Who must submit an IRB application?
When is IRB review required?
What is CITI Training?
How do I submit my application?
Which level of review is my research?
Which form should I use?
How long does IRB review and approval take?
What criteria is used to determine approval?
What Consent Form template do I use?
How do I modify my protocol once it has been approved?
Will I need to submit an annual renewal?
How do I close my protocol?
What if I have an unanticipated problem or adverse event?
How long should I keep my study records?
Who must submit an IRB application?
All BSU faculty, students (graduate and undergraduate), and staff planning to conduct research with human subjects must submit an application for review and approval BEFORE starting to advertise, recruit or conduct research procedures.
- See PI Eligibility if you are not a BSU tenure-track faculty member.
- See Does IRB Review Apply if you are not sure if your research involves “human subjects.”
- See Does My Class Assignment Require IRB Review if you are having students conduct a class assignment that may involve research.
- See External Researchers if you are not affiliated with Boise State University.
In addition, you must have IRB approval prior to implementing amendments to previously approved research (except when necessary to eliminate apparent immediate hazards to participants). The IRB homepage has a calendar of submission deadlines for studies requiring review by the convened board. New submissions requesting expedited review or exempt status can be submitted at any time and are reviewed on an on-going basis.
The IRB must review all studies that meet the federal definition of human subjects research, regardless of sponsorship. To determine whether your study is considered human subjects research you must first determine:
- Does your study meet the federal definition of research?
- Does your study include human subjects?
If you answer yes to both of these questions, your study is considered human subjects research and IRB review is required.
1. Is it RESEARCH?
The DHHS federal regulations (45 CFR 46.102) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Click below for more information on systematic investigation and generalizable:
A systematic investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es) or developing theory.
Examples of systematic investigations:
- surveys and questionnaires
- interviews and focus groups
- observational studies
- analysis of existing data or biological specimens
- evaluations of social or educational programs
- medical chart review studies
- group comparison studies
- interventional research
Gray Areas: Case studies prepared and disseminated for educational purposes are not systematic investigations and therefore not considered research. If you are unable to prepare the case study report without disclosing information that would make it possible to identify the individual, you must obtain permission from the individual before using his/her data.
Some student research projects conducted as part of course requirements may also need IRB review if it falls under the federal definition of research (see Does My Class Assignment Require IRB Approval)
Pilot research (see Pilot Research and Protocol Development)
Developing or contributing to generalizable knowledge means that the intent or purpose of the systematic investigation is dissemination of findings. Common ways of disseminating results include publishing or presenting.
To help determine the intent or purpose of the activity, ask this question: Would the project be conducted as proposed if the principal investigator knew he/she would never receive any form of academic recognition for the project, including publication of results in a peer-reviewed journal or presentation at at academic meeting or conference. If prohibition from receiving any form of academic recognition for the project would affect the conduct of the project in any way, then research is a motive for the activity to a degree that the project should be classified as research from the regulatory standpoint.
Gray areas: Quality Improvement (QI) is not considered research if the primary intent of the QI is to inform or improve a local process. However, if your primary intent is to generalize the results outside of your local area, the activity is research and will need IRB review.
If your project does not meet the federal definition of research, IRB review is not required. If your project does meet the definition of research, you must also determine if your project includes human subjects.
2. Are there HUMAN SUBJECTS?
The DHHS federal regulations (45 CFR 46.102) define a 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.”
The definition of a human subject focuses on what information or material is obtained from people. If you will obtain either data through interaction or intervention or identifiable private information, the research involves human subjects.
Click on the titles below for more information on interaction, intervention and identifiable private information.
An 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. Examples include surveys, interviews, observations, physical measurements, specimen collection (blood, DNA), etc.
Note: Projects that focus on information-gathering where questions focus on existing policies, practices or procedures, (e.g., canvassing about inter-library loan policies or rising journal costs), rather than individuals or their opinions about those policies, do not constitute human subjects research.
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.
If your study is considered research but does not involve human subjects as defined in the federal regulations, your study is not considered human subjects research and does not fall under the purview of the IRB. You do not need to submit an application.
If your project is considered research and involves human subjects, your study is considered human subjects research and IRB review is required. You submit an application for IRB review and approval before you begin any data collection. The IRB does NOT provide retrospective approval.
If you have any questions about whether or not your study is considered human subjects research, contact the IRB Coordinator (firstname.lastname@example.org).
All principal and co-investigators are required to complete the online CITI Training course for the protection of human participants in research before the IRB will approve a study. Investigators must renew their training every three years. See Training (CITI) and Education for more information.
The Office of Research Compliance prefers all applications and supporting documents (e.g., consent forms, permission letters, surveys, etc.) to be submitted electronically to HumanSubjects@boisestate.edu.
There is a signature page that must be signed by all required investigators. You can scan and send a PDF of this page with all signatures to HumanSubjects@boisestate.edu or bring a copy to the Office of Research Compliance in Riverfront Hall Suite 311, send via campus mail to MS1138 or fax to 208-426-2055. The IRB staff and reviewers reserve the right to return any submission that is incomplete or on outdated forms.
Investigators make an initial determination for which type of review is appropriate for their study (full board, expedited, or exempt) and submit an electronic copy of the protocol and supporting documentation to the ORC. For more information about each type of review, please see Types of Review.
Exempt Protocol Application: Use the exempt protocol application for research projects that involve minimal risk and fall under one of the exempt categories. Only the IRB Chair or a designated IRB staff member may determine if a protocol can be granted exempt status under the six categories described in 45 CFR 46.101(b). Thus, this category requires initial IRB review, but the study is then exempted from continuing review, unless any changes are made to the protocol (see Modifications to Approved Research below).
For determining exemption eligibility, see Types of Review.
Expedited or Full Board Protocol Application: The same form is used for both expedited and full board review. To determine which level of review is necessary, see Types of Review.
Please use current forms. The IRB staff and reviewers reserve the right to return any submission that is incomplete or on outdated forms.
Several factors affect the amount of time a review will take. These factors include how many other applications were received ahead of yours, whether all investigators on the application have completed the required CITI training, and whether the application is complete or if there is missing information. The IRB reviews applications in the order in which they were received. You will be sent an email acknowledgement when your protocol application has been received. From the date of receipt, the amount of time a review takes is estimated as follows:
- Exempt reviews generally take 7 to 10 business days.
- Expedited reviews generally take three to four weeks, depending on the time of year.
- Full Board reviews generally take four to six weeks.
In order to grant approval to a research study, the IRB must find and document that the following criteria are met (per 45 CFR 46.116(a)(b)) at the time of initial approval and sustained through continuing review and requests for an amendment:
- Risks to participants are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes;
- Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies participants would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;
- Selection of participants is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving International Research or Vulnerable Populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
- Informed consent will be sought from each prospective participant or the participant’s legally authorized representative, in accordance with, and to the extent required by regulations (or a request to waive or alter the elements of consent must be approved);
- Informed consent will be appropriately documented, in accordance with, and to the extent required by regulations (refer to informed consent section below);
- When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of participants (refer to data safety monitoring section); and
- When appropriate, there are adequate provisions to protect the privacy of participants and to maintain the confidentiality of data (this criterion applies to all studies).
- When some or all of the participants are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, refugees, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these participants.
The consent process that takes place between an investigator and participant must be captured in a document called an “informed consent form”, or “consent form.” Ordinarily, all research participants must indicate in writing their willingness to participate in research by signing an informed consent form. However, signed consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research, or in research where the participants are to remain anonymous. In these cases, the IRB gives an investigator permission to alter the consent process (waiver of signed consent), and the investigator should prepare an information sheet appropriate for the study. Federal regulations identify certain specific elements required for informed consent. Depending on the nature of the research, the IRB may require additional elements. For more information, see Informed Consent Process.
A PI may amend his/her approved protocol by submitting a Modification Form. This includes changes that reduce risks to subjects as well as administrative changes such as adding or removing investigators. Requests for modification must be submitted for IRB review and approval prior to being implemented. The PI is responsible for providing all material requested on the instructions. An exception may be made when the changes are necessary to eliminate apparent immediate hazards to the participants (see Unanticipated Problems below).
Click for more information on the Modification Review Process.
Federal regulations (45 CFR 46.109 (e)) require the IRB to conduct a continuing review of expedited and full board research at intervals appropriate to the degree of risk, but not less than once per year. Therefore, a PI is required to submit an annual renewal form for IRB review and approval if the research will continue past the approved protocol’s expiration date. (The expiration date may be less than one year from the protocol’s approval date if the IRB determines an early review is appropriate to the degree of risk.)
The IRB cannot accept a Renewal Form after a protocol expires. There can be no “grace period” for a renewal after the expiration date of the protocol. The BSU IRB and Federal Regulations do not permit extensions of human subjects research projects beyond the IRB approval date.
The Office of Research Compliance will send out renewal reminders 60 and 30 days before the expiration of protocols applications, but it is the Principal Investigator’s responsibility to submit a renewal in a timely fashion. If the renewal form is not received by the expiration date, the protocol will be closed and a new protocol application must be submitted to continue research with human subjects.
Click for more information on the renewal process and determining if a renewal is required for your project.
To formally close a protocol, principal investigators may submit a Final Report Form to the Office of Research Compliance. Because there is no provision for any grace period beyond the expiration date for the research study, the final report should be submitted prior to the protocol’s expiration date. If a final report is not received prior to this date, the study will be considered closed and the principal investigator will receive notification that all human subject research activities are no longer approved under the IRB.
A protocol is eligible for closure if:
- Data collection is complete.
- There is no more participant contact (including follow-up interviews, calls, surveys, etc.).
- The only research activating remaining is data analysis of de-identified data.
It is the responsibility of the Principal Investigator to assess events that occur during the course of a research protocol. Unexpected problems or events whose nature, severity and frequency are not described in the information provided to the IRB or to the subjects must be submitted to the IRB for consideration if they involve risk to the participants or others and are related to either a research intervention or interaction or to the conduct of the study in general. Examples include, but are not limited to: subject experiences, new scientific findings, unexpected complications, missteps in study procedures, or in consent documentation, or breaches of confidentiality. The PI must determine which of the following descriptions apply. The IRB will review reports and make a final determination, indicating agreement or disagreement with the PI’s assessment, and reasons for the determination.
An adverse event is an event that occurs during the course of the research that either causes physical or psychological harm or increases the risk of such harm or results in a loss of privacy or confidentiality to a research participant or to others. The IRB must determine with the help of the PI if such events are anticipated or unanticipated, and also if they are serious and related to the research.
Adverse Events that occur at the University or at an off-campus study site are required to be reported to the IRB on an Adverse Event Report, within the following time frames:
- If Serious and Related to the Research, within 2 days of discovery of the event.
- For all other events, within 5 days of discovery of the event.
The Federal regulations on human subject protection in research require that all research-related records be retained for at least 3 years after the study has been completed (45 CFR 46.115(b)). Individual funding sources, federal or private, may have increased record retention periods; check your funding source for this information. For externally funded studies, information about financial record retention requirements can found under University Policy #1020.
All research records at the University shall be accessible for inspection and copying by the IRB, the Office of Research Compliance and applicable federal agencies or research sponsors.