Types of IRB Review
Projects that Require IRB Review
Determining whether a project must be reviewed by the IRB is a two-step process: First, is the activity research, and, second, does it involve the participation of human subjects? To answer these questions, one must refer to the federal definitions of "research" and "human subjects", which are presented below. If the answer on both counts is "yes", then the project must be reviewed and approved by the IRB before subject recruitment is initiated, and the research staff must have completed training in the ethical use of humans in research.
As defined by the Code of Federal Regulations (45 CFR 46), research is "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." If there is a possibility that a project using human subjects might be published or widely disseminated, then the student or staff member must obtain IRB approval before starting the project or recruiting human subjects. In addition, pilot research work or methodological development that involves the participation of human subjects must also receive IRB review and approval because this work constitutes "research development" as described in the federal definition. Student capstone projects and/or research that involve human subjects must receive IRB review and approval. An example of a project that would not be submitted for IRB review is a student's project that is conducted as a class assignment and that will not be communicated beyond the class.
Defining Human Subject
The CFR defines human subject as "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." 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, such as interviews, surveys and questionnaires. 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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., medical records).
Projects that require IRB Review: Examples
A TESU staff person plans to survey low income, disadvantaged students with low test scores in Reading to determine effective teaching styles of online graduates of TESU teacher education programs as compared to traditional degree holders.
The researcher plans to interview high level students with special needs to determine their ability to use online educational platforms and services.
A staff person plans to survey TESU alumnus members in the MS in Management program to determine how the MS program led to improved skills and advancement in their careers. Alumnus are not staff members of TESU.
Projects that Do Not Require IRB Review: Examples
A staff person will survey fellow students in the TESU MS in Management program to assess job motivators in the retail industry. Only fellow students employed in retail would be surveyed, and the information is used only for course work.
A TESU staff person is seeking to assess the perception of online graduate students in education concerning teaching styles that are effective with low income, disadvantaged elementary students with low test scores in Reading available from the New Jersey Report Card.
Research Exemptions from IRB Review
Under Federal regulations [45 CFR 46.101 (b)], certain categories of activity are considered research but may be declared exempt from review by the IRB. *This determination must be made by the IRB prior to the research being conducted.
Certain low-risk research is exempt from the requirements in the Federal regulations concerning IRB review and approval. If a study falls into one of the exempt categories, researchers still have ethical responsibilities to protect participants' rights. The researcher should not make the final determination of exemption from the applicable Federal regulations or the provisions of the institution. Researchers should check with their institution's guidelines or IRB policies to determine who will make the determination of exemption for a proposed study.
The following are the six exempt categories as listed in 45 CFR 46.101(b):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless:
- Information obtained is recorded in such a manner that human participants can be identified, directly or through identifiers linked to them.
- Any disclosure of the human participant's responses outside the research could reasonably place the participant at risk of criminal or civil liability or be damaging to the participant's financial standing, employability, or reputation.
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:
- The participants are elected or appointed public officials or candidates for public office.
- Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the researcher in such a manner that participants cannot be identified, directly or through identifiers linked to them.
- Research and demonstration projects conducted by or subject to the approval of Federal department or agency heads and designed to study, evaluate, or otherwise examine public health benefit or service programs
- Taste and food-quality evaluation and consumer acceptance studies
These exemptions do not apply to research involving prisoners, fetuses, pregnant women, or newborns. Further, the exemption in item 2 above does not apply to children, except in research involving observations of public behavior when the researcher(s) do not participate in the activities being observed. Interviews, surveys, and interactive observations are not exempt, while educational tests and non-interactive observations are exempt.
Note that when research is conducted in countries outside the United States by foreign Principal Investigators, the rules for IRB review and exemption may differ if the bases for the institutional assurances are founded upon documents other than the Belmont Report and the Common Rule. Note that research conducted in countries outside the United States by U.S.-based Principal Investigators is not affected by this potential modification. Researchers should review the section covering international research for further information and always consult with their institution's IRB.
Planning a Research Study
When an investigator plans to conduct research involving human subjects, he/she is advised to contact the department representative of the IRB. Aspects of a project which may be problematic can be discussed and alternative procedures suggested. At this point, the research often can be designed in a way which will facilitate approval.
Determining Human Subjects Involvement: The initial determination as to whether a research project should be considered human subjects research should be made by the investigator. He/she should consult the IRB board member for advice on this question. Final authority for making this determination rests with the IRB or its designee.
In general, research that involves data gathered solely for internal use (e.g., program evaluation or institutional research) would not need to be reviewed. If, however, the results of this research will be disseminated to audiences external to the University, then the research must receive prior approval. If no dissemination is planned at the time the data are gathered, but the possibility of future dissemination exists, the project director would be advised to submit the project for approval prior to initiating the research.
Once it has been determined that an activity is to be considered human subjects research, it will be reviewed under one of two categories: Project Category I is eligible for "expedited review" and Project Category II requires "full review." The review procedures for each of these are described below. Each researcher should make the initial determination regarding the appropriate category of review, although the IRB or its designee may require review under another category. The researcher can always request a higher level of review than that required.
Below are listed the project categories, along with examples of the types of projects included in each category:
Research Category I (Expedited Review)
- Anonymous mail surveys on innocuous topics.
- Anonymous, non-interactive, nonparticipating observation of public behavior.
- Secondary analysis of existing data.
- Educational research involving no interaction with students; e.g., passive observance of regular advising activity or test-taking activity.
- Research involving the use of educational records if information taken from these sources is provided to the researcher in such a manner that subjects cannot be identified.
- Research on individual or group behavior of adults where there is no psychological intervention, physiological intervention or deception.
- Interviews and surveys on non-sensitive topics where confidentiality is assured.
Research Category II (Full Review)
- Research that might put subjects at risk.
- Research involving psychological or physiological intervention.
- Non-curricular, interactive research in schools, test sites, hospitals.
- Research involving deception.
- Interviews or surveys on sensitive topics.
- Research on persons who are under age 18, are in prison, have mental disabilities.
- Research conducted outside the United States, regardless of the procedures involved.
Conditions of Approval: Approval of a project by the IRB only signifies that the procedures adequately protect the rights and welfare of the subjects and should not be taken to indicate College approval to conduct the research.
Approval of a project by the IRB applies only to the procedures submitted in the proposal. The investigator must secure prior approval from the IRB for any changes in the procedures that will affect the use of human subjects. The investigator must also report to the IRB any problems that arise in connection with the use of human subjects.
Approval for projects is valid for one year only. Investigators must request a continuation for the approval yearly if the activity lasts more than one year. Only two (2) continuations will be granted for a given project. After three years, the project must be resubmitted.
"Informed consent" means the knowing consent of an individual, or her/his legally authorized representative, who is able to exercise free power of choice without undue inducement or any form of force, fraud, deceit, duress or other form of constraint or coercion. An investigator shall seek consent only under the following circumstances:
- Sufficient opportunity is provided to the prospective subject or her/his representative, to consider whether or not to participate;
- The possibility of coercion or undue influence is minimized;
- The information that is given to the prospective subject, or her/his representative, shall be in language understandable to the subject or representative; and
- The subject, or her/his representative, cannot be made to waive or appear to waive any of her/his legal rights, or release or appear to release the investigator, the sponsor, the institution or its agents from liability for negligence.
The federal regulations detail the following basic elements of information necessary to such consent:
- A statement that the study involves research, an explanation of the purpose of the research and the expected duration of the subject's participation and a description of the procedures to be followed;
- A description of any foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others that may be reasonably expected from the research;
- A statement describing the extent to which confidentiality of records identifying the subject will be maintained;
- An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights and whom to contact in the event of a research-related injury;
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which that subject is otherwise entitled and the subject may discontinue participation at any time; and
- For research involving more than minimal risk, an explanation that the University does not have a formal plan or program to provide medical treatment or compensation for any injury which occurs as a result of the subject's participation (the subject should also be informed that this does not waive any of her/his legal rights).
When appropriate, one or more of the following elements of information shall also be provided to each subject:
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- An identification of any procedures that are experimental;
- A statement that the research may involve risks to the subject that are currently unforeseeable;
- Anticipated circumstances under which the subject's participation may be terminated without regard to the subject's consent;
- Any additional costs to the subject that may result from participation;
- The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
- A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to participate will be provided to the subject; and
- The approximate number of subjects involved in the study.
In projects where subjects are determined to be at risk, the actual procedure utilized in obtaining "legally effective informed consent" must be fully documented. This is accomplished by using a written consent form embodying all of the elements of information required for the project. The consent form must be read by or to the subject or her/his legally authorized representative and signed by the person giving consent. A copy of the consent form should be given to the person signing the form and the signed form must be maintained in the investigator's files for an indefinite period of time following completion of the study.
In projects where risk to subjects has been determined to be no more than minimal, provision may be made for oral or written presentation and consent. Under this procedure, the subject is informed of those basic elements of consent which are applicable to low risk procedures and no signed document is necessary on the part of the subject. However, the Board must approve a sample copy of the presentation. A major exception to this policy occurs when research involves persons under the age of 18 as subjects, in which case, written consent from a parent or a guardian is usually required.
In some cases, the IRB may approve a consent procedure which does not include, or which alters some or all of the elements of informed consent or may entirely waive the requirement to obtain informed consent.