Application- Human Subjects Research:
Complete ALL items and send hard copy of application and all required materials to Kathy Roberts, SH202

Title of Project
Application Type: / Initial Submission ☐ / Revision ☐
IRB #: ______/ Request for Renewal ☐
IRB #:* ______
Project Proposal Duration / Desired Project Start Date: ______
* End date is one year after application is approved.
Review Category: Check ONE: / Exempt Review☐ / Expedited Review☐ / Full Review☐
Exempt Research Categories (Complete only if applying for an Exempt Review)
Check ONE of the categories of exemption for which you are applying under (see exempt category list). After checking the appropriate box, please complete Parts A, B, D, E, F, H and I.
☐ Category 1 ☐ Category 4
☐ Category 2 ☐ Category 5
☐ Category 3 ☐Category 6
Provide an explanation as to why you believe that the project is exempt from IRB review. The Siena College IRB reserves the right determine whether a project must undergo IRB review.
Principal Investigator (PI):
Campus Phone (xxx.xxxx)
Siena Email
Investigator Status
(please check one): /

Faculty/Staff ☐ Undergraduate ☐ Graduate ☐ Other, Specify: ______

Co-Investigator(s):
Phone- Day
Email
Student Conducted Research under Faculty Supervision

Students conducting research involving human subjects as the PI must do so under faculty supervision. Please complete the information below by providing the name, department and telephone number of the faculty supervisor. The faculty supervisor must also review the proposal and provide approval by signing this form on the signature page (Section I.). The application will not be reviewed unless both the PI (student) and faculty supervisor sign the application.

Type of project: ☐ Group project for course # ______☐ Ind. study ☐ Capstone / Honors Thesis
☐ Summer Scholars ☐ Other (describe):

Faculty Supervisor Name

Department
Office Location
Phone
Email
Students should provide adequate time for the faculty supervisor to assurethat all the necessary materials are included and the application is thorough and completedcorrectly. Failure to provide all required information will delay the review process.
A. Project Description
In the space below, briefly describe your research in which human subjects will be used.Include the following information:
  • Purpose / goal(s) of the research
  • Research methodology:
  • Target population recruitment of participants and/or sources of data. Indicate if participants/data comprise special and/ or vulnerable population(s).
  • Allinstruments that will be used (e.g. surveys, interview questions, tests). Include a copy of the instrument(s) as Appendix A.
  • Data collection methods for each instrument (e.g. online, face to face, etc.).
  • Describe any unique aspects of the research (e.g. location of data collection is outside US, subjects that speak language other than English)
  • Describe how the findings will be disseminated.

Project Funding Source(s) * (provide a copy of the grant proposal, if applicable)
*If investigator is part of a grant from another institution, specify title of grant, investigator’s name, and institutional affiliation.
B. Subject Population
Indicate the type of subject and institutional affiliation of your participants; estimate the total number of human subjects that will be involved in the research, even if the sample size is currently unknown. For archival data of human subjects, please indicate the number of subjects sampled.

Human Subject Type(must be specified in Part A.)

/ #

Adults

Special or vulnerable population:
Minors (17 years of age and younger)
Prisoners
Pregnant Women
Other, please describe: ______
Total Number of Subjects

Organization Type

/

Checkall that apply.

Siena College

/

☐

/
College, Other / ☐ /
School (P-12) / ☐ /

Hospital

/

☐

/
Prison / ☐ /
Other (describe): / ☐ /
C. Subjects
1. How will subjects be identified or chosen (e.g. records, classes, referrals, canvassing)? Be specific. If subjects are chosen from records or recruited through the use of any type of list or roster, indicate the name, title, and institutional/organizational affiliation of the individual who will be responsible forapproving the use of the records. (If subjects are being recruited via records or rosters, please complete section G2 of this application.)
2. How will subjects be initially contacted (e.g. Posting on Social Media, Daily Digest, ads, telephone, letter, sign-up sheets)? Be specific. Please include a copy of the e-mail text and/or the content for your social media posting that will be used in Appendix C.
3. Will subjects receive inducements before or rewards during or after the study? If yes, explain.
4. Will the subject be charged for any research-related procedures? If yes, explain the charges.

D. Research Methods

/

Check all that apply

Obtaining information from archives or files

/

☐

/

Observing

/

☐

/

Interviews

/

☐

/

Focus Groups

/

☐

/

Surveys

Online*………………………………………………………………………………………………………………
Hard copy………………………………………………………………………………………………………..…
* If you do not activate the setting for anonymity, your informed consent document should reflect that the participant’s responses are confidential. Also indicate the use of the setting in Section F.#3. If you choose to use the setting for anonymity, it is possible for participants to submit multiple responses. /

☐☐

Psychometric Testing (e.g. MMPI)

/

☐

/

Interventions/Treatments (e.g. education, training, therapy, behavior modification)

/

☐

/

Subjects be recorded (e.g. audio/ video)?

/

☐ Yes ☐ No

E. Risks Involved
The purpose of this section is to determine whether human subjects involved in the proposed research project will be placed at risk (i.e. “if they may be exposed to the possibility of harm – physical, sociological, or some other potential for harm – as a consequence of any activity which goes beyond the application of those established and accepted methods necessary to meet their needs.”)
In the shaded area to the right hand side of each statement. Indicate:
Y: Yes: If yes, explain the potential risk, the precautions in place to reduce the risk and the procedures that will be used to mitigate the risk should it occur:
N: No
N/A: Does not apply
Does the research for this project involve?
  1. Possible invasion of the privacy of a subject or family, including the use of personal information of records?
If yes, explain: / ☐ Y
☐ N
☐ N/A
  1. The administration of physical stimuli other than auditory and visual stimuli associated with normal classroom situations?
If yes, explain: / ☐ Y
☐ N
☐ N/A
  1. Deprivation of physiological requirements such as nutrition or sleep; manipulation of psychological and/or social variables, e.g. sensory deprivation, social isolation, or psychological stresses?
If yes, explain: / ☐ Y
☐ N
☐ N/A
4a. Deception as part of the experimental procedure?
If yes, explain: / ☐ Y
☐ N
☐ N/A
4b. If yes to 4a, describe how participants will be informed of the deception during the debriefing process.
  1. Any probing for information that an individual might consider personal or sensitive?
If yes, explain: / ☐ Y
☐ N
☐ N/A
  1. The presentation to the subject of any materials that they might find offensive, threatening or degrading?
If yes, explain: / ☐ Y
☐ N
☐ N/A
  1. The requirement of physical exertion beyond normal classroom situations?
If yes, explain: / ☐ Y
☐ N
☐ N/A
  1. Other. Describe any potential risks and the precautions that have or will be taken to minimize them. Use additional sheet if necessary.
If yes, explain: / ☐ Y
☐ N
☐ N/A
F. Confidentiality/ Anonymity
1. Will any data be made a part of a permanent record that can be identified with the subject? If yes, briefly explain.
2. Will the subject’s participation in the study be made a part of any permanent record? Will it be available to a supervisor, teacher or employer? If yes, briefly explain.
3. List the steps that will be taken to ensure confidentiality or anonymity.
G. Informed Consent
Informed consent is necessary forhuman subjectresearch and other activities involving human subjects that do not employ deception. It may be secured in several ways, but the method of obtaining consent must always be documented. The IRB reserves the right, upon review of the research and its attendant risks, to require alternate and/or more stringent means of securing consent if necessary to protect the subject(s).
  1. Describe procedures that will be used to obtain informed consent. Attach any informed consent document(s) as Appendix G1. If you are not obtaining informed consent, justify why it will not be obtained (e.g., an unobtrusive study of naturally occurring public behavior). Click here for Informed Consent Templates.

  1. FOR RESEARCH WORKING WITH PARTNER ORGANIZATIONS: Approval must be obtained from appropriate responsible authorities (e.g. school officials or company/institutional officials) for each organization involved in the research. List each organization below. Attach the official document(s) indicating that permission has been granted as Appendix G2.

H. Storage, Securing, and Disposal of Materials
  1. Describe procedures for storage ofdocuments and/or data collected for the study includingidentifying information (if applicable).
    It is suggested that hard copies of documents and/or data with identifiers be kept in locked cabinets/rooms.

  1. How will documents and/ or data including identifying information (if applicable) be secured?
    Access to electronic files should be password protected. If not removing identifiers, provide justification and a procedure to maintain protection of confidentiality or anonymity.

3. Describe procedures for ultimate disposal of documents and/ or data including identifying information (if applicable) collected for the study.
It is recommended to keep data for a minimum of three years and to remove identifiers as soonas possible.

I. Signaturesand Certifications

I certify that the information concerning the procedures to be taken for protection of human subjects is complete, correct, and factual. As the Principal Investigator, I will seek and obtain prior approval if there is any substantive modification in the protocol and I will report promptly any unexpected or otherwise significant adverse effects encountered in the course of the study. I will also request an extension if the research extends beyond the end date indicated on this application.
Signature of Principal Investigator / Date
Signature(s) of Co-Principal Investigator (s) / Date
FACULTY SUPERVISOR/INSTRUCTOR SIGNATURE: If the PI is a student, the application MUST be reviewed and signed by the faculty supervisor or instructor to indicate knowledge, review, and approval of the proposal. Faculty have a responsibility to carefully review the entire proposal and required affiliated materials (e.g. research instruments, Informed Consent Form, NIH Certificate) for completeness, clarity, and accuracy. The submission of incomplete or incorrectly completed applications will delay the review process.
The application will not be reviewed unless both the PI (student) and faculty member sign the application.
Signature of Faculty Supervisor/Instructor / Date

RevisedMarch 2016
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