Research Guidance

Am I eligible to submit an application to conduct research?
The following list of persons from the Seton Hall University community may submit a study application to the Institutional Review Board (IRB):

All tenured and tenure-track Assistant, Associate and Full Professors;
All full-time contract faculty holding the rank of Lecturer, Assistant, Associate or Full Professor;
Faculty who are on adjunct or clinical appointments with written permission of their department chairperson; and,
Graduate and Doctoral students completing research related to their degree program. Students must submit written permission of the faculty member that is overseeing their training (e.g., mentor/advisor) with the application. It is recommended that this faculty member be listed on the application as both the faculty sponsor and co-investigator.

Undergraduate students may not submit an application to the IRB as a principal investigator. A faculty member meeting either of the top 2 criterion should be identified to satisfy that role; the undergraduate student can be listed as a co-investigator.

How do I complete the human subject protection training?
Any faculty, staff member or student of Seton Hall University who is a member of the study team and is engaged in the conduct of human subject research must complete the web-based Collaborative IRB Training Initiative (CITI) Program in the Protection of Human Subjects in Research available at https://about.citiprogram.org/en/homepage. The certificate is valid for two years.

If you have never taken a CITI course, you will have to complete one of the following trainings based on the type of research you perform:

Biomedical
Social-Behavioral

For a step-by-step tutorial on how to complete an initial account registration, click here

If you have previously taken the CITI course and your training is about to expire, you can complete the refresher course.

CITI will automatically add the "Refresher" course to your list of courses 90 days before your CITI Training expires.
System generated emails to inform you on the approaching expiration will be sent to the email used during registration.
You may only take the refresher course 3 times. After that, you are required to complete the Basic course again.

For a step-by-step tutorial on how to initiate a refresher course through the CITI portal, click here

If you have previously registered and taken a CITI training course at another institution

You can login to the CITI program portal with you existing credentials
In the top right corner, select the down arrow next to your username and ID and click on profiles.
Scroll to the "Institutional Profiles" and select "Add an Affiliation"
Enter Seton Hall University as the organization
Check the boxes to agree to the terms of service and affirmation of affiliation, and continue
Update any changes to your information
Select the appropriate course (Basic or Refresher) for your research area
Answer remaining questions and submit

After you have completed all of the modules and passed the quizzes with a score of 70% or better, you will be able to download and print a Course Completion Report. You will be required to submit a copy of your course completion certificate with each application to the IRB.

If you have never taken a CITI training course, click here.

If you have previously registered, taken a CITI training course, and your training has expired, click here.

Is my proposal considered research?
According to 45 CFR Section 46.102(l):

Research is "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge."

Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

The following types of activities are deemed not to be research:

Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

The following link provides additional examples and guidance for activities that are not considered human subjects research and are quality improvement activities.

Does my study involve "human subjects?"
According to 45 CFR Section 46.102(e):

A human subject is "a living individual about whom an investigator (whether professional or student) conducting research:"

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens;
- Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes
- Interaction includes communication or interpersonal contact between investigator and subject.
Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record).
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

What is "generalizable knowledge" and how does it relate to my proposal?
Generalizable knowledge refers to information gained through a systematic investigation that may be expressed as theories, principles, or statements of relationships that can be generally applied to our experiences or perceptions. This information is collected with the intent to draw general conclusions, inform on policy or procedures, or generalize findings beyond a single individual or an internal program. The information is collected with the expectation of being shared with others in a discipline and is created to make a conclusion on a topic.

Generalizable knowledge includes one or more of the following concepts:

The information contributes to a theoretical framework or an established body of knowledge;
The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study;
Publication, presentation or other distribution of the results is intended to inform the field of study; and,
The results are intended to be replicated in other settings

What is a vulnerable population?
Vulnerable populations include the economically disadvantaged, racial and ethnic minorities, the uninsured, low-income children, the elderly, the homeless, those with human immunodeficiency virus (HIV), and those with other chronic health conditions, including severe mental illness. It may also include rural residents, who often encounter barriers to accessing healthcare services. The vulnerability of these individuals is enhanced by race, ethnicity, age, sex, and factors such as income, insurance coverage (or lack thereof), and absence of a usual source of care. Their health and healthcare problems intersect with social factors, including housing, poverty, and inadequate education.

What type of review does my study proposal require?
If your study meets the criterion for human subject research, it may be subject to one of three types of review by the Seton Hall University Institutional Review Board (IRB):

The level of review by the IRB is based on the level of risk that a subject who participates in your study may experience during their involvement. The risk level in your study is compared to the standard definition of "minimal risk" as defined by the federal regulations:

Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [45.CFR.46.102(j)]

Minimal Risk studies may be eligible for expedited review (insert link) or exempt status (insert scroll link). Studies that are considered greater than minimal risk will require full committee review (insert scroll link) by the Seton Hall University IRB, or by the Hackensack Meridian Health IRB. Guidance on the appropriate IRB can be found here (link to HMH decision).

Full Committee Review
Full committee review is required for studies that are:

Greater than minimal risk, OR
Minimal risk but do not fit in a category for expedited review (insert scroll link to below), OR
Any study that is funded by an agency requiring this level of review

Expedited Review
Expedited review studies typically are reviewed by a small number of IRB reviewers. Expedited review is appropriate for studies that according to 45 CFR 46.110:

Are considered no more than minimal risk, AND
Fit into one or more of the nine expedited review categories:

Category 1: Approved drug or device being used for its approved indication

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 approved uses (e.g., dosing schedule and amount) of the product are not eligible for expedited review.)
Research on medical devices for which;

an investigational device exemption application (21 CFR Part 812) is not required; or
the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Special note: The drug or device can only be used in the study for its approved and labeled purposes. The remaining study procedures must also be of minimal risk in order to qualify for expedited review.

Category 2: Blood sampling (limited amounts)
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml (~37 tablespoons) in an 8-week period and collection may not occur more frequently than 2 times per week; or
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 (~1.5 tablespoons) or 3 ml per kg in an 8-week period and collection may not occur more frequently than 2 times per week.

Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).

Category 3: Noninvasive specimen collection
Prospective collection of biological specimens for research purposes by noninvasive means.

Category 4: Noninvasive, routine clinical procedures, such as MRI or EKG (no sedation, general anesthesia, x-rays or microwaves)
Collection of data through noninvasive procedures that do not involve the use of general anesthesia or sedation and are routinely employed in clinical practice or evaluation, excluding procedures involving x-rays or microwaves.
Examples:

Electrocardiography, electroencephalography, thermography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography
Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
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
Magnetic resonance imaging (FDA-approved scanners of 3 Tesla or under)

Category 5: Use of data or specimens collected for non-research or research purposes (e.g. chart reviews)
Research involving materials (data, documents, records or specimens) that have been previously collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).

This category refers to materials collected for "non-research purposes," but can be used to cover research materials if the investigator's role is simply to analyze them. That is, if an investigator is receiving materials from colleagues who have separate approval to collect them, and the materials are handled with protections for confidentially, the investigator may apply for expedited review for the analysis.
Under limited circumstances, research involving private information or specimens may be exempt or may not qualify as human subject's research. If the project is not human subjects research, IRB review is not required.

Examples:
Retrospective chart review
Analysis of specimens that contain protected health information

Category 6: Collection of data from voice, video, digital, or image recordings
Collection of data from voice, video, digital, or image recordings made for research purposes.
Example: Using video recordings to examine communication styles between educators and students

Category 7: Low-risk behavioral research
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.
Note: Some research in this category may qualify for exempt certification, most commonly under exempt category 2.
Example: Interviewing teenagers about the influence of social media on body image.
Reminder:

Category 8: Continuing review of inactive research or studies that are essentially complete
Continuing review of research previously approved by the convened IRB as follows:

Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
Where no subjects have been enrolled and no additional risks have been identified; or
Where the remaining research activities are limited to data analysis.

Category 9: Continuing review of other minimal risk research studies
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.

Special Note about Expedited Review category: This level of review 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.

Exempt Research
The Common Rule (45 CFR 46.104) identifies several categories of research that may be exempt from federal policy on the protection of human subjects. To qualify for this level of review, the research must not be greater than minimal risk (link to minimal risk) and must meet one or more of the six categories that are considered exempt research. Exempt research must be initially reviewed by the IRB to verify that it meets the criterion for this status; an investigator is not authorized to make this determination. Upon receiving the designation, the study is exempt from further comprehensive review unless there are modifications to the study procedures or population that would otherwise change eligibility under one of the six categories. Projects that do not meet the criteria for human subjects' research are excluded from IRB review (link to NHRS).

The exempt categories include:

Category 1 – Educational research
Research conducted in established or commonly accepted educational settings, involving normal educational practices that are not likely to adversely impact students' opportunity to learn or assessment of educators.

Examples:

Evaluating the use of accepted or revised standardized tests
Testing or comparing a curriculum or lesson
Most research on regular and special education instructional strategies,
Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 – Surveys, interviews, educational tests, public observations
Research that only includes interactions involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recordings) and at least one of the following are met:

The information recorded by the investigator cannot be used to identify the subject directly or through identifiers linked to the subjects; OR
Any disclosure of responses outside of the research would NOT reasonably place subject at risk of criminal or civil liability, or be damaging to the financial standing, employability, educational advancement, reputation; OR
The information recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination. The IRB will determine whether there are adequate plans to protect the privacy of subjects and to maintain the confidentiality of the data as required by §46.111(a)(7).

Examples:

Surveying teachers, nurses, or doctors about a technique or an outcome that is performed
Conducting a focus group about an experience or an opinion of a community program

Category 3 – Benign Behavioral Interventions
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 collection of the information and at least one of the following criteria is met:

The information recorded by the investigator cannot be used to identify the subject directly or through identifiers linked to the subjects; OR
Any disclosure of responses outside of the research would NOT reasonably place subject at risk of criminal or civil liability, or be damaging to the financial standing, employability, educational advancement, reputation; OR
The information recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination. The IRB will determine whether there are adequate plans to protect the privacy of subjects and to maintain the confidentiality of the data as required by §46.111(a)(7).

Examples:

Solving puzzles under various noise conditions
Being exposed to stimulation through color, light or sound (at safe levels), simulated events
Performing cognitive tasks

Additional Considerations
Study population

This exemption applies only to adult subjects.
Adults with decisional impairment cannot be purposefully included
Studies with interventions involving children do not meet the exempt criteria.

Procedures

Research procedures in this exempt category should generally be limited to:
- communication or interpersonal contact with the subject,
- the performance of a cognitive, intellectual, educational or behavioral task, or
- manipulation of the subject's physical, sensory, social, or emotional environment
Data collection in this exempt category is limited to:
- verbal (oral) or written responses by the subject
- data entry by the subject
- observation of the subject
- audiovisual recording
Benign behavioral interventions must be brief in duration (a few minutes or hours)
Must not cause harm, pain or distress.
Risks to subjects are defined as minimal in nature (link to minimal risk)
Unlikely to have significant emotional discomfort or adverse lasting impact
Must not be offensive or embarrassing to subjects
Deception can only be used if the subject prospectively agrees to the use of deception. Subjects must be informed prior to initiating the intervention that they will be unaware of, or misled regarding the true nature or purpose of the research. They will also be told whether further information will be provided at the conclusion of the research activities. A post-intervention de-briefing of participants should be included.
Medical interventions and procedures are not permissible in this exemption
Physical (bodily) tasks and physical exercise should not be included in this exempt category.
This category does not include the use of wearable technologies that track movement, activity patterns, heart rate, etc.

Category 4 – Secondary Research Using Identifiable Private Information or Biospecimens
Secondary research with identifiable Information/specimens collected for some other initial activity, if ONE of following:

The information recorded by the investigator cannot be used to identify the subject directly or through identifiers linked to the subjects; OR
Any disclosure of responses outside of the research would NOT reasonably place subject at risk of criminal or civil liability, or be damaging to the financial standing, employability, educational advancement, reputation; OR
The information recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination. The IRB will determine whether there are adequate plans to protect the privacy of subjects and to maintain the confidentiality of the data as required by §46.111(a)(7); OR
Research information collected by or on behalf of federal government using government generated or collected information obtained for non-research activities

Category 5 – Federal research or demonstration projects
Research and demonstration projects that are conducted or supported by a Federal department or agency or department, AND are designed to study, evaluate, improve, or otherwise examine public benefit or service programs. This may include 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.

Federal agencies must publish a list of projects covered by this exemption prior to research commencing

Category 6 – Taste and food quality evaluation studies
Taste and food quality evaluation and consumer acceptance studies,

if wholesome foods without additives are consumed, OR
if a 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 the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Not Human Subjects Research
Projects that either do not involve human subjects (link to human subjects) or fail to meet the definition of research (link to research) are excluded from IRB review. This is not the same as exempt research.

What criterion is needed for my study to get approved?
According to § 46.111, the following criteria is necessary for the IRB to approve a research study.
(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

Risks to subjects are minimized:
- By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
- Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
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 benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
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. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
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.
Informed consent will be appropriately documented or appropriately waived in accordance with § 46.117.
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- The Secretary of HHS will, after consultation with the Office of Management and Budget's privacy office and other Federal departments and agencies that have adopted this policy, issue guidance to assist IRBs in assessing what provisions are adequate to protect the privacy of subjects and to maintain the confidentiality of data.
- [Reserved]
For purposes of conducting the limited IRB review required by § 46.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
- Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of § 46.116(a)(1)-(4), (a)(6), and (d);
- Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with § 46.117; and
- If there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

My study may be considered greater than minimal risk. What IRB should I submit to?
The following list includes numerous examples of study designs and research procedures that should be sent to the Hackensack Meridian Health (HMH) Institutional Review Board (IRB; https://irb.humed.com) for review.

If you are a Seton Hall University faculty member or graduate/doctoral student engaging in any of the indicated research types, you must follow the registration procedures required by the Hackensack Meridian Health IRB prior to submitting an application for review. Your proposal must comply with the expected submission requirements and have approval from your respective College/School Pre-IRB prior to submission, as the Pre-IRB chair will be required to sign-off on your application in the HMH e-IRB portal before it is released for review.

The example of study designs and research procedures include, but are not limited to any study in human subjects that:

meets the World Health Organization definition of a clinical trial;
requires a data safety monitoring board (DSMB). Briefly, the DSMB is composed of independent experts who have the requisite skills, knowledge and contemporary point-of-view that perform a scheduled evaluation of safety, efficacy, compliance, progress, and adherence to approved protocols, among other functions. Further guidance on the purview and function of the DSMB can be found here;
requires approval from the Food and Drug Administration (FDA) for"off-label" and investigational use of marketed drugs, biologics and medical devices, or use of non-approved or investigational medical devices on human participants that has a corresponding application for Investigational New Drug (IND) or Investigational Device Exemption (IDE) status;
aims to prospectively evaluate potential changes in structure or function of the human body as part of a structured intervention;
aims to enroll participants with active medical conditions and diagnoses that are under physician-supervised care including, but not limited to AIDS/HIV, alcoholism, affective or mood disorder, cancer, or another organ system;
evaluates any substance (e.g., pharmaceutical, nutritional supplement, device) that is orally ingested orally, applied topically to the skin, or introduced into the body by other means;
collects tissue or specimen (e.g., blood, saliva, urine, stool, hair, mucosal swabs, skin, exhaled breath condensate, etc.) to make inferences on health status, structure and function relationships under normal or pathological conditions, or for genotyping, genetic manipulation or genome sequencing;
uses radiation emitting devices or exposes participants to radioactive materials for data collection purposes (e.g., x-ray, computed tomography, etc.);
uses a procedure/device that requires specialized training, certification, or licensure as a means for data collection;
is a treatment or procedure related to the medical emergencies in human participants;
uses or evaluates stem cells or related therapies;
is related to vaccine research; and,
is related to organ transplantation(s).

If there are any questions, please call Jose L. Lopez, Ph.D. (Director of the Seton Hall University IRB) at (973) 761-9334 or send an email to [email protected].