FAQ's of the IRB
What is the Institutional Review Board (IRB) and why does it exist?
The institutional review board or IRB is an independent, administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution.
Why does JMU have an IRB?
As a recipient of federal funds for research, JMU is required to have an IRB that meets federal requirements to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.
As well, JMU is required to register with the Federal Office of Human Research Protections (OHRP) through a process called Federal Wide Assurance. In this Assurance, JMU is given the option to designate whether the University and the IRB will follow federal regulations for only federally funded research or for all research.
What are the responsibilities of the IRB?
In accordance with Title 45 of the Code of Federal Regulations, Part 46.111, in order to approve research, the IRB must determine that all of the following requirements are satisfied:
1. Risks to subjects are minimized.
(a) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(b) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, 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 research). The IRB should not consider 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.
3. Selection of subjects 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 vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons and economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by 46.116.
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by 46.116.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to the maintain the confidentiality of data.
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, and economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
It is the function of the IRB to: (1) determine and certify that all projects reviewed by the IRB conform to University policies and procedures and the regulations and policies set forth under the Common Rule regarding the health, welfare, safety, rights, and privileges of human subjects; and (2) assist the investigator in complying with federal and state regulations.
What authority does the IRB have?
The IRB has the authority to suspend, place restrictions, or terminate the approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IRB requirements or that have been associated with unexpected adverse events. The IRB has the authority to observe or have a third party observe the consent process and the research if the IRB determines it to be indicated.
The IRB jurisdiction extends to all research (funded and not funded) involving human subjects conducted at James Madison University, as well as research conducted elsewhere by JMU faculty, staff, and students.
The IRB makes its independent determination whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected.
Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution. However, those officials may NOT approve research if it has been disapproved by the IRB.
If the IRB chair, member, or staff person feels that the IRB has been unduly influenced by any party, corrective action will be taken to prevent additional occurrences.
- Human tissues; or
- Records gathered on human subjects
How do I know if I am conducting research with human participants?
Research is defined as “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question. This does not mean that your study needs to be replicable, but rather that you intend to develop or contribute to a field of knowledge in a manner consistent with your discipline.
Human subjects are “…living individuals about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, identifiable private information.”
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g., providing stimuli to gauge reaction and response).
Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).
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 a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
To meet the definition of research with human subjects, you must be conducting research AND obtain information from human subjects in the research.
If you are unsure if your project involves research with human subjects, please consult with the Office of Research Integrity (ORI), who can provide guidance in making this determination.
When am I required to submit a protocol involving research with human participants to the IRB?
All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data, as well as any advertising or other recruitment procedures.
Do I need to complete IRB training?
Federal guidelines mandate that all investigators and key personnel who are directly responsible for the design and conduct of the human subject's part of the project be properly trained prior to working with human subjects. Faculty advisors guiding students through human subjects research are also required to complete training. Approvals for including human participants in proposed research projects will be not be granted until this training has been completed and verified by ORI.
The IRB may accept alternate training in lieu of the CITI training if the researcher can produce documentation related to the training course/s, the institution offering the training, the date of completion and the score received. Such documentation should accompany the proposal submission or be sent to the IRB office upon request. Please see Training for more information.
I am just doing a simple survey; do I need to submit my protocol to the IRB?
Yes, if the study meets the definition for research with human participants, as explained above. JMU’s Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
I am not collecting any identifying information in my human participant research project. Do I need to submit my protocol to the IRB for review?
Yes, if your research project involves active data collection. Federal regulations and JMU 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.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review. Please contact the ORI for further guidance.
- The review criteria are the same.
- Both types of review are documented communication process between investigators and reviewers.
- Expediting reviewers and the full IRB can request modifications to submissions and can approve protocols, continuing reviews, and amendments to approved protocols.
- Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter review periods may be required.
A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB.
Exempt research does not have to be reviewed by the IRB at all. Instead, the determination of exempt is made by the Office of Research Integrity (ORI) or the chair of the IRB and the only review of the study is by ORI or the IRB chair.
What determines whether a study is Exempt, Expedited, or goes to the Full Board?
Research may be eligible for exemption from the federal regulations if all the activities associated with the research fall into one or more of six categories. Of the six categories, three are frequently used by social and behavioral scientists. They are:
1. Some research conducted in established or commonly accepted educational settings, involving normal educational practices.
2. Some research involving educational tests (cognitive, diagnostic, aptitude achievement), survey procedures, interview procedures, or observation of public behavior. (NOTE: This category does not apply to research involving children.)
3. Some research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data are publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.
While these studies do not require review in accordance with the federal regulations, some procedure is necessary to make the determination that they are eligible for exemption. Institutional procedures vary, but the common element is that the institution, not the investigator must make the determination.
To be eligible for Expedited review research must meet two criteria:
1. Post no more than minimal risk to subjects.
"No more than 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."
2. All of the activities associated with the research fall into one or more of the expedited categories specified in the regulations.
Eligible activities are similar to those for Exempt research (some surveys, interviews, and data analysis) with the addition of some minor or non-invasive medical procedures, such as blood pressure readings, weight measurements, MRI use in research and blood draws.
Studies sent to the Full Board for review typically involve potentially vulnerable populations and/or studies that involve sensitive topics including, but not limited to, illegal behaviors, drug use, alcohol use, or other dangerous behaviors and trauma.
In addition, JMU requires all human subject research involving External Funding to be reviewed by the Full Board at a convened meeting.
Do I need to submit an application for Exempt research?
Yes - the JMU human subjects' policy requires the Office of Research Integrity (ORI) to make the initial determination that a protocol is exempt or nonexempt. JMU faculty, staff, and students may not conduct exempt research until they receive exempt notification from ORI.
I am not collecting any identifying information. Do I still need an informed consent form?
Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, etc.), a modified informed consent form (referred to as a “Cover Letter”) may be used. That is, all of the elements of consent must be documented for the participant, but the signature line is replaced with a statement informing the participant that completion and return of the survey is considered implied consent.
What is the difference between anonymous and confidential research?
A response is anonymous if NOBODY but the respondent knows who it came from. For example, a survey questionnaire which is returned without any identifiers at all is anonymous. In contrast, a confidential situation is one in which someone KNOWS the identity of the respondent but that information is protected by some measure(s). For example, if you promise to remove the name from a survey questionnaire and to substitute code numbers, you are protecting confidentiality; but, as long as YOU saw the name you cannot claim it is anonymous. It is important to remember that names are not the only identifiers. If you have only one senior citizen in your class, for example, then a questionnaire passed out to the class which asked for age would not be anonymous. There must be no identifiers for the data to qualify as anonymous; data cannot be made anonymous by stripping identifiers (since whoever stripped the identifiers had an opportunity to know the identities).
What should I do when my research involves participants with limited English?
If you are planning to study a group of human subjects with limited English skills it is your job as the researcher to be responsible for ensuring the participants truly comprehend the purpose of the study, and what will be required for their participation. If the research subject's native language is not English, please provide assurance in your protocol (not the consent form) that they will only interview subjects with good English speaking/reading/writing skills. Otherwise, the consent form must be translated. Please remember, consent forms must be written at an eighth grade reading level as well as the research subject's native language.
If I am conducting research and not collecting identifying information, but I am planning to publish my results, does this qualify for Exemption?
No - If the researcher plans to publish, present publicly, or otherwise share the results of his/her research (for example, at a state, regional, or national conference) that expands the generalized body of knowledge, the protocol is NOT eligible for exemption.
I want to pay my participants to encourage participation in my research. What do I need to know?
Please refer to the JMU Financial Procedures Manual regarding payments to research subjects.
I will be collaborating with another institution. Do I need to submit to JMU’s IRB and the other institution?
Investigators should contact the ORI whenever collaborative research is occurring. Separate protocols for each institution may not be necessary.
I am a researcher from another institution? Do I need to submit a protocol to JMU’s IRB?
If you have an approved IRB protocol from your institution, it may not be necessary to submit a protocol to JMU’s IRB. We will need your currently approved IRB protocol that shows approval for JMU’s involvement, approval documentation from your IRB, and all required materials (i.e., tools, consent, etc.). We will process the previously approved protocol through our IRB as long as all required information is included to avoid you having to do extra work.
My research will be done in another country. Do I have to obtain IRB review and approval from JMU?
Yes. If you are JMU faculty or staff, or a JMU student, and you are the person responsible for the conduct of the study (PI), you must get JMU IRB approval to conduct your research regardless of where the research takes place. You should also be aware that your project may need local IRB approval (or the equivalent ethical review) in addition to JMU’s.
When may I begin data collection for my study?
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A notice will be sent to you via e-mail when your project has IRB approval.
When should a modification (addendum) to an approved research study be submitted?
Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study. Please complete an Addendum Request form, which can be found on the Forms page.
Does approval of an addendum to an approved research study extend the original approval date?
No. The project end date of the original approval is not changed by the review and approval of an addendum. Please submit an Extension Request form, which can be found on the Forms page, prior to the project end date to ensure there is no lapse in IRB approval.
After my approved protocol has passed the one year expiration date what do I do?
If IRB approval of the human research expires, all study procedures related to the protocol under review 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 regulations. You need to receive continued approval from the IRB in order to continue research. Although the IRB office sends reminders, it is ultimately your responsibility to submit the continuing review report in a timely fashion to ensure there is no lapse in IRB approval.