IRB Guidance

Guidelines

Computer/Internet-Based Research

Computer/Internet-Based Research provides guidance about protecting participants when storing data on computers and conducting research on the web.

Deception/Debriefing

Deception/Debriefing is guidance for the use of deception in research and debriefing requirements.

Definitions of “Human Subjects” and “Research”

Definitions of “Human Subjects” and “Research” steps through the definitions of “human subjects” “research” to assist in identifying if IRB review may be needed for a project.

Focus Groups

Focus Groups is guidance for the use of focus groups to obtain data.

International Research

International Research is guidance on conducting research outside the United States.

Instructor’s Guide to Class Assignments

Instructor’s Guide to Class Assignments assists instructors in determining when class projects meet the definition of research with human subjects and require IRB review.  Also includes basic guidelines on standard practices to use in class projects involving interaction with individuals, even if it is not under IRB purview.

Informed Consent Process

Informed Consent Process Guidelines for the different items to consider during the consent process.

Investigator Responsibilities

Investigator Responsibilities Guidelines outline investigator and key personnel responsibilities.

Modifications

Modifications outlines how to make changes to your protocol application once it has been approved.

NIH-Defined Clinical Trials

NIH-Defined Clinical Trials Guidelines outlines the National Institutes of Health (NIH) definition of a clinical trial and additional requirements.

Normal Educational Practice

Normal Educational Practice Guideline discusses educational research which may or may not qualify for review under the exempt criteria.

OHRP

OHRP provides a brief introduction to the Federal office that oversees research with human participants.

Oral Histories

Oral Histories Guidelines utilizes a few scenarios and examples to help distinguish when oral histories may be deemed human subject research requiring IRB review

Pilot Studies

Pilot Studies provides guidance for investigators collecting data to determine a studies feasibility or refine processes or data and IRB review requirements.

Principal Investigator Eligibility

Principal Investigator Eligibility outlines the qualifications to be a Principal Investigator on an IRB protocol application along with some important exceptions.

Recruitment and Advertising

Recruitment and Advertising  provides guidance for recruitment and advertising, including a recruitment flyer template.

Renewal Process

Renewal Process summarizes how to renew your protocol application.

Snowball Sampling Recruitment Methods

Snowball Sampling Recruitment Methods discusses how the recruitment method may be approved by the IRB under some circumstances.  These guidelines include the IRB recommended safeguards if a snowball recruitment method is to be used and sample recruitment letter.

Social & Behavioral vs. Biomedical

Social & Behavioral vs. Biomedical provides guidance on which IRB should review a protocol application based upon the research activities.

Types of Review

Types of Review describes the three types of IRB review (exempt, expedited, and full board).

Using University Students in Research

Using University Students in Research provides guidance for investigators using Boise State students who are or have been enrolled in one of the classes they are teaching.  Guidance includes information about curriculum and non-curriculum research, consent and FERPA.

Vulnerable Populations

Vulnerable Populations provides guidance on research with human subjects that are considered vulnerable.

Definitions

Adverse Event

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.

Assent

Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or person who is cognitively impaired) to participate in research.

Attrition

A reduction or decrease in numbers. Subject attrition is the withdrawal of a research subject from a study.

Belmont Report

A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1979.

Broad Consent

Written consent, granted at a prior time for use of an individual’s identifiable private information and/or biospecimen(s) allowing future research to take place with that information and/or biospecimen(s).

Child/Minor

A person who has not attained the legal age for consent to treatments or procedures involved in the research.

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.

Coercion

Use of a credible threat of harm or force to control another. Pertaining to unacceptable subject recruitment methods which involve undue influence or indirect pressure for participation from a subject. (For example, an employee may feel pressure from their supervisor if told to participate in a research project or a subject may feel coerced to participate if the payment were unusually large.)

Common Rule

The central federal policy adopted “in common” by 16 federal departments and agencies (and concurred, with some modifications, by the FDA) that support and/or conduct research involving human subjects. The adoption of the federal policy in 1991 implements a recommendation of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research that all federal departments and agencies “adopt as a common core the regulations governing research with human subjects issued by the Department of Health and Human Services (codified at 45 CFR 46, Subpart A), as periodically amended or revised, while permitting additions by any department or agency that are not inconsistent with these core provisions” (OPRR Guidebook, Chapter 2).

Confidentiality

Confidentiality refers to data. It is the treatment of information already revealed and states that there is an expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without authorization.

Consent

See Informed Consent

Co-PI

Co-Principal Investigator. Any individual who collaborates with the PI in the design and/or conduct of a research project, including those with access to data.

Data

Refers to information that is collected for analysis or used to reason or make a decision.

Deception

Withholding particular information about the research project from participants until completion of their participation when prior knowledge would adversely affect the integrity of the data gathered.

Exempt

Exempt does not mean review is not required. Some research may be eligible for an exemption from IRB review (expedited or full board review) according to the Common Rule codified in 45 CFR 46.104. Only minimal risk research qualifies for exemption and shall only be determined by the IRB, not the investigator.

Expedited

A level of review by the committee. The Common Rule codified in 45 CFR 46.110specifies that research activities may be eligible for expedited review if the protocol involves only minimal risk or a previously reviewed protocol is receiving modifications that are only minor. Expedited review is carried out by the IRB Chair or by one or more experienced reviewers designated by the chair. Such expedited reviews have the force of full reviews, except that if the protocol is found not acceptable, then it must receive review by the full committee; the chair or designee alone cannot reject a protocol.

Full Board

A level of review by the committee. This category of review applies to all research that does not fall under exempt or expedited review categories. In general, full board review will be required for all projects involving: a) more than minimal risk to participants, b) the deception of subjects, c) sensitive behavioral research (such as research relating to illegal or sexual activity), and d) at-risk populations (e.g., pregnant women, human fetuses, neonates, prisoners, children, individuals with cognitive impairments).

FWA

Federalwide Assurance. A written documentation of an institution’s commitment to comply with the federal regulations that establishes standards for human subjects research. The FWA is submitted to and approved by the Office for Human Research Protection (OHRP). Boise State University has received an FWA.

Guardian

An individual who is authorized under applicable state or local law to consent on behalf of another person (e.g., children).

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, (2) identifiable private information, or (3) identifiable biospecimen. 45 CFR 46.102(e)(1)

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.  45CFR46.102(e)(6)

Identifiable Private Information

Private information for which the identity of the subject is or may readily be ascertainedby the investigator or associated with the information.  45CFR46.102(e)(5)

Informed Consent

An individual’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.

Institution

Any public or private entity, or department or agency (including federal, state, and other agencies), or IRB for the purpose of enacting an Institutional Authorization Agreement.  45CFR46.102(f)

Institutional Authorization Agreement (IAA)

A signed Agreement between two Institutional Review Boards designating the primary and secondary responsibilities of IRB review and oversight as outlined by OHRP Template.

Interaction

Communication or interpersonal contact between investigator (or designee) and subject.  45CFR46.102(e)(3)

Intervention

Both physical procedures by which information or biospecimens are gathered (e.g. venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. 45CFR46.102(e)(2)

IRB

Institutional Review Board.  An institutional committee formed to ensure the protection of human subjects in research per federal mandates.  45CFR46.102(g)

IRB Approval

The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements. 45 CFR 46.102(h)

Legally Authorized Representative

An individual or judicial or other body authorized under applicable law to consent on behalf of  a prospective subject to the subject’s participation in the procedure(s) involved in the research, including parent or guardian (as designated by law) and recognized by institutional policy as acceptable for providing consent on behalf of the subject. 45CFR46.102(i)

Limited IRB Review

A type of review that uses identifiable private information and/or identifiable biospecimens for research, gaining access to that data through consent granted previously with Broad Consent.

Minimal Risk

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(j)

OHRP

Office of Human Research Protections. The office under the Department of Health and Human Services (DHHS) responsible for monitoring and promoting compliance with regulations (45 CFR 46) governing the ethical standards of biomedical and behavioral/social science research involving human subjects.

ORC

Office of Research Compliance. The administrative office responsible for oversight of the human subjects review process, whether funded or not funded.

Principal Investigator. The individual with the primary responsibility for the design and conduct of a research project.

The IRB requires PIs to be a Boise State University full, assistant, or associate professor, or director. Visiting faculty, adjuncts, instructors, and staff may be listed as a PI as long as a Boise State full, assistant, or associate professor or director is listed as the co-PI.

If you are not affiliated with Boise State, the IRB will review your research for approval, but you may be charged. Please contact the Office of Research Compliance for additional information.

If this protocol application is part of a grant requesting federal money, the PI must fall under the Boise State PI eligibility policy 5020.

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record). 45CFR46.102(e)(4)

Protocol Application

The form used to summarize the formal design or plan of an experiment or research activity to be reviewed by the IRB committee for approval. Often referred to as just “protocol.”

Public Health Authority

An agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from a contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.  45 CFR 46.102(k)

Research

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. 45 CFR 46.102(l)

Secondary Research

Research using data gathered initially for non-research purposes.

Special Populations

The Office for Human Research Protections (OHRP) has identified populations in need of special protections in research, including fetuses, children and minors, those with impaired decision-making abilities or susceptible to coercion or undue influence, and prisoners. IRBs must apply additional regulations and criteria and give special consideration to recruitment, subject selection, informed consent, privacy, and confidentiality issues before approving research involving these populations.

Unanticipated Problems

OHRP guidance, unanticipated problems or events include any incident, experience, or outcome that meets all of the following criteria:

• unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
• related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
• suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Written, or In Writing

Refers to writing on a tangible medium (e.g. paper) or in an electronic format.

FAQ

Who must submit an IRB application?

All Boise State 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 Boise State 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.

When is IRB review required?

Refer to Definitions of “Human Subjects” and “Research”

What is CITI Training?

CITI training refers to an web-based system Boise State uses to deliver and track some research compliance training requirements. All personnel listed on an IRB protocol application are required to complete training for the protection of human participants in research before the IRB will approve a study. Investigators must renew their training every three years. More information about CITI and training requirements is available on the CITI Training page.

How do I submit my application?

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 via email, bring a copy to the Office of Research Compliance in Riverfront Hall Suite 311, or send via campus mail to MS1138.

The IRB staff and reviewers reserve the right to return any submission that is incomplete or on outdated forms.

Which level of review is my research?

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.

Which form should I use?

Both IRBs use the same protocol applications.  Exempt studies must use the Exempt Protocol Application.  Expedited or full board studies must use the Expedited or Full Board Protocol Application.

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.

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.

How long does IRB review and approval take?

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 3 weeks.
• Expedited and Full Board reviews generally take six weeks.
• Modification/Renewals generally take 1-3 weeks, depending on the the changes.

What criteria is used to determine approval?

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.

Which consent form template should I use?

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.

How do I modify my protocol once it has been approved?

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.

Will I need to submit an annual renewal?

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 Boise State 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.

How do I close my protocol?

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.

What if I have an unanticipated problem or adverse event?

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.

How long should I keep my study records?

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.