Application

Participant Criteria

Please provide additional information about your participants.

What characteristics make an individual  eligible to be in your study (i.e., your inclusion criteria)?

· For example, do your participants have to be 18 or older? Must they work in a specific career or field? Do they have to be part of a specific racial or ethnic group?

· If you will have multiple participant populations/groups, like a teacher group and an administrator group, please list the populations/groups separately and provide the inclusion criteria for each.

· If your participants will necessarily be 18 years old or older due to their occupation (e.g., licensed teachers, military personnel, etc.)

· or another aspect of your criteria (e.g., senior citizens), the 18-or-older age requirement does not need to be listed below.

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What characteristics make an individual  ineligible to be in your study (i.e., your exclusion criteria)?

· For example, will you exclude persons under 18 years of age?

· Note: Exclusion criteria are not simply the inverse of inclusion criteria--these are specific characteristics that would disqualify an individual from participating.

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Are you related to any of your participants?

Yes

No

Types of Participants

Who will be the  focus of your study? (Check all that apply).

Adult Participants (18+)

Minors (under 18 years)

Seniors (65+)

College or University Students

Armed Forces Members (active duty, retired, discharged, etc.)

Persons Residing in the European Union (EU)

Inpatients, Outpatients, or Patient Controls

Pregnant Women

Fetuses

Individuals with Cognitive Disabilities

Individuals with Physical Disabilities

Individuals Incapable of Giving Consent

Prisoners or Institutionalized Individuals

Specific Ethnic or Racial Group(s)

Other Potentially Elevated Risk Populations

Please provide a rationale for selecting the above groups(s).

(i.e., Why will these specific groups enable you to answer your research question? Why is the inclusion of these groups necessary?)

Provide the maximum number of participants you plan to enroll for each participant group.

You will not be approved to enroll a number greater than the number listed. If at a later time it becomes apparent that you need to increase your

sample size, you will need to amend your protocol prior to doing so. As appropriate, sample sizes should be justified in accordance with the study

design and methodology.

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Screening

Please make note of the following guidelines:

· Screening involves ensuring that the individuals who express interest in your study meet your study criteria.

· Screening occurs  before study data is collected from individuals.

· Screening may involve the collection of  some demographic information, but that is not the purpose of screening.

· Screening does not involve deciding who among your screened and consented participants will engage in your separate study procedures.

How and when will you screen your potential participants?

Common options are listed below:

Potential participants will answer screening questions when they talk to me in person/call/email me to express their interest in my study.

Potential participants will click on a link in the recruitment email to a screening survey.

Potential participants will be emailed a link to a screening survey after they contact me to express their interest in my study.

I/a designated official from my study site(s) will identify individuals who meet my study criteria and contact them by email, etc.

I will list my participant criteria in my recruitment document and consent form, but I will not utilize additional screening procedures.

Other (describe):

If you will use a screening survey/questions, please attach your screening document(s) as  separate Word documents* here. 

*If you are using a proprietary screening tool (e.g., PAR-Q), it can be submitted as a PDF.

Attach

Note:  If any screening documents will need to be provided in a different language, the translated documents should also be attached here.

Recruitment of Participants

This section will collect additional information on the recruitment of potential participants.

How will you contact potential participants to recruit them for your study?

Select the recruitment method(s) you plan to use:

Email/Phone

Social Media

Flyer/Handout

In-person/Verbal

Other (describe):

Does your study have a limited recruitment window?

E.g., The study site is a summer camp that is only open for three months out of the year, the site only allows data collection during specific months, etc.

Yes

No

Attach your recruitment documents as  separate Word documents here.

Depending on your above responses, you may need to attach multiple recruitment documents:

· Email(s)

· Letter(s)

· Social media post(s)

· Flyer(s), etc.

Attach

, required

Sample documents:  Recruitment (Flyer)  ,   Recruitment (Email/Letter)  ,   Recruitment (Follow-up)  ,   Recruitment (Verbal)  ,   Recruitment (Social Media

Determination of Consent Waiver Eligibility

The below questions will help us determine if your project qualifies for a waiver of consent, consent elements, or signed consent.

Does your project involve deception?

Deception may include, but is not limited to, the following:

· Withholding the full/true purpose of the study.

· Withholding information about experimental/controls groups.

· Audio/video recording or photographing participants without their knowledge.

Yes

No

Does your project involve anonymous data collection methods?

Anonymous means you will not be able to link individual participants to their personal responses at any time (e.g., anonymous surveys).

Yes

No

Does your project involve a participant population where signing forms is not the norm?

A "yes" response would only apply in very specific situations with certain cultural groups where signing documents could put the person in danger,

or where signing a name would be seen as culturally improper/offensive.

Yes

No

Obtaining Parental Consent and Child Assent

This section will gather details about the parental consent and child assent processes.

Does your study require parental/guardian consent?

If any of your participants are under 18 years of age, parental consent is most likely a requirement.

Yes

No

Is child assent required for your study?

Assent is required unless the child is not capable of assenting due to age, psychological state, or sedation OR the research holds out the prospect of

a direct benefit that is only available within the context of the research.

· Children under the age of 13 should receive a separate child assent form written at their grade level that they can read or that can be read to them.

· Children between the ages of 13 and 17 can provide assent on the parental consent form.

Yes

No

General Data Protection Regulation (GDPR) Consent

This section will gather details about the consent process for persons residing within European Union (EU).

Does your study involve the collection of data from or about persons in the European Union (EU)?

Yes

No

Obtaining Consent

This section will gather details about the consent process.

How and when will you provide consent information to participants?

Depending on your research plan, you may utilize more than one option. As appropriate, please select the method(s) you plan to use:

Consent information will be provided as a Word/PDF attachment to my recruitment email(s).

Consent information will be provided as a Google Form or other online document linked to my recruitment document/sent via a

separate email.

Consent information will be sent as an email attachment  after a potential participant responds by phone/email/private message to

my recruitment call/email/social media post.

Consent information will be provided as the first page participants see after clicking on the survey link/scanning the

QR code embedded in my recruitment email/flyer.

Consent information will be handed to the potential participant(s) in person (i.e., a physical copy) prior to taking part in any study activities.

Other (describe):

How and when will signed consent be obtained?

Most studies will involve either anonymous data collection  or  confidential data collection. However, some may involve both (e.g.,

an anonymous survey and confidential interview). With this in mind, please make the appropriate selection(s) below:

My study involves anonymous data collection methods.

· Anonymous means you will not be able to link individuals to their data at any time.

My study involves confidential data collection methods.

· Confidential means you will be able to link individuals to their data, but will use pseudonyms or codes to conceal identities.

I'm not sure.

Please attach your consent form(s) as  separate Word documents.

If you have multiple participant groups, you may need to submit a consent form for each group.

Attach

Study Design

This section gathers additional information about planned procedures.

Will your study involve any of the following?

Check the applicable boxes.  If none apply, select "N/A."

Extra costs to the participants  (tests, hospitalization, etc.)

Alcohol consumption

Protected Health Information  (from health practitioners/institutions)

VO2 Max Exercise

Pilot study procedures  (which will be published/included in data analysis)

Use of blood

The use of rDNA or biohazardous material

The use of human tissues or cell lines

Fluids that could mask the presence of blood  (including urine/feces)

Use of radiation or radioisotopes

N/A

Procedures

This section will gather additional information about all planned study procedures.

In an ordered list, please describe the procedures for each participant group.

Be concise. Please include time estimates for each procedure. For example:

1. Online survey. 10 minutes.

2. Interview. 30-45 minutes.

If different participant groups are involved,  you must also specify which procedures correspond to each group. For example:

1. Online Survey. 15 minutes. (All participants).

2. Focus Group. 45 minutes. (4-5 participants from Group A).

3. Recorded Interview. 30 minutes. (3 participants from Group B).

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Please attach all of your data collection instruments as  separate Word documents*. *If any of your data collection instruments are proprietary/validated instruments, you may submit them as PDFs.

Possible attachments may include:

· Survey/Questionnaire questions  

· Interview questions

· Observation protocols

· Session outlines

· Prompts

· Checklists

· Educational handouts, etc.

Attach

Note:  If any documents written in a language other than English will need to be provided to participants, the translated documents should also

be attached here. Note: If you are using a survey link, the survey link  must also be provided above using the attach button.

Compensation

For research purposes, compensation involves reimbursing participants for their time and effort spent completing your research procedures. Compensation is 

not the same as benefits to participation, which are addressed later in the application. Please make note of the following guidelines:

· Compensation for students or others in a group setting cannot be offered unless each participant will receive the same amount of compensation for

· each completed procedure. An opportunity involving equal time and effort to receive the same compensation must be made available for individuals

· who choose not to participate.

· Certain states outlaw the use of lotteries, raffles, or drawings as a means of compensating research participants. Your IRB analyst may offer additional

· guidance regarding this matter.

· Research compensation exceeding $600 per participant within a one-year period is considered income and will need to be filed on the participants’

· income tax returns.

· If your study is grant funded, the Office of Sponsored Programs (OSP) policies may affect how you compensate participants.

· Contact the IRB or OSP for additional information.

Will this project involve participant compensation?

Compensation may include gift cards, meals, extra credit, etc.

Yes

No

Study Sites & Permissions

This section with gather information about study locations and any necessary permissions.

Please state the actual location(s)/site(s) at which the study will be conducted. If the study will occur online, state "online/virtual."

Be specific. Include the city, state, school/district name, clinic name, etc.

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Will you need to receive conditional IRB approval before your study location(s) will grant permission?

The conditional IRB approval letter states that a study is ready for complete IRB approval once documentation of permission is received.

Yes

No

Please submit any permission letters you have obtained.

· If you are still in the process of obtaining permission letters, they can be uploaded at a later time.

· If you would like us to review your permission request template(s) or permission letter template(s), please submit those here.

· Acceptable permission documentation includes signed statements on official letterhead and/or time and date stamped email correspondence

·  from an appropriate official/authority. appropriate official/authority.

Attach

Sample documents:  Permission Request  ,   Permission Response

Privacy & Data Analysis

This section will collect additional information about how you plan to protect privacy and analyze your data.

For each procedure you listed in the procedures section, describe the steps you will take to protect the privacy of your participants.

Guidance is provided below:

· If you will conduct interviews, will they take place in a private setting where others cannot overhear the conversation? Where will your interviews occur?

· If you will collect health-related, physical, athletic performance data, or biospecimens, will you do so in a place and manner that allows for participant privacy?

· Examples of data include height, weight, BMI, running speed, and blood samples. Where will your data collection occur?

· If you plan to use online surveys, will you utilize a survey platform that offers adequate security? How does the platform ensure privacy?

· If you plan to use paper surveys, how will the surveys be collected in a manner that will prevent others from viewing individual responses?

· How will they be collected and by whom?

Where will the data be stored and who will have access to the data?

· Examples of  where include a password-locked computer, a locked drawer, a locked filing cabinet, etc.

· Examples of  who include the researcher, the researcher and faculty chair/sponsor, etc. (Student researchers must list their faculty chair/sponsor as

· someone who will have access to the data.)

Will you destroy the data after the retention period ends?

It is strongly advised that data be retained for  a minimum of 3 years  after the study has been completed.

Yes

No

Will you retain the data or biological samples, if applicable, for future research?

Yes

No

How will the data be analyzed?

As applicable to your methodology (i.e., quantitative, qualitative, mixed methods), briefly describe the method(s) you will use to analyze your data.

Please describe any plans you may have for the publication or presentation of your data.

Plans include publication for your thesis or dissertation, if applicable.

Will this project involve the use of archival data or secondary data?

· Archival data is information previously collected for a purpose other than the proposed research. Examples include student grades and patient medical records.

· Secondary data is data that was previously collected for the purpose of research. For example, a researcher may choose to utilize survey data that

· was collected as part of an earlier study.

· If you plan to collect documents from participants or an organization  (e.g., meeting minutes, policies, syllabi, notes, etc.) please choose "yes."

Yes

No

Media Use

This section gathers additional information about any planned use of media and/or audio/video devices.

Will this project involve any of the following?

Check the applicable boxes. If none apply, select "N/A."

Audio recording of participants

Video recording of participants

Taking photographs of participants

N/A

Note: If you would like to use participant documents or photographs in presentations or publications beyond your research,

you will need to have them sign a materials release form.

Does your study involve anonymous data collection methods, confidential data collection methods, or both?

· Confidentiality  means that the researcher can identify participants and link them to their data, but the researcher will not reveal participant identities

· to anyone outside of the study.

· Anonymity  means that although the researcher knows whom he or she invited to participate in his or her study, once the data is collected,

· the researcher cannot link individuals to their personal data. This means that no personally-identifying information can be collected in an anonymous study.

My study involves anonymous data collection methods.

My study involves confidential data collection methods.

My study involves  both  anonymous and confidential data collection methods.

Risks

This section will gather information about any potential risks involved with your project.

No study is without risks. Please check the applicable box(es) for any potential risks associated with your study:

Information risks (e.g., loss of privacy and/or breach of confidentiality if the data is lost or stolen)

Psychological or emotional risks (e.g., fear, stress, guilt, triggering of past emotional experiences, etc.)

Social risks (e.g., social stigma)

Economic risks (e.g., loss of employment or insurability)

Physical risks (e.g., fatigue; pain or discomfort; potential for injury, illness or disease, or death)

Legal risks (e.g., risk of prosecution, mandatory reporting)

Genetic privacy risk (e.g., stigmatization, self-stigmatization, limits to insurance coverage or employability, etc.)

List the steps you will take to minimize each of the risks you’ve just identified above.

For example, data will be stored on a locked computer only accessible to the researcher/study team; study participants will be directly monitored for

any signs of fatigue/illness, etc.

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Will alternative procedures or treatments that might be advantageous to the participants be made available?

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Is this project considered  greater than minimal risk?

Remember, minimal risk means that 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.

Yes

No

Benefits

This section will gather information about any potential benefits involved with your project.

· Direct benefits are those benefits that  the participants may receive from taking part in your study.

· Compensation for participation is not a benefit, so it is not listed in this section.

Please check the applicable box(es) for any direct benefits associated with your study:

Psychological or emotional benefits

Learning benefits

Physical benefits

Diagnostic or therapeutic benefits

Other (describe):

Provide details about the expected direct benefits.

For example, participants will increase their knowledge/skills as a result of the intervention provided; participants will receive a copy of their diagnostic test results, etc.

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· Benefits to society are those benefits that individuals who share characteristics with your participants but were not part of your

· study may receive, along with general benefits to science and humanity.

Provide details about the expected benefits to society.

For example, increased public knowledge on the topic, improved learning outcomes, etc.

Evaluation of Risks and Benefits

This section establishes whether or not the study is worth doing based on the risks and benefits described.

Evaluate the risk-benefit ratio.

Why is the study worth doing, even with any identified risks?

Human Subjects Training Documentation

Note: This upload is  only required for non-affiliated, non-LU personnel. If you are affiliated with LU, we are able to view your CITI training report.

Attach

FinalisedResearchProspectusweek9.docx1.docx

Sample documents:  CITI Program Website

External Investigator Agreement

Note: This upload is  only required for non-affiliated, non-LU personnel. If you are affiliated with LU, you are able to provide certification within the Cayuse system.

Attach

citiCompletionCertificate_10696739_65164090.pdf

Proof of Permission to Use LU Participants, Data, or Groups

Note: If you are  not using LU participants, data, or groups, you do not need to include an attachment here.

Attach

DNP Permission

Note: If you are not in the  Doctor of Nursing Practice Program (School of Nursing), you do not need to include an attachment here.

Attach

Sample documents:  Permission Request  ,   Permission Letter

Screening

Note: If your study  does not involve a screening instrument, you will not need to provide an attachment here.

Attach

Recruitment

Note: If you are strictly using  archival data, you may not need to include an attachment here.

Attach

Sample documents:  Recruitment (Flyer)  ,   Recruitment (Email/Letter)  ,   Recruitment (Follow-up)  ,   Recruitment (Verbal)  ,   Recruitment (Social Media)

Parental Consent

Note: If your study  does not involve minors, you will not need to provide an attachment here.

Attach

Sample documents:  Parental Consent  ,   Parental Opt-Out

Archival Data Forms, Templates, or Collection Sheets

Note: If you are  not using archival data, you will not need to provide an attachment here.

Attach

Archival Data Permission

Note: If you are  not using archival data, you will not need to provide an attachment here.

Attach

Sample documents:  Permission Request  ,   Permission Letter

Data Collection Instruments

Note: If you are  strictly using archival data, you may not need to provide an attachment here.

Attach

Site Permission

Note: If you do not require  external permission(s) to conduct your study, you may not need to provide an attachment here.

Attach

Sample documents:  Permission Request  ,   Permission Response

Child Assent

Note: If your study  does not involve minors, you will not need to provide an attachment here.

Attach

Sample documents:  Child Assent

Consent Templates

Note: If you are  strictly using archival data, you may not need to provide an attachment here.

Attach

Sample documents:  Consent (General)  ,   Consent (Medical)  ,   Consent (Blood Draw)  ,   Information Sheet  ,   Consent (Anonymous Data)  ,   Consent (Confidential Data)

Debriefing

Note: If your study  does not involve deception, you will not need to provide an attachment here.

Attach

Sample documents:  Debriefing

GDPR Consent

Note: If your study  does not involve European Union (EU) residents, you will not need to provide an attachment here.

Attach