Office of Regulatory & Research Compliance
MSC 309 - (Phone) 437-3850(Fax) 437-3855
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.
ü Recruitment Materials
ü Supplemental Forms
ü All documents/appendices referenced in the application
ü 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
Date: ______
Date of determination: ______
Submission #
IRB Protocol Submission
Ver 11.01.13.01
New Submission De novo submission at end of 5th year 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 / Department
Affiliation:
Must be UAlbany / University at Albany College of Nanoscale Science and Engineering
The Neural Stem Cell Institute Other (specify):
Position and Title: / Faculty Staff UAlbany Undergraduate Student UAlbany Graduate Student Other specify : () TITLE:
Address: / E-mail Address must be UAlbany domain email address
Phone: / 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 / Department
Affiliation: / University at Albany College of Nanoscale Science and Engineering The Neural Stem Cell Institute Other (specify):
Position and Title: / Faculty Staff UAlbany Undergraduate Student
UAlbany Graduate Student Other specify : ()
TITLE:
Address: / E-mail Address:
Phone: / 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
Is this research supported by funding? Yes Internal External NO – SKIP TO Question #1, below.
Source: 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 College for Nanoscale Science and Engineering
The Neural Stem Cell Institute Other (specify):
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.
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, 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 administered by internet/email Interview observation test/task
focus groups audio recording video recording 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;
§ 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 Waiver 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.
5. Whenever 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.”
Will 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.). When 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.