HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 1
STUDENT HANDBOOK:
A GUIDE TO HUMAN SUBJECTS’ PROTECTION IN RESEARCH
HRP-105
Last Updated on January 21, 2022
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 2
TABLE OF CONTENTS
Page
1. Introduction to the Student Handbook 4
2. What Is An IRB? 4
3. What Regulations, Policies and Practices Apply? 4
o Regulatory Authority
o Federal Regulation
o State Statutes
o Rutgers Policy and Organizational Support
o Industry Best Practices
o Publication Best Practices
4. What Ethical Principles Apply? 7
o Respect for Persons
o Beneficence
o Justice
5. Will My Research Need IRB Review? 7
o Is It Research?
o Does My Project Involve Human Subjects?
o What If My Study Does Not Meet the Definition of Human Subjects’
Research?
o What If I Am Not Sure If My Project Involves Research with Human
Subjects?
o Some Research Examples: Bio-Specimens, Classroom Exercises, Surveys,
Questionnaires And Focus Groups, Theses, Dissertations & Work on Faculty
Research
6. What Are the Different Types of IRB Review? 12
o Exempt
o Expedited
o Full Board
o IRB Office Support (For Questions About Review Categories)
7. What Does the IRB Consider in Their Review? 16
o Common Rule – Protection of Human Subjects
o Food and Drug Administration (FDA)
o Common Rule – Vulnerability in Research
o HIPAA Privacy Rule
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 3
o Other Laws and Regulations May Apply
8. What Study Documents Do I Need to Submit to the IRB? 20
o Documents Needed
o Study Document Templates Available
9. Do I Need Special Training? 21
10.What Are My Responsibilities as a Researcher? 21
11.May I Serve as The Principal Investigator? 22
12.Do I Need a Faculty Advisor? 23
13.How Do I Apply for IRB Review of My Research? 23
14.What Are My Responsibilities to Communicate with the IRB? 23
o Initial Review
o Continuing Review
o Changes to the Research Plan
o Unanticipated Events or Protocol Deviations
o Study Closure or Study Withdrawal
o Data Storage after Study Closure
15.What Other Things Should I Consider? 25
o Site Approvals, Other Sites’ IRB Approvals and Authorization Agreements
o Research Opportunities at Other Institutions and IRB Approval
o International Research
o Sponsored Research
o Research Using Social Media/Internet
o Research Using Mobile Devices
o Conflict of Interest
o Clinical Trial Registration
o HSPP Quality Assurance Audits
16.In Closing 28
17.Now What? (A Checklist of Things to Do to Get Started!) 29
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1. INTRODUCTION TO THE STUDENT HANDBOOK – A Guide to Human Subjects’
Protection in Research
Rutgers, The State University of New Jersey, is legally and ethically bound to protect the rights and welfare
of humans participating in research conducted by its faculty, staff, and students. Federal regulation, state
law, University policy, and professional standards of the investigator’s academic discipline demand
compliant, ethical and responsible conduct of social, behavioral, educational, and biomedical research
involving human subjects. We offer this Handbook to help students meet their regulatory and ethical
responsibilities when conducting research involving human subjects. We answer many of the questions
students new to research may have about working with an IRB and identify where to find additional
resources.
The Rutgers’ Office for Research (OFR) recognizes the value of student participation in the research
process. It is a valuable learning experience that helps ensure future social benefit from the efforts of
well-trained researchers. We encourage students to contact us directly if they need help navigating the
IRB process. Contact the Rutgers HSPP|IRB office either by visiting our “Contact Us” Webpage or by
sending an email: IRBOff[email protected]. An IRB staff member will partner with you to ensure
your project proceeds promptly and compliantly.
2. WHAT IS AN IRB?
An Institutional Review Board (IRB) is a committee designated by an institution to review, approve, and
conduct periodic post-approval reviews of human research studies that fall within its scope of authority,
as required by federal or state regulation and university policy. This university supports the IRB campus
wide. Each committee is composed of respected scientists, non-scientists, community members, staff, and
a variety of specialists from diverse fields of study.
The primary purpose of IRB review is to protect the rights and welfare of individuals involved in human
subjects’ research conducted by faculty, staff and students of the institution. Many other countries also
require IRB review and approval of proposed human research studies but, outside of the U.S., such
committees may be called “Privacy Boards” or “Research Ethics Boards”.
3. WHAT REGULATIONS, POLICIES AND PRACTICES APPLY TO HUMAN SUBJECTS’
RESEARCH?
Federal regulation, State law, University policies and industry best practices shape what constitutes
appropriate conduct of research involving human subjects.
Regulatory Authority
Federal, State and local laws and regulations may require human subjects’ research to be conducted in
particular ways. The University requires its researchers to be knowledgeable about and comply with the
laws and regulations of the country and state in which they are conducting research and all research
documents must reflect compliance with such laws and regulations.
Federal Regulation
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By federal regulation, U.S. institutions, companies and organizations that receive federal funding and
conduct human subjects’ research—such as Rutgers University and its affiliated hospitals and clinics—
must use an IRB and follow specific review and approval practices
[45 CFR 46] http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/#.
Institutions, companies and organizations that do not receive federal funding—such as pharmaceutical
and medical device companies—but conduct human subjects’ research with Food and Drug
Administration (FDA) regulated products (drugs, devices, biologicals and nutraceuticals) that require FDA
approval before sale to consumers must also use an IRB and abide by its determinations [21 CFR 50, 21
CFR 56] http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm.
Further, investigator-initiated clinical trials conducted by Rutgers’ investigators that meet clinical trials
registration requirements under the FDA Amendments Act of 2011 (FDAAA) must register their clinical
trial on the ClinicalTrials.gov website. To learn more, go to https://research.rutgers.edu/researcher-
support/research-compliance/human-subjects-protection-program-irbs/clinical-trials. For a subset of
clinical trials, investigators are also required to fulfill the FDAAA requirements for reporting results and
adverse events on the site at the end of the research.
Federal agencies that fund research, such as National Institutes of Health (NIH), National Science
Foundation (NSF), Department of Education, Department of Defense, and others, may publish additional
regulations with which researchers must comply. Depending on research design, FDA regulations, the
funding agency, or research activities occurring at non-U.S. study sites, research may need to comply with
the International Council of Harmonization Good Clinical Practices
http://www.ich.org/products/guidelines.html.
Institutions, companies and organizations not bound by regulation—such as foundations and other types
of private funding agencies—may require IRB review as a best practice to safeguard subjects’ rights and
welfare.
All institutions and organizations, regardless of funding, are bound by the HIPAA Privacy Rule which
regulates the use of subjects’ personally identifiable health information found in patients’ electronic
medical records [See HIPAA Privacy Rule in Section 7].
State Statutes:
States may have laws and regulations beyond what is federally required to safeguard rights and
protection for their residents participating in research. New Jersey requires surrogacy protections for
individuals who lack the decisional ability to consent to medical research. New Jersey requires
additional protection for students in school research. Further, New Jersey recognizes a child as an adult
at 18 years of age, while other states may not recognize adulthood until age 19 or older. A listing of
many (but not all) New Jersey laws relevant to research is found at
https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-
program-irbs/policies-and. You are responsible to know and comply with the applicable laws in the
countries and states in which you conduct your research.
Rutgers Policy and Organizational Support
Committed to protecting the rights and welfare of human subjects involved in research, The University
requires all human subjects’ research to be conducted in compliance with applicable Federal and State
laws, requirements of public and private funding agencies, and the University’s internal policies and
procedures for the solicitation and management of externally sponsored programs and for the allocation
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of internal research (see Rutgers Policy Library, Sections 10.1.8 and 90.2.11
http://policies.rutgers.edu/view-policies/table-contents). All research that meets the definition of human
subjects’ research must be reviewed by an University-sanctioned IRB before research activities may begin.
Once approved, investigators must comply with IRB decisions and instructions, and communication
requirements until such time as the IRB deems the project closed. Later in this document we review the
various types of IRB decisions, instructions and communication requirements.
The University’s Office for Research (OFR) is organized to support the research activities of faculty, staff
and students. OFR oversees research compliance to ensure the conduct of research promotes the integrity
of the scientific record, including training and certification. The Human Subjects Protection Program
(HSPP) which provides oversight for the IRB (research with humans), IACUC (research with animals), fCOI
(financial conflict of interest in research), Export Control (oversight to regulate the export of certain
research goods and knowledge to/from persons, companies, or entities residing in non-U.S. locations),
and Research Integrity (ensuring high ethical standards in the conduct of research through research
training programs and activities related to such research training), are its principle areas of responsibility.
OFR provides subject matter expertise and administrative support to the IRB committees through the
efforts of its Human Subjects Protection Program (HSPP). To learn more about OFR, HSPP or any of the
areas of compliance listed above, go to https://research.rutgers.edu/researcher-support/research-
compliance .
Industry Best Practices
In addition to laws, regulation, university policy and grantor requirements, many research institutions
follow best practices outlined by voluntary accrediting agencies to safeguard subjects rights and welfare
(e.g., Association for the Accreditation of Human Research Protection Programs, http://aahrpp.org and
Alion, http://www.alionhrpp.com/faq/). Details of research best practice and the regulations on which
they rest are outlined at such websites.
Publication Best Practices
Irrespective of legal, regulatory, University and grantee requirements, most major journals—national and
international—require proof of IRB review and approval of interventional research involving human
subjects’ as a condition of publication.
4. WHAT ETHICAL PRINCIPLES APPLY TO HUMAN SUBJECTS’ RESEARCH?
The Belmont Report, published by the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research in 1979, provides the ethical foundation which guides federal
research regulations and IRB review of human subjects’ research. The Belmont Report highlights three
basic ethical principles:
Respect for Persons incorporates at least two ethical convictions: “first, that individuals should be treated
as autonomous agents, and second, that persons with diminished autonomy are entitled to
protection.” The Report clarifies, “respect for persons requires that subjects, to the degree that
they are capable, be given the opportunity to choose what shall or shall not happen to them.” The
cornerstone of protecting respect for persons is the informed consent process, whereby the
researcher provides individuals with the details about the study and their rights as study subjects,
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anticipated harms and benefits, alternatives to participation, and an opportunity to ask questions
before deciding whether to participate in the study.
http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html#xrespect
Beneficence incorporates at least two obligations: “first, do no harm and (2) maximize possible benefits
and minimize possible harms.” Regarding particular projects, researchers must design projects in
ways that ensure anticipated risks of harm from the research are minimized, possible benefits are
maximized, and harms and benefits are proportional to one another.
http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html#xbenefit
Justice demands that society’s members share equally the benefits and burdens of research. In other
words, the selection of subjects should be justified by the scientific question(s) being asked and
not as a matter of convenience or bias. Further, the principle requires that the communities of
people who undertake the burdens of research are likely to benefit from the research.
http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html#xjust
Later sections in this guide highlight what study design elements and documents the IRB reviews to
determine that the three ethical principles outlined in The Belmont Report have been appropriately
applied to the proposed research.
5. WILL MY RESEARCH NEED IRB REVIEW?
Your proposed project may or may not require IRB review depending on whether (1) it qualifies as
research, and (2) involves human subjects. Both criteria must be satisfied for a study to be deemed human
subjects’ research requiring IRB review. Definitions of relevant terms are found in this section followed by
a description of how the criteria are applied to different types of research activities.
Is It Research?
The first question that must be considered is whether a project fits the regulatory definition of research.
The federal regulations define research as “a systematic investigation, including development, testing
and evaluation, designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(d)]
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html .
• A systematic investigation is not a federally defined term but typically involves the collection of
data in an organized and consistent way and analyzed in some scientifically reliable fashion
permitting conclusions to be drawn.
• Generalizable knowledge is not a federally defined term but typically considered as the
learned/collected information expressed in theories, principles, and statements of relationships
that can be applied more widely than the specific site and individuals participating in the research
project. With this said, generalized knowledge in qualitative research typically regards
transferability, especially for those who are consuming their work so that another may transcribe
and transfer the findings into practice.
The requirement that a proposed project involves systematic investigation is usually met because
observation and data collection methodologies are, by their very definition, systematic. That the proposed
project seeks to generate knowledge that has applicability beyond the context of the single study, on the
other hand, may not always be the case as you will see when you review the different types of research
examples provided later in this section.
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Does My Project Involve Human Subjects?
The second question that must be considered is whether the proposed research involves human subjects.
The federal regulations define a human subject as “a living individual about whom an investigator
conducting research obtains (1) information or biospecimens through intervention or interaction with
the individual, and uses, studies, or analyzes the information or biospecimens; or
(2) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable
biospecimens [45 CFR 46.102(e)(i)(ii)]. Notice several concepts are relevant to whether the project is
considered to involve human subjects:
• Living individual refers to data (information or specimens) collected from living persons.
• About whom means the information collected is personal information about a person
(information collected solely about an organization or its processes is not human subjects
research);
• Intervention includes physical procedures by which data are gathered (e.g., blood draw, cheek
swap, saliva sample) and manipulation of the subject or subject’s environment that are performed
for research purposes.
• Interaction means communication or interpersonal contact between researcher and subject.
• Private information means 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, information in their medical record).
• Identifiable private information means the identity of the subject is or may readily be ascertained
by the researcher or associated with the information collected. [See HIPAA Privacy Rule in Section
7] .
• Identifiable biospecimen means that a biospecimen for which the identity of the subject is or may
readily be ascertained by the investigator or associated with the biospecimen. [See HIPAA Privacy
Rule in Section 7] .
If the project meets the definition of research AND involves human subjects, the project must be reviewed
and approved by the IRB before it is conducted.
IMPORTANT: IRB approval CANNOT be backdated. If you begin your project without IRB approval and
later learn that your study required IRB approval, the research activities you conducted without IRB
approval CANNOT be used to fulfil degree requirements or published in most peer-reviewed journals.
What if my study does not meet the definition of human subjects’ research?
The researcher is responsible for the initial assessment as to whether an activity constitutes human
subjects research based on the federal definitions. If one or more of the criteria listed above to define
human subjects research is not met, the project does not require IRB review. IMPORTANT: Since the
University holds researchers responsible if the determination is not correct, student researchers are
encouraged—and most Schools require—students to submit their proposed research to the IRB to
determine whether it constitutes human subjects research requiring IRB review and approval.
When you submit your project for an IRB determination, you must: (1) be sure to provide sufficient
information about your proposed project in your IRB application in order for a determination to be
made accurately and swiftly (such as, study purpose and design—so the IRB can determine whether it is
research—and what data will be collected, how it will be collected and from whom—so the IRB can
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determine if human subjects will be involved in the research); and (2) state that you believe your project
does not qualify as human subjects research.
The U.S. Department of Health and Human Services offers a decision-tree to help IRBs determine when
projects constitute human subjects research. You might find it
helpful. http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1.
What If I Am Not Sure If My Project Involves Research with Human Subjects?
Determining whether a project constitutes human subjects research can be tricky because of the multiple
criteria at play and when more than one methodology is employed to collect data. Your faculty advisor
and the IRB are available to help you think through whether your project does or does not qualify as
human subjects’ research requiring IRB review.
What Are Some Research Project Examples to Help Me Think About Whether My Project Is Human
Subjects’ Research?
Following are some examples of different types of projects and a discussion about what activities do/do
not qualify them as human subjects’ research. Reviewing them may help you determine whether your
project is human subjects’ research.
Analysis of Bio-specimens
Bio-specimens range from tissue samples to blood, sputum, urine, sweat, and bone marrow. Some
research studies propose to prospectively collect fresh specimens from individuals; others propose to
use archived samples that were originally collected during a necessary clinical procedure or another’s
research and is now stored in laboratories of hospitals, medical centers, or tissue repositories. Assuming
the project is deemed research (systematic and generalizable), the key to determining if analysis of bio-
specimens constitutes research with human subjects is found in the answers to 3 questions:
(1) Are the specimen donors living? If none of the specimen donors are living individuals, your
project does not constitute human subjects’ research per the Common Rule. However, HIPAA
regulations may apply [See HIPAA Privacy Rule in Section 7]
(2) Who is collecting fresh specimens, if applicable? If you or members of your research team are
interacting with the subjects from whom the specimens will be collected, it is human subjects’
research because intervention or interaction by study staff with subjects will occur. If persons
unrelated to the study are interacting with individuals to collect the specimens (e.g., clinic
staff), and who will then forward the samples to study staff, it may not be human subjects’
research because no intervention or interaction by study staff will occur. But we cannot be
sure until we answer Question 3.
(3) Will private identifiable information about the subject be affixed to the specimen vials or
slides or included in documents that may accompany them? If the answer is yes, then it is
human subjects’ research because individuals’ private identifying information is being
collected for research. If the answer is no—the identity of the subject donating the specimen
remains anonymous, and no intervention or interaction with study staff will occur—then the
research is not human subjects’ research. [To learn more about private identifiable
information, see HIPAA Privacy Rule in Section 7].
Classroom Exercises
Most exercises assigned to students in research methodology classes are designed to teach skills and
provide students the opportunity to practice research methods such as observation, interview or survey
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techniques, tissue or data analysis, or environmental testing. Typically, exercises are limited in scope,
designed exclusively to teach students and not to develop or contribute to generalizable knowledge, and
are not undertaken with that goal in mind. In such cases, IRB review is not necessary. However, when
exercises are designed to develop or contribute to generalizable knowledge, then IRB review is required.
Responsibility for determining whether classroom exercises require IRB review/approval rests with the
IRB. Faculty will find guidelines and the appropriate form to submit to request an IRB review of class-
based research assignments to determine if the activities constitute human subjects research at
https://research.rutgers.edu/researcher-support/administrative-offices/human-subjects-protection-
program-irbs/identifying-human. The Rutgers Faculty member can submit an eIRB application for a Non-
Human Subjects Research Determination by logging into eIRB to create an initial submission via
www.eIRB.rutgers.edu.
Regardless of whether projects require IRB review, both faculty and students should follow federal
guidelines and University policy when designing and conducting class exercises with human subjects to
protect the rights and welfare of human subjects.
Quality Assurance (QA)/Quality Improvement Projects (QI)
Quality Assurance, Quality Improvement, Program Evaluation, Evidence-Based Practice, and
Benchmarking activities that are designed to determine whether aspects of an organization’s existing
practices are being performed in line with established standards are called Quality Assurance (QA).
Quality Improvement (QI) extends that process to continuously evaluate and learn from organizational
experience in a cycle (i.e., plan-do-study-act). In general, QA/QI activities are not research because they
evaluate existing practices against established standards (not untested practices), and the results are not
generalizable beyond the organization. Further, the activity does not increase risks of harm because,
ostensibly, QA/QI works to reduce risks of harm in the organization by its efforts. As a result, standard
QA/QI projects are not deemed human subjects’ research and do not need IRB review/approval. For
more information, see the Guidance Topics online, then click upon the “Quality Activities” topic.
IMPORTANT: Since the University holds researchers responsible if the designation of QA/QI is not correct,
student researchers are encouraged—and most Schools require—students to submit their proposed
research to the IRB to determine whether it constitutes human subjects research requiring IRB review and
approval.
When research activities are woven into QA/QI projects, such as introducing experimental procedures or
randomizing subjects care to different procedures rather than choosing the best procedure for individual
subjects, IRB review/approval is necessary.
Research Using Data Sets
• Public databases are data files prepared by investigators, data suppliers, organizations or
governments with the intent of making them available for public use. The data available are usually
not individually identifiable, are not maintained in a readily identifiable form, or are identifiable
without expectation of privacy. Rutgers library has access to an extensive array of public databases
(see http://andromeda.rutgersw.edu/~natalieb/pub.htm) available for student research. Research
with public databases is not considered human subjects research and does not require IRB approval,
unless you plan to merge data from different datasets which may result in (re) identification of
individuals. If the study plans to merge data sets, IRB review/approval may be necessary.
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• Private or Restricted-Access databases are data files prepared by investigators, organizations or
governments with the intent of making them available for internal use or available on a restricted-
access basis only. Data may or may not be individually identifiable or maintained in a readily
identifiable form by completing the data holder's authorization form. Access to restricted-level data
requires an application for IRB review and approval. Unless the data holder requires a specific level of
review, then the Researcher can request Exemption Review. For private data where no subjects’
personally identifying information is included in the database to be shared, then the research does
not constitute human subjects research. The organization providing the private database must provide
written confirmation that no identifiers or links to identifiers will ever be shared with the researcher.
Surveys, Questionnaires and Focus Groups
The most often used methodological strategies students employ to collect data for research are surveys,
questionnaires and focus groups. Depending on whether there is interaction between the researcher and
subjects or collection of subjects’ identifying information determines whether the proposed research
constitutes human subjects research requiring IRB review. The IRB will look closely at how you propose to
interact with subjects (if applicable) and your data collection plan to make sure your study is designed
using the least invasive data collection procedures necessary to accomplish the research goals and that
subjects’ privacy and confidentiality are adequately protected. Your faculty advisor can guide you in
designing your study in a way that minimizes potential privacy and confidentiality harms to subjects.
Theses and Dissertations
Student research activities include, but are not limited to, projects that result in undergraduate honors
theses, masters’ theses, or doctoral dissertations. IRB approval is generally required if the intent of the
research is to develop new or expanded generalizable knowledge AND human subjects are involved,
either directly or through use of identifiable data about them.
Students must work with a faculty advisor(s) to prepare and submit their research to the IRB during the
proposal stage of the thesis or dissertation. This requirement applies regardless of funding or funding
source. Start this process early to assure you have sufficient time to complete the project and satisfy the
necessary department, IRB, and other University requirements and reviews so you graduate on time!
Work on Faculty IRB-Approved Research
Students may serve as researchers on a Faculty member’s existing project that already has IRB approval.
In such cases, the Faculty principal investigator must submit a modification request to the IRB to add the
student to the existing project. Students may not engage in research activities until the modification is
IRB-approved.
Depending on the scope and purpose of the student’s part in the research, the IRB may require the project
to be submitted separately as new research.
Remember, no human subjects’ research activities may begin without IRB review and approval. Regardless
of whether the activity is human subjects’ research or not, your project must be executed in a manner
that is ethical and respects the rights and welfare of the people in them.
6. WHAT ARE THE DIFFERENT TYPES OF IRB REVIEW?
All research that meets the definition of human subjects’ research must obtain IRB approval or an
exemption determination from them. IRB review and approval must occur prior to the initiation of any
research activities, such as contact or recruitment of subjects or collection of tissue samples or data.
Research involving human subjects cannot be initiated until IRB approval is granted. The IRB cannot grant
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retroactive approval after research has been initiated or completed. There is no special IRB review process
for student research.
The different types of IRB review—exempt, expedited and full board—is outlined below.
Exempt Review
Federal regulations permit certain studies which present little or no risk of harm to subjects to be exempt
from continuing review once the IRB has approved it. That means the study must be initially reviewed by
an IRB member, but it does not require ongoing IRB oversight after study approval is granted. If a
researcher wishes to change the research plan after obtaining an exemption, the IRB must re-review the
project before changes can be implemented.
Except for research involving certain vulnerable populations and for FDA-regulated research, the IRB may
grant exempt status if it meets federal exemption criteria:
1. when the study holds minimal risk of harm to subjects; AND
2. subject selection does not include persons who are vulnerable; AND
3. adequate provisions exist to protect the privacy interests of subjects and the confidentiality of
subject data.
The following are 2 examples of exempt research. They qualify for exempt review because they present
little or no risk of harm to subjects, no subjects are vulnerable and there are adequate provisions to
protect subjects’ privacy and confidentiality by having no interaction with them or collecting identifiers
about them.
a) Example A. The research plans to collect specimens collected previously for Non research
purposes. Samples will be obtained from a pathology lab. The researcher will not interact
with subjects and will not record any information from the specimen slides that could be
used to identify the subjects from which the specimens were derived.
b) Example B. The research plans to conduct an anonymous online survey about adult
use/enjoyment of video game applications. The researcher plans to post a notice at an
adult community center. People interested in completing the survey may access the
survey directly online. No interaction between subject and researcher will occur and the
survey will not ask or record any identifying information about the people who complete
the survey.
A list of the types of research that may qualify for an exempt determination is found online on the
HSPP|IRB website in the Study Risk Levels Guidance, https://research.rutgers.edu/node/1578 .
Expedited Review
Not all research that requires IRB review warrants review by the full IRB at a convened meeting. Federal
regulations permit certain types of research to be reviewed by a designated member of the IRB or a
subcommittee, thereby, ‘expediting’ the IRB review process. A designated member of the IRB will then
periodically review the research—no less than once a year—to monitor its progress. Two general
categories of research can qualify for expedited review:
(1) The research must involve no greater than minimal risks of harm to subjects. Regulations define
minimal risk to mean 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 the daily
life or during the performance of routine physical or psychological examinations or tests” of
normal, healthy persons [45 CFR 46.102(i) and 21 CFR 56.102(i)]. Following are two examples of
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studies qualifying for expedited review. Both studies present minimal risks of harm to subjects.
Expedited review may be required so the IRB is able to monitor the researcher’s ongoing use and
storage of subject identifiers:
a. Example A: The researcher plans to conduct research on specimens previously collected
for non-research purposes and record and keep subject identifiers in their research notes.
No physical risks of harm exist because the specimens were previously collected.
However, a possible risk to the confidentiality of subjects’ data does exist because
personal identifiers will be retained.
b. Example B: The researcher plans an online survey of young adults about their ease of use
and enjoyment of a war game application labelled M for mature players. Players will be
recruited by an advertisement posted in the Student Union at a local college which directs
students to an online link to take the survey. Players’ names and e-mail addresses will be
recorded to ensure no duplicate surveys are recorded and, if necessary, the researcher
can contact subjects to clarify missing or confusing responses to survey questions. Names
and e-addresses will be redacted from the record when data analysis is completed.
(2) minor changes in previously IRB-approved research during the period for which approval is
granted. That is, if you/your Faculty Advisor request modifications to your IRB-approved research
and the proposed changes do not increase risks of harm to subjects, the modification may qualify
for expedited review. Here are 2 examples. One qualifies for continued expedited review, the
other may not:
a. Example A: A modification is submitted requesting access to an additional 25 specimens
previously collected for non-research purposes. Like the original request, the researcher
plans to record and keep identifiers in their research notes. No additional risks of harm
are anticipated with the proposed increase in number of specimens to be tested. The
study likely remains eligible for expedited review.
b. Example B: A modification is submitted requesting expansion of the survey to determine
young college students’ use and enjoyment of a war game application rated M for mature
audiences to include questions specific to feelings (good and bad) when ‘killing’ enemy
combatants in the game. The IRB may refer this modification to Full Board review if the
reviewer deems the sensitivity of the questions and/or collecting identifiers constitutes
an increased risk of psychological harm or privacy concerns, respectively.
A more comprehensive explanation of the circumstances under which research qualifies for expedited
review can be found online on the HSPP|IRB website in the Study Risk Levels Guidance,
https://research.rutgers.edu/node/1578
Full Board Review
Studies that involve greater than minimal risk of harm, such as testing experimental chemicals or devices
on humans, employing complex research designs (e.g., randomized control or placebo), or researching
sensitive topics (e.g., infectious disease, illegal drug use, genetic predisposition to disease) require IRB full
board review. Projects posing no more than minimal risks of harm to subjects but that involve vulnerable
persons, such as, children, pregnant women, fetuses, prisoners, persons lacking decision-making capacity,
and others may require full board review [See Common Rule - Vulnerability in Research in Section 7 to
learn more about this topic.].
Last, projects that do not or no longer qualify for exempt or expedited review or the complexity of study
design exceeds the expertise of an individual reviewer, may also be reviewed by the full board at a
convened meeting. Following are two examples of studies that require full board review because the
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studies involve greater than minimal risk of harm to subjects or is minimal risk but involves a vulnerable
population:
a. Example A: The researcher plans to prospectively collect tissue samples from subjects and
conduct genetic testing on the samples to determine, among other things, whether they hold
genetic markers predictive of early-onset Alzheimer’s disease. The researcher will record and
keep subjects’ identifiers in their research record. Physical risks of harm exist because the
specimens are being collected by invasive procedure (needle stick/draw) and a possible risk
to the confidentiality of subjects’ exists as well because identifying information will be linked
to the data generated. Further, risks to the subjects’ psychological well-being and economic
stability exist if confidentiality of the research data is breached revealing a subject’s likely
destiny with disease. The IRB would require full board review because the research involves
greater than minimal risks of harm to subjects.
b. Example B: The researcher plans interviews with students (<18 years of age) at a local high
school about their accessibility to and enjoyment of war game applications intended for
adults. The researcher is keen to learn how teenage children gain access to adult videos,
whether parents provide access/permission to viewing videos and, if not, what disciplinary
measures result, if any, when a child’s viewing is divulged. The study proposes to conduct
research with a vulnerable population (children) about sensitive topics (illegal behavior and
parental discipline). The study also proposes to elicit information about secondary subject(s),
the parent(s). Risks of physical and psychological harm exist as well as legal jeopardy for child
and parent. This study would require IRB full board review.
The schedule of IRB full board meeting dates, including submission deadlines, for the current year may be
found online under “Submission Deadlines” .
IRB Office Support
Prior to any type of IRB review, a designated IRB Office staff member conducts an initial administrative
review of each application. The staff reviewer may request clarification, changes or additional materials if
the application or supporting materials are incomplete or unclear. Once the staff member determines the
submission packet is complete, the application is forwarded to an IRB member or the full board for review.
After review, the IRB will correspond with you/your Faculty Advisor to advise that your study has been
approved, approved with minor changes, approval with stipulations or approval is deferred until revisions
to the study are made. Any IRB-required changes will be outlined in the correspondence.
Revisions must be re-reviewed by the IRB and approved before research may be initiated.
Depending on the type of review, number of clarifications needed, the scope of changes or revisions
required, if any, and the promptness of your/your Faculty Advisor’s responses to such requests, a
proposed project may take up to four weeks for IRB review. Due to the complexity of laws and customs,
IRB review of proposed international research may take longer. Please plan your research deadlines
accordingly.
IMPORTANT: You MAY NOT initiate any research activities until you/your Faculty Advisor receives a
written notice of IRB approval of your research, or a Non-Human Subjects’ Research Determination.
7. WHAT DOES THE IRB CONSIDER IN THEIR REVIEW?
When the IRB reviews proposed research, it must determine that the research meets federal regulation,
state law and University policy, and appropriately applies the ethical principles outlined in the Belmont
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Report—respect for persons, beneficence, and justice. In what follows, two important federal regulations
that regularly apply to student research are outlined, The Common Rule and the Health Insurance
Portability and Accountability Act. The Belmont Report may be found here [Go to Ethical Principles in
Section 4 to learn more about ethical foundation of human research regulations.].
Common Rule – General Protections
U.S. Dept. of Health and Human Services [45 CFR 46] Section 46.111 of the Common Rule outlines eight
criteria that must be satisfied to protect subjects in research before an IRB may approve proposed
research http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.111.
The FDA requires satisfaction of the same criteria, plus more, when conducting clinical research leading
to the development of drugs and devices, [21 CFR 50, 21 CFR 56]
http://www.hhs.gov/ohrp/regulationsand-policy/regulations/fda/index.html.
1. Risks of harm to subjects are minimized [Beneficence]
a. Use only procedures which are consistent with sound research design and do not
unnecessarily expose subjects to risk of harm; and
b. Whenever appropriate, use only procedures already being performed on the subjects for
diagnostic or treatment purposes.
c. Consider possible economic, legal, physical, psychological and social harms that may
occur to subjects because of participating in the research.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects
[Beneficence]
a. Assure there is a fair balance between the risks of harm or burden to subjects that may
result from study participation and any anticipated benefits of participation or the
knowledge to society that is expected to result from it.
3. Selection of subjects is equitable [Justice]
a. Selection of subjects should be justified by the scientific question(s) being asked and not as
a matter of convenience or availability. Pay special attention to problems that may arise
when involving vulnerable populations in research.
4. Informed consent will be sought [Respect for Persons]
a. Researchers must obtain the informed consent of the subject or the subject’s legally
authorized representative before enrolling them in research.
b. The IRB looks closely at the offer of participation outlined in proposed research protocols
to ensure the consent process supports an environment where individuals voluntarily
decide, and are not unduly influenced or coerced, to participate in research. The IRB also
looks closely at consent documents to determine if adequate information is provided
about the proposed study and whether it is written in a fashion that the target audience
can easily understand.
c. Consent documents must contain specific types of information about the proposed
research. Go to the Rutgers HSPP|IRB site to learn about what informational elements
are required for your proposed research: https://research.rutgers.edu/researcher-
support/research-compliance/human-subjects-protection-program-toolkit
d. If the proposed study includes a non-English speaking population or a vulnerable
population, such as children, prisoners, persons lacking decision-making capabilities,
economically disadvantaged or educationally disadvantaged, additional protections apply
[See Common Rule - Vulnerability in Research in this Section].
e. Under certain circumstances, the IRB may waive the need for written consent, authorizing
oral consent instead.
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f. The IRB may waive specific required elements of consent. It may also waive the
requirement to obtain informed consent under certain circumstances. Go to the
applicable HSPP|IRB site to learn more about waivers: See Guidance Topics online, then
click upon, “Waivers of Informed Consent” topic section.
5. Informed Consent will be appropriately documented (respect for persons)
a. Researchers must document informed consent using a written consent form approved by
the IRB and signed by the subject or the subject’s legally authorized representative. A
copy must be given to the person signing the form. The IRB may waive the requirement
to document consent under certain circumstances. See Guidance Topics online, then click
upon “Informed Consent” topic section.
6. Research plan makes adequate provision for monitoring data to ensure subject safety
(beneficence)
a. Some studies must monitor the quality of data collection and management, and the
accumulating outcomes to assure subject safety and the scientific integrity of the study.
Studies that require data safety monitoring are complex and pose greater than minimal
risk to subjects. Such risky research usually requires faculty to serve as the principal
investigator and coordinate oversight by a qualified data monitoring board. For learn
more about data safety monitoring, See Guidance Topics online, then click upon “Data
and Safety Monitoring” topic section.
7. Adequate provisions are made to protect the privacy of subjects and to maintain confidentiality
of their data (beneficence)
a. Privacy is defined in terms of a person having control over the extent, time, and
circumstances of sharing oneself or a part of oneself with others. The IRB will look closely
as the study methods used to identify and contact potential subjects, whether the
setting(s) in which the researcher and subject meet afford(s) privacy, what methods are
used to obtain private information about subjects whether the justification for its
collection is sound, and that the minimum amount of information is collected to meet the
needs of the research.
b. Confidentiality is a duty to protect the data that were collected or generated about the
subject during the research. The IRB will assess the research plan—what private
information about the subject will be collected or generated—and the security plan—
what measures will be taken to protect the data from improper disclosure, such as not
collecting identifiers, de-identifying data after collection, coding research data and storing
the links to identifiers in a separate location, encrypting data files, etc...
8. Additional protections exist to safeguard the rights and welfare of subjects vulnerable to
coercion or undue influence (respect for persons)
a. When some or all of the subjects are likely to be vulnerable—lack the capacity, skills, status,
or resources needed to protect their own interests--the protocol plan must outline
additional steps that will be taken to protect these subjects’ rights and welfare, such as,
a need for a parent or surrogate to help may decisions, provide more information or
provide it in a culturally or linguistically accessible way, offer the research at a location
more accessible to the subjects, etc.
Common Rule – Vulnerability in Research
Special regulatory and ethical considerations apply when research involves vulnerable persons.
Vulnerability in research means that, due to contextual and/or relational circumstances, persons lack the
freedom or capability to protect their self-interests when deciding whether to enroll, decline to enroll or
withdraw from research. The Common Rule [45 CFR 46, Subpart B-D], FDA [21 CFR 50 & 56] and The
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 17
Belmont Report identify some groups they deem vulnerable: pregnant women, human fetuses, neonates,
prisoners, children, persons with physical handicaps or mental disabilities, persons who are
disadvantaged economically or educationally, racial minorities, the very sick and the institutionalized.
Additionally, some individuals may be situationally vulnerable because of the type of research or an offer
of participation in it. For example, persons may feel obligated or coerced to enroll in research because of
real or perceived differences in role relationships (such as, between students and teachers in school
research; patients and caregivers or providers in health care research; employees and supervisors in
organizational research, prisoners and wardens in prison research, to name a few). As a result, additional
design elements often need to be built into the protocol plan, the recruitment plan, and/or the consent
(or assent/parental permission) process to protect persons’ autonomy to make decisions in their self-
interests.
To learn more about additional protections for vulnerable persons in research, go our Guidance Topics
online: https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-
protection-program-irbs/hspp-guidance-topics . You can also find links to The Common Rule and FDA
regulations on the topic, as well as a link to The Belmont Report:
https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-
program-irbs/policies-and . You will also find on that page NJ State Statutes, and University policy
regarding required protections of special populations, as well as related protocol, consent and assent
templates, on how best to protect vulnerable populations.
Your Faculty Advisor and IRB staff are available to help you think through what appropriate additional
strategies are necessary to protect vulnerable persons in your research, if applicable.
HIPAA Privacy Rule
As outlined above [See What Does the IRB Consider, criteria #7 in this Section], the Common Rule requires
researchers to protect subjects’ private information, regardless of the data source—from whom or
where—the information was obtained. However, another federal regulation also exists to protect
subjects’ private information, but it is narrowly focused on just one data source—patients’ electronic
medical records. The Health Insurance Portability and Accountability Act otherwise known as the “HIPAA
Privacy Rule”, demands researchers protect the confidentiality and security of patients’ personally
identifiable health information found specifically in patients’ electronic medical records. Among other
things, HIPAA regulates when researchers may access and use such information also known as Protected
Health Information, or PHI.
To qualify as protected health information, or PHI, the information must possess three qualities:
(1) it must include one of 18 identifiers deemed capable of identifying an individual;
a. To see the list of 18 identifiers, go to: See Guidance Topics online, then click upon the
“Health Insurance Portability and Accountability Act (HIPAA) and Protected Health
Information (PHI)” topic section.
(2) it must relate to a person’s health, health care, or payment of health care;
a. Examples of health information would include, any information in a patient’s medical
chart, lab values, results of diagnostic testing or imaging, psychological tests, biological
specimens, billing documents, etc.
(3) it must exist in an institution, organization or business that electronically transmits such health
information to accomplish a health-related transaction;
a. Examples of covered entities include hospitals, health care clinics or business entities that
support the services of a hospital or health care clinic care clinic.
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To access PHI, researchers must obtain an individual’s authorization (permission) to access their electronic
medical record.
In the context of research, if you plan to collect PHI, the University requires the authorization to be
appended to the consent document, rather than separate from it. HSPP|IRB provides the necessary
authorization language at its consent template page. Go to https://research.rutgers.edu/researcher-
support/research-compliance/human-subjects-protection-program-toolkit and click on the adult
consent form. The authorization section, “Permission (Authorization) to Use or Share Health Information
that identifies you for a Research Study” starts on page nine. Follow the instructions. Because the
authorization must hold certain pieces of information per HIPAA, and the language found in the
template is mandatory per Rutgers policy, you are allowed no freedom or flexibility to rearrange or omit
any sections within the authorization. Simply fill in the blanks to customize the authorization to your
study if you are collecting PHI.
When you propose to collect a child’s PHI, the HIPAA Authorization must be contained within the Parental
Permission form; the authorization may be omitted from the child’s assent document.
[Note: There are two sections in the consent template that request permission to gather information
about the subject: one section is before the HIPAA authorization and the other one is found within the
authorization. The section before the authorization refers to all information you will collect, regardless of
the source from where you will collect it. The section within the authorization refers to any information
you wish to glean specifically from the medical record, specifically. If you are not collecting PHI from the
electronic medical record, delete the authorization section completely. You do not need it. If you are not
collecting PHI or private identifiable information about the subject at all, you may also delete the section
that appears before the authorization section, as well.]
HIPAA allows the requirement to obtain subject authorization to use PHI to be waived by a Privacy Board
under certain circumstances. HIPAA also allows a covered entity to disclose a limited data set to a
researcher if a data use agreement is in place. Rutgers’ IRBs serve as the institution’s Privacy Board, so
any request for a waiver of authorization or proposed use of a limited data set must be submitted to the
IRB. Details about HIPAA waivers and limited data sets/data use agreements are found in the Human
Subjects Protection Program Standard Operating Procedures, (HRP-101) MANUAL -Human Subjects
Protection Program Plan. You may also find information at the HSPP|IRB’s Guidance Topics online, then
click upon the “Health Insurance Portability and Accountability Act (HIPAA) and Protected Health
Information (PHI)” topic section.
Other Regulations May Apply
Depending on research design or the population targeted for inclusion in the research, other regulations
may apply. A list of other regulations, laws, policy relevant to human subjects’ research may be found at
the following HSPP|IRB link, https://research.rutgers.edu/researcher-support/research-
compliance/human-subjects-protection-program-irbs/hspp-guidance-topics . It is the responsibility of
the researcher to identify and be knowledgeable about all applicable laws and regulations that may
apply to their research.
8. WHAT STUDY DOCUMENTS DO I NEED TO SUBMIT TO THE IRB?
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The IRB will review the following project documents to determine if your proposed research meets
regulatory compliance and ethical standards:
• Student’s research plan (the protocol).
• Consent or assent documents, as applicable.
• Data collection tools (including surveys, questionnaires, etc.).
• Recruitment materials (including flyers, tear-off sheets, ads, etc.).
• Evidence of CITI completion by all study staff.
• Conflict of Interest forms completed by all study staff.
• Site approvals, as applicable; and
• Other documents, as applicable or requested by the IRB.
Helpful Study Document Templates
HSPP|IRB offers a variety of protocol, consent and assent, as well as other document templates to help
students craft the study documents necessary for IRB review. Go to
https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-
program-toolkit . A list of templates relevant to your research will appear. Contact your faculty advisor if
you have questions about which templates best fit your proposed research aims and why. Contact IRB
staff if you need assistance determining what documents must be submitted to the IRB for their review.
9. DO I NEED SPECIAL TRAINING?
Yes. All persons planning to conduct human subjects’ research—faculty, staff, students, and faculty
advisors of students—must complete an online research ethics and compliance education program, prior
to IRB approval of proposed human subjects’ research, including research that may be deemed exempt.
The online program is called Collaborative Institutional Training Initiative (CITI Training). Proof of CITI
training completion by all members of the research team must be submitted with the application for IRB
review. Study personnel may not participate in human subjects research until their CITI training is
completed. CITI Certification is valid for a three-year period, after which time refresher training must be
completed. See https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-
protection-program-irbs/hsppirb-educational for more information or go directly to
https://www.citiprogram.org/ to enroll and gain access to the online program.
Additional training may be required by other Federal or State regulators or funding agencies. For example,
NIH requires completion of a Responsible Conduct of Research course. The University, or individual
Schools or Departments within the University may require additional courses, seminars or workshops prior
to authorizing students to conduct human subjects’ research, as well. Check with your Department or
School for additional requirements and instructions on how to satisfy such requirements.
10.WHAT ARE MY RESPONSIBILITIES AS A RESEARCHER?
Student researchers have an obligation to protect the rights and welfare of human subjects participating
in their research. To that end, following is a list of student researcher responsibilities aimed at affording
such protections:
• Research projects undertaken by students should be appropriate to their educational level and
be commensurate with their training.
o Speak with your advisor about your previous experience and coursework to determine if
it is appropriate and adequate for the research you are proposing and the risk(s) of harm
you are proposing for your research subjects.
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• Students must conduct research in an appropriate manner, consistent with ethical standards for
their discipline and in accordance with federal requirements, state law, and university policies.
o You must be knowledgeable about and comply with laws, regulations, policies and
standards. Coursework, CITI training, Faculty Advisor guidance, and IRB support will help
you identify and comply with them. As a student, you are held to the same ethical and
regulatory standards as faculty and staff of the University and are responsible for
ensuring the rights and welfare of human subjects in the research.
o If you suspect other(s) have failed to maintain ethical standards in research, you must
report such misconduct to the appropriate University authorities. Guidance on what
constitutes research misconduct and how to report it may be found in the Policy section
of the OFR Research Integrity, https://research.rutgers.edu/researcher-
support/research-compliance/research-integrity .
• Students must comply with all IRB requirements for research review (initial and continuing), its
conduct and study closure. There is no special IRB review process for student research. The
student researcher is expected to follow all current IRB policies, procedures and deadlines for IRB
initial approval, continuing review, change requests, and other protocol matters.
o Review Section 14, “What are my Responsibilities to Communicate with the IRB?” to
learn more about continuing and other IRB review requirements.
• Students must maintain adequate and timely communication on all research matters with faculty
advisors, IRB and other committees, University officials, and funders, if any.
• Students must identify an University faculty member to serve as their faculty advisor on the
research.
• Students must protect the research data from unauthorized disclosure.
11.MAY I SERVE AS THE PRINCIPAL INVESTIGATOR (PI)?
It depends. A principal investigator is the individual who assumes full responsibility for a research project,
including the supervision of any co-investigators, research assistants, house staff and students.
Undergraduates may serve on a research project, but not as the principal investigator. Graduate students
may serve as principal investigators if their School and/or Department allow them to do so (and the IRB
approves). Graduate students must check with their School or Department to learn if they qualify to serve
as a principal investigator. If a graduate student is designated as the PI, additional responsibilities accrue
to them, including obtaining a full-time Rutgers faculty member to serve as their advisor and co-
investigator on the proposed project.
Detailed information about Research Roles (responsibilities and qualifications) of a principal investigator
and of study personnel can be found online at: https://research.rutgers.edu/researcher-
support/administrative-offices/human-subjects-protection-program-irbs/research-roles . Some funding
agencies require the student to be listed as the Principal Investigator of Record. HSPP|IRB will work with
the student, School or Department, and the Office of Sponsored Research (ORSP) when such
requirements apply.
12.DO I NEED A FACULTY ADVISOR?
Yes. You must identify a full-time Rutgers University faculty member to serve as your faculty advisor.
Ideally, your advisor should be familiar with conducting research involving human subjects. Your advisor
must complete CITI training [To learn about required CITI training, go to Section Do I Need Special
Training.].
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Your faculty advisor will work closely with you to design, submit and conduct your research. They will
assess whether you possess adequate qualifications to conduct the proposed research in a way that
safeguards the rights and welfare of subjects. They will monitor your progress throughout the research
to ensure it complies with necessary policies and procedures, laws and regulations, and ethical standards
of your discipline. Your faculty advisor will help you close the study when completed. When you have
questions, your advisor should be the first person you contact. Your advisor will assist you with
submissions and communication with the IRB and will help you close the study when completed.
13.HOW DO I APPLY FOR IRB REVIEW OF MY RESEARCH?
All human subjects research is reviewed using the Rutgers electronic submission system, known as eIRB
(electronic Institutional Review Board), which is a completely paperless process. You can access eIRB via
the IRB’s website or by opening your web-browser (I.e., Safari, Mozilla, Chrome but not Internet Explorer)
and typing www.eIRB.rutgers.edu. To begin an application in eIRB, please follow these steps:
• Prepare all your supporting documents to be attached with your eIRB Application (research
protocol, consent forms, site approvals, etc.)
• Access eIRB using your Rutgers NetID.
• Complete the eIRB online application.
• Respond to any requests for revisions or clarifications if requested.
• Your IRB Approval Letter will be electronically generated in eIRB and sent via email from the
system to the listed PI. In addition, the PI may obtain the approval notice and all IRB-stamped
approved documents in eIRB under the Notification and Stamped Documents tabs in eIRB.
14.WHAT ARE MY RESPONSIBILITIES TO COMMUNICATE WITH THE IRB?
You and your Faculty Advisor hold joint responsibility to communicate with the IRB when certain
milestones or events occur in the conduct of the research. Obligations to communicate with the IRB do
not end until the IRB accepts your/Faculty Advisor request to close the study.
Initial Review
Of course, you/your Faculty Advisor must provide sufficient information to the IRB so they can determine
if the proposed research is regulatory-compliant and ethically sound. Once reviewed, the IRB will notify
you/your Faculty Advisor of any changes you must make or additional documents you must provide to
them before they are able to approve the proposed research, if any. Follow their instructions.
Continuing Review
In the Notice of IRB Approval, the IRB will advise you/your Faculty Advisor if or how often your study must
be re-reviewed by the IRB during its conduct. Again, follow their instructions.
Changes to the Research Plan
You/your faculty advisor must notify the IRB of any change(s) you wish to make to an IRB-approved
protocol. This includes any request to add to, revise, or remove elements from any document previously
approved by the IRB (such as the application, protocol, consent document, recruitment materials, data
collection tools, etc.). For example, if a member of study team changes (such as who serves as your Faculty
Advisor) or you wish to change a study design element, you/your Faculty Advisor must submit a
modification request in eIRB and submit it to the IRB and receive their approval before you make any
changes.
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Unanticipated Events or Protocol Deviations
If an unexpected or adverse event occurs (such as unexpected subject discomfort…or…your laptop holding
research data is stolen), or you notice that you have deviated from the protocol plan (such as failing to
secure consent from a subject…or…overlooking a step in protocol plan), you/your Faculty Advisor must
submit a report to the IRB that outlines the details of the event or deviation as soon as possible after it
occurs. The report must also outline what corrective action(s) you/your Faculty Advisor took and any
changes to the protocol you propose to assure the problem(s) does not repeat. [If research documents
containing subjects’ identifiers or your laptop storing research data are misplaced or stolen, follow the
reporting requirements as outlined at University Policy 70.1.3 Incident Management
http://policies.rutgers.edu/sites/policies/files/70.1.3%20-%20current.pdf.]
Study Closure or Study Withdrawal
You/your Faculty Advisor must submit a request for study closure to the IRB when you wish to close the
study: (1) because you have completed data gathering and will no longer interact with subjects or hold
their private information, or (2) determine you are unable to complete the research once activities have
commenced. If you conducted the research to satisfy degree requirements, do not close out the study
until your faculty advisor(s) confirm you have successfully defended your honors project, thesis or
dissertation and no further analysis of your research data will be necessary.
You/your Faculty Advisor must submit a request to withdraw your IRB-approved study if, for whatever
reason, you change your mind about conducting the research before any research activities were initiated
(such as recruitment, consent, specimen or data collection).
Data Storage after Study Closure
Your research responsibilities do not end when your study closes. Data retention is an important part of
the research process. Research data must be preserved for a set period to comply with federal law,
University policy, and funding agency requirements. The data must be well organized and accessible for
any reason, including audits.
Your project’s data retention requirements depend on the type of data involved. At a minimum, the
university requires research data to be retained for 3 years after study closure. If you collected Protected
Health Information (PHI), the HIPAA Privacy Rule [See HIPAA Privacy Rule in Section 7] requires research
data to be retained for 6 years after study closure. Your Academic School/Department and/or the
agency/organization funding your research (if you received funding for your project) may require data to
be retained even longer. Please check with your School/Department and funding agency (if applicable)
and comply with the longest time required. You may keep your data longer, but not shorter than required.
Some federal (such as FDA) and funding agencies may require investigators to retain subject identifiers for
long periods of time for safety reasons. Other studies may retain subject identifiers because, by design,
they need long term follow-up or future contact with subjects. In such cases, in addition to details about
the length of data storage, the IRB will be keen to review in the protocol you submit to them how you will
protect any data elements you retain that can identify subjects in the study. You will need to outline where
such identifiers will be stored and who/how it will be protected from unauthorized access.
If there is no regulatory agency requirement, funding agency demand or study design justification to retain
identifiers, it affords greater protections to destroy identifiers as soon as possible after the data is
collected. In such cases, the protocol should detail when identifiers will be removed from the data
collected and how you will destroy identifiers and/or the key codes that can re-identity subjects. While
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you may destroy the identifiers early, you must still retain the de-identified data for the number of years
required consistent with federal law, University policy, or funding agency demands, as outlined above.
When you graduate or leave the university, for any reason, you must arrange to leave a copy of the
research data with your advisor; they will also retain your research records for the required period of time.
If you conducted your research at a non-Rutgers facility and your data is being stored there, you must
ensure that Rutgers can have access to the data upon request. For more information, go to Guidance
Topics then click upon “Research Recordkeeping and Retention” section.
15. WHAT OTHER THINGS SHOULD I CONSIDER?
Site Approvals, Other Sites’ IRB Approvals and Authorization Agreements
If you plan to conduct research at a non-Rutgers University institution or organization, such as an
elementary school, community center, or clinic x), you must obtain written permission (called Site
Approvals or Letters of Cooperation) from an authority of the site (Principal, Director, etc.), as identified
by the site (not by you) to conduct the research on their property or using their data or samples.
Approvals/Letters of Cooperation must be submitted to the IRB before IRB approval of the research may
be granted. A Letter of Cooperation Template, complete with instructions, is found at
https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-protection-
program-toolkit.
If you plan to have employees of the non-Rutgers site ‘engage in the research’ with you [that is, they will
intervene for research purposes with any of the subjects of the research, such as, obtain subjects’
identifiable information or identifiable biological specimens, perform invasive or noninvasive procedure,
interact with subjects to collect research data or obtain research consent, etc.], you must obtain IRB
approval from both the Rutgers IRB and the site’s IRB. You can learn more about when institutions are
considered Engaged in Research online at: https://research.rutgers.edu/researcher-support/research-
compliance/human-subjects-protection-program-toolkit in the following Worksheet: HRP-311 -
WORKSHEET - Engagement Determination
Sometimes institutions will work together and craft an agreement, called an IRB Authorization
Agreement or Reliance Agreement, to recognize one site’s IRB as the lead review to cover research at
both institutions. If a site asks you if they can cooperate with Rutgers IRB to effectuate an Authorization
Agreement, coordinate a conversation between the site and the Rutgers IRB. You can learn more about
reliance agreements online: https://research.rutgers.edu/researcher-support/research-
compliance/human-subjects-protection-program-irbs/irb-submission-1 .
Non-Rutgers University site approvals, other institutions’ IRB approval, and Authorization Agreements can
be tricky. IRB staff will help you navigate this process. To best help you, it is important your protocol plan
clearly outlines which research tasks will be delegated to members of our University and which will be
delegated to members of the non-Rutgers University institution or organization, if any. If you plan to
conduct research at a Rutgers University-owned or –operated site written permission from the site is not
required by the IRB. However, you/your faculty advisor should coordinate your activities with the site
before its conduct. Please note, approvals and authorizations take time. Plan your research timetable
accordingly.
Research Opportunities at Other Institutions and IRB Approval
Rutgers' students may engage in human subjects’ research through collaboration with researchers at
other institutions. However, regardless of IRB review/approval obtained at the other institution, Rutgers’
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 24
students must also submit the research to a Rutgers IRB and secure their approval before engaging in
research with the other institution.
International Research
The University is committed to protecting people who participate in human subjects’ research whether
the work is conducted domestically or internationally. If human subjects’ research will take place outside
of the United States, there are additional requirements, so the IRB process should be started as soon as
possible. It is essential that researchers have sufficient knowledge of country laws, regulations and the
local research context to be able to design and conduct research in a way that protects the rights and
welfare of the subjects and respects their customs and practices. For more information, please visit the
HSPP|IRB’s website under Guidance Topics then click upon “International Research” section. A
compilation of international laws, regulations and guidelines is found here:
http://www.hhs.gov/ohrp/international/compilation-human-research-standards/.
Students who conduct international research must comply with The University’s information technologies
policies on travel with electronic devices. Visit the Rutgers, Information Security website for more
information on how to protect devices and the data stored on them at
https://it.rutgers.edu/2019/08/14/how-to-keep-your-data-safe-while-traveling/ . With respect to data
storage, the University provides, at no-cost the opportunity to store data via a cloud service known as Box,
https://it.rutgers.edu/box/. Box is an independent cloud service for securely storing and sharing file via
encryption. It is available, at no cost, to all Rutgers faculty, staff, and students. Box allows for the storage
of restricted data like files containing protected health information (PHI)(Please note that PHI can be
stored in Box provided it is stored in a Restricted folder). Box supports all Windows, MacOS, Android, iOS,
and Linux devices and has a full-featured web interface that can be used on other platforms. The service
is used widely in higher education and can be used to share information with anyone. For more
information, please visit: https://it.rutgers.edu/cloud-storage/knowledgebase/data-classification-and-
storage-matrix-comparing-box-onedrive-and-google-drive/
Further, students may be subject to federal export control laws and regulations. For example, the
movement of equipment and data stored on laptops and other electronic devices the student may use in
the research, as well as shipping materials to/from the international site are regulated by federal export
control laws. Visit the OFR Export Control website to learn more about research rules and responsibilities
around export control at https://research.rutgers.edu/researcher-support/research-compliance/export-
control.
Sponsored Research
The Rutgers Office of Research and Sponsored Programs (ORSP) provides a range of services to faculty and
staff seeking funding from public and private non-for-profit sponsors. Services include guidance on
proposal submission and award set-up, interpreting sponsor guidelines, and meeting compliance
requirements, to name a few. The IRBs work with researchers and ORSP to ensure human subjects’
research compliance requirements are met, as well as appropriate and timely coordination of IRB review
of funded research. Visit ORSP’s website to learn more about the services they provide
https://research.rutgers.edu/researcher-support/administrative-offices/research-sponsored-programs
Research Using Social Media
Conducting research using social media requires special considerations, particularly around issues of
privacy and confidentiality. All studies, including those using computer and internet technologies, must
(a) ensure that the procedures fulfill the criteria for informed consent: voluntariness, adequate
information, and comprehensibility of the information provided; (b) maintain the confidentiality of
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 25
information obtained from an about human subjects; and (c) adequately address the possible risks of harm
to subjects, including psychosocial stress and related risks; and (d) equitable representation of the
population from which subjects will be recruited to participate. For more information, please visit the
HSPP|IRB’s website under Guidance Topics then click upon “Internet Research” section.
Research Using Mobile Devices
Conducting research using mobile devices also requires special considerations around issues of privacy
and confidentiality, especially when communicating with subjects, storing subject data, and transporting
subject data. Please review relevant guidelines and guidance at the Rutgers Office of Information
Technology, especially:
• Policy 70.1.1 Acceptable use Policy for Information Technology
Resources http://policies.rutgers.edu/sites/policies/files/70.1.1%20-%20current.pdf;
• Using Rutgers Resources While Off Campus https://oit.rutgers.edu/remote; and
• Mobile Device Management Policy for RBHS Staff/Guests
https://oit.rutgers.edu/connect/getting-started/mdm-policy.
Conflict of Interest
Per University Policy 90.2.5, all University faculty, staff, and students who conduct research, funded or
unfunded must disclose financial information that may influence or may be perceived to influence their
work. The policy is intended to promote objectivity in research with the reasonable expectation that the
design, conduct, and reporting of the research will be free from bias resulting from research conflict of
interest. To learn more about reporting requirements, visit the OFR’s conflict of interest webpage at
https://research.rutgers.edu/researcher-support/research-compliance/conflict-interest .
Clinical Trials Registration
ClinicalTrials.gov (http://clinicaltrials.gov/) is a public database that offers up-to-date information for
locating federally and privately supported clinical trials for a wide range of diseases and conditions.
Researchers conducting clinical trials that meet certain federal requirements must register their clinical
trial at this site. The responsibility to register rests with the principal investigator. More information is
found here: https://research.rutgers.edu/researcher-support/research-compliance/human-subjects-
protection-program-irbs/clinical-trials.
HSPP Quality Assurance Audits
Consistent with its mission to create a culture of research integrity and compliance, the HSPP Audit
Team conducts random, periodic audits of University research involving human subjects. Your research
may (or may not) be subject to an unannounced quality assurance audit sometime before study closure.
To learn more about audits or the regulations that shape them, visit
https://research.rutgers.edu/node/1471 .
16. IN CLOSING
We all share responsibility for assuring that the rights and welfare of the individuals involved in University
research. The University, your School or Department, your Faculty Advisor and IRB staff stand ready to
help you navigate the IRB process to make the research experience meaningful and rewarding to you and
further the research mission of The University. Our collaborative efforts to work as partners in research
serve to minimize the burdens to human volunteers and maximize the benefits to science and society.
Good Luck in your research endeavors!
HRP-109 Student Handbook: A Guide to Human Subjects’ Protection in Research, Version Date 1.21.22 Page 26
17. NOW WHAT?
Follow this checklist to get started on your goal to conduct meaningful and compliant human subjects’
research.
☐ Read the Student Handbook: A Guide to Human Subjects’ Protection in Research.
☐
Complete all courses your School/Department deems pre-requisite to conducting human subjects’
research. [Special Training, Section 9]
☐
Identify a faculty advisor. [Faculty Advisor, Section 12]
☐
Register with CITI and complete your online training. [Special Training, Section 9]
☐
Work with your faculty advisor to identify and review relevant regulations, laws, institutional policies
and discipline practices that inform how you must conduct the research you imagine responsibly and
compliantly. [Regulations/Policies, Section 3]
☐
With Faculty Advisor oversight, draft the research documents you need for the IRB submission packet
(i.e., protocol, consent documents, data collection tools, etc.). [Needed Study Documents, Section
8]
☐
Secure written Site Approval and/or IRB Approval from institutions where you propose to conduct
research activities, if any. [Things to Consider - Approvals & Authorizations, Section 15]
☐
Submit financial disclosure form/documents to the Conflict-of-Interest Committee. [Things to
Consider - Conflicts of Interest, Section 15]
☐
Ensure you have completed all documents required by the Rutgers Office of Sponsored Research and
the grantor if your research is funded. [Things to Consider - Sponsored Research, Section 15]
☐
Coordinate your efforts with Rutgers Export Control if you propose international research. [Things to
Consider - International Research, Section 15]
☐ Work with your advisor to complete an IRB application, append required research documents and
permissions, and submit the packet for IRB review when you have completed the steps above. [How
do I Apply for IRB Review, Section 13; Needed Study Documents, Section 8]
IMPORTANT: Remember, you may not engage in any form of human subjects’ research, including
reviewing patient charts, recruiting or enrolling human subjects or analyzing databases until written IRB
approval is secured or a Non-Human Subject’s Research Determination is made.
