- The Basics
- Do I Need to Submit an IRB Application?
- I am just doing a simple survey; do I need to submit my proposal to the IRB?
- I am not collecting any identifying information in my research study. Do I need to submit my proposal to the IRB for review?
- I am only working with previously collected data; do I need to submit an application?
- I believe my protocol is exempt. Do I have to submit an application for IRB review?
- My research is based on de-identified tissue samples; is it exempt?
- I will be collaborating with another institution; do I need to submit to BYU's IRB and the other institution?
- My research will be done in another state or country. Do I have to obtain IRB review and approval from BYU?
- Human Subjects Training
- Application Process
- When should I submit an application?
- How do I submit my application for IRB review?
- What do I need to include with my application?
- I want to conduct a study that involves the use of deception or less than full disclosure. Is this allowed? What do I need to consider?
- Should I wait until my research proposal has been funded to submit a protocol for IRB approval?
- Consent Process
- After Submitting a Protocol
- The Review Process
- After the Protocol is Approved
- What do I have to do if I need to make changes to my approved research study?
- When should a modification (amendment) to an approved research study be submitted?
- Who submits the modification (amendment) form?
- How do I obtain continued approval (renewal) for my research study?
- After my approved protocol has passed the one year expiration date what do I do?
- Unanticipated Problems/Adverse Events
- In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
- Can the IRB temporarily or permanently discontinue a research project as result of an unanticipated problem involving risks to participants or others?
- Can the IRB request revisions to the approved research study and the informed consent form as a result of an unanticipated problem?
About the IRB
Brigham Young University Institutional Review Board for Human Subjects (IRB) is a federally mandated compliance committee. Any institution that receives federal funds is required to establish an IRB to review all research that directly or indirectly involves human participants.
The purpose of the review and approval of research conducted by students, faculty and staff is to assure the protection of human subjects, the investigator, and the university. In addition, as a recipient of federal research funding and student scholarships, the university is required to assure and provide for the protection of all participants in the university's research endeavors. Failure to do so could lead to the loss of federal funding to the university (this means ALL funding, including student financial aid) and increased liability to the university and/or the investigator.
BYU IRB is housed in the Office of Research and Creative Activities in the Abraham Smoot Building, A-285. You can contact us at 801-422-3606 or email@example.com.
What is the definition of Research?
Research is defined as a systematic investigation, including research development, testing and evaluation that is designed to develop or contribute to generalizable knowledge. Research generally is described in a protocol that sets forth explicit objectives and formal procedures designed to investigate those objectives. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101
A Systematic Investigation means an activity that may include, but is not exclusive to the:
- Collection of observational or qualitative data;
- Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups;
- Private information, such as medical, family, or employment information, or residual administrative records including earnings, and treatment histories that can be readily identified with individuals, even if the information was not specifically collected for the study in question;
- Collection of data using experimental designs such as clinical trials; or
- Tissue specimens, obtained for routine medical care that would have been discarded if not used for research, or DNA samples, where samples or specimens can be linked to a living individual.
Contribution to Generalizable Knowledge is key to distinguish "research" from "activities" that cannot be applied beyond the target population to other settings. Regardless of publication, if the intent is to discover information that can be applied in other settings, it is research.
Generalizable Knowledge is knowledge that is "expressed in theories, principles, and statements of relationships" that can be widely applied to our experiences. The information is collected to share with other people within a discipline; the information is created to make a broad statement about a group of people, procedures, programs, etc. "Generalizable knowledge" would include one or more of the following concepts:
- The information contributes to a theoretical framework of an established body of knowledge;
- The primary beneficiaries of research are other investigators, scholars, and practitioners in the field of study;
- Publication, presentation, or other distribution of the results is intended to inform the field of study;
- The results are intended to be replicated in other settings;
- The knowledge is a web-based publication for professional purposes. (Used with permission from Michigan State University's IRB)
Review the intent of the research activity; if there is intent to share the results of the study with others, it is research. Studies that are not published are still considered research. Human subjects protection in research extend beyond the parameters of publication.
What is the definition of human subject?
A human subject is defined as any living individual(s) about whom an investigator conducting research obtains data:
- Through intervention or interaction with the individual, or
- Through identifiable private information
- Manipulation of the research participant's environment; or
- Application of procedures or treatments, such as drugs, devices or biologics; or
- Administration of psychological therapies or counseling to change behavior or promote well-being.
- Communication (direct or indirect) with the participant; or
- Interpersonal contact with the participant (for example, surveys and interviews); or
- Physical procedures to collect data, such as taking blood samples.
Private Information includes:
- Information about behavior that the subject expects will not be observed or recorded
- Specific information about the individual that the individual can reasonably expect will not be made public (for example, a conversation in the park).
Private information must be individually identifiable (i.e., data can be linked to individual human participants or may readily be ascertained by the investigator) to obtain the information to constitute human subjects research.
How do I know I am conducting human subjects research?
If your scholarly activity constitutes research with the intent to generalize and involve human subjects as outlined above, then it falls under the purview of the IRB. If a research project qualifies for IRB review an application should be submitted and approved prior to data collection.
I am just doing a simple survey; do I need to submit my proposal to the IRB?
BYU's Federal Wide Assurance with the Department of Health and Human Services says all research conducted under the auspices of this institution will undergo the IRB review and approval process. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
Do I Need to Submit an IRB Application?
I am not collecting any identifying information in my research study. Do I need to submit my proposal to the IRB for review?
Yes, if your research project involves active data collection. Federal regulations and BYU policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
I am only working with previously collected data; do I need to submit an application?
Yes. Federal regulations require that if the study will use existing data, documents, records, pathological specimens or diagnostic specimens from human subjects, it is to be submitted for review.
I believe my protocol is exempt. Do I have to submit an application for IRB reviews?
Yes. BYU policy requires that all proposed exempt research is reviewed by the IRB for final determination of status.
My research is based on de-identified tissue samples; is it exempt?
Research involving the study of existing pathological specimens from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for an exemption. However, all of the de-identified specimens must exist prior to the start of the research study for this to apply. Submit an application for a determination.
I will be collaborating with another institution; do I need to submit to BYU's IRB and the other institution?
If you are BYU faculty or staff, or a BYU student, and you are the person responsible for the conduct of the study (PI), you must obtain BYU IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.
My research will be done in another state or country. Do I have to obtain IRB review and approval from BYU?
Yes. If you are BYU faculty or staff, or a BYU student, you must obtain BYU IRB approval to conduct your research regardless of where the research will take place. Moreover, you will also need to submit proof that the research has been reviewed and approved by the IRB/human ethics committee where the study will be conducted. You should also be aware of local and/or state laws that may impact the conduct of your research.
Human Subjects Training
What training do I need?
All faculty, students, staff, and their research personnel proposing to use human subjects in research under the auspices of BYU are required to complete the human participants training offered through CITI.
Approvals for use of human participants in proposed research projects will be approved after this training has been completed and verified.
Please visit the CITI tutorial page for more information.
When should I submit an application?
It is the responsibility of the principal investigator (PI) to submit an application for review before the research begins. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
How do I submit my application for IRB review?
The PI can access the application and information about how to submit the application here.
Faculty or staff may submit protocols to the IRB via email using an official BYU email account (i.e. firstname.lastname@example.org). Please send protocol to email@example.com.
All student investigators must submit in hard copy. Please bring one (1) printed unstapled, signed copy of your completed application to the ORCA Office (A-285 ASB).
What do I need to include with my application?
- Complete and correct contact information
- If principal investigator (PI) is a student, include a faculty signature
- If principal investigator is a student, the PI has signed the application
- All consent documents (English and translated versions) have been included
- Assent documents
- Parental permission documents
- If consent is not a full-length consent document requiring a signature, a Request for Waiver or Modification of Consent form
- All questionnaires, surveys, interview questions, discussion questions
- Bio sketches of all research personnel (each bio sketch should be no longer than 2 pages)
- Letters of support from sponsoring institutions/organizations, if applicable
- Photographic Release
- Video Release
- Recruiting Materials (including scripts, flyers/posters, letters, emails, screen shots of online recruiting advertisements classroom announcement script, etc.)
- A copy of research grant methodology section, if applicable
I want to conduct a study that involves the use of deception or less than full disclosure. Is this allowed? What do I need to consider?
Yes, the use of deception in research is not prohibited by either the federal regulations or BYU.
Federal regulations permit but establish limitations on the use of deception. The investigator must provide scientific and ethical justification for deceptive procedures for the IRB review and approval. The missing information should not increase the risks of the study, and subjects must be fully debriefed. Subjects must have the opportunity to ask questions about the new information and be given the opportunity to withdraw from the study and have their data removed. Deception may not be utilized to obtain enrollments.
Some research can only be conducted without the full knowledge of the research subjects. Yet the use of deception in research raises special problems that the IRB will review closely. One consideration is whether the deception is necessary. An investigator proposing to use deception should justify its use. Present federal rules prohibit the use of deceptive techniques which place subjects at more than minimal risk.
Should I wait until my research proposal has been funded to submit a protocol for IRB approval?
It depends. If you will be conducting the research regardless of funding, then no, you should submit your IRB protocol as soon as the research plans have been finalized.
If the research is contingent on funding, then yes, you should wait to submit to the IRB. Please keep in mind that the approval process can take 3-8 weeks.
Human research subjects must be informed of the risks, benefits, and procedures involved in a study. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies.
Are there different types of informed consent? What are they?
The informed consent process can take on various forms:
- Signed informed consent is the standard expectation in research with human participants. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the investigator.
- In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements.
- In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:
- A waiver of using a signed consent form; (e.g., giving participants an information sheet but not collecting signatures)
- A waiver of written consent; (e.g., using oral consent procedures)
- A waiver of some or all of the elements of informed consent (e.g., in research that involves deception).
Do I always have to obtain the informed consent of human subjects?
In general, yes, but there are some limited exceptions. The IRB is responsible for ensuring that basic ethical principles are utilized in all research. The expectation that the informed consent of research participants be obtained is based upon the Belmont Report's principle of respect for persons, and regarded as extremely important in conducting ethical research. The IRB has the authority to waive some or all of the federal requirements for informed consent in certain extenuating circumstances. A request for waiver of informed consent must be specifically justified by the investigator in the proposal to the IRB.
What is a "waiver/modification" of informed consent?
A waiver/modification of informed consent is a request whereby:
- A physical signature is not required;
- The request would alter some or all of the required elements of informed consent; OR
- The request would completely waive the requirement to obtain informed consent.
How does the "waiver/modification" of informed consent work?
The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:
- The research involves no more than minimal risk;
- The waiver of informed consent will not adversely affect the rights and welfare of the subjects;
- It is not practicable to conduct the research without the waiver or alteration;
- Whenever appropriate, participants will be provided with additional pertinent information after their participation.
Examples of a modified consent form include implied and verbal consent statements. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
- The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she wants documentation), OR
- The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews).
PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.
Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.
The IRB will take into consideration the risks and potential harms involved in the research before granting a waiver or modification of informed consent. Additionally, there are restrictions for when the IRB may waive the requirements for child assent and parental permission.
After Submitting a Protocol
What happens after I submit my protocol?
Be sure to watch for IRB comments. IRB staff may contact you by email or phone to obtain further information or to inform you of IRB questions/comments that require you to submit a response.
Please check your email for IRB comments during the month your protocol is being reviewed. Approval of your project may be delayed if responses to comments are not received promptly.
Can I begin working on my protocol before I receive IRB approval?
No, wait for IRB Approval. You may not begin your research until you have been notified of the IRB's approval. Be sure to allow time for the IRB to review and approve your protocol before you begin your research.
Under no circumstances should you interpret a lack of communication from the IRB as an approval.
The Review Process
What does a review entail?
IRB members have been trained in ethical principles and in BYU procedures governing human subjects in research. IRB members examine applications to ensure that risk and harm are minimized; benefits to science, humanity, and research subjects are maximized; the autonomy and privacy rights of subjects are protected; and the costs and benefits of research are fairly distributed among persons and groups. IRB members examine consent forms closely to ensure that the necessary language and instructions are included and that subjects are fully informed of the risks as well as their rights.
How long does it take to review an application?
Depending on the level of review you should receive a letter of determination regarding your application in 5 days to one week (exempt) 4-6 weeks (expedited), or 6-8 weeks (full board).
At certain times of the year, typically between February through April and in November/December, a large volume of protocols appear in the reviewing queue. More complex protocols often take more time.
Sometimes, the investigator needs to make modifications to the research and to the protocol as a result of review. The faster you make these changes, the less time it will take for approval.
After the Protocol is Approved
What do I have to do if I need to make changes to my approved research study?
Investigators with an approved protocol must submit an Amendment/Modification of Research Form if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team. The administrator and/or chair of IRB review all amendment applications, and assign them to either expedited or full committee review.
When should a modification (amendment) to an approved research study be submitted?
All changes to an approved protocol must be submitted for review and approval before you incorporate the changes into the research project, including but not limited to, changing surveys/questionnaires, adding participants, sampling a different target population, a title change, change in principal investigator, change of funding source, increased time for participant participation, etc.
The proposed modification(s) should be made by submitting the amendment form and revised documents (consent, recruiting materials, surveys, etc.) to the IRB for review and approval.
Who submits the modification (amendment) form?
The IRB will accept proposed changes from the principal investigator only.
How do I obtain continued approval (renewal) for my research study?
It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her research study. As a courtesy, approximately 60 and 30 days prior to the expiration date, the IRB office will send a memo via email to the principal investigator. The memo contains instructions about how to renew the research study.
If no response is received from the principal investigator, and the expiration date passes, the research will be closed. If the protocol is allowed to expire, all research on the study must cease until renewed approval is granted.
After my approved protocol has passed the one year expiration date what do I do?
If the protocol expires, all study procedures related to the research must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures is a violation of federal regulation.
You need to complete a new application and resubmit the protocol to the IRB for review. When the research has been approved again, the investigator can restart the research activities.
Please note that there is no flexibility in the federal regulations to "extend" the expiration date.
Unanticipated Problems/Adverse Events
In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PI's becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant.
All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the PI. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.
The Unexpected Event Report form is available on the IRB website.
Can the IRB temporarily or permanently discontinue a research project as result of an unanticipated problem involving risks to participants or others?
Yes. If an unanticipated problem poses a risk(s) to the participants or others, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research study or permanently discontinue the research study.
Can the IRB request revisions to the approved research study and the informed consent form as a result of an unanticipated problem
Yes. As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.