Institutional Review Board (IRB)
Office of Regulatory & Research Compliance
MSC 309 - (Phone) 437-3850(Fax) 437-3855
orrc@albany.edu
Institutional Review Board (IRB)
Protocol Submission
Ver 11.01.13
To submit an IRB protocol for review, please submit this form. Be sure to:

Complete all applicable sections. Do not reference other sections for your responses
(e.g., “see section…” or "see attached…")

Submit signed, hard copy of application (we cannot accept electronic submissions).
Handwritten submissions cannot be accepted and will be returned to you without being
reviewed.

Include all applicable supporting attachments. Incomplete submissions may be
returned without review.
 Recruitment Materials
 Supplemental Forms
 All documents/appendices referenced in the application
 CITI Human Subject Completion Report for each investigator
To avoid delays, please be sure to include all supporting, applicable attachments.
If you have any questions or need assistance in completing your application, please feel free to
contact the Office of Regulatory & Research Compliance. Staff members are available to assist
and guide you through the review and approval process.
Please remove this page before submitting protocol
Institutional Review Board (IRB)
Office of Regulatory & Research Compliance (ORRC)
University at Albany, MSC 309
(Phone) 518-437-3850 (Fax) 518-437-3855 (E-mail) irb@albany.edu
Date Received
ORRC Assigned : JG ___ TR ___
AB___
Date: _______________
Submission #
Date of determination: ________________
IRB Protocol Submission
Ver 11.01.13.01
De novo submission at end of 5th year
New Submission
Replacing Protocol #
Approval Period: Non-exempt IRB protocols are approved for up to 1 year (12 month), and may be renewed annually for up to 5
years. A new application must be submitted and reviewed, de novo, at the end of the 5th year if that activity is still ongoing.
Project Title:
Duration of Study:
from
to anticipated completion date
Recruitment Utilizing Psychology 101 Research Pool?
Yes
No
The Principal Investigator (PI) is the individual who has absolute responsibility for the overall conduct of all activities involving
human subjects, and for ensuring the project is carried out in compliance with the terms, conditions, and policies of the sponsor, the
IRB, and the University at Albany. For student protocols, UAlbany requires that a faculty advisor serve as co-investigator.
Copy of CITI Human Subject Training Completion Report must be attached for PI/Co-PI and all key personnel.
Principal investigator Information:
Name
Affiliation:
Must be UAlbany
Position and Title:
Address:
Phone:
Department
University at Albany
College of Nanoscale Science and Engineering
The Neural Stem Cell Institute
Other (specify):
Faculty
Staff
UAlbany Undergraduate Student
UAlbany Graduate Student
Other specify : (
) TITLE:
E-mail Address
must be UAlbany domain email address
CITI Completion Report Attached?
Yes
No
ORRC Use ONLY:
Verified :_____
Co-Principal investigator: (Individual designated to oversee research in PI’s absence and Faculty Advisor, when PI is Student)
Name
Affiliation:
Position and Title:
Address:
Phone:
Department
University at Albany
College of Nanoscale Science and Engineering
Stem Cell Institute
Other (specify):
Faculty
Staff
UAlbany Undergraduate Student
UAlbany Graduate Student
Other specify : (
)
TITLE:
The Neural
E-mail Address:
CITI Completion Report Attached?
Yes
No
ORRC Use ONLY:
Verified :_____
If there are additional co-investigators or Key Personnel, please complete and attach Additional Key Study Personnel Form
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Funded Research Studies
Is this research supported by funding?
Source:
Yes
Internal
External
NO – SKIP TO Question #1, below.
Sponsor/Agency/Department Name:
Funding Information:
Status:
Awarded
Award pending; JIT information has been requested
Other (specify):
PI Name on Award:
Title of Award/Application [Must be identical to protocol/exemption title]:
PI’s Affiliation or Institution:
University at Albany
The Neural Stem Cell Institute
Other (specify):
College for Nanoscale Science and Engineering
University at Albany Grant/Award Number:
University at Albany COEUS IP Number:
Office of Sponsored Programs Grant Administrator Name:
RESEARCH PROJECTS INVOLVING EXTERNAL (NON-UALBANY) COLLABORATORS
Please answer question # 1 and #2 before completing this protocol submission.
1.
WILL THE PROPOSED STUDY INVOLVE A COLLABORATING EXTERNAL ORGANIZATION?
NO
YES
IF NO – CONTINUE TO QUESTION #2
IF YES -- NOTE: For some collaborative studies, an “IRB Authorization Agreement” may be arranged between UAlbany and the
collaborating organization to avoid need for multiple reviews for single project.
PLEASE REFER TO AND COMPLETE AN IRB AUTHORIZATION REQUEST FORM BEFORE PROCEEDING AND CONTACT THE
OFFICE OF REGULATORY & RESEARCH COMPLIANCE.
2.
WILL THE PROPOSED ACTIVITIES INVOLVE A COLLABORATING INDIVIDUAL EXTERNAL INVESTIGATOR?
NO
YES
IF NO – CONTINUE TO COMPLETE THIS SUBMISSION FORM.
IF YES -- NOTE: AN INDIVIDUAL EXTERNAL INVESTIGATOR AGREEMENT REQUEST MUST BE SUBMITTED FOR EACH EXTERNAL INDIVIDUAL
LISTED IN THE PROTOCOL SUBMISSION.
PLEASE REFER TO AND COMPLETE AN INDIVIDUAL EXTERNAL INVESTIGATOR REQUEST FORM BEFORE PROCEEDING AND
CONTACT THE OFFICE OF REGULATORY & RESEARCH COMPLIANCE.
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RESEARCH PROJECT INFORMATION
A. WILL RESEARCH FINDINGS BE DISSEMINATED? (E.G. JOURNALS, DISSERTATION, ETC.):
YES
NO
IF YES, IDENTIFY:
IF NO, PLEASE STATE PURPOSE OF RESEARCH (E.G. CLASS PROJECT ONLY, ETC.):
B. PROJECT DESCRIPTION. - A BRIEF, NON-TECHNICAL DESCRIPTION OF THE STUDY. DO NOT USE JARGON OR TERMS OF
ART OR TECHNICAL LANGUAGE. WRITE PROJECT DESCRIPTION IN STYLE SUITABLE FOR PRESENTATION TO A FRESHMAN
CLASS. IF NOT PROVIDED IN LAYPERSON’S TERMS, SUBMISSION WILL BE RETURNED UNREVIEWED.
This section should provide an overview of the study in layperson’s language.
C. PURPOSE AND RATIONALE.
PROVIDE A BRIEF SUMMARY OF THE BACKGROUND INFORMATION, STATE THE RESEARCH QUESTION(S), AND TELL WHY THE STUDY
IS NEEDED.
Please provide a description that includes information about the importance of the subject area; the principal
research questions to be answered or hypotheses to be tested; how the study results will be used, when applicable,
why the study is necessary;
D. HUMAN PARTICIPANTS/SUBJECTS.
SPECIFY NUMBER, GENDER, ETHNICITY, RACE, AND AGE RANGE FOR EACH SUBJECT POPULATION.
EVEN IF THE STUDY DOES NOT INVOLVE DIRECT INTERACTION (E.G., EXISTING DATA).LIST ANY VULNERABLE POPULATIONS (I.E..
CHILDREN, PRISONERS, ADULTS WITH COGNITIVE IMPAIRMENT, ETC.)
Describe the demographics of the study population in terms of sex, age, race, ethnicity, and age, and provide the
expected sample size. If there are multiple populations, describe the specific demographics for each population.
ANTICIPATED TOTAL NUMBER OF PARTICIPANTS
DESCRIPTION OF EACH SEPARATE POPULATION:
VULNERABLE PARTICIPANTS?
NO
YES
PLEASE DESCRIBE:
E. INCLUSION/EXCLUSION CRITERIA.
LIST REQUIRED CHARACTERISTICS OF POTENTIAL SUBJECTS, AND THOSE THAT PRECLUDE ENROLLMENT OR INVOLVEMENT OF
SUBJECTS OR THEIR DATA. JUSTIFY EXCLUSION OF ANY GROUP, ESPECIALLY BY CRITERIA BASED ON GENDER, ETHNICITY,
RACE, OR AGE.
Describe the social/behavioral or biomedical characteristics of the subject sample that will be recruited. Specify age
range and, where applicable, conditions/syndromes, ethnicity, etc. For example: “female Canadians, aged 18 and
older, who are currently enrolled in a pottery class.”
F. FULL DESCRIPTION OF THE STUDY DESIGN, METHODS AND PROCEDURES.
DESCRIBE THE RESEARCH STUDY. DISCUSS THE STUDY DESIGN AND PROCEDURES. BE SURE TO PROVIDE SEQUENTIAL
DESCRIPTION OF WHAT SUBJECTS WILL BE ASKED TO DO, HOW DATA ARE TO BE COLLECTED (E.G., QUESTIONNAIRE,
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INTERVIEW , FOCUS GROUP, ETC.), AND WHO WILL COLLECT DATA. INDICATE THE NUMBER AND DURATION OF CONTACTS WITH
EACH SUBJECT AND FOLLOW-UP PROCEDURES.
The study design and procedures should describe, step by step, what subjects will be asked to do, how data will be
collected (e.g., questionnaire, interview, focus group, etc.), and who will collect the data. The number and duration of
contacts with each subject and follow-up procedures should be included. All study materials, including data
collection tools (surveys, data collection sheets, etc.) must be included with the protocol submission and related
supplemental forms should be completed.
DESCRIBE STUDY DESIGN AND PROCEDURES :
G. DATA COLLECTION METHODS - PLEASE CHECK ALL THAT APPLY.
QUESTIONNAIRE/SURVEY
FOCUS GROUPS
ADMINISTERED BY INTERNET/EMAIL
AUDIO RECORDING
VIDEO RECORDING
INTERVIEW
OBSERVATION
TEST/TASK
REVIEW OR ANALYSIS OF EXISTING DATA
USE OF EXPERIMENTAL EQUIPMENT OR DEVICE (NOT AUDIO OR VIDEO)
OTHER – PLEASE EXPLAIN:
H. RECRUITMENT.
DESCRIBE RECRUITMENT METHODS. DESCRIBE HOW HUMAN SUBJECTS WILL BE CONTACTED AND BY WHOM, WHAT THEY WILL
BE TOLD ABOUT THE STUDY (PROVIDE THE SCRIPT) AND HOW THEY WILL BE SELECTED FOR PARTICIPATION. A COMPLETE
DESCRIPTION OF HOW SUBJECT INFORMATION WILL BE OBTAINED SHOULD BE INCLUDED, IF APPLICABLE. ATTACH COPIES OF
ALL RECRUITMENT MATERIALS WITH THIS APPLICATION.
Recruitment methods and processes, including location, timing, persons conducting the recruitment, screening
processes, and any materials to be used, need to be described and/or provided.
If potential subjects’ contact information will be obtained, a complete description of how it will be obtained should be
provided.
A detailed, step-by-step description of how subjects will be approached to solicit interest in the study is required;
e.g., “subjects will be approached in the lobby of the Spectrum Theater and asked …”
METHODS (PLEASE CHECK ALL THAT APPLY):
TELEPHONE
E-MAIL
FLYER
ADVERTISEMENT
IN CLASSROOM, MEDICAL/PSYCHOLOGICAL TREATMENT OFFICE, SOCIAL SERVICE OFFICE
-- EXPLAIN
INTERNET/SOCIAL MEDIA EXPLAIN: (E.G., NAME OF NEWSPAPER, WEB SITE, ETC.)
I . INFORMED CONSENT PROCESS.
DESCRIBE WHO WILL BE OBTAINING CONSENT AND FROM WHOM, STEPS THAT WILL BE TAKEN TO MINIMIZE COERCION OR UNDUE
INFLUENCE. IF CHILDREN WILL BE ENROLLED AS SUBJECTS, DESCRIBE THE PROVISIONS FOR OBTAINING PARENTAL
PERMISSION AND ASSENT OF THE CHILD. IF DECISIONALLY IMPAIRED ADULTS ARE TO BE ENROLLED, DESCRIBE THE PROVISION
FOR OBTAINING SURROGATE CONSENT FROM A LEGALLY AUTHORIZED REPRESENTATIVE (LAR). IF NON-ENGLISH SPEAKING
PEOPLE WILL BE ENROLLED, EXPLAIN HOW CONSENT IN THE NATIVE LANGUAGE WILL BE OBTAINED. ADDRESS BOTH WRITTEN
TRANSLATION OF THE CONSENT AND THE AVAILABILITY OF ORAL INTERPRETATION. IT IS EXPECTED THAT THE INFORMATION IN
THE CONSENT DOCUMENT(S) WILL BE COMMUNICATED TO PARTICIPANTS OR THEIR LAR.
Informed consent is required for expedited and full protocols, unless the requirement is waived by the IRB.
The investigator should describe a process which:
 gives a subject adequate information concerning the study;
 provides adequate opportunity for the subject to consider all options;
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responds to the subject's questions;
ensures that the subject has comprehended this information;
obtains the subject's voluntary agreement to participate;
and continues to provide information as the subject or situation requires.
Describe the process of obtaining informed consent from subjects. Attach copies of all consent forms and
scripts with this application.
J. IS A W AIVER OF DOCUMENTATION (I.E., SIGNED INFORMED CONSENT) REQUESTED?
The requirement to obtain signatures of participants may be waived by IRB. This is typical and recommended for
UA research when the researcher is not otherwise collecting participant identifiers.
YES
NO
IF YES, PLEASE CHECK ONE BELOW AND EXPLAIN:
THE ONLY RECORD LINKING THE SUBJECT AND THE RESEARCH WOULD BE THE CONSENT DOCUMENT AND THE
PRINCIPAL RISK WOULD BE POTENTIAL HARM RESULTING FROM A BREACH OF CONFIDENTIALITY (E.G., STUDY TOPIC IS
SENSITIVE SO THAT PUBLIC KNOWLEDGE OF PARTICIPATION COULD BE DAMAGING.
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 (E.G. PHONE SURVEY.)
JUSTIFICATION:
K. IS A REQUEST TO ALTER OR WAIVE ELEMENT(S) OF INFORMED CONSENT BEING REQUESTED
THE IRB MAY APPROVE A CONSENT PROCEDURE WHICH OMITS OR WHICH ALTERS SOME OR ALL OF THE ELEMENTS OF
INFORMED CONSENT. A PRINCIPAL INVESTIGATOR MAY REQUEST A WAIVER OF ONE OR MORE ELEMENTS OF INFORMED
CONSENT BY INDICATING THIS REQUEST TO THE IRB?
An example of research that might be eligible for IRB approval of waiver of elements of informed consent is research
involving deception. Please consult with ORRC staff for more information on informed consent waivers.
YES
NO
IF YES, THE REQUEST MUST BE ACCOMPANIED BY A COMPLETE EXPLANATION/JUSTIFICATION IN RESPONSE TO ALL FOUR
STATEMENTS BELOW:
1. IDENTIFY THE ELEMENT(S) THAT FOR WHICH A REQUEST TO ALTER OR WAIVE IS SOUGHT.
2. THE PROPOSED RESEARCH PRESENTS NO MORE THAN MINIMAL RISK OF HARM TO SUBJECTS. MINIMAL RISK
MEANS THAT THE PROBABILITY AND MAGNITUDE OF HARM ARE NOT GREATER THAN THOSE ORDINARILY
ENCOUNTERED IN DAILY LIFE OR DURING ROUTINE EXAMINATIONS OF THE GENERAL POPULATION. THE IRB WILL
DETERMINE WHETHER A RISK IS MINIMAL.
3. THE WAIVER OR ALTERATION OF CONSENT WILL NOT ADVERSELY AFFECT THE RIGHTS AND WELFARE OF THE
SUBJECTS.
4. THE RESEARCH COULD NOT PRACTICABLY BE CARRIED OUT WITHOUT THE WAIVER OR ALTERATION.
"IMPRACTICABLE" IS NOT AN INCONVENIENCE OR INCREASE IN TIME OR EXPENSE TO THE INVESTIGATOR OR
INVESTIGATION, BUT RATHER IT IS FOR INSTANCES IN WHICH THE ADDITIONAL COST WOULD MAKE THE RESEARCH
PROHIBITIVELY EXPENSIVE OR WHERE THE IDENTIFICATION AND CONTACT OF THOUSANDS OF POTENTIAL
SUBJECTS, WHILE NOT IMPOSSIBLE, MAY NOT BE FEASIBLE FOR THE ANTICIPATED RESULTS OF THE STUDY.
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5. W HENEVER APPROPRIATE, THE SUBJECTS WILL BE PROVIDED WITH ADDITIONAL PERTINENT INFORMATION AFTER
PARTICIPATION.
THE IRB WILL DETERMINE WHETHER ALTERATION OR WAIVER IS APPROPRIATE AND PERMISSIBLE FOR THE PARTICULAR
PROTOCOL UNDER REVIEW.
L. TIME COST TO SUBJECTS.
Investigators should address all time spent by subjects completing the study procedures, e.g., .5 hour each week
over the course of five weeks, approximately four hours at the study site, etc.
AMOUNT OF ANTICIPATED PARTICIPATION TIME:
M. INCENTIVE INFORMATION.
The intent of compensation to research subjects is for their time and inconvenience, not for the risk associated with
their research participation. Note: it is not a “benefit.”
W ILL SUBJECTS BE PAID OR OTHERWISE COMPENSATED FOR RESEARCH PARTICIPATION?
YES
NO
IF YES, DESCRIBE THE NATURE OF ANY COMPENSATION TO SUBJECTS. INCLUDE CASH, GIFTS, CLASS CREDIT, ETC. AND
INDICATE METHOD OF PAYMENT (E.G. CHECK, GIFT CARD, ETC.). W HEN AND HOW IS COMPENSATION PROVIDED TO
SUBJECT(S)?
EXPLAIN.
LIST PRO-RATING FOR COMPENSATION/INCENTIVES FOR STUDY PARTICIPANTS WHO WITHDRAW.
N. BENEFITS TO SUBJECTS AND/OR SOCIETY.
DESCRIBE ANY POTENTIAL FOR DIRECT BENEFIT TO INDIVIDUAL SUBJECTS, AS WELL AS THE BENEFIT TO SOCIETY BASED ON
SCIENTIFIC KNOWLEDGE TO BE GAINED; THESE SHOULD BE CLEARLY DISTINGUISHED. CONSIDER THE NATURE, MAGNITUDE,
AND LIKELIHOOD OF ANY DIRECT BENEFIT TO SUBJECTS. IF THERE IS NO DIRECT BENEFIT TO THE INDIVIDUAL SUBJECT, SAY SO
HERE AND IN THE CONSENT FORM (IF THERE IS A CONSENT FORM). DO NOT LIST MONETARY PAYMENT OR OTHER
COMPENSATION AS A BENEFIT.
O. FULL DESCRIPTION OF RISKS AND MEASURES TO MINIMIZE RISKS.
INCLUDE ANY RISK OF PSYCHOSOCIAL HARM (E.G., EMOTIONAL DISTRESS, EMBARRASSMENT, BREACH OF CONFIDENTIALITY),
ECONOMIC HARM (E.G., LOSS OF EMPLOYMENT, LOSS OF PROFESSIONAL STANDING WITHIN THE COMMUNITY), LEGAL
JEOPARDY (E.G., DISCLOSURE OF ILLEGAL ACTIVITY OR NEGLIGENCE), RISK OF PAIN OR PHYSICAL INJURY, OR BREACH OF
CONFIDENTIALITY. DESCRIBE WHAT WILL BE DONE TO MINIMIZE THESE RISKS. DESCRIBE PROCEDURES FOR FOLLOW-UP,
WHEN NECESSARY, SUCH AS MEDICAL OR PSYCHOLOGICAL REFERRAL.
P. DATA MONITORING AND ANALYSIS.
TELL HOW THE QUALITATIVE AND/OR QUANTITATIVE DATA WILL BE ANALYZED. DESCRIBE THE PROVISIONS FOR MONITORING
THE DATA TO ENSURE THE SAFETY OF PARTICIPANTS.
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Q. DESCRIPTION OF PROVISIONS FOR SUBJECT CONFIDENTIALITY.
DESCRIBE THE PHYSICAL AND VIRTUAL MEASURES YOU WILL USE TO REASONABLY ENSURE THAT UNAUTHORIZED ACCESS TO
IDENTIFIABLE STUDY DATA DOES NOT OCCUR. DESCRIBE A PLAN FOR DATA RETENTION AND DISPOSITION. RESEARCH DATA FOR
UNFUNDED RESEARCH MUST BE KEPT FOR AT LEAST THREE YEARS; DATA FOR FUNDED RESEARCH MUST BE KEPT FOR AT
LEAST SIX YEARS.
ADDITIONAL FORMS THAT MAY BE REQUIRED
Please complete and submit the applicable SUPPLEMENTAL FORM(S), below, with all other required attachments
together with this primary form.
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Research involving Sensitive Topics (e.g., Sexual Behavior, Illegal Conduct, etc.)
Research using Deception
Electronic/On-Line Data Collection
Data collection using Focus Groups
Research conducted in International Settings
Research involving Children as Participants
Use of the Psychology 101 Participant Pool
Research involving use of Experimental Equipment
Oral History or Ethnographic/Naturalistic Research
Use of Secondary/Existing Data
Research Conducted at UAlbany Campus as Data Collection Site
Research involving use of Human Tissue Samples
All Supplemental Forms are located on the IRB Forms Page of the ORRC website.
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Principal Investigator Certification:
As PRINCIPAL INVESTIGATOR, I certify that the information provided above is accurate and complete to the best of my
knowledge.
As principal investigator, I have ultimate responsibility for the conduct of this study, the ethical performance of the
project, the protection of the rights and welfare of human subjects and strict adherence to any stipulations designated by
the IRB. I agree to comply with all UAlbany policies and procedures, as well as with all applicable Federal, State and local
laws regarding the protection of human subjects in research.
_____________________________________________
Principal Investigator Signature
_________________
Date
Printed Name:
Co-Principal Investigator (and, when applicable -- Faculty Advisor) Certification:
As Co- PRINCIPAL INVESTIGATOR, I share the responsibility for the conduct of this study, the ethical performance of the
project, the protection of the rights and welfare of human subjects and strict adherence to any stipulations designated by
the IRB. I agree to comply with all UAlbany policies and procedures, as well as with all applicable Federal, State and local
laws regarding the protection of human subjects in research.
(When applicable--if also Faculty Advisor)
I will guide the student in the development of the protocol, and be accountable for ensuring that student researcher is
aware of his/her responsibilities as investigator, and for ensuring that the IRB is immediately notified in the event of
research-related, unanticipated events or findings during the study that would affect the risks or benefits of participation.
_____________________________________________
_________________
Co-Principal Investigator Signature
Date
Printed Name:
Co-Principal Investigator (and, when applicable -- Faculty Advisor) Certification:
As Co- PRINCIPAL INVESTIGATOR, I share the responsibility for the conduct of this study, the ethical performance of the
project, the protection of the rights and welfare of human subjects and strict adherence to any stipulations designated by
the IRB. I agree to comply with all UAlbany policies and procedures, as well as with all applicable Federal, State and local
laws regarding the protection of human subjects in research.
(When applicable--if also Faculty Advisor)
I will guide the student in the development of the protocol, and be accountable for ensuring that student researcher is
aware of his/her responsibilities as investigator, and for ensuring that the IRB is immediately notified in the event of
research-related, unanticipated events or findings during the study that would affect the risks or benefits of participation.
_____________________________________________
Co-Principal Investigator Signature
_________________
Date
Printed Name:
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