Category II:	Institutional	Review Board EXPEDITED Protocol	Application for Use of Human	Participants in Research

Applicant Information

Title of Protocol:

Title

Name of Lead Principal Investigator (PI):

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Co-Investigator (If Applicable)

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Department:

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Campus Address:

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Email:	Phone:

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PI’s Status (Check Box):

Has another IRB reviewed this protocol?

☐ Yes	☐ No

If yes, please identify the institute where the IRB approval is and which institution will serve as the primary institution for IRB Review (if applicable):

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Is the principal investigator or any co-investigator affiliated with another institution?

☐ Yes	☐ No

If yes, please identify the institute where the PI or any Co-investigator are affiliated with (if applicable):

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Are you certified through CITI for the Social/Behavioral course?

☐Yes (Certifications expire after 3 years)	☐ In Progress

Undergraduate and Graduate Student Applicants:

Student researchers serving as PI’s, please provide the following information about your faculty/sponsor (research advisor). Students may NOT submit applications without their sponsor’s approval.

Research Sponsor’s Name	Department	Email	Social/Behavioral CITI Training Completed
Click or tap here to enter text.	Click or tap here to enter text.	Click or tap here to enter text.	☐Yes ☐ In Progress
Click or tap here to enter text.	Click or tap here to enter text.	Click or tap here to enter text.	☐Yes ☐ In Progress

Co-Investigator and Research Staff

Are there co-investigators or research staff (other faculty, staff, undergraduate students, graduate students) working with you?

☐Yes (If yes please complete Appendix B on the next page)	☐ No

Appendix Form B:

Complete this form only when applicable to your project. Add rows to this form in the event that you need the extra space. If you have not yet identified the undergraduates or graduate students to be involved with the study, under Name type a description of the students (e.g., “upper-division undergraduates”). When you are finished, save this file in Word, Rich Text Format, or Adobe format.

Send it with your application to irb@cortland.edu.

Co-Investigators: List all co-investigators. Every co-investigator assumes equal responsibility for the execution of the study and all co-investigators must sign Appendix Form A – Investigator Assurance.
Name	Institution, Address, Email, Phone Number	Degree/Field	Social/Behavioral CITI Training Completed (yes/in progress)
☐Yes ☐ In Progress
☐Yes ☐ In Progress
Graduate Student Research Assistants (Note: CITI Training is required for all graduate students engaged in research)
Name	Department	Role on the project	Social/Behavioral CITI Training Completed (yes/in progress)
☐Yes ☐ In Progress
☐Yes ☐ In Progress
Undergraduate Student Research Assistants (Note: Level of research methods training and IRB training should be commiserate with the degree of risk identified in the protocol and the level of direct, continuous supervision).
Name	Department	Role on the project	Research Methods Training	Social/Behavioral CITI Training Completed (yes/in progress)
☐Yes ☐ In Progress
☐Yes ☐ In Progress

Project Information

Project type (Place an “X” next to the statement that best describes the purpose of this research):

☐Pilot data for a grant/fellowship proposal or R & D

☐Thesis or dissertation research (Complete thesis box below)

☐Program evaluation that will be disseminated off Campus Technology Services

☐Pre-submission review for a grant proposal or fellowship application (data collection is	contingent upon finding)

☐Other (please explain below):

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If you selected thesis/dissertation, please provide contact information for your committee chair below:

Name	Email	Phone	College/University where your degree will be awarded:
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Project Period

(Can indicate a period up to one year); place an X in the “From” or “To” boxes on the left, OR type the exact start and end dates in the boxes on the right)

☐ From: Date of IRB Approval	☐ To: One year after Approval

Project Start Date:

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Project End Date:

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Project Funding (Place an “X” next to the statement that best describes the funding source for this research):

☐Not Funded

☐Applying/applied for funding

☐Internal Funding (e.g. department, UUP, Research Foundation)

☐External Funding from a Government Source

☐External Funding from a Private Source

☐Other (explain in space below):

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If funded, provide agency and grant/contract number:

Agency	Grant/Contract Number

Category II Expedited Sections

Abbreviated section titles appear below; read the full text of each section number before choosing a section (see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html). Investigators make a preliminary decision, in consideration of all procedures from recruitment through dissemination. After reading the protocol, the IRB Administrator makes a final determination concerning the review category and section number appropriate for the study. All requests for waivers or exceptions are considered by the Full Board, as required by federal regulations

Indicate by typing an “X” into the box on the left the requested section of review. If your study does not fit one of these categories, it CANNOT be reviewed as exempt.

☐	1.	Clinical studies of drugs and medical devices (limitations apply)
☐	2.	Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture (time and volume limits apply)
☐	3.	Prospective collection of biological specimens for research purposes by noninvasive means (see examples)
☐	4.	Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice (see limitations and examples)
☐	5.	Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (some of this research will be exempt, see definition of minimal risk)
☐	6.	Collection of data from voice, video, digital, or image recordings made for research purposes (see definition of minimal risk)
☐	7.	Research on individual or group characteristics or behavior (see examples); survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies (some of this research will be exempt, see definition of minimal risk)

Research Procedures Involving Specific Risks to be Documented

The conditions listed below often require additional documentation or may involve a different category of review. Check a box to alert the IRB when a condition listed below applies to the study (mark an X next to all that apply):

☐	Questions are of a sensitive or controversial nature; given the standards of the Cortland community, the research would likely be viewed as controversial; or the research may generate public concern.
☐	Questions are asked involving any kind of activity that may be illegal, illicit, unethical or are violations of institutional policy; OR participants' responses, if known outside of research could increase risk of civil/criminal liability or damage financial standing or employability (this includes the recreational use of drugs/alcohol).
☐	Research involves the use of equipment (ranging from playground or camp equipment to experimental apparatus) that may or may not be attached to participants.
☐	Deception is used or debriefing is necessary to check the participants' wellbeing (physical or psychological) or protect their welfare.
☐	Procedures are used that involve assignment to groups, the manipulation of subjects' behavior or responses, an intervention, or any procedure intended to change the participant's opinions, thoughts, feelings, or behavior.
☐	Procedures involves the assessment of mental health status, a questionnaire allowing the diagnosis of a mental illness (DSM-IV axis 1 or axis 2), or the survey asks questions about suicidal ideation or suicide attempts.

Study Purpose and Procedures

Study Purpose

Describe the purpose of this study, the objectives, aims, gap in knowledge the study addresses, and/or the rationale for performing the study.

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Research Design:

Begin this section with a statement describing the design of your study. Be sure to explain the study type, (eg. experimental, descriptive, ethnography), methodology, variables, etc. Define technical terms so that all members of the IRB can understand.

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Research Protocol:

Explain the procedures of your study; explain what you plan to ask participants to do, include scripts and instructions that will be given to participants, (as appendices), along with other details about how you plan to execute the research activities. Describe the procedures chronologically, beginning with advertisement and recruitment to the end of the participants’ involvement in the study. Note that the IRB cannot approve a study in concept. The application must have enough detail to understand precisely how the research will be executed. A well-written protocol contains sufficient detail so that another researcher in your field could replicate your procedures.

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Email to irb@cortland.edu a copy of all instructions to participants, scripts, surveys, measurement instruments, stimuli, etc.

Assessment of Anticipated Benefits

In the space below, describe the anticipated benefits to participants (directly or indirectly), to science, and/or benefits to society. Incentives for participation should not be listed as a benefit.

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Assessment of Risk

The term risk is defined as the probability of harm or injury (physical, psychological, social, or economic). To assess risk, investigators should be able to (1) describe potential risks or discomforts; (2) estimate the probability of the risk; and (3) assess the severity (mild, moderate, severe), should that risk occur. Use the OHRP's definition of minimal risk as the benchmark; minimal risk is when the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Using the definition of minimal risk stated above, choose the statement that best describes this study:

☐ Research involving less than minimal risk

☐ Research involving no more than minimal risk

☐ Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual participants

☐ Research involving greater than minimal risk, but presenting no prospect of direct benefit to the individual participants, but likely to yield generalizable knowledge about the participants' disorder or condition

☐ Research involving greater than minimal risk that does not fit any of the above conditions

Nearly all research activities pose at least some risk to participants. Identify and describe, in the space below, reasonably foreseeable risks associated with this research (for some studies, e.g., survey research, reasonably foreseeable risks may be confined to confidentiality risk). For each risk, explain what precautions, safeguards, and alternatives have been incorporated into the research activity to reduce the probability and magnitude of discomfort or harm. Expedited research activities, by definition, must pose no more than minimal risk to participants.

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Recruitment and Participant Selection

In the space below, describe the social demographics of your target population. Include all important defining characteristics of your potential sample. In particular, specify any on-campus or community groups from which you will recruit (for example, SUNY Cortland faculty, staff, students; students at Cortland JSHS; members of the Cortland Chamber of Commerce, etc.) and explain any relationship you have with that group, past or present (if applicable).

Target Demographic	Click or tap here to enter text.
Target sample size (If the study has multiple phases, include a target sample size for each phase.)	Click or tap here to enter text.

Classification of Recruitment Procedures

Place an “X” in the box that applies to this study, and send all recruitment materials to the IRB for review before implementation. The IRB highly recommends that all investigators read the instructions concerning participant recruitment, as recruitment issues are the most common source of delays in gaining approval.

Issues relating to the relationship among the investigators and the individuals targeted for recruitment:

☐ This study involves no contact with participants (e.g., use of existing data)

☐ Recruitment is targeted at individuals who will remain anonymous during recruitment and are individuals not already known to the investigators (e.g., random digit dialing, newspaper advertisement, flyers posted, etc.)

☐ Recruitment is targeted at individuals already known to the investigators (e.g., the use of students in the investigator’s course; employees of the college). Provide a detailed explanation in the Procedures section.

☐ Recruitment is targeted at individuals not already known to the investigator, but are known to another group or organization who will assist with recruitment. Provide a detailed explanation in the Procedures section.

Issues relating to how the participants will volunteer for the study:

☐ The participant responds by signing-up or showing-up at the date/time/location where data collection will occur.

☐ The participant responds by providing the investigator with contact information to schedule an appointment at a later time.

☐ The participant is solicited by a third party (e.g., another professor, school principal, director or owner of a business or recreational facility) and the participant responds by contacting the investigator.

☐ Other (please explain):

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Issues regarding the use of inclusion/exclusion criteria:

Defining the appropriate group of participants for a research project involves a variety of factors - requirements of scientific design, susceptibility to risk, likelihood of benefit, practicability, and considerations of fairness. IRBs are required to make a specific determination that the selection of participants is equitable. Do you plan to use any inclusion or exclusion criteria to select participants for this study?

☐ Yes (If you marked "yes," state the criteria and justification in the box below. Type inclusion and/or exclusion criteria; provide a scientific justification for any inclusion/exclusion criteria used)

☐ No

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Note: Send copies of ALL recruitment materials (flyers, email, advertisements, parent information sheets, etc) as an email attachment to irb@cortland.edu.

Informed Consent

(Please attach any/all Consent/Assent forms/statements you plan to use for IRB review as appendices to: irb@cortland.edu)

Are you requesting a waiver to document informed consent? This is when a researcher provides all of the elements of informed consent but does not collect signed consent forms. This IS typically requested for online surveys or in the case of otherwise anonymous research, where signed consent forms could increase the risk to participants (from breach of confidentiality).

☐ Yes	☐ No

If you marked yes, provide a justification in the box below

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Are you requesting a waiver to provide informed consent or withhold elements of informed consent? In this case, you are asking to omit administering some or all of the elements of informed consent (e.g., unobtrusive observation or studies that involve the use of deception). This is rarely granted by the IRB without significant justification, and extensive safeguards for participants.

☐ Yes	☐ No

If you marked yes, provide a justification in the box below

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Incentives and Remuneration for Participation

Part A: Incentives and Remuneration

If you are using incentives or remunerations, explain what you will be giving, how much and when it will be given. If the research is required for course credit or for extra credit, explain how the incentive will be offered without undue influence (also complete Part B). If you plan to provide monetary awards of any kind (including cash, gifts, or gift certificates) please check with Research and Sponsored Programs, your funding agency, or the Business Office to make sure promises are not made to participants that cannot be kept. If you will not be using incentives or remuneration, simply enter “N/A” in the space below.

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Research Involving Students as Participants – Alternate Assignments

Part B: Alternate Assignments

If participation is required for a course or if participation is offered as extra credit, the principle investigator assures that all professors involved with participant recruitment or data collection have agreed to provide an alternate assignment for their classes that meet the federal requirements:

☐ Yes	☐ No

If you marked No, explain in the box below.

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Participant Expenses (with or without reimbursement)

Part C: Expenses and Reimbursement

☐ Yes, participants will incur expenses to participate (if yes, explain in the space below)

☐ No, participants will not incur expenses to participate

In the box below, outline any expenses the participant will incur because of their involvement with this study. If participants are being reimbursed for expenses (e.g., mileage to and from the research location, parking, child care, etc.) outline the expenses and state the amount of reimbursement.

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Privacy and Confidentiality

Mark an “X’ in the box next to each that applies to this study:

☐ Paper documents/records

☐ Audio recording, video recording, or photographs

☐ Recording of physiological data

☐ Biological specimens

☐ Internet-based survey (provide location of planned web site in the box below) Computer administered survey that is not online

☐ Other (if other was checked, provide information about your method of recording participant responses in the box below)

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Identifying Participant Response

If you intend on using surveys in your protocol, please refrain from using Google Forms or Google Docs. Use the campus supported Formstack or Select Survey to create your survey. If you have any questions on an alternative survey creator you plan to use, please contact Joshua Peluso.

Mark an “X” next to the circumstance below that applies to your study (mark one):

☐ Anonymous, no participant identifiers will be collected (not at any point during the research).

(Note that audio and video- recordings of participants cannot be considered anonymous)

☐ Indirect link to participant identifiers: Identifiers will permit an indirect link to participants (i.e., a code will be assigned to the data and a key linking the code to the identity of the participant exists somewhere, either temporarily or permanently).

☐ Indirect link to participant identifiers: Open-ended interview format or open-ended questions on a survey may unintentionally elicit identifying participant responses (questions may elicit the names of individuals, places, events, objects that could identify an individual or group); this could also occur when investigating the doctor/patient or client/therapist relationship, a context where personal information may be inadvertently or unintentionally recorded.

☐ Direct link to participant identifiers: Participant identifiers will be maintained with the data (i.e., personal or private information about the participants are associated with the data, either temporarily or permanently). In box directly below, explain and justify direct link to participant identifiers, state how long they will be kept.

☐ Other (explain in box below):

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If identifiers are collected, temporarily or permanently, include information about where identifiers will be kept, how long identifying information will be kept and when identifying information will be destroyed. Below, explain how open-ended data will be purged of any unintentional identifying information revealed (names of people, places, events, etc).

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Storage of Data and Privacy After Research Participation is Complete

Will data be transported from a data collection site to the college or other location (in paper or electronic format)?

☐ Yes	☐ No

(If yes, in the box below, explain how the data will be transported in a way that protects the participants’ privacy)

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Data will be stored in which formats (Mark an “X” next to ALL that apply):

☐ In paper format

☐ In electronic format (on a desktop computer or on a campus server).

☐ On a portable device (e.g., laptop, portable hard drive)

☐ On the internet (off-campus server). Indicate the programs and servers used in the box below:

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☐ Other (explain in space below):

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Consent forms will be stored in which formats (mark an “X” next to all that apply):

☐ In paper format

☐ In electronic format (on a desktop computer or on a campus server).

☐ On a portable device (e.g., laptop, portable hard drive)

☐ On the internet (off-campus server). Indicate the programs and servers used in the box below:

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☐ Other (explain in space below):

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Data and consent forms (if documented) will be retained in this (these) format(s) for (mark an “X” next to longest time that applies):

☐ Three years after study completion (minimum required by federal, state, and SUNY guidelines

☐ Seven years after study completion (required for most federally funded research)

☐ Other (explain in the box below):

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Where will the data and consent forms be permanently stored?

☐ On-campus, faculty-staff locked office/laboratory

☐ On-campus other location (specify in box below):

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☐ Off-campus location (specify in box below):

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Reporting of Research Results

Place an “X” in the boxes that apply:

☐ Dissemination is at the group level (e.g., group means, standard deviations) so that individual responses (people, places, objects, and events, including participating K-12 schools or the college will) could not necessarily be identified

☐ Dissemination includes reporting and/or describing individual responses that could identify the names of participants or their acquaintances, the location of data collection, etc. (justify this procedure and explain consent process below)

If the questions in this section did not completely describe your document handling/storage procedures, in the space below explain how the participants’ privacy, confidentiality, or anonymity will be protected. If you plan to disseminate responses in a way that would identify the place of data collection, individual students or groups of students, faculty, the community, etc. provide an explanation and justification in box below.

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Additional Information or Documents

The box below is reserved for any additional information you wish to provide.

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You can email any additional documents you would like to provide to: irb@cortland.edu. (See note at the bottom of this form regarding required documents.