Office of Regulatory & Research Compliance
MSC 309 - (Phone) 437-3850 (Fax) 437-3855
IRB Exemption Request Application
Ver 11.01.13.01
Please submit this form to apply for IRB exemption.
To avoid delays, please be sure to include all supporting, applicable attachments.
All research involving human subjects, conducted under the auspices of the University at Albany, by its researchers must receive review and approval by the IRB prior to initiation of the research. Unless otherwise required by the IRB, research activities designated in 45 CFR 46 in which the only involvement of human subjects will be in one or more of the following categories may be considered by exempt review by the IRB:
Exempt Category #: / Category Title:1
/ Investigational Strategies in Educational SettingThis exemption may include children (< age of 18) as participants
Research conducted in established or commonly accepted education settings, involving normal education practices, such as:
ü Research on regular and special education instructional strategies, or
ü Research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
2
/ Surveys/Interviews, Standard Educational Tests, Passive Observations of Public BehaviorResearch involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.
Note: This exemption may include children (< age of 18) as participants ONLY when activity is Passive Observation of Public Behavior when the investigator observes public behavior but does not participate in the behavior or activity.
3
/ Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement);orSurvey, interview, or observation of public behavior ONLY IF:
- 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.
4
/ Existing Research Data, Records Review, Pathological SpecimensResearch involving the collection or study of Existing Research data, documents, records pathological specimens or diagnostic specimens.If these sources are publicly available or if the information is recorded by the PI in such a way that the subject cannot be identified, directly or through identifiers linked to the subject.
Note: data, specimens etc. must exist at the time of the application.
Submissions that do not qualify for exempt review include the following:
- Research involving prisoners;
- Research involving involves multiple procedures, methods, or interactions (e.g., interviews and review of existing research data);
- Research that does not fit into one of the exempt categories listed in 45 CFR 46.
PLEASE DETACH THIS SHEET BEFORE SUBMITTING
/ Institutional Review Board (IRB)Office of Regulatory & Research Compliance
MSC 309- (Phone) 437-3850 (Fax) 437-3855
Date Received / ORRC Assigned : ______
Date: ______
Date of determination: ______
Submission #
IRB Exemption Request Application
Ver 09.02.2015
Project Title:Duration of Study: from to completion date
NOTE: The Completion Date will be the expiration date. Anticipated date can be no longer than 3 years from approval date. If your research is expected to continue beyond 3 years, a renewal will be required at that time.
Recruitment Utilizing Psychology101 Research Pool? Yes No
Please check the category of exemption for which you are applying.
1- -- Investigational Strategies in Educational Setting
2- -- Surveys/Interviews, Standard Educational Tests, Passive Observations of Public Behavior
3- -- Educational Tests
Survey, interview, observation Public Officials
Required by Federal Statute
4- -- Existing Research Data
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: / University at Albany College of Nanoscale Science and Engineering
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
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:
Please answer question # 1 and #2 before completing this 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.
Project Title:Principal Investigator Name:
1. Please provide summary, in layperson’s terms, of the proposed research. This summary is expected to provide an overall snapshot of the intended activity. The description should include:
Project Summary
Research Description
a. Describe all RESEARCH procedures, including tests, recording, observation, collection of data, analysis of existing materials, etc.
b. What types of interactions will occur between investigators and subjects?
c. Where (in what context) will these interactions occur?
d. Criteria for participant selection (i.e., upon what basis will participants be included or excluded?):
e. Who will collect the data?
f. How often will subjects be contacted, and why?
g. How will research results be used (e.g., publications/journals, dissertation, etc.)?
h. Location/data collection site of research
2. Is the information obtained recorded in such a manner that you or anyone else could identify the human participants, directly or through codes or demographic information linked to the participants?
Yes No
3. Will identifiable private information be collected from other sources (e.g., medical records)?
Yes No
Skip this question if research involves only use of Existing Research data.
4. Describe the participants you plan to recruit and the criteria used in the selection process. Indicate if there are any special inclusion or exclusion criteria. Include the expected number of participants and age range.
Describe the plans for the recruitment of participants and how contact will be made.
Skip this question if research involves only use of Existing Research data.
5. Will participants receive compensation or other incentives (e.g., free services, cash payments, gift certificates, parking, classroom credit, travel reimbursement) to participate in the research study? / Yes
No
If Yes à Describe the incentive, including the amount and timing of all payments.
Compensation plans should be pro-rated (not contingent upon study completion) and should consider participation withdrawals, as applicable.
6. Could any disclosure of the human participants’ responses outside the research reasonably place the participants at risk of criminal or civil liability or be damaging to the participants’ financial standing, employability, or reputation?
7. If you are requesting permission to study Existing Research data, documents, records, or specimens (category #4)
a. What are the types of data, documents, records, or specimens?
b. What is the source of the data, documents, records, or specimens?
c. Are the data, documents, records, or specimens publicly available (i.e., can the general public obtain the data or specimens? Data are not considered publicly available if access is limited to researchers or is password protected or requires certain data use agreements)?
i. If the data, records, or specimens are not publicly available, are you required to obtain permission to access these? Yes No If the answer is “yes,” attach a copy of the correspondence granting you permission.
d. If using Existing Research datasets how are data recorded? (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.)
e. Are all data in existence as of the date the exemption application is submitted to the IRB?
No -- If No, over what time period will these be collected, from what source, and who will collect the data?
If No, this form should not be used unless this project qualifies for a “no human subjects” determination Otherwise, this project must be submitted for expedited review.
If Yes, List the date range of records to be studied:
8. Additional Information, Clarification, or Comments for the IRB Reviewer:
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:
1