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A.GENERAL INFORMATION
1.
Where is the IRB office?
2.
Who should be contacted for questions about
IRB policy and procedures?
3.
How can investigators obtain IRB forms?
4.
What is the IRB?
5.
Who serves on the IRB?
B.POLICY
1.
Upon what federal regulations is IRB policy
based?
2.
What is the Belmont Report and how has it
influenced federal regulations regarding the protection of human
subjects?
3.
How do the ethical principles identified in
the Belmont Report relate to human subjects protection?
C.
IRB REVIEW
1.
How often does the IRB meet?
2.
What are the criteria for IRB review of a
protocol?
3.
Why is it necessary for the federal
government to require that institutions review proposed research
projects?Don't all researchers take the appropriate
steps to protect
subjects on their own?
4.
When is IRB review required?
5.
What are the different types of IRB
review, and how do they differ from one another?
6.
How is minimal risk defined?
7.
What is the deadline for submission
of protocols for IRB review or exemption?
8.
If the project will not be completed by
the IRB expiration date, what is the procedure for requesting continuation?
9.
Submitting an Amendment to an Existing Protocol (including exempt): When it is necessary to change or add
procedures on an approved protocol, what is the process for
obtaining IRB approval of the change?
10.
What are the researcher's responsibilities
if an adverse or unexpected event occurs on an
approved protocol?
D.INFORMED CONSENT
1.
What is informed consent?
2.
What elements should be included in a
consent document?
3.
Are sample consent forms available
for review?
4.
What is assent?
5.
Under what conditions may
documentation of informed
consent
bewaived?
6.
Under what conditions may some or all
of the elements of informed
consent be waived?
E.SPECIFIC POPULATIONS OR METHODOLOGIES
1.
How do the regulations apply to Oral History
projects?
2.
What additional requirements apply to research
with prisoners?
3.
For collaborative research at the 3T MRI
Facility in Newark,
is IRB approval from both the Rutgers and
UMDNJ IRBs
required?
4.
How does the recently enacted New Jersey
Survey Law affect survey research in schools?
5.
When is a Certificate of
Confidentiality required?
F.EDUCATION IN THE PROTECTION OF HUMAN SUBJECTS
1.
What is the Human Subjects Certification Program
(HSCP)?
2.
How is access information (UserID, password,
instructions) to HSPC obtained?
3.
How are certification letters obtained
after successful completion of HSCP?
4.
What is the process for securing a letter
for NIH, certifying successful completion of education in
the protection
of human subjects for all key personnel?
A.
General Information
1.
Where is the IRB office?
IRB
functions are conducted under the auspices of the Office for Research and
Sponsored Programs (ORSP) in ASB-III, that is located at 3 Rutgers Plaza,
New Brunswick, NJ 08901 (Cook Campus).
For directions, go to the ORSP website:
http://orsp.rutgers.edu/location.php.
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2.
Who should be contacted for questions about
IRB policy
and procedures?
For forms and other general questions (other than what is found on this
page), please contact
Cathy Rivera, Acting Administrative Assistant, by telephone at 732/932-0150 ext. 2120 or by email at: rivera@orsp.rutgers.edu
.
Michelle Gibel, CIM, IRB Administrator may be contacted by telephone at 732/932-0150 ext. 2104
or by email at:gibel@orsp.rutgers.edu
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3.
How can investigators obtain IRB forms?
All
of the IRB forms are available for download from the ORSP website:http://orsp.rutgers.edu/Humans/default.php,
and are available in hard copy at the IRB office. Researchers
are encouraged to download the latest form instead of re-using saved
applications.
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4.
What is the IRB?
The
Institutional Review Board for the Protection of Human Subjects in
Research (IRB) is the body
at Rutgers, The State University of New Jersey (Rutgers), charged with the
protection of individuals who volunteer to participate in research
conducted by University personnel. All
research protocols that involve human subjects must be reviewed and
approved by the IRB prior to initiation of study procedures.
The IRB is an autonomous body, i.e., decisions of the Board may not
be influenced by any individual, department, office or other University
entity.
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5.
Who serves on the IRB?
IRB
members are appointed by the Associate Vice President for Research and
Sponsored Programs for one-year terms, and may be reappointed for
successive periods. In
accordance with applicable federal regulations, the Board must have a
minimum of five members, including at least oneindividual who would be
considered a non-scientist.Members
are selected from faculty, staff, students, and community members.
Considerable effort is expended to recruit individuals from all
three University campuses who have expertise in different areas.This diversity helpsto ensure that protocols are evaluated fairly
by knowledgeable individuals. If
necessary, non-voting consultants may be enlisted to review specific
protocols for which there is no IRB member with sufficientknowledge of
the research method or scientific disciplineto conduct a substantive
review.
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B.
Policy
1.
Upon what federal regulations is IRB policy
based?
·
The
primary regulation that pertains to humansubjects research is Title 45 of
the Code ofFederal Regulations, Part 46 (45
CFR 46).Thisstatute
defines relevant terms and describes allaspects of human subjects
protection, includingthe composition of review boards, criteria for
protocol review, guidelines for informed consent,requirements for
record-keeping, specialprotections for vulnerable populations, types of
review, and procedures for dealing with non-compliance.
It is based on the ethical principlesidentified in the Belmont
Report. As written, 45 CFR 46 applies only to federally funded research, however, Rutgers
maintains an agreement withthe federal Department of Health and Human
Services (DHHS) that extends the protections of
45 CFR 46
to all research conducted by University personnel, regardless
of the source of funding, or lack thereof.This agreement is the Federal Wide Assurance (No.: FWA00003913) and is required before the institution may receive federal research funds.
·
If
a protocol includes the use of FDA-regulated drugs, devices, or biologics,
then Title 21 of the Code of Federal Regulations (21
CFR) is applicable.The
terms described in 21 CFR and 45 CFR 46 are similar in many ways, but
there are important differences that investigators should be aware of
(comparison of regulations: http://www.fda.gov/oc/ohrt/irbs/appendixe.html).
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2.
What
is the Belmont
Report
and how has it influenced federal regulations regarding the protection of
human subjects?
On July 12, 1974, the National Research Act (Pub. L. 93-348) was
signed into law, there-by creating the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research. One of
the charges to the Commission was to identify the basic ethical principles
that should underlie the conduct of biomedical and behavioral research
involving human subjects and to develop guidelines which should be
followed to assure that such research is conducted in accordance with
those principles. In carrying out the above, the Commission was directed
to consider: (i) the boundaries between biomedical and behavioral
research and the accepted and routine practice of medicine, (ii)
the role of assessment of risk-benefit criteria in the determination of
the appropriateness of research involving human subjects, (iii)
appropriate guidelines for the selection of human subjects for
participation in such research and (iv) the nature and definition
of informed consent in various research settings.
The
Belmont Report attempts to summarize the basic ethical principles (respect
for persons, beneficence, and justice) identified by the Commission in the
course of its deliberations.Unlike
most other reports of the Commission, the Belmont Report does not make
specific recommendations for administrative action by the Secretary of the
Department of Health and Human Services (formerly the Department of
Health, Education, and Welfare). Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the
Department's policy.
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3.
How
do the ethical principles identified in the Belmont
Report
relate to human subjects protection?
Respect for persons: 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 principle
of respect for persons thus divides into two separate moral requirements:
the requirement to acknowledge autonomy and the requirement to protect
those with diminished autonomy. In
most cases of research involving human subjects, respect for persons
demands that subjects enter into the research voluntarily and with
adequate information (informed consent).
Respect for the immature and the incapacitated may require
protecting them as they mature or while they are incapacitated (e.g.,
assent of the subject, permission from a parent/guardian).
Beneficence: Persons
are treated in an ethical manner not only by respecting their decisions
and protecting them from harm, but also by making efforts to secure their
well-being. Such treatment falls under the principle of beneficence.
The obligations of beneficence affect both individual investigators
and society at large, because they extend both to particular research
projects and to the entire enterprise of research. In the case of
particular projects, investigators and members of their institutions are
obliged to give forethought to the maximization of benefits and the
reduction of risk that might occur from the research investigation. In the
case of scientific research in general, members of the larger society are
obliged to recognize the longer term benefits and risks that may result
from the improvement of knowledge and from the development of novel
medical, psychotherapeutic, and social procedures.
Justice: Who
ought to receive the benefits of research and bear its burdens? This is a
question of justice, in the sense of "fairness in distribution"
or "what is deserved." An injustice occurs when some benefit to
which a person is entitled is denied without good reason or when some
burden is imposed unduly.
Questions
of justice have long been associated with social practices such as
punishment, taxation and political representation. Until recently these
questions have not generally been associated with scientific research.
However, they are foreshadowed even in the earliest reflections on the
ethics of research involving human subjects. For example, during the 19th
and early 20th centuries the burdens of serving as research subjects fell
largely upon poor ward patients, while the benefits of improved medical
care flowed primarily to private patients.
Against this historical background, it can be seen how conceptions
of justice are relevant to research involving human subjects. For example,
the selection of research subjects needs to be scrutinized in order to
determine whether some classes (e.g., welfare patients, particular racial
and ethnic minorities, or persons confined to institutions) are being
systematically selected simply because of their easy availability, their
compromised position,or their manipulability, rather than for reasons
directly related to the problem being studied. Finally, whenever research
supported by public funds leads to the development of therapeutic devices
and procedures, justice demands both that these not provide advantages
only to those who can afford them and that such research shouldnot unduly
involve persons from groups unlikely to be among the beneficiaries of
subsequent applications of the research.
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C.
IRB Review
1.
How often does the IRB meet?
The
IRB meets monthly, except during August, when there is no meeting.
The deadline for submission of materials for review at the IRB
meeting is the 12th of the preceding month.E.g.: Applications submitted by the 12th of September will be reviewed
at the October IRB meeting.Applications for
Exempt review may be submitted at any time and are reviewed on a rolling
basis.
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2.
What are the criteria for IRB review of a
protocol?
When reviewing a protocol, the IRB must make the following
determinations:
(1)
Risks to subjects are minimized: (i) by using procedures which are
consistent with sound research design and which do not unnecessarily
expose subjects to risk, and (ii) whenever appropriate, by using
procedures already being performed on the subjects for diagnostic or
treatment purposes.
(2)
Risks to subjects are reasonable in relation to anticipated benefits, if
any, to subjects, and the importance of the knowledge that may reasonably
be expected to result. In evaluating risks and benefits, the IRB should
consider only those risks and benefits that may result from the research
(as distinguished from risks and 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 (for example, the possible effects of the research on public
policy) as among those research risks that fall within the purview of its
responsibility.
(3)
Selection of subjects is equitable. In making this assessment the IRB
should take into account the purposes of the research and the setting in
which the research will be conducted and should be particularly cognizant
of the special problems of research involving vulnerable populations, such
as children, prisoners, pregnant women, mentally disable persons, or
economically or educationally disadvantaged persons.
(4)
Informed consent will be sought from each prospective subject or the
subject's legally authorized representative, in accordance with, and to
the extent required by §46.116.
(5)
Informed consent will be appropriately documented, in accordance with, and
to the extent required by §46.117.
(6)
When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
(7)
When appropriate, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.
When
some or all of the subjects are likely to be vulnerable to coercion or
undue influence, such as children, prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons,
additional safeguards have been included in the study to protect the
rights and welfare of these subjects.
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3.
Why is it necessary for the federal
government to require that institutions review proposed research projects?
Don't all researchers take the appropriate steps to protect
subjects on their own?
The vast majority of researchers plan and conduct their research in
accordance with sound ethical principles.
However, there is adequate documentation that some investigators do
not take the necessary steps, either through conscious choice or as a
result of ignorance, to protect the individuals who volunteer to
participate in their research. When
the researcher is affiliated with an academic institution, repercussions
for failing to protect subjects affect not only the investigator, but the
institution as well. For this
reason, oversight by an institutional review board is necessary to ensure
that projects include the appropriate safeguards to protect human
subjects. The federal
regulations postulated at 45
CFR 46 and 21
CFR describe those protections and form the basis for IRB policy.
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4.
When is IRB review required?
IRB
review is required whenever an investigator who is affiliated with the
institution conducts research with human subjects.
Research is defined in 45
CFR 46 as "a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to
generalizable knowledge". Student
projects are considered to be research whether or not there is intent to
disseminate study results, if all other conditions are met.
A human subject is defined in 45
CFR 46 as "a living individual about whom an investigator
(whether professional or student) conducting research obtains (1) data
through intervention or interaction with the individual, or (2)
identifiable private information".
Individuals who provide information for research that is not about
themselves are not considered to be human subjects in this context.
While researchers should take steps to ensure that these
individuals arenot placed at risk, it is not necessary for the IRB to
approve their participation.
IRB
purview is limited to those projects that involve both research and
human subjects.
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5.
What are the different types of IRB review,
and how do they differ from one another?
There
are three levels of IRB review: exemption,
expedited review, and full review.
Exemption: Protocols that present extremely low levels of risk to participants and include only procedures described in six specific categories of research (available online at: <http://orsp.rutgers.edu/Humans/documents/hsexempt.php>) may qualify for exemption. The investigator must complete a Request for Exemption form, attach a copy of the research protocol and all relevant documents, and submit two copies of the packet (1 original plus 1 copy) to the IRB for review. After administrative review is completed, the investigator is notified of the outcome by email or regular mail.
Expedited Review: Protocols
that present no more than minimal risk to subjects and include only
procedures described in nine specific categories of research (available
online at: http://orsp.rutgers.edu/Humans/documents/hsexped.php)
may qualify for expedited review. The
investigator must complete an Application for IRB Review of A Research
Protocol that Involves Human Subjects (http://orsp.rutgers.edu/Humans/default.php),
attach a copy of the research protocol and all relevant documents, and
submit five copies of the entire packet to the IRB for review.After review by two assigned IRB members, the investigator is
advised of the outcome by email or regular mail.
Full Review: Protocols
that do not meet the criteria for either exemption or expedited review
must be reviewed by the convened IRB.
The investigator must complete an Application for
IRB Review of A Research Protocol that Involves Human Subjects (http://orsp.rutgers.edu/Humans/default.php),
attach a copy of the research protocol and all relevant documents, and
submit five copies of the entire packet to the IRB for review.
After preliminary review by two IRB members, the protocol is
presented and discussed at a convened meeting of the full IRB.
The investigator is notified of the outcome shortly after the
meeting by email or regular mail.
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6.
How is minimal risk defined?
A
risk is minimal where the probability and magnitude of harm or discomfort
anticipated in theproposed research are not greater, in and of
themselves, than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests
[Federal Policy 45 CFR 46.102(i)]. For example, the risk of drawing a
small amount of blood from a healthy individual for research purposes is
no greater than the risk of doing so as part of routine physical
examination.
The
definition of minimal risk for research involving prisoners differs
somewhat from that given for non-institutionalized adults.
Per 45 CFR 46.303, when prisoners are subjects in research,
"minimal
risk" is the probability and magnitude of physical or psychological
harm that is normally encountered in the daily lives, or in the routine
medical, dental, or psychological examination of healthy persons.
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7.
What is the deadline for submission of protocols for IRB review or
exemption?
Investigators
requesting full or expedited review of a protocol should submit the IRB
application and all relevant attachments to the IRB office no later that
the 12th of the month immediately preceding the
IRB meeting at which it will be reviewed.
For example, submit by May 12 for the June IRB meeting.
The
IRB meets monthly except in August, when there is no meeting.
Protocols submitted for full review between June 12 and August 12
will be reviewed at the September meeting.
However, the expedited review process continues without
interruption throughout the summer.
Applications
for exemption are accepted throughout the month, and reviewed on a rolling
basis. There is no disruption
of the exemption review process in the summer.
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8.
If the project will not be completed by the IRB expiration date,
what is the procedure for requesting continuation?
Federal
regulations require that all non-exempt protocols involving human subjects
be reviewed by the IRB at least annually.
Approximately two months prior to the expiration date of a
protocol, the investigator will receive a Request for Continuing Review
form by mail, from the IRB office. If
the project, including data analysis, will not be completed by the
expiration date, then the investigator should complete the form and return
it by the due date so that there is no interruption in the approval
period.
Enrollment
of new subjects cannot occur on a project if it becomes inactive.
In addition, research intervention or interaction with already
enrolled subjects must stop if a project becomes inactive unless the IRB
determines that it is in the best interest of individual subjects to
continue. If a
protocol becomes inactive, submission of a new Request for IRB Review and
Clearance may be required.
Exemptions
do not have expiration dates, therefore, continuing review is not
required.
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9.
Submitting an Amendment to an Existing Protocol (including Exempt): When it is necessary to change or add procedures on an approved
protocol, what is the process for obtaining IRB approval of the change?
Note that any
deviation from the approved research protocol must be reviewed by
the IRB prior to implementation of those changes. For
example, any changes in the consent form or the questionnaires/interview
guides must be submitted to the IRB prior to use.
To request an amendment (change) or addendum (addition) to an approved
protocol, send four copies of the amendment request to Michelle Gibel, by
campus mail (ORSP, ASB-III, Cook), regular mail (ORSP, ASB-III, 3
Rutgers Plaza, New Brunswick, NJ 08901)
or one copy via email at
<gibel@orsp.rutgers.edu>.
Include the following information:
description of the change or addition, rationale for the
modification, unmarked copy of new documents (e.g., consent form, study
instrument, advertisement), and the revised documents (noting all changes
by bolding additions and deletions via strikethrough;
or via the track-changes feature in MSWord).
After
IRB review, a Notice of Approval or revised Notice of Exemption will be
mailed to the investigator. Changes
to approved protocols may not be implemented until the change is approved
by the IRB. Amendments to non-exempt protocols must be
submitted by the 12th of the month for review at the following
month's IRB meeting.
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10.
What are the researcher's responsibilities if an adverse or
unexpected event occurs on an approved protocol?
An
Adverse/Unexpected Event is defined as: (1) any medical, psychological or
behavioral event that is undesirable and unintended, although not
necessarily unexpected; (2) an event in which the outcome is fatal or life
threatening, causes permanent disability, causes hospitalization or
prolongation of hospitalization; (3) an overdose; or (4) a complaint by a
research subject or family member of a research subject concerning the
research or the protocol.
If
an adverse or unexpected event occurs on an approved protocol, the
investigator is required to submit an Adverse/Unexpected Event Report to
the IRB. The form and
specific instructions may be downloaded from the ORSP website at:
http://orsp.rutgers.edu/Humans/default.php
. The investigators must notify the IRB in a timely manner
(typically within 48 hours of the event).
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D.
Informed Consent
1.
What is informed consent?
Informed
consent is one of the primary ethical requirements underpinning research
with human subjects; it reflects the basic principle of respect
for persons. It is too often forgotten that informed
consent is an ongoing process,not a piece of paper or a discrete moment
in time. Informed consent assures that prospective human subjects will
understand the nature of the research and can knowledgeably and voluntarily
decide whether or not to participate.
The prospective subject should be presented with the information,
then given an opportunity to ask questions and have them answered, prior
to signing the consent document.
Extensive information related to informed consent may be reviewed
online at: http://orsp.rutgers.edu/Humans/default.php.
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2.
What information should be included in a
consent document?
(a)
Basic elements of informed consent:
(1)
a statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed,and
identification of any procedures which are experimental;
(2)
a description of any reasonably foreseeable risks or discomforts to the
subject;
(3)
a description of any benefits to the subject or to others which mayreasonably be expected from the research;
(4)
a disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;
(5)
a statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained;
(6)
for research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist
of, or where further information may be obtained;
(7)
an explanation of whom to contact for answers to pertinent questions about
the research and research subjects' rights, and whom to contact in the
event of a research-related injury to the subject
(8)
a statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time
without penalty or loss of benefits to which the subject is otherwise
entitled.
(b)
additional elements of informed consent. When appropriate, one or more of
the following elements of information shall also be provided to each
subject:
(1)
a statement that the particular treatment or procedure may involve risks
to the subject (or to the embryo or fetus, if the subject is or may become
pregnant) which are currently unforeseeable;
(2)
anticipated circumstances under which the subject's participationmay be
terminated by the investigator without regard to the subject's consent;
(3)
any additional costs to the subject that may result from participation in
the research;
(4)
the consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject;
(5)
A statement that significant new findings developed during the course of
the research which may relate to the subject's willingness to continue
participation will be provided to the subject; and
(6)
the approximate number of subjects involved in the study.
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3.
Are sample consent forms available for
review?
Yes.
Sample consent forms may be found within the Informed Consent guidance
material that is available online on the Rutgers Institutional Review
Board website: http://orsp.rutgers.edu/Humans/downloads/Expedited/icguidanceprep2.htm.
Numerous
sample forms are presented, to provide guidance to researchers from
various disciplines. Additional
forms will be added periodically.
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4.
What is assent?
Assent
is defined as, "
A child's affirmative agreement to participate in research. Mere failure
to object should not be construed as assent [45
CFR 46.402(b)]". While
children may be legally incapable of giving informed consent, they
nevertheless may possess the ability to assent to or dissent from
participation. Out of respect for children as developing persons, children
should be asked whether or not they wish to participate in the research,
particularly if the research: (1) does not involve interventions likely to
be of benefit to the subjects; and (2) the children can comprehend and
appreciate what it means to be a volunteer for the benefit of others. The
IRB must determine for each protocol - depending on such factors as the
nature of the research and the age, status, and condition of the proposed
subjects - whether all or some of the children are capable of assenting to
participation. Where appropriate, IRB’s may choose to review on a
case-by-case basis whether assent should be sought from given individual
subjects.
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5.
Under what conditions may
documentation of informed consent be waived?
The
IRB may waive the requirement for written documentation of informed
consent, (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116),
if it finds and documents either of the following:
a.
Signed consent is the only record linking the subject to the research and
the greatest risk of the research is a breach of confidentiality;
b. The research presents no more than minimal risk and involves procedures
for which consent wouldn't normally be obtained outside of the research
context.
In
situations in which signed consent will not be obtained, it is often
advisableto present subjects with an information sheet or letter that
contains the elements of informed consent, for their future reference.
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6.
Under what conditions may some or all of
the elements of informed consent be waived?
Consent
is required from any human subject in research unless informed consent has
been specifically waived by the IRB. The IRB may waive consent under two
sets of circumstances:
a.
if the project involves no more than minimal risk; the waiver
doesn't adversely affect subjects; the research couldn't practicably
carried out without the waiver; and, where appropriate, subjects are given
information about the project afterwards.
b.the research or demonstration project is to be conducted by or
subject to the approval of state or local government officials and is
designed to study, evaluate, or otherwise examine: (i) public benefit or
service programs; (ii) procedures for obtaining benefits or services under
those programs; (iii) possible changes in or alternatives to those
programs or procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs; and the research
could not practicably be carried out without the waiver or alteration.
Otherwise,
written informed consent must be obtained. For additional information,
review the applicable federal regulation online at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116.
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E.
Specific Populations or Methodology
1.
How do the regulations apply to Oral History projects?
If
the archived data will be made publicly available then the research must
be prospectively reviewed and approved by the Rutgers IRB before the
research project begins. The IRB requires that the researcher make
provisions for obtaining informed consent from all participants and
documentthe process. Participants in oral history projects should be
allowed to review the material prior to public archive and decide if they
wish any or all of the oral history archived.
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2.
What additional requirements apply to research with prisoners?
Under
the terms of 45 CFR 46, Subpart C, prisoners are considered to be members
of a vulnerable population and therefore entitled to special protections
if they participate in research activities.
Subpart C defines both the types of permissible research with
prisoners, and the safeguards that must be followed.
For additional information, review the regulations at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#subpartc
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3.
For collaborative research at the 3T MRI Facility in Newark, is IRB approval from both the Rutgers and UMDNJ IRBs required?
Yes. A Cooperative Agreement no longer exists between the University of Medicine and Dentistry of New Jersey (UMDNJ) and Rutgers regarding IRB review of collaborative protocols conducted at the 3T MRI Facility located on the UMDNJ campus in Newark. As a result, investigators who propose to conduct research at the Facility need to submit an application to both the UMDNJ-New Jersey Medical School IRB and to Rutgers IRB.
UMDNJ application forms may be downloaded from the UMDNJ-Newark Campus IRB website: http://www.umdnj.edu/irbnweb Rutgers IRB forms may be downloaded from the Rutgers website http://orsp.rutgers.edu These sites also contains the most current information available about the IRB deadline dates and review processes. Investigators may contact the UMDNJ-Newark Campus IRB staff by telephone at: 973/972-3608 and the Rutgers IRB office at 732-932-0150 ext 2104.
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4.
How does the recently enacted New Jersey Survey Law affect survey
research in schools?
Effective
January 7, 2002, New Jersey law requires that school districts obtain
written parental consent prior to administering to students surveys or
other specific study instruments which would reveal information concerning
certain topics listed in the law (NJSA 18A:36-34).
If written informed consentis not obtained, then students may not
participate in surveys or assessments which fall within the scope of the
law.
Although
this new law refers explicitly to surveys and other instruments which the
school district administers, but not to research which is not administered
by the school district, cautious districts may interpret this law to apply
to all research conducted in its schools. Investigators who have approved
or proposed protocols that include the administration of surveys,
assessments, analyses or evaluations in a New Jersey school district
should be aware of this new legislation, and recognize that written
parental permission may be required in districts that did not previously
request it. In addition, it
is possible that some districts will react conservatively and decide to
restrict all survey research rather than attempt to obtain parental
permission for each individual study.
Protocols
that involve surveys in schools should be submitted to the IRB as usual;
however, in spite of IRB approval, the final decision of whether or not to
permit the survey to be conducted rests with the individual school
district.Investigators are
advised to secure permission from the district as early as possible so
that consent procedures may be modified if necessary.
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5.
When is a Certificate of Confidentiality required?
A
Certificate of Confidentiality is issued by a federal agency when
protection against compelled disclosure of identifying information about
subjects of biomedical, behavioral, clinical, and other research is
necessary. For additional
information, review the information posted by the federal Department of
Health and Human Services (DHHS) at:
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/certconpriv.htm.
Investigators
who are considering submitting an application for a Certificate of
Confidentiality are advised to plan well in advance, as the process can be
very lengthy. If
participation in research is likely to place an individual at risk of
criminal liability, the IRB may require that a Certificate be obtained.
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F.
Education in the Protection of Human Subjects in Research
1.
What is the Human Subjects Certification Program (HSCP)?
HSCP
is a web-based education program for
all principal investigators and other key personnel who are named
on protocols that involve human subjects.
As a requirement for an assurance of compliance, which allows an
institution to receive federal funding for research involving human
subjects, the federal Office for Human Research Protections (OHRP)has
mandated that principal investigators and other key personnel involvedin
human subject protocols participate in education designed to increase
understanding of the regulations, policies, and ethical standards
governingthe protection of human subjects.
The
education program provides the means to satisfy the education requirement
of the National Institutes of Health (NIH). All principal investigators
and key personnel who are involved in human subject research for which
funding by NIH is requested or has been awarded must participate in
educationon the protection of human subjects in research. Certification
of successfulcompletion of the education program is required before NIH
funds will be awarded for competing applications or contract proposals
involving human subjects. Investigators submitting non-competing renewal
applications for grants or annual reports for contracts that involve human
subject researchmust also include the certification in their annual
progress reports.
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2.
How is access information (User ID, password, instructions) to HSCP obtained?
To
obtain a User ID, password, and instructions to HSCP, complete the online
registration form on the Sakai website at:
http://165.230.179.165/sakai/default.asp.
Within
three business days, the relevant information will be sent to you by
email. If you prefer to
review the material and complete the test using a paper format, contact
Cathy Rivera at 732/932-0150 ext. 2120 or by email at:
rivera@orsp.rutgers.edu
for a copy.
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3.
How are certification letters obtained after successful completion
of HSCP?
To
print a copy of your certification letter, go to:
http://orsp.rutgers.edu/sakai/
and follow the instructions.You will need your User ID to activate the function.
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4.
What is the process for securing a letter for NIH, certifying
successful completion of education in the protection of human subjects for
all key personnel?
IRB
staff will generate the letter of education certification upon request by
the investigator, or in response to a request by NIH.
Certification of all individuals named as key personnel in the
grant application or contract proposal who are affiliated with Rutgers
will be verified internally. Key
personnel who are not affiliated with Rutgers may satisfy the education
requirement by either of two methods: a) successfully complete the Rutgers
online education program; or b) provide written certification from their
institution that they have successfully completed a comparable program.
Key personnel who
have no contact with human subjects, or with confidential data about human
subjects are exempt from the education requirement; however, the principal
investigator must provide this information to ORSP in writing.
To request a letter, or for additional information, contact Michelle Gibel, CIM, at 732/932-0150 ext. 2104 or by email at:
gibel@orsp.rutgers.edu.
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