To search the Frequently Asked Questions (FAQs) either select one below, or scroll through to view them all.
- How do I know if I need IRB approval?
- What is a “human subject”?
- Who is the IRB?
- What is “Minimal Risk?”
- Why informed consent?
- What are the components of informed consent?
- What are the types of review?
- What classifies as a modification?
- How do I add a co-investigator to my research project?
- When will I hear from the IRB about approval of my study?
- When can I start my research?
- Do I need to renew my research study application once it has been approved?
- When is the next IRB Meeting?
- There is a problem with a research study on campus. What do I do?
- What is Bellevue College’s Policy on human subject research?
- Do classroom projects require IRB review?
- Do pilot projects require IRB review?
- Does “existing data” analysis require IRB review?
- Do internet/online based projects require IRB review?
- Final Considerations
How do I know if I need IRB approval?
If it is “research” and involves “human subjects” as defined in 45 CFR 46.102 you must submit an IRB research project application for review. If you have any questions about the requirements, contact the IRB Chair.
What is a human subject?
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.
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 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). 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. CFR 46.102
Who is the IRB?
The IRB at Bellevue College follows the guidelines established in the Code of Federal Regulations for IRB membership. The IRB has at least five members with various backgrounds and expertise. The IRB is made up of scientists and non-scientists and contains at least one member who is not associated with Bellevue College. The IRB takes special care to ensure that no IRB member can review any project in which they could have a conflicting interest. For more information, please visit CFR 46.107.
What is “Minimal Risk?”
“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.” 45 CFR 46.102
Why Informed Consent?
Every research project involving human subjects must secure signed informed consent. Subjects must be fully informed about the nature of the research, the procedures, the risks, and the benefits, and must agree voluntarily to participate. The consent form itself is only a part of the consent process. How you inform the subjects, present and review the consent form with them, and answer any questions, are all important parts of the process and should be built into your research design.
Components of Informed Consent
The regulations require that the following information must be conveyed to each subject:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
- A description of any reasonably foreseeable risks or discomforts to the subject;
- A description of any benefits to the subject or to others which may reasonably be expected from the research;
- A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
- For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
- 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 to the subject; and
- A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
The basic required elements of informed consent can be found in the HHS regulations at 45 CFR 46.116(a).
Types of Review
There are three categories of IRB review of proposed studies:
1. Exempt 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.
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. For further information on exemption review categories, please click here.
2. Expedited Review
For IRB purposes, the term “expedited” refers to a process, not a timeline, where the review is conducted by, typically, only one or two IRB members and not the full board.
Studies that involve no more than minimal risk for participants (no greater than the risks we would encounter in our daily lives) generally do not have to be reviewed at a convened IRB meeting. Studies that involve more than minimal risk cannot be reviewed by this expedited process and must be assigned to the next available convened IRB meeting. For more information about the Expedited Review Process, please click here.
3. Full Board Review
Research studies involving more than minimal risk to human subjects are required by federal regulations to be reviewed by the IRB full board. Projects that are not eligible for either expedited or exempt review require a full board review.
What classifies as a modification?
Modifications are categorized into minor changes and significant changes. To submit modifications to the IRB, the Principal Investigator completes the IRB Research Modification Form.
Minor modification/change – A proposed change in research related activities that does not significantly affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
Examples of minor changes to a research study include but are not limited to, the following:
- Change of protocol title
- Change in principal or co-investigator
- Change of research site
- Addition of procedures that do not significantly increase risk to subjects, considering the original purpose and study design of the approved study
- Removal of research procedures that would thereby reduce the risk to subjects
- Addition of non-sensitive questions to survey or interview procedures
- Addition of or revisions to recruitment materials or strategies
- Administrative changes to the approved documents (e.g., correction of spelling, grammatical or typographical errors)
Significant modification/change – A proposed change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
Examples of significant changes to a study may include, but are not limited to, the following:
- Change of informed consent
- Change to instruments used
- Addition of a new and/or separate subject population (e.g., control group, additional cohort, vulnerable population, etc.)
- Addition of research procedures that involve greater than minimal risk to subjects
- Addition of surveys/questionnaires/interview procedures that could have adverse psychological consequences for subjects or damage their financial standing, employability, insurability, or reputation
- Removal of follow-up visits that appear necessary for monitoring subject safety and welfare
- Change in the purpose of the original project, or study, or use of the data, from that initially provided to subjects and to the IIRB
How do I add a co-investigator to my research project?
Submit a Research Modification Form. A change in leadership qualifies as a minor modification and can be submitted to the IRB chair without requiring a re-review of the research application.
When will I hear from the IRB about approval of my study?
Depending on the type or level of review required, the time it takes to be approved and receive the approval letter varies. The approximate times for approval are as follows:
Exempt review: 7-10 business days (from application submission to granting of exemption)
Expedited review: 14 business days (from application submission to primary review)
Full Board Review: 7 days (after monthly board meeting)
When can I start my research?
Research can only begin once you have received an approval letter from the IRB. Subjects should not be contacted or recruited prior to receiving the approval letter.
Do I need to renew my research study application once it has been approved?
Yes, following IRB approval, each study must be renewed at least once per year if no other requirements are set by the IRB’s approval. Federal regulations require that protocols be renewed no less frequently than annually. To renew the application, investigators must fill out and submit the Annual Review Form.
When is the next IRB Meeting?
IRB meetings are held on a monthly basis to review proposals submitted during the previous month. The IRB does not meet in the month of August.
There is a problem with a research study on campus. What do I do?
Any staff or student at Bellevue College who is aware of any problems involving risks to subjects or others; serious or continuing noncompliance with the federal regulations or the requirements or determinations of the IRB must report the information to the IRB Chair.
The report can be made by emailing the IRB Chair. The chair will then alert the appropriate institutional officials, the head of the agency supporting the research, any applicable regulatory body, and the Office for Human Research Protections.
What is Bellevue College’s Policy on human subject research?
Do classroom projects require IRB review?
Certain activities have the characteristics of research but do not meet the regulatory definition of research needing IRB review. For information on the college policy with the use of human participants in instructional activities, please see Policy 3650 – Use of Human Participants in Instructional Activities. Please also review the Classroom Assignment Decision Tree.
Examples of activities that may not need IRB review are:
- Data collection for internal departmental, school, or other college administrative purposes (e.g. teaching evaluations, course evaluations)
- If your research is a class project or term paper and will not be published in any form at any time.
- Reviews and searches of existing literature and research involving a living individual, such as a biography, that is not generalizable beyond that individual.
Use the following guidelines to determine if your activities in the classroom are subject to IRB review. IRB review is NOT required if all of the following are true:
- The project is limited to surveys/questionnaires/interviews/observations of public behavior directly related to topics being studied in an official college course.
- The above surveys/questionnaires/activities, etc. contain no sensitive personal questions (e.g., no questions about drug use, sexual behavior or attitudes, criminal activity, grades, medical history) or other personal information that could stigmatize an individual.
- No identifying information is recorded to link a person with the data such that it could reasonably harm the individual’s reputation, employability, financial standing, or place them at risk for criminal or civil liability.
- The participants in the project are not from a vulnerable or special population (e.g., pregnant women, prisoners, minors, cognitively impaired individuals).
- The collected data does not leave the classroom setting, or if the project involves collecting data on an organization, agency or company, the data are shared only with that entity.
- No Bellevue College employee or student is receiving financial compensation for collecting, organizing, analyzing, or reporting the data.
If not all of these conditions are met, or if your project does not fall into any of these categories, your project will require IRB notification and formal IRB approval before you can start with your project.
The following are examples of projects that do require IRB notification but are exempt from IRB review. Nonetheless, formal paperwork needs to be submitted to the IRB prior to the start of such project since the decision on the exempt status is the sole responsibility of the IRB committee.
- The study of or comparison among instructional techniques, curricula, or classroom management methods.
- The use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless this involves any one under the age of 18.
- The collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is collected in a way that cannot be linked either directly or through identifiers to an individual.
Do pilot projects require IRB review?
Pilot projects are preliminary investigations performed to determine if a study is feasible. The purpose is to refine data collection procedures and research design on a small scale.
The questions asked usually do not contribute to generalizable knowledge and as such do not qualify as research and do not need IRB review.
Exceptions that require IRB approval prior to the start of the pilot project:
- Vulnerable populations, methods with more than minimal risk, or sensitive data will be used.
- The possibility exists that the collected data will be used in some form or another for publication purposes.
Does “existing data” analysis require IRB review?
Existing data are also called secondary data. Such secondary data analysis involves using existing data from others sources to answer new questions.
IRB review and approval is NOT needed if the source of the data is public (data from public libraries, newspaper) and analysis of the data will not make the data individually identifiable.
IRB review and approval IS needed if the source of the data is not public (government and private data bases) and the existing data has not previously received IRB approval.
Do internet/online based projects require IRB review?
If the data collected via the Internet and computers involves human subjects and is intended for eventual publication purposes, then it requires IRB review and approval.
All such studies involving internet technologies must ensure compliance with the principles of voluntary participation and informed consent, the anonymity and confidentiality of the participants, and address the potential risks to the human subjects involved.
- All research with children, including adolescents, must be reviewed by the IRB committee.
Children are considered a vulnerable research population. They are less able to give fully-informed consent with respect to the research involved. Safeguard procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children.
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18.
- Even in the case where a project is not subject for review, the instructor/faculty member is responsible to uphold all applicable (e.g., American Psychology Association, American Counseling Association, National Institute of Health, etc.) ethical standards and guidelines in course-related research activities when it comes to the treatment of human subjects.
- It is the responsibility of the supervising instructor/faculty member to determine whether projects are subject to review. It is always best to err on the safe side and seek consultation from the IRB committee if a question arises regarding human subjects, research and classroom activities.
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Last Updated February 1, 2023