The role of the HSRB is to protect the rights of human subjects as well as to ensure compliance with federal regulations of research projects for faculty and student researchers.

All research projects involving human subjects must receive review and approval from the HSRB prior to collecting data in accordance with Federal Regulations. THERE ARE NO EXCEPTIONS.

Failure to receive prior review may result in disciplinary action by the College and/or legal actions against the faculty members, students, staff members, and the College; suspension or termination of a research project; and, in the case of students, potential delays of graduation.

Federal Guidelines
The legal authority for the Human Subjects Review Board (HSRB) comes from the Federal Policy for the Protection of Human Subjects (described in 45 CFR Part 46). In addition, Monmouth College will file with the Public Health Service a statement of assurance committing the College to compliance with Federal Policy. No research involving humans may be undertaken without prior review and approval by the HSRB.

Any research project must have a full-board review if it involves vulnerable individuals as subject. Vulnerable individuals include:

• children
• individuals in institutions (e.g., prisons, nursing homes, halfway houses)
• physically or mentally disabled individuals
• anyone unable to provide their own informed consent

Any research project must have a full-board review if it involves socially unacceptable stimuli or potentially questionable procedures or materials such as (but not restricted to) the following:

• shock or other forms of punishment
• sexually explicit materials or questions
• handling of money or other valuable commodities
• extraction of blood or other bodily fluids
• questions about drug use
• administration of substances to subjects
• questions about sexual orientation or sexual experience
• purposeful creation of anxiety
• any procedure which might be considered an invasion of privacy.

In these cases, review is required whether the project receives external funding, internal finding, or no funding and is required whether a faculty member, undergraduate, or staff member conducts the project. Note that the HSRB is required to review any federally funded research project.

Projects that do not need to be reviewed
Projects related to teaching or classroom demonstrations that will not be used in any way for publication or presentation do not need to be reviewed. If the results of a classroom project or teaching demonstration will be published or presented in any form it must be reviewed by the HSRB.

Also, class projects where data is are collected by students should be reviewed only if they involve (a) non-student subjects, (b) vulnerable individuals, such as children, or (c) socially unacceptable stimuli (e.g., sexually explicit materials or questions, questions about drug use, questions about sexual orientation or sexual experience, purposeful creation of anxiety). If an entire class is conducting a project with similar goals, the instructor may complete a single proposal with an explanation about how the subjects’ rights will be protected.

Legal Requirements and Definitions for Research Involving Human Subjects
The legal authority for the Human Subjects Review Board (HSRB) comes from the Federal Policy for the Protection of Human Subjects (described in 45 CFR Part 46).

"Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

"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."

Confidentiality means that the identity of the individual providing information to the researcher will not be revealed and will remain secret.

Anonymous means that the name or other identifying characteristics of participants will not be disclosed to the researcher.

"No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative."

All participation must be voluntary; the investigators shall respect the individual’s right to decline to participate in and to withdraw from the research at any time without actual or implied pressure.

Care shall be taken in the protection from harm of human subjects including physical, psychological, or social injury that may occur as a consequence of participation. No procedure may be used if it is likely to cause serious or lasting harm to a participant.

“Minimal risk means that 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.”

Before using a procedure involving deception or concealment, the investigator has a responsibility to: (1) justify the study against scientific educational values, (2) determine whether alternatives are available that do not use deception, and (3) ensure that participants are given explanation as soon as possible.

"Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.”

"Interactions include 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 which the individual can reasonably expect will not be made public."

"HSRB approval means the determination of the HSRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by ... institutional and federal requirements....An HSRB shall have the authority to suspend ... research that is not being conducted in accordance with the HSRB's requirements."

"An HSRB shall require documentation of informed consent.... Informed consent will be sought from each prospective subject or the subject's legally authorized representative. Informed consent will be appropriately documented...by the use of a written form approved by the HSRB."

"When some or all of the subjects are likely to be vulnerable..., such as children,... or economically or educationally disadvantaged persons, additional safeguards (should) be included...to protect the rights and welfare of these subjects."


Go to Types of Review Categories