Human Research Approval

NIU Institutional Review Board (IRB)

The Institutional Review Board (IRB) reviews research proposals that involve human participants to provide oversight in protecting the rights, welfare and wellbeing of subjects in research.

Applications for New Studies

Submissions

To create IRB submissions (initial, continuation, amendment), log in through the InfoEd online submission portal. View instructions on completing an info ed application.

Additional Materials

In addition to completing the e-form application, a complete IRB submission package must also contain any of the following content that is relevant for a given study:

All recruitment materials, such as flyers, advertisements, letters and/or the text of any emails or oral presentations.
A copy of any letters or emails that will be used to seek permission from research sites, such as schools or medical facilities.
Copies of all consent forms, parent permission forms, and/or assent forms.
Copies of all measures used, such as surveys, focus group or interview questions, or visual image examples.
A copy of any debriefing procedures, if applicable.
A copy of any support service information that will be provided, if applicable.

Training

All personnel on research projects involving human subjects who will interact with participants or have access to identifiable data must complete the CITI "Social and Behavioral Research - Basic/Refresher, Refresher Course" training program or provide documentation of equivalent training before beginning the research.

Please note that IRB policy now requires updated CITI training every five years.

Timeline

IRB applications should be submitted through the InfoEd system a minimum of 20 business days prior to the date when the research will begin. Although it is often possible to receive IRB approval in less than 20 business days, approval times vary depending on the completeness of the application, the level of review required, and the volume of protocols under review.

Changes to Approved Study

Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IRB for any modifications of the previously approved research before implementing the proposed modification unless the change is made to eliminate an immediate risk to the participants.

If the investigators change the research in order to eliminate apparent immediate hazards to subjects without prior IRB approval, they should report those changes promptly to the IRB.

Changes to a previously approved protocol may include adding or removing research personnel, changing the study population, requesting a greater number of participants, changes in compensation, changes in recruitment materials, or changes in study procedures or instruments. These and other changes to approved protocols should be submitted to the IRB for review by creating an amendment submission inside the existing protocol in InfoEd.

In addition to completing the e-form application, please upload copies of any study materials which have been revised using the "Add" button above the e-form application on the amendment submission page.

If you are unsure whether your changes can be handled as an amendment to your existing study, or would require a new application, please contact the Office of Research Compliance, Integrity and Safety (815-753-8588, pwallace@niu.edu) for guidance.

Continuing Review/Terminations

Annual continuation of IRB approval is required for all human subjects research projects which are not Exempt. The Principal Investigator is responsible for fulfilling requirements associated with continuing review in time for the IRB to carry out review prior to the expiration date of the current IRB approval. The form should be submitted at least 15 days before the study’s expiration date for expedited review projects and 30 days before expiration for projects requiring full board review to ensure adequate time for the IRB to process the continuing review.

The expiration date for your project is located on the initial IRB approval letter for your project, or on the last continuing review approval letter.

Reminder Notices

The Office of Research Compliance, Integrity & Safety generates continuing review reminder notices for each active study. The Principal Investigator (and advisor, if this is a student project) will receive the continuation reminder by email, typically at least 30 days in advance for expedited review projects and at least 60 days in advance for projects requiring full board review.

Internal Reminders

Investigators are strongly encouraged to devise an additional system for ensuring the submission of continuing reviews. It is your responsibility to ensure that your project approval does not expire. If you misplace the continuation form or do not receive a continuation form from the Office of Research Compliance, you may either contact them for a replacement or use the following form:

Application for Continuation of Approval

Closing a Study

If all research-related interventions or interactions with human subjects have been completed and all data has been de-identified, the research project can now be closed. A continuation form should be completed for projects which are closed so that the IRB has a record of the final subject numbers for your project and can close out the file for your project.

Termination of a Study

If IRB approval expires before continuing review and approval occur, investigators must stop all research activities involving human subjects related to that study, except where they judge that it is in the best interests of already enrolled subjects to continue to participate. When investigators make this judgment, they must promptly notify the IRB. When the IRB reviews the investigator’s decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects, or obtaining or analyzing identifiable private information about human subjects. Investigators may resume the human subjects research activity once continuing review and approval by the IRB has occurred.

Investigators have up to 30 days after the study expires to obtain approval. Otherwise, the IRB will close the study and a new IRB application will have to be submitted in order to resume the research.

Reporting Adverse Events or Unanticipated Problems

An adverse event is defined as: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research (the event can be physical and/or psychological)

An unanticipated problem is defined as any incident, experience, or outcome that meets all three of the following criteria:

Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied.
Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
Suggests that the research places subjects or others at greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The primary investigator of research approved for the use of human subjects is responsible for reporting any adverse events or unanticipated problems to the Office of Research Compliance (using the Reporting Form) as soon as possible, but no later than 7 days after first becoming aware of the problem. The principal investigator must independently begin initiation of any measures necessary to ensure subject safety while preparing and submitting the required reports.

The report must contain sufficient information for the IRB to make an assessment of risk. The IRB may request additional information from the PI, which should be provided within one business week, or sooner if specified by the IRB.

Event reports will be reviewed by one or more IRB members, typically the Chair or Vice-Chair or member designated by the Chair. Upon receiving a report of an unanticipated problem or adverse event, the IRB reviewer(s) may take one or more of the following actions:

Acknowledge the report, with no changes to the informed consent and/or protocol necessary.
Request additional information.
Request changes to the informed consent and/or protocol in response to the report.
Approve changes to the informed consent and/or protocol submitted by the PI in response to the report as long as these modifications are minor changes..
Refer the report to the next convened IRB meeting.
The research study may be temporarily suspended and/or the research study procedures discontinued/terminated. The IRB has the authority to suspend or terminate its approval of a study. When practical, such action will be taken by vote of the members at a convened IRB meeting. In the case of an emergency, in order to protect the safety of the study subject(s) the IRB Chair or a Vice-Chair may suspend enrollment and/or any portion of a study without waiting for a convened meeting of the IRB; however, the Chair or a Vice-Chair may not terminate the study. In such cases, the IRB Chair (or Vice-Chair, as appropriate) will notify the IRB members of the suspension at the next regularly scheduled meetings of the IRB.

A suspension/termination may be appropriate for any of the following reasons:

Unexpected death or serious harm to a study subject.
Unanticipated problems involving serious harm or risk of serious harm to a study subject, such as known or suspected contamination of a study drug.
Failure of the Principal Investigator to provide information requested by the IRB.
Known or potential non-compliance of the Principal Investigator and/or a research team member with human subject regulations or the requirements or determinations of the IRB.
Other circumstances that, in the judgment of the IRB, the IRB Chair, or a Vice-Chair necessitate suspension/termination to protect study subjects from harm.

In all cases, in a timely manner, the IRB Chair or Vice-Chair will inform the Principal Investigator in writing of the suspension/termination. The letter to the Principal Investigator must state the reason for the suspension/termination. In cases of immediate, significant risk to human subjects, the IRB Chair or designee may communicate the suspension/termination orally while written materials are prepared. In the case of a suspension, the letter is to specify whether the suspension applies only to the enrollment of new subjects, or also requires the cessation of all study procedures on subjects who have already been enrolled.

In the case of a termination, no new subjects may be enrolled and all study activities involving enrolled subjects must cease. Exceptions may be made by the Chair or Vice-Chair in circumstances where subjects are receiving an intervention that cannot be discontinued for safety reasons. These potential instances will be reviewed on a case-by-case basis. The IRB Chair or Vice-Chair will immediately notify the Institutional Officials and the Research Compliance Coordinator of the suspension or termination.

IRB Review Process

All proposed research activities that involve the use of human subjects must be reviewed and approved (or determined to be exempt) prior to the start of data collection. Projects that are not reviewed and approved prior to the start of data collection cannot receive "retroactive" approval.

The Review: Projects that qualify for Exempt status or are routed for Expedited review do not need to wait for a convened IRB meeting, although the IRB meeting agendas include all applications allowing board members to review any or all of them. Projects that involve greater than minimal risk will be scheduled for a convened meeting of the IRB members. The IRB meeting schedule is posted on the right side of this page. The IRB makes the final determination of a project’s review category; therefore, all projects require completion of the standard IRB e-form in the InfoEd system.

Timeline: Generally, an exempt determination takes a few days, and projects that involve no more than minimal risk are approved through an Expedited process that can take 1-2 weeks.

Student Projects: All student projects, require approval from a faculty advisor. That approval will occur as part of the routing in the InfoEd system.

Updated Exempt Categories

Research activities in which the only involvement of human participants will be in one or more of the following categories:

Research in Established or Commonly Accepted Educational Settings

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction.
Educational Tests, Surveys, Interviews, Observations of Public Behavior

Research that includes only interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of 3 criteria are met:

i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;

ii. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; OR

iii. The information obtained is recorded by the investigator in such a manner that the identity of human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited review to make the determination required by 45 CFR 46.111(a)(7) (which relate to there being adequate provisions for protecting privacy and maintaining confidentiality) AND the research is not subject to subpart D.
Benign Behavioral Interventions in Conjunction with the Collection of Information from Adult Subjects

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects;
- Any disclosure of the subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
- The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subject, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7)
Secondary Research for Which Consent Is Not Required

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available; or
- The information is recorded by the investigator in such a way that the identity of the subjects cannot readily be ascertained directly or through identifiers linked to the subjects, and the investigator does not contact subjects, and the investigator will not re-identify subjects; or
- The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under HIPAA (i.e., the use is regulated for purposes of “health care operations” or “research” or for “public health activities and purposes” as those terms are defined at 45 CFR part 164) ; or
- The research is conducted by or on behalf of a federal department or agency using government-generated or government-collected information obtained for nonresearch activities if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with certain federal statutes.
Research and Demonstration Projects Conducted or Supported by a Federal Department or Agency

Applies to research and demonstration projects that are conducted or supported by a federal department or agency, or otherwise subject to the approval of department or agency heads. Applies to activities that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including, but not limited to: procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.

Each federal department/agency conducting or supporting research and demo projects must establish, on a publicly accessible federal website or in another appropriate manner, a list of the research and demo projects the federal department/agency conducts or supports under this provision. The project must be published on this list before beginning the research involving human subjects. Department/agency heads can determine what sort of information will be included on this list and maintain its oversight. HHS will develop a resource that all Common Rule departments and agencies can use to satisfy this requirement.
Taste and Food Quality Evaluation and Consumer Acceptance Studies

This exemption applies if wholesome foods without additives are consumed, or if food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural, chemical or environmental contaminant at or below the level found to be safe by FDA or approved by the EPA or the USDA’s Food Safety and Inspection Service.
Storage or Maintenance for Secondary Research Use for which Broad Consent is Required

Exemption Category 7 applies to storing and maintaining identifiable private information/specimens for secondary research use.
Secondary Research Use of Identifiable Private Information or Identifiable Biospecimens for which Broad Consent is Required

Exemption Category 8 applies to the secondary research use of identifiable private information/specimens for specific secondary research studies.

Exemption Category 8 applies to secondary research studies that involve use of identifiable private information/specimens, provided the following criteria are met:
- Broad consent for storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with 45 CFR 46.116(a)(1)-(4), (a)(6), and (d);
- Documentation of informed consent or waiver of documentation of consent was obtained in accordance with 45 CFR 46.117;
- An IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7), and to make the determination that the research to be conducted is within the scope of the broad consent; and
  
  iv. The investigator does not include returning individual research results to subjects as part of the study plan. However, it is permissible under the exemption to return individual research results when required by law regardless of whether or not such return is described in the study plan.

Subcommittee Review (Expedited) Categories

(A) Research activities that (1) present no more than minimal risk to human subjects and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

(B) The categories in this list apply regardless of the age of subjects, except as noted.

(C) The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Research Categories

Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
1. Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
1. from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than two times per week; or
2. from other adults and children, considering the age, weight and health of the subjects, the collection procedure, the amount of blood to be collected and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than two times per week.
Prospective collection of biological specimens for research purposes by noninvasive means.

Examples:

(a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum base or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, infrared imaging, doppler blood flow and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). ( This rule applies if the data is not anonymous).
Collection of data from voice, video, digital, or image recordings made for research purposes.
Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
Continuing review of research previously approved by the convened IRB as follows:
1. where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; (iii) the research remains active only for long-term follow-up of subjects; or
2. where no subjects have been enrolled and no additional risks have been identified; or
3. where the remaining research activities are limited to data analysis.

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Other Projects

Other projects requiring full IRB review should be submitted to the ORC by the researcher as soon as possible, but no less than ten days before the next scheduled IRB meeting date. IRB meetings are generally held on the second and fourth Wednesdays of the month except during holiday and university break periods.

Please note that copies of all documentation related to a project should be retained in a secure location for at least three years after its conclusion. Also, because a copy of the consent form used in any project must be given to the subjects involved, it is recommended that a line is included in the consent form for the subject to acknowledge receipt of a copy. Sample consent forms are also available on the ORC website.

IRB applications should be submitted to the Office of Research Compliance, Integrity and Safety (ORCIS) a minimum of 20 business days prior to the date when the research will begin. Please note that additional lead time is required for departmental review of applications prior to sending it to ORCIS. Although it is often possible to receive IRB approval in less than 20 business days, approval times vary depending on the completeness of the application, the level of review required and the volume of protocols under review.

Additional Info

Compliance, Integrity and Safety

Contact Us

Assistant Director of Research Compliance, Integrity, and Safety
(for questions related to the IRB approval process)
Patty Wallace
Phone: 815-753-8588
Fax: 815-753-1631
Email: pwallace@niu.edu

IRB Chair
MJ Blaschak
Phone: 815-753-1438
Email: mblaschak@niu.edu