INSTITUTIONAL REVIEW BOARD
(Including University Policy, Application Form, and Procedures for Obtaining Approval)
OFFICE OF THE VICE PRESIDENT FOR
ACADEMIC AFFAIRS
Table of
Contents
Section 1 – Definitions Pg
6
Section 2 – Categories
of Research Requiring IRB Approval Pg
6
A. Exempt Review Category and
Procedures
B.
Expedited Review Category and Procedures
C.
Full Review Category and Procedures
Section 3 – Materials Required for
Application to the IRB Pg
11
A. IRB Full Application
B.
Project Description
C. Sponsor Protocol
D. Consent/Permission/Assent Forms
Section 4 – Review Time
Considerations Pg
13
Section 5 – Criteria for IRB
Approval of Research Pg
13
Section 6 – Approval Periods Pg
14
Section 7 – Responsibilities of
Investigators Conducting IRB
Approved Activities Pg
15
Section 8 – IRB Disapproval Pg
15
Section 9 – Submission for Teaching
Activities Pg
16
Section 10 – Research Involving
Minors Pg
16
A. Additional Protections
B. Activities That Qualify for
Exemption or Expedited Review
Section 11 – Vulnerable Populations Pg
17
A. Definitions
B.
Pregnant Women or Fetuses
Section 12 – General Issues in
Informed Consent Requirements Pg
18
A.
Research Requiring Informed Consent
B. Waiver of Informed Consent
C. Circumstances Under Which Consent
Must be Sought
D. Documentation of Informed Consent
E. Consent from Non-English Speaking
Subjects
F. Capacity to Provide Consent for
Research
G.
Who Can Provide Consent if a Subject is Incapable of Doing So
H. Required Procedures to be
followed by Person Obtaining Consent
Section 13 – Required Format for
Consent Form: Adult Subjects Pg
21
Section 14 –
Consent/Permission/Assent Requirements: Minor Subjects Pg 26
Section 15 – Continued Review of
IRB-Approved Activities Pg
33
Section 16 – Exemptions from IRB Prior-Approval
Requirement Pg 36
Section 17 – IRB Records Pg
37
Section 18 – Violations of IRB
Policy Pg
38
Section 19 – Training of
Investigators in the Protection of Human
Subjects
in Research Activities Pg
39
Section 20 – Conflict of Interest /
Financial Disclosure Pg
39
Appendix A – LIU Policy
Appendix B – Forms
Request for Exemption
Full or Expedited Review
INTRODUCTION
These guidelines are an elaboration of
The basic ethical principles that underlie the
Federal Policy are summarized in the Belmont Report. These regulations have been adopted by
The
Institutional Review Board at each campus location (
Members
of the Institutional Review Board are appointed by the Vice President for
Academic Affairs (the Institutional
Official), as designated on the Federal-Wide Assurance, following consideration
of recommendations from Deans, Chairs, Provosts, current members, the Assistant
Vice President for Sponsored Research, and/or members of the community (for non-University
positions). Members are appointed for a
renewable, three-year term. All members
have full voting rights; no proxy voting is permitted. Attendance records and member contributions
to the committee are reviewed by the IRB Chair, the Assistant Vice President
for Sponsored Research (IRB Executive Secretary), and the Vice President for
Academic Affairs, to determine if appointments will be renewed. Appointments of the Chair and co-Chair are
made by the Vice President for Academic Affairs. There is no remuneration for individuals
serving as IRB members. No IRB member
participates in the review of any study on which s/he is an investigator or
co-investigator or where a potential for conflict of interest exists.
The
Institutional Official, or his/her designee, conducts an orientation for new
members in which relevant materials are provided (Belmont Report, federal
regulations, University Policy, IRB Guidelines, etc.), and the details
concerning committee function and procedures are discussed. The new member attends at least two IRB
meetings for the purpose of observation, without participating in the review of
studies.
The
IRB may, at its discretion, invite individuals with competence in special areas
(consultant) to assist in the review of complex issues that require expertise
beyond, or in addition to that available on the committee. The consultant does not take part in voting
with the committee. Similarly, investigators
may request, or be invited, to attend IRB meetings to clarify issues with the
members concerning their proposed research activity. Such guests do not take part in committee
deliberations or voting.
The
IRB reports to the Vice President for Academic Affairs. The Executive Secretary, who is a non-voting
member of the committee, serves as the liaison between the research
investigators and the IRB. The Executive
Secretary provides administrative and secretarial support for the committee,
and assists the investigators through the application and approval
process. S/he acts on behalf of the
committee and the University when providing assurance of human subjects’
approval to sponsoring agencies, or when dealing with regulatory agencies. S/he is responsible for monitoring the IRB’s
compliance, and updating IRB procedures with current and/or new relevant
federal or state regulations.
Correspondence
(including application materials) to the IRB may be directed to:
Executive Secretary, IRB
University Office of
Sponsored Research
Bush- Brown Hall, Room 207
700 Northern Boulevard
A
living individual about whom an investigator conducting research obtains data
directly, through intervention or interaction with the individual or
indirectly, through study of the individual’s existing data and/or biological
specimens.
The
probability and magnitude of harm or discomfort that is anticipated in a
research activity are not greater, in and of themselves, than those ordinarily
encountered in daily life or during performance of routine physical or
psychological examinations or tests.
A
systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge.
Research
in this category is considered exempt from full committee review and follows
the federal definitions for exemption.
However, the IRB requires that such activities be on file and be issued
an approval date so that the status of the research may be reviewed on a
continuing basis. A copy of the request
for exemption will be made available to all IRB members at a regularly
scheduled meeting of the committee.
·
Research on regular and special education instructional strategies, OR
·
Research on the effectiveness of, or the comparison among instructional
techniques, curricula, or classroom management methods.
UNLESS ALL OF THE FOLLOWING CONDITIONS EXIST:
·
The human subjects are elected or appointed public officials or
candidates for public office, OR
·
Federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information will be maintained
throughout the research and thereafter.
Exempt Review Procedures: The investigator(s) may request exempt review
by submitting the LIU Exempt Request form (Appendix B, Forms). If it is determined that an application falls
into the exempt category, the primary reviewer may be the Executive Secretary. Once the review has been completed, the
investigator will be notified by memo from the Executive Secretary on behalf of
the committee regarding the status of the application. Notification will indicate either that the
application was fully approved based on the exempt category or that
modifications/clarifications are required or that a full application must be
submitted for full committee review. A
copy of the application and findings will be made available to all IRB members
at a regularly scheduled meeting.
Research
activities that present no more than minimal risk to human subjects, AND
involve only procedures in one or more of the following categories, as defined
in the federal regulations, may be reviewed using the expedited review
procedures described below. The
categories apply regardless of the age of the subjects except as noted.
Expedited
review is NOT permitted when identification of the subjects and/or their
responses would reasonably place them at risk of criminal or civil liability or
be damaging to the subjects’ financial standing, employability, insurability,
reputation, or be stigmatizing. The IRB
may review minor changes to research approved by the full committee via
expedited review. (A minor change is one
that has no substantive effect upon the protocol risk already approved by the
full committee as being acceptable research risk.)
·
From health, nonpregnant adults who weight at 110 pounds. For these subjects, the amounts drawn may not
exceed 550 ml in an 8 week period and collection may not occur more frequently
than 2 times per week; OR
·
From other adults and children (under 18 years old) considering the
age, weight, and health of the subjects, the collection procedure, the amount
of blood to be collected, and the frequency with which it will be
collected. For these subjects, the
amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week
period and collection may not occur more frequently than 2 times per week.
·
The research is permanently closed to the enrollment of new subjects;
·
All subjects have completed all research-related interventions; and
·
Research remains active only for long-term follow-up of subjects; or
·
Where no subjects have been enrolled and no additional risks have been
identified; or
·
Where the remaining research activities are limited to data analysis.
Expedited Review Procedures: The investigator(s) must submit
a full application but may request expedited review (Appendix B, Forms). The review may be carried out by the Chair of
the IRB and/or by one or more experienced reviewers chosen by the Executive
Secretary from among the IRB members. In
reviewing the research, the reviewers may exercise all the authorities of the
IRB except that the reviewer(s) may not disapprove the research (disapproval
may only be decided at a meeting of the full committee). Once the review has been completed, the
investigator will be notified by memo from the Executive Secretary on behalf of
the committee regarding the status of the application. Notification will indicate that the
application was fully approved, that it required modifications/clarifications
in order to secure approval, or deferred for full committee review. A copy of the application and findings will
be made available to all IRB members at a regularly scheduled meeting.
The expedited review category, and corresponding
review procedure is applicable to research involving minor subjects, as long as
the particular activity does not require that the subject be 18 years old or
older.
All research not noted above will be reviewed by the
IRB at one of its convened meetings. The
schedule of meetings is available from the Assistant for Program Review in the
Office of Sponsored Research and online from the Office of Sponsored Research’s
website.
1. A quorum (majority)
of members, including at least one non-
scientific member, must be present for a meeting to be held.
2. Copies of all applications
to be reviewed at the meeting are distributed to the members approximately 10
working days before the meeting.
3. Each application is assigned
a primary reviewer who presents the application and begins the committee
deliberations; each member is responsible for reviewing each application.
4. After the meeting, the
investigator is notified by memo from the Executive Secretary on behalf of the
committee regarding the status of the application. The application may be approved, requires clarifications/modifications
in order to secure approval (conditional approval); deferred (i.e., response
from investigator must be brought back to full committee), or disapproved.
Full Review Procedures: The investigator(s) must submit a full
application (Appendix B, Forms). The
review will be carried out as noted above.
Research activities that involve human subjects must be on file with
the IRB and must be approved PRIOR to the commencement of the activity. Only one original copy of the application is
required to be submitted regardless of the category of review. Note:
The IRB will determine if a different category is applicable than the
one indicated by the investigator.
The application must be complete with the following
original signatures:
1. The investigator, who
ensures accuracy of the information contained within the submitted materials
and, upon approval, assures compliance with all aspects of Section IV,
“Responsibility of Investigator Conducting IRB Approved Activities”;
2. The Chair of the department,
who certifies that the activity as scientifically meritorious and that the
investigator(s) have the expertise required to carry out the protocol; and
3. If applicable, signature of
the faculty supervisor of the student investigator. The supervisor assumes complete
responsibility for the student’s research including a) ensuring accuracy of the
information contained within the submitted materials and b) assuring compliance
with all aspects of Section IV, “Responsibility of Investigator Conducting IRB
Approved Activities”.
This section clearly discusses, in LAY LANGUAGE, the
research protocol. In addition to detailing
all procedures in which human subjects are involved, the following must be
included.
1. Discussion of the scientific
significance and goal of the study.
2. Description of subject
recruitment procedures, including copies of all advertisements, posters, scripts,
etc. to be used.
3. Inclusion/exclusion criteria
for subject enrollment. It is federally
required that the application include specific justification if women,
minorities and/or minors are to be excluded in the research activity.
4. Disclosure, if the
investigator proposes to include him/herself, or members of his or her family
as subjects in the proposed research.
5. Potential risks and benefits
to subjects.
6. Highlights of potential
problems related to risk/benefit, confidentiality, or other ethical problems.
7. Copies of all interviews,
surveys, questionnaires, data collection forms, etc. to be used during the
course of the project.
When funding is being sought or has been approved by
an external agency (NIH, NYS Education, pharmaceutical company, philanthropic
organization, etc.), the grant or sponsor protocol should be submitted in
addition to (not in lieu of) the project description. Regardless of the review category, one copy
of the grant or sponsor protocol must be submitted if it is not currently on
file with the Office of Sponsored Research.
These should be on departmental letterhead and
standardized to conform to the IRB required format (see Section 13). Note that consent forms are used to
consent subjects 18 years or older, permission forms are used to obtain
permission from parents of subjects 17 years or younger (since the subjects
themselves cannot consent to being in the study), and assent forms are
used to obtain agreement from the minor subject in the study.
For those consent forms that must be translated into
a foreign language, an affidavit of accurate translation must be provided from
an appropriate translator who is unaffiliated with the study (see Section 12).
For those studies where minors will be included, the
IRB may (rarely) waive the need for a parent permission form and minor’s
assent as a condition for approval.
However, these documents will still need to be submitted for review and
approval prior to enrollment of minors in the study (see Sections 10 and 12).
The
length of time required for review of an application by the IRB is
dependent upon the review category into which an application falls. Expedited reviews are sent to committee
members on a regular basis and the time required for review is dependent upon
the availability of the IRB members. Review
(not full approval) is generally completed within 2 weeks of receipt date.
The
deadline for applications requiring full committee review at a convened meeting
of the IRB is at least 10 business days prior to the meeting date. This allows
for distribution of the application to the committee members as well as
members’ review time prior to the full meeting. Exact meeting dates can be obtained from the
Assistant for Project Review in the Office of Sponsored Research of from the
Office of Sponsored Research’s website.
For research in which outside funding is involved, it is recommended that
the IRB materials be submitted far enough in advance of the grant submission
deadline or start date to allow for at least two (2) successive meetings of the
IRB (in case of deferral).
SECTION 5
CRITERIA FOR IRB APPROVAL OF
RESEARCH
In order to approve a
research project, the Institutional Review Board must determine that all of the
following requirements are satisfied:
1. Risks to subjects are
minimized by using procedures which are consistent with sound research design
and which do not unnecessarily expose subjects to risk, and 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.
3. Selection of subjects is
equitable, in relation to the purposes of the research and the setting in which
the research will be conducted.
4. Informed consent is obtained
in compliance with the IRB policy as outlined in these guidelines.
5. Where appropriate, the
research plan makes adequate provision for monitoring the data collected to
ensure the safety of subjects.
6. Where appropriate, there are
adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data.
7. Where some or all of the
subjects are likely to be vulnerable to coercion or undue influence, such as
persons with acute or severe physical or mental illness, or persons who are
economically or educationally disadvantaged, appropriate additional safeguards
have been included in the study to protect the rights and welfare of these
subjects.
8. All personnel associated
with the research that either deal directly with the human subject or with
human tissue and/or data and where the project is federally funded, have
successfully completed LIU’s training program on the protection of human
subjects in research.
SECTION 6
APPROVAL PERIODS
IRB approval periods are
granted on the basis of degree of risk associated with the particular protocol
(but no longer than one year). In the
case of full committee reviews, this one-year criterion starts on the date the
application receives final approval.
Certain projects may require review more often than annually based on
other factors aside from degree of risk.
A project approved by the IRB may be subject to further appropriate
review and approval by officials of the institution. However, those officials may not approve
research if the Institutional Review Board has not approved it.
SECTION 7
RESPONSIBILITES OF
INVESTIGATORS CONDUCTING IRB APPROVED ACTIVITIES
Once his/her project is
approved by the IRB, the investigator(s) must:
1. Conduct every aspect of the
project as outlined in the application and as approved by the IRB.
2. Promptly report any
revisions or amendments to the research activity for review and approval by the
IRB PRIOR to commencement of the revised protocol. (The only exception to this policy is in
situations where changes in protocol are required to eliminate apparent,
immediate hazards to the subjects).
3. Promptly report any
unanticipated problems involving risks to subjects or others.
4. Assume full responsibility
for selecting subjects in strict accordance with the inclusion/exclusion
criteria outlined in the application materials.
5. Where
consent/permission/assent form(s) have been approved for the research activity,
only IRB approved, stamped forms may be used in the consent process.
The IRB has the authority to
suspend, terminate, or place restrictions on any study in which the
investigator has not met the above requirements, or in the event where
information is disclosed to the IRB that indicates that the rights and/or
welfare of human subjects are at risk.
SECTION 8
IRB DISAPPROVAL
Disapproval of an activity
may be determined only at meetings of the full committee regardless of the
category of review. If the IRB does not
approve a research activity, the principal investigator(s) has the right to
appeal that decision either in writing or in person at an IRB meeting. If the investigator is not satisfied with the
decision subsequently reached by the IRB, s/he may request re-review by the IRB
whenever significant changes are made to the research protocol or significant
new information becomes available. This
re-review requires the submission of a new, updated full application that
clearly indicates the changes.
SECTION 9
SUBMISSION FOR TEACHING
ACTIVITIES
Participation by students in
any teaching activity which involves the potential of more than minimal risk
(i.e., more than the risk found in everyday activities) to the student, or is
unusual or not necessary to the student’s course of study or training in which
it occurs, must be accompanied by the student’s voluntary, informed consent and
must be reviewed and approved by the IRB prior to commencement of the activity.
SECTION 10
RESEARCH INVOLVING MINORS
(IN
Minors are considered a
vulnerable population and additional protections must be considered in all
research activities in which minors are, or may be included.
A. Additional Protections:
1. Obtaining parental
permission in most cases. An exception
would be if the IRB determines that a research protocol is designed for
conditions, or for a subject population, for which parental or guardian
permission is not a reasonable requirement to protect the subjects (for
example, neglected or abused children.)
An appropriate mechanism for protecting the children who will
participate must be in place, and the waiver has to be consistent with Federal,
state or local law. A waiver of parental
permission must also meet the criteria for consent waiver outlined in Section
12.
2. Obtaining minor assent,
except where the IRB specifically grants a waiver. In determining whether children are capable
of assenting, the IRB must take into account the ages, maturity, and
psychological state of the children involved.
The IRB may require documentation of assent, such that the minor is
presented with an assent form to review and sign.
3. Allowance of participation
in only certain categories of research.
These categories include:
a. minimal risk;
b. more than minimal risk with
the possibility of direct benefit;
c. more than minimal risk
without the possibility of direct benefit, but ALL of the following conditions
are met:
1) the risk must represent a
minor increase over minimal risk
2) the research intervention or
procedure presents experiences to subjects that are reasonably commensurate
with those inherent in their actual or expected medical, dental, psychological,
social, or educational situations
3) the intervention or
procedure is likely to yield generalizable knowledge about the subjects’
disorder or condition which is of vital importance to the understanding or
amelioration of the subjects’ disorder or condition; and
4) the assent of the minor
subject and permission from BOTH parents/guardians are solicited in accordance
with 45CFR46.
B. Activities that qualify
for exemption or expedited review
1. The exempt review and
procedures, as outlined in these guidelines, applies to research involving
minor subjects with the exception of exemption #2. The exemption for research involving survey
or interview procedures or observation of public behavior does not apply to
research with minors (17 years of age or younger), except for research
involving observations of public behavior when the investigator(s) do not
participate in the activities being observed.
2. The expedited review and
procedures, as outlined in these guidelines, is applicable to research
involving minor subjects, as long as the particular activity does not require
that the subject be 18 years old or older.
3. The full committee must
review all other research involving minors.
SECTION 11
VULNERABLE POPULATIONS:
PREGNANAT WOMEN, FETUSES, NONVIABLE NEONATES
A. Definitions
1. Fetus – the product of
conception from implantation until delivery
2. Neonate – a newborn
3. Viable – being able to
survive to the point of independently maintaining heartbeat and respiration
4. Nonviable neonate – a
newborn that, although living after delivery, is not viable
B. Pregnant Women or Fetuses
Only the pregnant woman’s
consent is needed if there is possibility of direct benefit to the pregnant
woman OR both the pregnant woman and the fetus, OR no direct benefit to the
woman or fetus but the risk to the fetus is minimal (as above).
Both the pregnant woman’s
and father’s (of the fetus) consent is needed if the only potential benefit is
to the fetus. Father requirement is
waived if he is unavailable, he is incompetent, he is temporarily incapacitated,
or the pregnancy is a result of rape or incest.
SECTION 12
GENERAL ISSUES IN INFORMED
CONSENT REQUIREMENTS
A.
Research Requiring Informed Consent
No investigator may involve
a human being as a subject, or use their data or tissue, in research unless the
investigator has obtained the informed consent of the subject or the subject’s
legally authorized representative. There
are two exceptions to this requirement:
1. Research in which the only
involvement of human subjects is that of anonymous observation.
2. The Food and Drug
Administration (FDA) permits an exception to the informed consent requirement
before the emergency use of a test article, under certain conditions.
B. Waiver of Informed
Consent
There are limited conditions
under which the Institutional Review Board may waive the requirement for
informed consent. An investigator must
provide evidence that the following conditions are met:
1. The research involves no
more than minimal risk to the subjects.
2. The waiver or alteration
will not adversely affect the rights and welfare of the subjects.
3. The research could not
practicably be carried out without the waiver or alteration.
4. Whenever appropriation, the
subjects will be provided with additional pertinent information after
participation
The Food and Drug
Administration permits an exception to the informed consent requirement before
the emergency use of a test article under certain conditions.
C. Circumstances Under Which
Consent Must Be Sought
Consent must be sought under
circumstances where the subject or representative is given enough time to
consider whether or not to be in the study and that minimize the possibility of
coercion or undue influence. Information
provided to the subject or representative must be written in simple language,
so all aspects of the research (e.g., purpose, risks, benefits) are clearly
stated, and an informed decision may be made.
The IRB encourages
researchers to ask potential subjects short questions, after the research has
been described and the consent form read, in order to assess that the potential
subject has at least a basic understanding of what the research involves. Examples:
“Tell me in your own words what this study is all about”; “What do you
think will happen to you in this study”; “What do you expect to gain by being
in this study”; “What risks might you experience”; “What options do you have if
you decide you don’t want to be in this study?”
D. Documentation of Informed
Consent
Documentation of informed
consent is required in most cases. The
IRB may waive the requirement for the investigator to obtain a signed consent
form for some or all subjects if it finds that:
1. The only record linking the
subject to the research would be the consent document, and the principal risk
would be potential harm resulting from a breach of confidentiality. The IRB may determine that each subject be
asked whether s/he wants documentation linking the subject with the research,
and the subject’s wishes will govern; OR
2. The research presents no
more than minimal risk of harm to subjects and involves no procedures for which
written consent is normally required outside of the research context.
In cases where the
requirement of documentation is waived (e.g., use of anonymous survey is
proposed), a consent document in the IRB required format must still be
used. However, the document is written
in letter format (‘Dear Subject’), and, rather than requiring the subject’s
signature to verify consent, the following text is used to end the letter:
‘If you
___________________________ (e.g., complete the attached survey, answer these
few questions, etc.), it means that you have read (or have had read to you) the
information contained in this letter, and would like to be a volunteer in this
research study. Thank you, (signatures
of investigators)’
E. Consent from Non-English Speaking Subjects
An important part of the
consent process is to provide information in a language understandable to the
subjects. There are two methods for
obtaining consent from non-English speaking subjects.
1. For those consent forms that
must be translated into a foreign language, an affidavit of accurate
translation must be provided from an appropriate translator who is unaffiliated
with the study. The translated consent
form and affidavit must be submitted and approved by the IRB before use of the
consent form. Or,
2. The Office for Human
Research Protection offers guidance on “Obtaining and Documenting Informed
Consent of Subjects Who do Not Speak English”.
This method involves use of an IRB approved English language consent
form, an IRB approved short consent form written in the non-English language,
and a witness fluent in both English and the language of the subject. The details are available online at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ic-non-el.htm
F. Capacity to Provide
Consent for Research
An essential part of the
consent process is assessing whether the potential subject has the capacity to
make a decision about participating in a given research study. The proposed subject population and the
inherent risks and benefits of a particular study will determine who should be
responsible for assessing the capacity of potential subjects. These factors will also determine the
procedures that should be followed if the subject is deemed incapable of
providing consent. An ethical balance
must exist between the need to conduct research that asks questions about
certain diseases or disorders, and the need to protect the affected, sometimes
vulnerable, subject populations whose inclusion in the study can help answer
those questions. However, the rights of
the potential subject are always preeminent.
Individuals who lack the
capacity to consent for themselves cannot be enrolled in research studies that
include more than minimal risk and no direct benefit. These types of studies can enroll individuals
who are able to consent for themselves.
Any additional safeguards required by the IRB will depend on the nature
of the study as well as on the time course (temporary, permanent, progressive
or fluctuating) and extent of the alteration in capacity. With increasing risk and decreasing benefit,
the safeguards imposed on the study will be necessarily more stringent.
A subject has the capacity
to consent to his or her own participation in a research activity if s/he
demonstrates an appreciation:
·
That the activity is research and not standard treatment;
·
Of the risks and benefits of a study;
·
Of the alternatives that are available if s/he does not participate;
·
That, if s/he chooses not to participate, this decision will be
accepted without penalty
G. Who Can Provide Consent
if a Subject is Incapable of Doing So
Individuals
who may consent on behalf of the subject include:
1. Individuals granted legally
documented authority to make decisions specifically regarding participation in
research.
2. Family member (in order of
priority – spouse, adult child, parent, adult sibling).
3. Individuals named in a
health care proxy for research protocols generally recognized in the medical
community as offering the optimal treatment choice.
These
individuals should receive education about the importance of their role, the
study, the health status of the patient, the rights to refuse to participate or
to withdraw consent at any time without penalty. This person should be taken through the
entire consent process and assent from the subject should be obtained whenever
possible.
H. Required Procedures to be followed by Person
Obtaining Consent
The individual who signs the
consent form as the “person obtaining consent” is responsible for leading the
potential subject through the entire consent process. It is the Principal Investigator’s
responsibility to train and supervise the study personnel who are obtaining
consent.
SECTION 13
REQUIRED FORMAT FOR CONSENT
FORM: ADULT SUBJECTS
(18 YEARS OR OLDER)
All consent forms MUST
·
Be printed on departmental letterhead
·
Be written at an 8th grade or lower reading level
(investigators are encouraged to use computer software applications or other
techniques to assess reading level)
·
Use a large font (at least 12 point)
·
Contain short paragraphs and short, simple and direct sentences
·
Define all abbreviations and acronyms when they first appear in text
·
Include the mandatory information/sentences/paragraphs shown below.
·
Follow the format, including headings, given below. Required information is listed as “mandatory”. (Note: Information in italics is presented
for explanation or example only; this information should be changed to fit each
project.)
Departmental Letterhead
Project Title:
Investigators: Names of Investigators, with
faculty, student status identified
Research Consent Form
You
are being asked to be a volunteer in a research study. (mandatory)
·
For protocols in which experimental treatments are proposed and/or the
potential risk to the subject is high, add, “You are encouraged to take your
time in making your decision. Discuss
this study with your friends and family.”
The
purpose of this study is: (mandatory)
·
This section should provide a brief description of the background and
purpose of the study. An estimate of the
# of subjects expected to participate in the study should be provided. If applicable, a statement should be included
regarding why the potential subject is eligible for this study (e.g., certain
type of cancer).
If
you decide to be in this study, your part will involve: (mandatory)
·
This section requires a simple and short description of all procedures
done for the purpose of the research activity.
·
The procedures should be addressed in the order in which they occur
(e.g., Screening visit, Visit #1, Visit #2, etc.). The frequency, scheduling and time commitment
of each procedure and visit, as well as the study’s total time commitment,
should be provided.
·
When a complicated protocol is proposed, the IRB encourages the
investigator to provide this information in a table or schema format.
·
Procedures that would be done whether or not the subject participates
in the research should not be included.
·
If blood drawing is involved, reference should be made to the amount
(in teaspoons or tablespoons) of blood that is to be drawn, as well as the
frequency and scheduling of the blood drawing procedure.
·
If subjects are being randomly assigned to different groups, the
consent form should reflect this randomization and should read: “You will be
randomly (by chance, like flipping a coin) assigned to one of…”
·
An investigational drug should be referred to as an ‘experimental drug’
·
A placebo should be referred to as ‘inactive substance’
·
Any audio- or video- taping should be addressed in this section as well
The
following risks/discomforts may occur as a result of your participation in this
study: (mandatory)
·
This section should describe the reasonably foreseeable risks and
discomforts that may be expected from each of the procedures that a subject
will be undergoing for research purposes.
Nonphysical risks (i.e., inability to work, inability to drive) should
be included as well.
·
All risks/discomforts should be grouped according to probability of
occurrence (i.e., rare, common) as well as whether or not they are temporary or
permanent.
·
If there are no risks or discomforts associated with a subject’s
participation, the consent form should include such a statement.
·
If the subject will be receiving a number of drugs (experimental or
standard), the risks should be presented for the entire regimen, rather than
listing the risks for each specific drug.
·
The risks associated with blood drawing should be states as “temporary
pain and bruising where the needle enters the skin, and sometimes, fainting”.
·
If there are special risks to pregnant/nursing women, fetuses, and/or
women of childbearing potential, these should be discussed in boldfaced print
with special instructions regarding need for effective birth control. Similar discussion for men should be included
for studies in which effects on sperm are possible.
The
following benefits to you are possible as a result of being in this study: (mandatory)
·
This section should describe any direct therapeutic benefits (to the
subject) or indirect benefits (to others) that may be derived from
participation in the study. If there are
no direct benefits associated with a subject’s participation, the consent form
should include such a statement.
You
will be compensated/reimbursed for your participation in this study … (mandatory)
·
This section should address compensation/reimbursement (money,
credits).
·
Compensation may be prorated; as such, this section should address the
scheduling of prorated payment (e.g., $25 per visit, $10 per blood draw, etc.)
·
If the subject is not going to be paid, or receive credit, the
applicable statement should be included.
The
following procedures will be followed in an effort to keep your personal information
confidential in this study: (mandatory)
·
This section should describe the extent, if any, to which
confidentiality of records that identify the subject will be maintained. Since the majority of studies propose to keep
the subject’s identity confidential, the following statement should be used to
start this section: ‘The following
procedures will be followed in an effort to keep your personal information
confidential in this study: Your identity will be coded,
and all data will be kept in a secured, limited access location. Your identity will not be revealed in any
publication or presentation of the results of this research. However, confidentiality cannot be
guaranteed; your personal information may be disclosed if required by law.’
·
For research activities, where confidentiality of subject identity is
not proposed (e.g., where subjects will be quoted by name) this section should
be very clear regarding where and how the quotes will be used. Subjects should also have the opportunity to
review the text in which their quotes or identity appear, to ensure proper
attribution.
·
The IRB has the right to review study and medical records. In addition, if there is FDA oversight (e.g.
protocol involves use of drugs, biologics or devices), and/or if the research
is sponsored (e.g., NIH, pharmaceutical company, philanthropic organization),
then the following statement should be added: ‘To ensure that this research
activity is being conducted properly, {Long Island University’s Institutional
Review Board and/or the Food and Drug Administration and/or the sponsor of the
study, ‘Acme Drug Company”} has {have} the right to review study and medical
records, but confidentiality will be maintained as allowed by law.”
·
If there will be payment to subjects, the following statement should be
added: ‘By accepting payment for participating in this study, certain
identifying information about you may be made available to professional
auditors to satisfy audit and federal reporting requirements, but
confidentiality will be preserved.
Please note that if you earn $600 or over in a calendar year as a
research subject, you may have to pay taxes on these earnings.’
·
If the study involves the use of video/audio taping of the subject,
include a statement specifically addressing who has access to the tapes, how
they are stored, for what purposes will the tapes be used, and what happens to
the tapes once the study is ended (i.e., Are they erased after all the
necessary information is collected from them?
Are they kept for archival purposes?).
The
following financial obligations are yours: (mandatory)
·
Describe the financial obligation of the subject as a participant in
the study.
·
If there are no costs, this information should be specified as well.
·
If the possible costs to the subject are high, a statement should be
added encouraging the subject to contact his/her insurance company, and/or
discuss the costs with the investigator prior to consenting to be in the study.
Alternative
treatments are available to you. These
consist of: (applicable only if the
study involves treatments)
·
Describe other treatments or procedures available if the subject
chooses not to participate or withdraws from the study.
In
case of injury as a result of being in this study, please contact (insert
name and phone number of investigator).
However, you and/or your insurance company will be responsible for
payment for any resulting treatment and/or hospitalization. (applicable only if the study involves the potential
for injury to the subject)
·
This statement should be included when blood-drawing protocols are
included in the project.
·
If any services are to be made available to the subject (i.e.,
psychology clinical, student health services, hospital, etc.) the statement
should be revised to include this information.
·
The last sentence may be modified in cases where the sponsoring
agency/company pays for such treatment.
The
consequences from withdrawing from this study are: (if applicable)
·
Describe the consequences if a subject withdraws from the research
(i.e., must show up for a visit to check for effects, not eligible for
compensation, etc.).
·
Describe the steps to be followed to withdraw from the project.
You
will be removed from the study if: (if applicable)
·
Describe the circumstances under which a subject will be removed from
the study (i.e., non-compliance, missing sessions, bad reaction to drug or
other stimulus, etc.).
Subject
Rights (mandatory as shown below)
Your
participation in this study is voluntary.
You do not have to be in this study if you do not want to be. You have the right to change your mind and
leave the study at any time without giving any reason, and without
penalty. Any new information that may
make you change your mind about being in this study will be given to you. You will get a copy of this consent form to
keep. You do not waive any of your legal
rights by signing this consent form.
Questions
about the Study or Your Rights as a Research Subject
(mandatory
as shown below)
If
you have any questions about the study, you may contact [insert name of
investigator] at telephone number [insert number]. If you have any questions about your rights
as a research subject, you may contact Ms. Kathryn S. Rockett, Executive
Secretary, Institutional Review Board, (516) 299-2523
If
you sign below, it means that you have read (or have had it read to you) the
information given in this consent form and you would like to be a volunteer in
this study.
________________________________________
Subject
Name
_____________________________________________________________
Subject
Signature Date
_____________________________________________________________
Signature
of Person Obtaining Consent Date
SECTION 14
CONSENT/PERMISSION/ASSENT
REQUIREMENTS: MINOR SUBJECTS (LESS THAN
18 YEARS OLD)
All consent forms MUST
·
Be printed on departmental letterhead
·
Be written at an 8th grade or lower reading level
(investigators are encouraged to use computer software applications or other
techniques to assess reading level)
·
Use a large font (at least 12 point)
·
Contain short paragraphs and short, simple and direct sentences
·
Define all abbreviations and acronyms when they first appear in text
·
Include the mandatory information/sentences/paragraphs shown below.
·
Follow the format, including headings, given below. Required information is listed as “mandatory”. (Note: Information in italics is presented
for explanation or example only; this information should be changed to fit each
project.)
Departmental Letterhead
Project Title:
Investigators: Names of Investigators, with
faculty, student status identified
Research Permission Form
(for Parents of Minor
Subjects)
You
are being asked to allow your child to be in a research study. (mandatory)
·
For protocols in which the potential risk to the subject is high, add “You
are encouraged to take your time in making your decision. Discuss this study with your family and
friends.”
The
purpose of this study is: (mandatory)
·
This section should provide a brief description of the background and
purpose of the study.
·
An estimate of the number of subjects expected to participate in the
study should be included.
·
If applicable, a statement should be included regarding why the
potential subject is eligible for this study.
If
you decide to allow your child to be in this study, his/her part will involve: (mandatory)
·
This section requires a simple and short description of all procedures
done for the purpose of the research activity.
·
The procedures should be addressed in the order in which they
occur. The frequency, scheduling and
time commitment of each procedure and visit, as well as the study’s total time
commitment, should be provided.
·
When a complicated protocol is proposed, the IRB encourages the
investigator to provide this information in a table or schema format.
·
Procedures that would be done whether or not the subject participates
in the research should not be included.
·
If blood drawing is involved, reference should be made to the amount
(in teaspoons or tablespoons) of blood that is to be drawn, as well as the frequency
and scheduling of the blood drawing procedure.
·
If subjects are being randomly assigned to different groups, the
permission form should reflect this randomization, and should read: “Your
child will be randomly (by chance, like flipping a coin) assigned to one of …”.
·
An investigational drug should be referred to as an “experimental
drug”.
·
A placebo should be referred to as an “inactive substance”.
·
Any audio- or video- taping should be addressed in this section.
The
following risks/discomforts may occur as a result of your child’s participation
in this study: (mandatory)
·
Describe the reasonably foreseeable risks and discomforts that may be
expected from each of the procedures that a subject will be undergoing for
research purposes. Nonphysical risks (i.e.,
inability to work, emotional upset) should be included as well.
·
All risks/discomforts should be grouped according to probability of
occurrence (i.e., rare, common) as well as whether or not they are temporary or
permanent.
·
If there are no risks or discomforts associated with a subject’s
participation, the permission form should include such a statement.
·
The risk associated with blood drawing should be stated as: “…temporary pain and
bruising where the needle enters the skin, and sometimes, fainting.”
·
If there are special risks related to pregnant females and/or females
of childbearing potential, these should be discussed in boldface print, with
special instructions regarding need for effective birth control. Similar discussion should be included for
studies in which effects on sperm are possible.
The
following benefits to your child are possible as a result of being in this
study: (mandatory)
·
Describe any direct (therapeutic) benefits to the subject or indirect
benefits (to others) that may be derived from participation in the study.
·
If there are no direct benefits associated with a subject’s
participation, the permission form should include such a statement.
You/your
child will be compensated/reimbursed for participation in this study … (mandatory)
·
Address compensation/reimbursement (money, credit, etc.) that will be
given as a result of participation. The
permission form should be clear regarding whether the parent/guardian and/or
minor subject receives the remuneration.
·
Compensation should be prorated and this section should address the
scheduling of prorated payment (e.g., $25 per visit, $10 per blood draw, etc.)
·
If the subject is not going to be paid or receive other compensation, a
statement to this effect should be included.
The
following procedures will be followed in an effort to keep your child’s
personal information confidential in this study. (mandatory)
·
Describe the extent, if any, to which confidentiality of records that
identify the subject will be maintained.
·
Since the majority of studies propose to keep subject’s identity
confidential, the following statement should be included: “His/Her identity
will be coded, and all data will be kept in a secured, limited access
location. Your child’s identity will not
be revealed in any publication or presentation of the results of this
research. However, confidentiality
cannot be guaranteed; your child’s personal information may be disclosed if
required by law.”
·
For research activities where confidentiality of subject identity is
not proposed (e.g., where subjects will be quoted by name) this section should
be very clear regarding where and how the quotes will be used. Subjects should also have the opportunity to
review the text in which their quotes or identity appear, to ensure proper
attribution.
·
The IRB has the right to review study and medical records. In addition, if there is a Food and Drug
Administration (FDA) oversight and/or if the research is sponsored, the
following statement should be included: (revise
as applicable) “To ensure that this research activity is being conducted
properly, Long Island University’s Institutional Review Board, [the Food and
Drug Administration and the sponsor of this study, “Acme Drug Company”] has
(have) the right to review study and medical records, but confidentiality will
be maintained as allowed by law.”
·
If there will be payment to subjects the following statement should be
added: “By
accepting payment for participating in this study, certain identifying
information about you may be made available to professional auditors to satisfy
audit and federal reporting requirements, but confidentiality will be
preserved. Please note that if you earn
$600 or over in a calendar year as a research subject, you may have to pay
taxes on these earnings.”
·
If the study involves use of video/audio taping of the subject, include
a statement specifically addressing who has access to the tapes, how they are
stored, for what purposes will the tapes be used, and what happens to the tapes
once the study is ended.
The
following financial obligations are yours: (mandatory)
·
Describe the financial obligation of the parent as a result of allowing
the child to participate in the study.
·
If there are no costs, this information should be specified as well.
·
If the possible costs to the subject are high, a statement should be
added encouraging the parent to contact his/her insurance company, and/or
discuss the costs with the investigator prior to permitting the child’s
participation in the study.
Alternative
treatments are available to you. These
consist of: (applicable only if the
study involves treatments)
·
Describe other treatments or procedures available if the parent chooses
not to have the child participate or withdraw the child from the study.
If
your child is injured as a result of being in this study, please contact
[insert investigator’s name and telephone number]. However, you and/or your insurance company
will be responsible for payment for any resulting treatment and/or hospitalization. (applicable only if the study involves the potential
for injury to the subject)
·
This statement should be included when blood-drawing protocols are
included in the project.
·
If any services are to be made available to the subject (i.e.,
psychology clinical, student health services, hospital, etc.) the statement
should be revised to include this information.
·
The last sentence may be modified in cases where the sponsoring
agency/company pays for such treatment.
The
consequences of withdrawing your child from this study are: (if applicable)
·
Describe the consequences if a parent decides to withdraw the child
from the research (e.g., must show up for a visit to check for effects, not
eligible for compensation, etc.)
·
Describe the steps to be followed to withdraw from the project.
Your
child will be removed from the study if: (if applicable)
·
Describe the circumstances under which the child will be removed from
the study (i.e., non-compliance, missing sessions, bad reaction to drug or
other stimulus, etc.).
Subject
Rights (mandatory as written below)
Your
child’s participation in this study is voluntary. You do not have to allow your child to be in
this study if you do not want him/her to be.
You have the right to change your mind and remove your child form the
study at any time without giving any reason, and without penalty. Any new information that may make you change
your mind about allowing your child to participate in this study will be given
to you. You will get a copy of this
permission form to keep. You do not
waive any of your or your child’s legal rights by signing this permission form.
Questions
about the Study or Your Child’s Rights as a Research Subject (mandatory as written below)
If
you have any questions about the study, you may contact [insert investigator
name and telephone number]. If you
have any questions about your child’s rights as a research subject, you may
contact Ms. Kathryn S. Rockett, Executive Secretary, Institutional Review
Board, 516-299-2523.
If
you sign below, it means that you have read (or have had it read to you) the
information given in this permission form, and you would like your child to
participate in this study.
___________________________________________
Subject
Name
_____________________________________________________________
Subject
Signature Date
_____________________________________________________________
Signature
of Person Obtaining Permission Date
======================================================
ASSENT (AND DOCUMENTATION OF
ASSENT) REQUIREMENT
The IRB requires that
provisions be made for obtaining the assent of children to be subjects in
certain research activities. Aside from
age (usually 11-17 years old), the maturity and psychological/physical state is
taken into account in determining the ability of obtaining assent. The IRB may require submission of an assent
document which states, in very simple, general terms, the purpose of the study,
what is expected of the child, the risks, benefits, the right to leave the study
at any time, and who the child can talk to (parent and/or investigator) if s/he
has questions about the study. Following
is an example of an Assent Form:
(Note: Information in italics is
presented for explanation and example only.
This information should be changed to fit each project.)
======================================================
Departmental Letterhead
Project
Title: The Effects of Providing Examples on Writing
Assent Forms
Principal
Investigator: Dr. P. Investigator
You
are being asked to be in a research study.
The
purpose of this study is to show you an example of how to write an assent form.
If
you agree to be in this study, you will be asked to review this example, and
then try to write your own. You will be
in this study for about 10 minutes.
You
will not have to pay anything to be in this study. You will receive no money for being in this
study.
The
only risks or discomforts involved in being in this study are that you may get a paper cut,
which can hurt. The only benefit to you as a subject in this
study is that you
may learn how to write better assent forms.
If
you get hurt as a result of being in this study, your parents/guardian has been
told what to do.
Your
rights:
The fact that you are in this study
will be kept a secret.
You don’t have to be in this study if
you don’t want to be.
You
can change your mind at any time and leave the study without any problem.
If
you have any questions about this study, you can ask your parents, or talk to
the study leader, Dr. P. Investigator, at 516-123-4567.
If
you sign below, it means that you have read the information on this sheet, and
you’d like to be in this study.
_____________________________________________________
Name
_____________________________________________________
Signature Date
SECTION
15
CONTINUED
REVIEW OF IRB-APPROVED ACTIVITIES
A. Observation of Research by IRB
The IRB has the authority to
inspect records, and to observe (or have a third party observe) the consent
process and the research of any activity that it approves.
B. Renewal Procedures
As detailed in Section XX,
the IRB approval periods are granted on the basis of degree of risk associated
with the particular protocol (but no greater than 1 year). It is the Principal Investigator’s
responsibility to maintain continued approval for his or her study. However, the Office of Sponsored Research
sends reminder notices as outlined below.
1. Renewal Notices
a. Approximately 3 months prior
to the end of the approval period, the investigator(s) will be sent a
memorandum outlining the materials that must be submitted in order to renew a
project for the next approval period.
b. After the initial notice to
renew, the investigator will receive a final notice one month prior to
expiration.
c. Projects are automatically
inactivated if the renewal materials are not received by the end of the month
in which their approval expires. The IRB
requires that all activities involving human subjects that were covered under
the originally approved protocol be stopped immediately. The Assistant for Project Review must be
contacted if and when the investigator wishes to reactivate the study.
2. Required renewal materials include:
a. Renewal application,
requiring completion, followed by signatures of the investigator, chair of the
department and in the case of undergraduate or graduate student investigators,
signature of the student’s advisor.
b. Progress report, which is a
summary of the human subjects aspects of the project over the past year,
including number of subjects run, adverse consequences, new information,
results of research, resulting publications, etc.
c. Consent/Permission/Assent
Forms to be used for the upcoming approval period.
C. Amendments, Adverse Events
All amendments to approved
protocols must be submitted to the IRB for review and approval prior to
commencement of the revised study or use of a revised consent/permission/assent
form. Adverse events that occur on-site
will be reviewed by the full committee at a convened meeting. Those occurring at another center conducting
the study (i.e., in the case of multi-center studies) will be reviewed in a
timely manner.
Changes to
consent/permission/assent forms that are required as a result of an amended
protocol, or subsequent to review of adverse events (i.e., addition to the
risks section of the consent form), should be made to the most current
IRB-approved version. The revised
version would be used to consent new subjects for enrollment in the study. However, in order to inform subjects who are
already enrolled in the study of the changes to the study, the following format
should be used. If the study involves
minors, an additional addendum directed to the parent, as well as a revised
assent form, should be drafted as well.
(Note: Information in italics is presented for explanation or example
only; this information should be changed to fit each project.)
======================================================
Departmental Letterhead
Project
title:
Investigators:
Addendum
to Consent Form
You
have already agreed to be a volunteer in the research study referenced
above.
In
the consent form you signed (attached), you were informed that you would be
told of any new information that might affect your willingness to continue in
this study.
This
addendum serves to tell you that … (e.g., your participation will be extended
another 3 weeks … OR … An additional questionnaire will be given to you to
complete … OR … An additional 3 tsp. of blood will be taken at your 4th
visit … etc. If applicable, explain why
the change is being implemented, and provide details regarding relevant changes
to risks, benefits, alternative treatments, etc. that occur as a result of the
revised protocol.)
You
are reminded that:
·
All other information from the original
consent form remains unchanged.
·
Your participation in this study
continues to be voluntary. You do not
have to be in this study if you don’t want to be.
·
You have the right to change your mind
and leave the study at any time without giving any reason, and without penalty.
·
Any new information that may make you
change your mind about being in this study will be given to you.
·
You will get a copy of this consent
addendum to keep.
·
You do not waive any of your legal
rights by signing this consent form.
If
you have any questions about this study, you may contact [insert investigator’s name
and telephone number].
If you have any questions about your rights as a research subject, you
may contact Ms. Kathryn S. Rockett, Executive Secretary, Institutional Review
Board, 516-299-2523.
If
you sign below, it means that you have read (or have had read to you) the
information given in this consent form, and you would like to continue to be a
volunteer in this study.
__________________________________________
Subject
Name
_____________________________________________________________
Subject
Signature Date
_____________________________________________________________
Signature
of Person Obtaining Consent Date
A serious event, other than death or a life
threatening event, is one that results in inpatient hospitalization or
prolongation of existing hospitalization, a persistent or significant
disability/incapacity; a congenital anomaly;/birth defect. It is also defined as a significant medical
event that requires medical or surgical intervention to prevent death, a
life-threatening event, or one of the other outcomes listed above. Reasonable judgment must be used to determine
what constitutes a serious event. Such
events do not have to be physical in nature; attention must be paid to psychological
harm and threats to privacy or subject safety.
ALL adverse events must be
reported to the IRB within 1 – 5 working days as per the following chart.
|
|
Death/Life Threatening |
Other Serious (not life
threatening) |
Non-Serious |
|
Expected |
Report to IRB within 5
working days of occurrence |
Report to IRB at time of
continuing review |
No report required |
|
Unexpected |
Report to IRB within 1
working day of occurrence |
Report to IRB within 5
working days of occurrence |
Report to IRB at time of
continuing review |
Expected – event is identified by
nature, severity or frequency in the risks section of the consent form
Unexpected – event is not identified
by nature, severity or frequency in the risks section of the consent form
Each report of an adverse
event must be signed by the Principal Investigator or Faculty Supervisor (not
student investigator). The Investigator
will be expected to provide a summary and assessment of the event. The report will be forwarded immediately to
the appropriate IRB Chair for review and course of action. The Executive Secretary will inform the
Institutional Official of all reports of adverse events. The Institutional Official will promptly
notify federal sponsors of problems as required under 45CFR46.103(b)(5); OHRP
will be notified where appropriate.
SECTION 16
EXEMPTIONS FROM IRB PRIOR
APPROVAL REQUIREMENT
The only activity that is
exempt form prior review and approval from the IRB involves the emergency use
of an investigational drug (i.e., not approved by the Food and Drug Administration). Emergency use is defined as the use of a test
article on a human subject in a life-threatening situation in which there is no
standard acceptable treatment available and in which there is not sufficient
time to obtain IRB approval.
The emergency use must be
reported to the IRB within 5 working days and should include:
1. Patient history
2. Justification for the
emergency use
3. Department chair endorsement
4. Consent form
5. Investigational drug
brochure and/or protocol (generally available from the pharmaceutical company.
Any subsequent use of the
investigational drug (i.e., use in another patient) must be approved by the IRB
via the standard application process prior to commencement of the activity.
The investigator is required
to obtain informed consent of the subject or the legally authorized
representative unless both the investigator and another independent physician
certified in writing all of the following:
1. The human subject is
confronted by a life-threatening situation necessitating the use of the test
article,
2. Informed consent cannot be
obtained because of an inability to communicate with, or obtain legally
effective consent from the subject,
3. Time is not sufficient to
obtain consent from the subject’s legal representative, AND
4. No alternative method of
approved or generally recognized therapy is available that provides and equal
or greater likelihood of saving the life of the subject.
If time is not sufficient to
obtain an independent physician’s determination that the above four conditions
apply, the investigator shall make the determination and, within 5 working days
after the use of the drug, have the determination reviewed and evaluated in
writing by such a physician.
Notification to the IRB is still required within the 5 working days.
SECTION 17
IRB RECORDS
The Executive Secretary of
the Institutional Review Board maintains the following IRB records:
1. Current list of IRB members,
qualifications, resumes.
2. Minutes of meetings,
including information regarding member attendance, discussions held, decisions
made, and voting results.
3. All materials submitted to
the committee for initial and continued review of each study including: IRB applications, protocol, submitted and
final consent forms, adverse reaction reports, proposed amendments, progress
reports, and, where applicable, sponsoring agencies’ requirements. This information is retained for a minimum
period of three years following the inactivation of a project.
SECTION 18
VIOLATIONS OF IRB POLICY
The IRB has the authority to
suspend, terminate, or place restrictions on any study in which the
investigator has not met the policy or procedural requirements addressed in
this handbook, and/or in the event where information is disclosed to the Office
of Sponsored Research and/or IRB that indicates that the rights and/or welfare
of human subjects are at risk.
Reports of violations of
this policy will be brought before the IRB at a convened meeting. The IRB will make a determination regarding
the need for additional information, or further investigation. The affected Departmental Chair and Dean and
the Vice President for Academic Affairs will be copied on all correspondence
between the committee and the involved party(ies). Upon determination that a violation of this
policy has occurred, the IRB may, for example, require that the activity in
question be halted until such time that corrective action is taken. If the IRB determines that the violation
involves possible scholarly or scientific misconduct, the Vice President for
Academic Affairs will be notified, through the Executive Secretary, and
appropriate action will be taken in accordance with established University
assurances, policies, and procedures.
In situations where subject
safety is involved, and/or the violations are apparent, the Chair of the IRB,
in consultation with other IRB members and/or administrators as appropriate,
may take immediate action (e.g., suspend the activities in question) prior to
review by the full committee.
In accordance with LIU’s
Federal Wide Assurance, the following violations will be reported to the Vice
President for Academic Affairs, OHRP, FDA, and affected sponsor(s) where
applicable:
1. Any unanticipated problems
involving risks to subjects or others.
2. Any serious or continuing
noncompliance with 45CFR46 or the determinations of the IRB.
3. Any suspension or
termination of IRB approval.
If the IRB determines that
the violation involves possible scholarly or scientific misconduct, the Vice
President for Academic Affairs will be notified and appropriate action will be
taken in accordance with established University assurances, policies, and
procedures.
All reports/allegations
regarding human subject research activities made to the Office of Sponsored
Research and/or the IRB will be held confidential, to the extent allowed by
law.
SECTION 19
TRAINING OF INVESTIGATORS IN
THE
PROTECTION OF HUMAN SUBJECTS
IN RESEARCH ACTIVITIES
All individuals who are
involved in human subjects research, who will work directly with subjects or
with data or biological specimens derived from subjects or patients, and who
has external funding from a federal agency, are required to be trained in the
protection of human subjects in research activities. If all such individuals are not trained, work
on on-going projects must be suspended.
Training must be verified by the Office of Sponsored Research.
This requirement may be met
by the successful completion of a seminar coordinated through the Office of
Sponsored Research. The seminar is
available to LIU faculty, staff, and students.
SECTION 20
CONFLICT OF INTEREST /
FINANCIAL DISCLOSURE
An institution conducting
research that is sponsored by a pharmaceutical company is usually paid in
accordance with the reasonable costs of conducting the study. This may include being paid on a ‘per
enrolled subject’ basis. These funds may
be used to support research work in the investigator’s laboratory. This, in and of itself does not constitute a
conflict of interest, but the subject has the right to disclosure of this
relationship. A section should be added
to the informed consent document as follows:
This
project is funded, in part, by a grant or contract from (insert name of
pharmaceutical company) to Long Island University, in support of the
investigator’s work on this study.
There are provisions in some
contracts for ‘enrollment incentives’ (also referred to as ‘competitive
enrollment’). This refers to the
situation where the institution will be paid more by the sponsor if a certain
quote is met. This method of
compensation raises ethical concerns, and constitutes an area of debate within
the field of Human Subjects research.
For example, the December 2001 report of the Association of Medical
College’s (AAMC) Task Force on Financial conflicts on interest in Clinical
Research states:
“Payments for subject
enrollment…should be permitted on to the extent such payments: