Institutional Review Board (IRB) FAQs

IRB is the acronym for Institutional Review Board. Any institution that receives federal funding to conduct research with human subjects, such as NJIT, is required to establish an IRB to review all research that directly or indirectly involves human subjects, and to set forth institutional policy governing such research.

The IRB has the authority to review, approve, disapprove or require changes in research or related activities involving human subjects.

Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at NJIT. However, those officials may not approve research that has not been approved by the IRB. The IRB's primary role is to ensure the protection of human subjects as participants of research at NJIT.

According to NJIT Policy, research is defined as "…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 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.

Human subjects are "...living individuals about whom an investigator (whether professional or student) conducting research obtains

1. data through intervention or interaction with the individual, or
2. identifiable private information."

Intervention includes both physical procedures by which data are gathered (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.

If you are unsure about your research project’s involvement with human subjects, please consult with the IRB Chairperson who can provide guidance in making this determination.

All research projects that will involve human subjects 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.

Yes, if the study meets the definition for research with human subjects, as explained above. Written approval from the IRB must be in place before any interventions or interactions with human subjects (e.g., recruitment) actually begin.

Yes. If your research project involves active data collection, federal regulations and NJIT policy require that ALL research involving intervention or interaction with human subjects, 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 subjects (e.g., secondary datasets), that do not have any identifiers, then the activity may not require IRB review.

Yes. Projects conducted by NJIT undergraduate and graduate students need IRB approval if they fit the definitions of “research” and “human subjects” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research.

However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.

Yes, researchers can be subjects in their own studies. However, NJIT policy regards this type of research (investigator self-experimentation) as research with human subjects, and generally requires the same review and approval as research that recruits other people as subjects.

Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.

The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt status does not, however, lessen the ethical obligations to subjects. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.

In order to have a research project recognized as exempt, investigators will need to request an exemption. The IRB Chairperson will evaluate the exemption request and notify investigators if their projects are eligible.

Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator may need to consult to determine if the change affects the eligibility of the research activity to continue to be exempt from IRB review and approval.

Yes. The Federal Regulations do make certain categories of research exempt from IRB review. However, NJIT policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.

If you are a member of the NJIT faculty or staff, or a NJIT student, and you are the person responsible for the conduct of the study (PI), you must get NJIT 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.

Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, meets the federal definition of 'human subjects research' and requires review by the IRB committee. Other case studies may not require IRB review.

You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. An email will be sent to you when your project has IRB approval.

Applications need to be submitted to the IRB via Streamlyne at least  10 days before the next scheduled meeting date for inclusion. For applications requiring full board review, you should allow at least 3-4 weeks for review and approval of your study.

No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.

The IRB committee is available to provide assistance to investigators who are engaged in research with human subjects. Dr. Eric Hetherington and Dr. Britt Holbrook, IRB Co-Chairs, are your resources for any general questions.

You can also explore the IRB website for detailed information about the IRB policies and procedures, forms, meeting schedules, committee members, and other important information.

To start your protocol, review the information on IRB Submissions & Protocols. Once you are familiar with the process and requirements, you will utilize the Streamlyne system to submit your materials for review. Training information for IRB submissions can be found here.

The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html).

Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.

Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject's perspective.

The IRB’s role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.

Fully informing subjects of the risks, benefits, and procedures involved in a study is a standard requirement in research with human subjects.

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 subjects are identified, and other experiments, such as exercise studies.

The informed consent process can take on various forms:

• Signed informed consent is the standard expectation in research with human subjects. 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 researcher.
• 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:
  1. A waiver of using a signed consent form (e.g., giving subjects an information sheet but not collecting signatures)
  2. A waiver of written consent (e.g., using oral consent procedures)
  3. A waiver of some or all of the elements of informed consent (e.g., in research that involves deception)

It is not uncommon for a research project to involve one or more of the above scenarios.

Both consent and assent involve informing potential subjects about the research and its risks and benefits, and documenting their understanding and agreement to participate.

The reason the different terms are used has to do with the age of the subjects. In research involving adults, "consent" is obtained from individuals to participate in the study.

In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to "assent" or agree to participate as well.

In general, yes, but there are some limited exceptions.

The NJIT IRB is responsible for ensuring that basic ethical principles are abided by in all research. The expectation that the informed consent of research subjects be obtained is based upon the 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 researcher in the proposal to the IRB.

Used most commonly, signed informed consent allows prospective subjects to document their agreement to take part in research activities by signing and dating the consent document.

A waiver of documentation of informed consent is a request whereby a signed consent document is not required.

Examples include implied and verbal consent. Consent will still be obtained from subjects; 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 want documentation) OR
• The research presents no more than minimal risk of harm to subjects 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.

Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, driver’s license numbers, etc.), a modified informed consent form (often called an information sheet) 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.

If, however, the procedures involve risk or biological sample collections, written consent may be required.

Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.

Implied consent is actually a type of a waiver of documentation of informed consent. Before granting such a waiver, the IRB may require the researcher to provide the subjects with a written summary or an information sheet about the research, including:

1. purpose of research
2. time involved
3. assessment of minimal risk
4. statement regarding benefit to subjects
5. contact for questions about the research
6. contact for questions about rights as a research participant

There are a number of instances where this type of consent is helpful. For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form.

The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.

For Internet-based surveys, it is sometimes appropriate to use implied informed consent. Subjects would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

If, for study design purposes, the researcher needs to keep track of who participated or if the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to subjects who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email.

This process may be appropriate for data collected via email, chat rooms, online interviews, etc. Alternatively, some Internet-based survey vendors and/or software packages provide a means to record whether a respondent has consented to participate before beginning a survey (e.g., a date/time stamp feature).

For protocols involving oral consent, the following information is required to be communicated to the participant:

• study purpose and procedures involved
• what will participant be asked to do - as well as the amount of time participant will spend
• the voluntary nature of participation in the study
• the participant is free to withdraw at any time
• the information collected will remain confidential
• offer the participant contact information for the researcher and the IRB

It may be pertinent to request the PI to offer additional information depending on the nature of the study. It is up to the IRB Committee to suggest additional information to be included in order to further protect the participant.

At NJIT, all investigators and research staff (including external collaborators) must successfully complete the on-line course for Human Subjects Protection given either by OHRP or CITI and update it every three years. All NJIT investigators and research staff also must successfully complete the CITI on-line course on Responsible Conduct of Research.

Additionally, investigators and research staff must be qualified by training and experience for the research they will be conducting. It is important to understand that the responsibility for the welfare of subjects lies with the principal investigator, even when subjects have given consent. Investigators and research staff must have the necessary training and expertise to:

• Ensure the rights, welfare and safety of subjects are protected
• Comply with regulations concerning IRB review and approval, including
  1. Informed consent requirements
  2. Reporting requirements
  3. Maintenance and retention of records (keep complete files during and 5 years after research ends)
• Supervise research conduct
• Apply relevant professional standards that are applicable to the research

All faculty, students, and external collaborators proposing to use human subjects in research under the auspices of NJIT are required to complete the human subjects training.

Approvals for including human subjects in proposed research projects will be not be granted until this training has been completed and verified by the IRB Committee.

NJIT faculty, staff and students can access required compliance training modules via the NJIT CITI program portal which offers web-based training courses to fulfill research compliance training needs. For more info, go to: http://far.52greenhome.com/research/compliance/citi-software.php.

The IRB may accept alternate training in lieu of the OHRP course if the researcher can produce documentation related to the training courses, 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 committee upon request.

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. Investigators with approved projects must submit an Amendment application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team.

Investigators with approved projects must submit an Amendment application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team. The administrator and chair of IRB review all amendment applications. Go to Streamlyne for IRB for guidance on Modification (Amendment) Training.

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 after expiration of an approved protocol is a violation of federal regulations. To avoid lapses in approval, continuing review submissions should be submitted at least 30 days before the expiration date.

You need to receive continued approval from the IRB in order to continue research.This can be requested through Streamlyne using the renewal procedures detailed in the training materials.

It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. For the renewal process and more information visit  IRB Submissions and Protocols.

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.

A serious adverse event is an adverse event that: 

• results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or 

• requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above

All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the Protocol PI or another researcher, ORIA, or a member of the IRB. 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.

Notifications for such events can be made via Streamlyne. Go to Streamlyne Training and review the training on Modifications.

Yes. If an unanticipated problem poses a risk(s) to the subjects 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.

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.

The Family Educational Rights and Privacy Act (FERPA) is a Federal law administered by the U.S. Department of Education; 34 CFR Part 99. FERPA aims to protect the privacy of Student Education Records. Student education records are often accessible to and used by instructors, teachers, and administrators for the purposes of conducting the duties of their job. However, this natural access cannot automatically be used for other intents and purposes, such as research.  If a researcher wants to use student data for research purposes, FERPA applies and consent is required, unless one of the exceptions to consent as outlined in FERPA is met. More information about FERPA.