To submit an IRB protocol, please submit this form (for IRB exempt research, please complete and submit Exempt Application. Please complete all 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.
To avoid delays, please be sure to include all supporting, applicable attachments. Incomplete submissions may be returned without review.
ü Recruitment Materials
ü Grant/Contract Application (if funded research)
ü Supplemental Forms
ü Any other documents referenced in the application
ü CITI Human Subject Completion Reports
Approval Period: An IRB protocol may be approved for up to 365 days. In order to obtain continuation approval for additional year, a status report must be submitted to the IRB. The IRB is required to conduct a status review of every approved protocol at least once every 365 days. A protocol may receive up to 4 continuation approvals (i.e., maximum total approval time is five years.) Once a protocol has reached the five-year mark, a new application must be submitted for de novo review.
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
Protocol Submission Form
Version 02.22.12
New Submission Renewal of project that reached 5-yr max - Previous protocol #Project Title:
Anticipated Duration of Study: from to (May state “upon IRB approval”)
Principal Investigator (PI) Information:
The PI is the individual who has absolute responsibility for the overall conduct of all activities involving human subjects, including all technical, compliance and administrative aspects. The PI is responsible for controlling the technical direction and academic quality of the project, 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.
Note: Copy of CITI Human Subject Training Completion Report must be attached for PI/Co-OI and all Key Personnel including faculty advisor.
Principal investigator Information:
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 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 :_____
*Must have a faculty advisor as co-investigator **Email is the primary communication of IRB/ORRC
If there are additional co-investigators or Key Personnel, please complete and attach Additional Key Study Personnel Form
Federal regulations require the IRB to review and approve those components of a grant application or contract proposal related to research involving human subjects to ensure they are congruent with the application/proposal. University at Albany policy extends this review to all funded protocols, whether funded internally or extramurally.
Is this research supported by funding? Yes -- Internal ExternalSource: Sponsor/Agency/Department Name:
NO – SKIP TO SECTION “Research Project Information”
Funded Research Information
If you have applied for funding/have been funded, attach a copy of the grant/contract application
Status:
Awarded Award pending; JIT information has been requested
Other (specify):
PI Name on Award:
Title of Award/Application:
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 Office of Sponsored Funds Grant Administrator Name:
Financial Conflicts of Interest:
University at Albany Investigators in the role of principal investigator, co-principal investigator (and any other Key Study Personnel who play a significant decision-making role in the research study) that conducts or plans to conduct funded research must submit an annual Disclosure of Significant Financial Interests and Obligations to the Office of Sponsored Programs on or before October 1, but no later than:
· submission of an application to an external sponsor, or
· acceptance of any award where there was no prior disclosure submitted for that work, or
· submission of a research protocol for review by the IRB
More Information is available at our website- Human Subjects in Research
If applicable, attach a copy of Disclosure of Financial Interests Form to this application.
Copy attached? Yes No
Research Project Information
Questions Common to All Studies. Complete answers must be provided. While you may reference other documents with supporting information, do not respond solely by stating “see attached.”
A. Is this a multi-site study or being conducted in collaboration or partnership with another institution or community agency?
No Yes if yes, list the other participating institution/agencies and explain the responsibilities and obligations of each site and complete Supplemental Form #15:
B. Will the proposed activities Involve a collaborating external Investigator?
No Yes If Yes - list the other participating institution/agencies and explain the responsibilities and obligations of external investigator and complete Supplemental Form #14:
C. Will the proposed activities be reviewed by IRB of collaborating Institution?
No Yes If yes - STOP - obtain the following information and contact the ORRC for guidance before going further:
name of collaborating institution:
Collaborating Institution IRB contact name/information:
Collaborating Institution IRB contact phone: email:
Please note: For some studies that are to be reviewed by another IRB, an “IRB Authorization Agreement” may be arranged between UAlbany and the collaborating organization to avoid need for multiple reviews for single project.
ORRC use only: Eligible for ceded review? Yes No Initials ______Date______
D. 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):
E. Project Description. Provide a brief and non-technical description of the study using everyday vocabulary)
*****do not use jargon or terms of art or technical language*****
Write project description in style suitable for presentation to a freshman class. IRB members include attorneys, community advocates, business men and women, as well as scientists from many disciplines. if description is not provided in LAYPERSON’S terms, protocol will be returned to you.
Do not reference previously submitted or approved protocols. Each protocol is reviewed independently.
F. purpose and rationale. Provide a brief summary of the background information, state the research question(s), and tell why the study is needed.
G. subjects. Specify number, gender, ethnicity, race, and age range. You should describe the subject population even if your study does not involve direct interaction (e.g., existing records). List any potentially vulnerable populations. Researchers are reminded that additional approvals may be needed from relevant “gatekeepers” to access subjects (e.g., school principals, facility directors, hospital or healthcare system administrators).
anticipated total number of participants
description of each separate population
will any participants be under the age of 18? yes no
H. 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. If pregnant women are excluded, or if women who become pregnant are withdrawn, specific justification must be provided.
I. 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.
describe study design and procedures (you are limited to 1000 characters):
methods (please check all that apply):
questionnaire/survey will it be anonymous? yes no will it be administered by internet/email? yes no
Interview observation focus groups test/task
audio recording video recording/photography secondary data analysis
review of personal files (e.g. school, medical records, etc)
other – please explain:
J. 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. Attach copies of all recruitment materials with this application.
methods (please check all that apply):
TELEPHONE e-mail flyer in classroom
advertisement internet/SOCIAL MEDIA Explain: (e.g., name of site, newspaper, etc.)
K. consent. describe the process of obtaining informed consent from subjects.
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. Attach copies of all consent forms and scripts with this application.
L. Is a Waiver of Documentation of Signed Informed Consent being requested?
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.)
Explain.
ORRC use only: The request is granted / denied by the IRB. Initials ______Date______
M. 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. Is a request to alter or waive element(s) of informed consent being requested?
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.
ORRC use only: The request is granted / denied by the IRB. Initials ______Date______
N. time cost to subjects.
amount of anticipated participation time:
O. incentive information.
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.
P. 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.
Q. 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.
ORRC use only: This study is minimal risk / more than minimal risk. Initials ______Date______
R. 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.
S. 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.