- Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc.
- Studies of institutions, policies, or processes (collection or analysis of data on “things” rather than information collected from people about themselves, their opinions, or views)
- Activities designed solely for quality improvement or evaluation of a particular program, course, etc.
- Oral histories or biographies (unless data will also be sued to contribute to generalizable knowledge)
- Training activities unless the training activity is conducted for research purposes
- Single case studies
Title: Research Involving Human Subjects
Author: Cynthia Monahan
Effective Date: June 18, 2014
Last Review/Update Date: May 31, 2016
Revision #: 3
Approved:
Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance
For Research Approved ON OR AFTER January 21, 2019
Purpose:
The purposes of this policy are to define activities that are subject to review and approval by the Charles River Campus (CRC) IRB and to outline the ethical obligations and legal requirements that must be followed by the IRB, investigators, students, and staff when reviewing and conducting human subjects research.
Definitions:
Department of Health and Human Services (DHHS) Definitions:
Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The following activities are deemed not to be research:
• 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
• 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.
• 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: A living individual about whom an investigator (whether professional or student) conducting research obtains:
• Information or biospecimens through intervention or interaction with the individual, and uses, studies, ,or analyzes the information or biospecimens OR
• Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Intervention: Both physical procedures by which information or biospeciments are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction: Communication or interpersonal contact between investigator and subject.
Note: This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction.
Private information: 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, student records, employee file, etc.)
Identifiable Private Information: Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information
Identifiable Biospecimen: 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: 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.
Food and Drug Administration (FDA) Definitions:
Clinical Investigation*: Any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit
* The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for FDA purposes
Human subject: An individual who is or becomes a participant 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
Test Article: Any drug (including a 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 act or under sections 351 and 354-360F of the Public Health Service Act (42 U.S.C. 262 and 263b-263n)
Medical Device Definitions:
Investigation: A clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device
Subject: A human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease
Policy:
Boston University is committed to conducting human subjects research following the ethical principles as outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. The basic ethical principles are: 1) respect for persons, 2) beneficence, and 3) justice. All individuals (IRB, investigators, students, and staff) involved in conducting human subjects research must adhere to these principles.
The CRC IRB is established in compliance with regulations of the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), as well as other applicable federal regulations, and state and local laws. This includes the following. This list is not all inclusive and may change depending on current funding sources:
• Office for Human Subjects Research (OHRP)
• Food and Drug Administration (FDA)
• Department of Defense (DOD)
• Department of Education (DOE)
• State and local laws
Human subjects research being conducted by members (faculty, students, or employees) of Boston University’s Charles River Campus must be reviewed and approved by the CRC IRB. The CRC IRB adheres to the DHHS and FDA definitions when determining if research activities are human subjects research.
The CRC IRB has the authority to approve, require modifications to secure approval, and to disapprove research activities being conducted by members of Boston University’s Charles River Campus. Officials of Boston University cannot approve research that has not been approved by the CRC IRB.
The CRC IRB does not have oversight over research conducted by members when they are acting independently of their official BU roles and responsibilities. This research will be determined to be independent of their official roles and responsibilities and not subject to IRB review if:
• The research is conducted on their own time and not reimbursed by Boston University or through Boston University accounts
• The research is conducted without the use of Boston University space, materials, supplies, or secretarial/staff support
• Any research publications, reports, or presentations will not list the member’s position and affiliation with Boston University
Investigators are responsible for determining if research projects involve human subjects and therefore require review by the CRC IRB. If an investigator is unsure if a project is human subjects research, he/she should contact the IRB for consultation. The IRB Director or IRB Analysts have the authority to make the determination of whether a research project meets the definition of human subjects research. Investigators who would like a written determination about whether the project is human subjects research can contact the IRB office with this request.
Classroom Protocols
Classroom activities are not considered to be human subjects research as there is no intent to develop or contribute to generalizable knowledge and they are being conducted for educational purposes only. The CRC IRB will consider these activities to be educational and not subject to IRB review when the following criteria are true:
• The classroom activity is not designed to develop or contribute to generalizable knowledge. The only purpose of the activity is to teach research methodology
• Activities are not considered to be generalizable because either:
o The results of the activity will not leave the classroom (e.g. the data/results will NOT be published or presented at meetings) OR
o The activity involves collecting data from or about a company, organization, or agency and the data/results will only be shared with that company, organization, or agency to be used internally for the purpose of quality assurance or quality improvement
• The activity is limited to surveys/questionnaires, interviews, observations of public behavior, conducting non-invasive biomechanical measurements (e.g. placing sensors on the skin), or standard educational exercises directly related to the class assignment for the official Boston University course.
It is the responsibility of the faculty member to determine if the assignment meets the criteria above. If the faculty member is unsure if the activity meets the criteria, he/she should contact the IRB for consultation
Examples of studies that generally require IRB Review (this list is considered to be guidance and is not all-inclusive):
• Pilot studies that involve human subjects
• Master’s theses
• Dissertations
• Use of identifiable information from medical records, student records, employment records, or other private sources,
• Research studies that collect data about human subjects through interaction or intervention with subjects, such as surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc.
• Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.
Examples of studies that generally do NOT require IRB Review (this list is considered to be guidance and is not all-inclusive):
• Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc.
• Studies of institutions, policies, or processes (collection or analysis of data on “things” rather than information collected from people about themselves, their opinions, or views)
• Activities designed solely for quality improvement or evaluation of a particular program, course, etc.
• Oral histories or biographies (unless data will also be sued to contribute to generalizable knowledge)
• Training activities unless the training activity is conducted for research purposes
• Single case studies
Title Research Involving Human Subjects
Author Cynthia Monahan
Effective Date June 18, 2014
Last Review/Update Date January 21, 2019
Revision # 4
Approved Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance