Institutional
Review Board
Please
answer all questions to the fullest extent possible, attach additional
pages as required. If a question is not
applicable to your research, write "NA", do not leave blanks. Do not change order or omit questions. All attachments must be labeled and sequentially
ordered as individual appendix items. Be
sure to refer to each appendix in the body of the application.
The
application must have original signatures of the
investigator(s), including faculty sponsor(s) in case of student projects, and
department chair. If you are required to revise the application and to return
it to the IRB, new signatures and dates are necessary to show that all parties
have approved of all revisions. The IRB will
not review protocols submitted by students without the signature of a
faculty advisor on the application.
As
of September 1, 2004 all Long Island University personnel (including students
and staff) involved in projects using human research subjects who have not
completed the Long Island University workshop, “Education in the Protection of
Human Research Subjects”, are required to complete an online training program
before beginning their research. To
complete training go to http://cme.cancer.gov/ . Once the training module has been completed,
you will be prompted to print out a certificate of completion. A copy of this certificate must be submitted
with your IRB application or your application will be returned. Please keep a copy of your certificate for
your records as it must be attached to all future IRB applications as proof of
training compliance.
If
research takes place at another facility, that facility and/or its
Institutional Review Board must also approve of the project before subjects may
be enrolled.
Using
the following checklist, and depending on the nature of the study, the
application should include:
___ All
required signatures
___ Training
certificate(s) attached
___ Consent
form(s) that will be given to human subjects
___ Copy
of scripts, posters, flyers, and letters to be used to recruit subjects
___ Narrative
script for any audio or videotape used during data collection
___ Cover
letter(s) to accompany a survey instrument
___ Complete
copy of newly developed survey instruments
___ Full
citation for standard or published instruments
___ Copy
of standard or published instruments with your modifications
___ Any screening tools used to establish
inclusion or exclusion (for example, demographic or medical history data forms)
___ Letter
of permission to use an off-campus site.
___ One copy of full application if research
is being submitted to an external agency for funding (i.e., NIH, private
foundation, etc.).
Applications
must be typed; if not typed, the application will be returned without
review. This instruction page should not
be submitted to the IRB.
August 2004
All investigators are expected to be
familiar with LIU policies and procedures governing the use of human subjects
in research. Failure to follow
application instructions may result in delay of the approval process. Applications should be typed; if not typed, they
will be returned without review. As of
September 1, 2004 all LIU personnel (including students and staff) involved in
projects using human research subjects are required to complete an online
training program before beginning their research. To complete training go to http://cme.cancer.gov/
and submit a copy of the certificate of
completion from that program as part of this application.
Project Title:*
_________________________________________________________________
______________________________________________________________________________
(*If part of a larger
program and/or if funded by an external agency, also provide the title of the
larger program and/or grant title:___________________________________________
_____________________________________________________________________________)
A. INVESTIGATORS:
LIU
Faculty Investigator / Sponsor:
_________________________________________________
Department:
___________________________________________________________________
Campus: ______________________________________________________________________
Phone: ______________________Fax: ___________________Email:
____________________
Student
Investigator:____________________________________________________________
Department:____________________________________________________________________
Campus:______________________________________________________________________
Phone:
_______________________Fax: __________________Email:_____________________
Address
for Correspondence ______________________________________________________
______________________________________________________________________________
On a separate
sheet list any co-investigator(s) and affiliations(s); be sure to identify
personnel who are not employees or students of LIU.
Type
of project (check one):
____Faculty research ____Doctoral dissertation _____Pre-doctoral research
_____Master’s thesis _____ Pilot study ____Other (specify):
B.
SOURCE OF FUNDING:
1.
___Externally Funded
Sponsor and Sponsor ID:
___________________________________________________
2.
___Seeking Funding:
Sponsor:_____________________________________Deadline:____________________
A full copy of the
grant proposal must be on file with the University Office of Sponsored Research
or appended to this application. _______On File _______ Appended
3.
________ Not Seeking Funding
C. DATA COLLECTION:
1.
Data collection, proposed
dates:__________________________________________________ (Note: the start date for
collection must be no earlier than the date full approval is received.)
2.
Site(s) of data collection:
_______________________________________________________
D.
COLLABORATIONS:
Will the
proposed activities be conducted in whole or in part at another
institution/organization?
________Yes ________No
If Yes, provide name(s) of participating
institution(s) and indicate their role(s) in the study. If the subjects are to be drawn from an
institution or organization [i.e., hospital, social service agency, employer,
prison, school, etc.] which has responsibility for the subjects, then
documentation of permission from that institution and its IRB or equivalent
must be submitted before final LIU approval can be given.
______________________________________________________________________________
______________________________________________________________________________
____________________________________________________________________________________________________________________________________________________________
E.
SUMMARY OF PROPOSED RESEARCH: Provide a brief description, in layman’s
terms, of the proposed research. The
description must include the purpose of the research and a summary of the
procedures to be used with the subjects.
F.
SUBJECTS:
1. Number of
subjects: #Males _________;
#Females____________
2. Subject Population (check all that apply):
_____Adults _____Minors (under 18)*
_____Prisoners* _____Mentally Impaired*
_____Physically Ill* _____Disabled*
_____Pregnant Women* _____Students*
_____Special racial or ethnic group
(specify)*_______________
*Rationale for
use of special groups or subjects whose ability to give voluntary informed
consent may be in question, must be fully explained and justified below. Append additional sheets as necessary.
3. Subject
Selection. Describe how subjects will be
identified and recruited. Be precise
and attach a copy of any and all
recruitment materials to be used (e.g., advertisements, flyers, letters,
scripts).
4. Initial Contact. Describe who will make initial contact, and
how it will be made. If subjects are
chosen from records, indicate who gave approval for use of the records. Written documentation of the
cooperation/permission from the holder or custodian of the records must be
attached. (The official holder of the record, i.e. primary physician,
therapist, or public school must make initial contact of subjects identified
through records search official.) Other
organizations may require that you also receive HIPPA permission from an
appropriate office or officer at their site.
If required, a copy of the HIPPA approval should be attached. (Note:
Long Island University is not a “covered entity” under HIPPA considerations.)
5. What are the criteria for inclusion or
exclusion of subjects? The basis of
exclusion from the study should be stated when subjects are asked to complete
screening questionnaires.
6.
Will subjects receive any inducements before participating or rewards or compensation
after participating? ____Yes ____No
If
Yes, please describe how much and in
what form (cash, travel expenses, meals, lottery, etc.)? This information must also be included in the
consent form. If using lottery or raffle,
describe who will be responsible for conducting, the location for the drawing,
and under whose supervision.
G. RISKS:
1.
Do any of the procedures involve physiological treatments or
intervention/invasion of the body by
mechanical, electronic, biological or any other means? ____Yes
____No
If
Yes, describe in detail the
intervention, the means to administer the intervention, the behavior expected
of subject(s) and the behavior of the investigator during the administration of
the intervention; how data will be gathered and recorded; identify any
anticipated and possible consequences of the procedure for the subject(s); what
steps will be taken to assure proper operation and maintenance of the means
used to administer the intervention; competence/qualifications of investigator;
and name, title, affiliation, telephone number of individual who will supervise
the procedure.
2.
Does the study involve the administration of any prescribed or proscribed
drugs?
____Yes ____No If Yes:
a. Name the drug(s):
_______________________________________________________
__________________________________________________________________________
b. Is it: _____prescribed or _____ proscribed
c. Describe the dosage:____________________________________________________
__________________________________________________________________________
__________________________________________________________________________
d. Route of
administration:_________________________________________________
__________________________________________________________________________
__________________________________________________________________________
e. Is this an FDA-approved use? ___Yes
___No
f. Will the subject be at risk of harm in any
way? ____Yes ____No
If Yes,
identify type of harm; possibility that it will occur; action(s) to be taken to
lessen possibility of occurrence; and action(s) to be taken in case of an
adverse reaction.
3. Identify
anticipated and possible physiological consequences of this procedure for the
subject(s); identify the site where the procedure/administration is to be
carried out; indicate the investigator’s competence/qualification to conduct
this procedure; and give name, title, affiliation, and phone number of
individual who will supervise the procedure.
4. Do you deceive subjects in any way? _____Yes
_____No
(A
study is deceptive if false information is given to subjects, false impressions
created, or information relating to the subjects’ participation is withheld.)
If
Yes, describe in detail the
deception involved, including any instructions to subjects or false impressions
created; why deception is necessary to accomplish the goals of the research;
and plan for debriefing subjects. Attach
a copy of any debriefing statement.
5.
Does the research involve subjects who are likely to be vulnerable to coercion
or undue influence, such as children (under 18), prisoners, pregnant women, mentally
disabled persons, or economically or educationally disadvantaged persons?
_____Yes _____No
If Yes, what, if any, additional
safeguards have been included to protect the rights and welfare of these
subjects?
6. Does the research involve any of the following?
a.
Major changes in diet or exercise?
____Yes ____No If Yes,
describe:
b.
Administration of physical stimuli other than auditory and visual
stimuli associated with normal classroom activities? ____Yes
____No If Yes, describe:
c.
Use of a new medical device?
____Yes ____No If Yes,
describe:
d.
Possible invasions of privacy of subjects, or their families, including
use of personal or medical information?
____Yes ____No If Yes,
describe:
e. Any probing for information that might be considered personal or
sensitive, or might make a subject
feel demeaned, embarrassed, appreciably anxious, or his or her privacy
violated? ____Yes ____No If Yes,
describe:
f. Any procedure involving invasion of the body, i.e., touching, contact, attachment to instruments, withdrawal of specimens? ____Yes ____No If Yes, describe:
g.
Presentation to the subject of any materials that he/she might find offensive, threatening or
degrading? ____Yes ____No
If Yes, describe:
h. Describe any other possible risks not
mentioned above.
7.
For any procedures involving potentially substantial risks to the physical,
psychological or social welfare of the human subjects, explain why your
selected methodology is preferable to or outweighs any alternative approaches.
8. If there are any substantial risks cited
above, assess their likelihood and seriousness.
a.
Describe the procedures for protecting against or minimizing these
risks.
b. Describe alternative and accepted
procedures or methods of treatment, if any were considered, and why they will
not be used.
c. Describe why these risks are reasonable
in relation to the anticipated benefits.
H. CONFIDENTIALITY OF DATA:
Specify
the steps to be taken to guard the anonymity of subjects and/or the
confidentiality of their responses. Safeguards to protect confidentiality
should be spelled out in the consent
form and should include a description of the ultimate disposal of
data.
1.
Will your data be treated as confidential?
_____Yes _____No If Yes,
explain:
2. How will your data be stored? Locked in department and then destroyed? Security maintained for further study? Other?
3. Will you gather information from a subject
while a recording (visual and/or aural) is taking place? ____Yes
____No If Yes, explain what safeguards will be employed to protect confidentiality
of data, i.e., coding, removal of identifiers, limitation of access to data,
locked file cabinets, black out of faces, etc.
Also complete question #4: (You will need special permission for taping
outlined in the consent form.)
4. Will the tapes be used for: ______ research
purposes ; ______educational purposes?
(Check
all that apply. Please note, in the case
of educational use it is possible that the subjects might be identified. This must be reflected in the consent form.
I. INFORMED CONSENT:
Informed
consent is necessary for all research involving human subjects and must be
documented. Use of subjects unable to
give personal consent for reasons of age, mental state, legal or other such
status, requires that consent be secured from parents or legal guardians.
Attach a clean original of
the written consent form to this application.
At the end of the review process, this will be stamped with IRB approval
and returned. If presented orally, a
written copy of the oral presentation must be submitted. The Principal Investigator must sign the
consent along with the participant. A
sample consent form and guidelines are part of this application as “Section J
Attachment”.
APPLICATION ENDORSEMENTS
Applications will not be reviewed without the appropriate endorsements.
Principal Investigator:
I certify that a) the information provided for this project is accurate; b) no other procedures will be used in this project; and c) any modifications in this project will be submitted for approval prior to use.
_______________________________________________ _______________________
Signature of Investigator Date
Faculty Supervisor:
I
certify that this project is under my direct supervision and that I am
responsible for insuring that the investigator complies with all provisions of
approval.
________________________________________________ _____________________
Department Chair:
My signature below certifies that I have reviewed this research protocol and that I attest to the scientific merit of this study and the competency of the investigator(s) to conduct the project.
_________________________________________ ___________________
Signature of Department Chair Date
NOTE: APPROVAL OF THIS PROJECT BY THE IRB ONLY
SIGNIFIES THAT THE PROCEDURES ADEQUATELY PROTECT THE RIGHTS AND WELFARE OF THE
SUBJECTS AND SHOULD NOT BE TAKEN TO INDICATE UNIVERSITY APPROVAL TO CONDUCT THE
RESEARCH
SECTION
J. ATTACHMENT
Requirements
for Informed Consent
Be sure to
provide the prospective subjects with sufficient opportunity to consider
whether or not to participate. Do not
coerce or use undue influence that would affect a subject's decision to
participate. No subject may be involved
in research unless the subject's prior written consent has been obtained. The consent form should be in language that
subjects can easily understand (8th grade level). Review the instructions below before
preparing the consent form. Be sure to
submit an original copy of the consent form as an attachment to the IRB
application.
A well-written
consent form should include the following:
1. statement identifying the researcher as LIU faculty or LIU student fulfilling degree requirements;
2. statement
that the study involves research;
3. statement of
the purpose(s) of the research;
4. time required for the subject's
participation;
5. description of the procedures to be followed
and identification of any that are experimental;
6. description of any reasonably foreseeable
risks or discomforts to the subjects;
7.
description of any benefits to the subject or to others that may
reasonably be expected from the research;
8.
disclosure of appropriate alternative procedures or courses of
treatment, if any, which might be advantageous to the subject;
9.
statement describing the extent to which confidentiality of records
identifying the subject will be maintained;
10.
for research involving more than minimal risk, an explanation as
to whether there will be 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;
11.
an explanation of whom to contact for answers to pertinent questions
about the research and subjects' rights;
12. the name of
the person to contact in the event of a research-related injury to the subject;
and
13.
statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled; the subject may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise entitled; withdrawal will
not effect subject's relationship with LIU or with any other organization or
institution.
When
appropriate, one or more
of the following elements of information should also be provided to each subject:
14.
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) that are currently unforeseeable;
15.
anticipated circumstances under which the subject's participation may be
terminated by the investigator without regard to the subject's consent;
16. any additional costs to the subject that may
result from participation in the research;
17.
consequences of a subject's decision to withdraw from the research and
procedures for orderly termination of participation by the subject;
18.
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
19. approximate
number of subjects involved in the study.
Following is a sample consent form. Using
the items listed above, please
revise this form so that it meets the requirements of your research project. Whenever possible, the consent should be on
institutional letterhead; if not, then the heading shown on the sample should
be used.
LONG ISLAND UNIVERSITY/ (INSERT CAMPUS NAME)
Informed Consent Form for Human Research
Subjects
You
are being asked to volunteer in a research study called (INSERT TITLE OF PROJECT), conducted by (INVESTIGATOR’S NAME, POSITION, DEPARTMENT). The purpose of the research is (SHOULD BE IN LAYMAN’S LANGUAGE).
As
a participant, you will be asked to (DESCRIBE
THE PROCEDURES AND TIME INVOLVED, SITE, DATES, POSSIBLE RISKS AND/OR
DISCOMFORT.) Of these procedures,
the following are experimental (IF
APPLICABLE, LIST EXPERIMENTAL PROCEDURES). While there is no direct benefit to you for participation
in the study, it is reasonable to expect that the results may provide
information of value for the field of (INSERT
FIELD)
Your
identity as a participant will remain confidential. Your name will not be included in any forms,
questionnaires, etc. This consent form
is the only document identifying you as a participant in this study; it will be
stored securely in (IDENTIFY LOCATION)
available only to the investigator (IF
APPLICABLE, LIST OTHERS WHO MAY HAVE ACCESS). Data collected may be destroyed at the end of
a legally prescribed period of time or stored for further research. Results will be reported only in the
aggregate. (EXPLAIN OTHERWISE IF THIS IS NOT THE CASE.) If you are interested in seeing these
results, you will send the principal investigator your name and address on the
enclosed postcard.
For
research involving more than minimal risk, (INCLUDE
SAME INFORMATION DESCRIBED IN SECTION H ABOVE).
(NOTE: REVIEW ITEMS 1 THROUGH 19 ABOVE FOR
ADDITIONAL INFORMATION YOU MAY NEED TO INCLUDE.)
If
you have questions about the research you may contact the investigator, (NAME, OFFICE PHONE) or the department
chair, (NAME, OFFICE PHONE). If you have questions concerning your rights
as a subject, you may contact the Executive Secretary of the Institutional
Review Board, Ms.
Your
participation in this research is voluntary.
Refusal to participate will involve no penalty or loss of benefits to
which you are otherwise entitled, and you may discontinue participation at any
time without penalty or loss of benefits to which you are otherwise entitled.
You
have fully read the above text and have had the opportunity to ask questions
about the purposes and procedures of this study. Your signature acknowledges
receipt of a copy of the consent form as well as your willingness to
participate.
___________________________________________
Typed/Printed
Name of Participant
___________________________________________ ______________
Signature
of Participant Date
__________________________________________
Typed/Printed
Name of Investigator
__________________________________________ ______________
Signature
of Investigator Date