Marketing Strategies on Sport Mangement Degree

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IRB-Application.docx

APPLICATION FOR THE USE OF HUMAN RESEARCH PARTICIPANTS

IRB APPLICATION #:       (To be assigned by the IRB) ______________________________________________________________________________

I. APPLICATION INSTRUCTIONS

1. Complete each section of this document by using your tab key to move your cursor to each gray form field and providing the requested information.

2. If you have questions, hover over the blue (?) , or refer to the IRB Application Instructions for additional clarification.

3. Review the IRB Application Checklist.

4. Email the completed application, with the following supporting documents (as separate word documents) to [email protected]:

a. Consent Forms, Permission Letters, Recruitment Materials

b. Surveys, Questionnaires, Interview Questions, Focus Group Questions

5. If you plan to use a specific Liberty University department or population for your study, you will need to obtain permission from the appropriate department chair/dean/coach/etc. Submit documentation of permission (email or letter) to the IRB along with this application and check the indicated box below verifying that you have done so.

6. Submit one signed copy of the signature page (available on the IRB website or electronically by request) to any of the following:

a. Email: As a scanned document to [email protected]

b. Fax: 434-522-0506

c. Mail: IRB 1971 University Blvd. Lynchburg, VA 24515

d. In Person: Green Hall, Suite 2845

7. Once received, the IRB processes applications on a first-come, first-served basis.

8. Preliminary review may take up to 3 weeks.

9. Most applications will require 3 sets of revisions.

10. The entire process may take between 1 and 2 months.

11. We cannot accept applications in formats other than Microsoft Word. Please do not send us One Drive files, Pdfs, Google Docs, or Html applications. Exception: The IRB’s signature page, proprietary instruments (i.e., survey creator has copyright), and documentation of permission may be submitted as pdfs.

Note: Applications and supporting documents with the following problems will be returned immediately for revisions:

1. Grammar, spelling, or punctuation errors

2. Lack of professionalism

3. Lack of consistency or clarity

4. Incomplete applications

**Failure to minimize these errors will cause delays in your processing time** ______________________________________________________________________________

II. BASIC PROTOCOL INFORMATION

1. STUDY/THESIS/DISSERTATION TITLE (?)

Title:      

2. PRINCIPAL INVESTIGATOR & PROTOCOL INFORMATION (?)

Principal Investigator (person conducting the research):      

Professional Title (Student, Professor, etc.):      

School/Department (School of Education, LUCOM, etc.):      

Phone:      

LU Email:      

Check all that apply:

|_| Faculty

|_| Online Graduate Student

|_| Staff

|_| Residential Undergraduate Student

|_| Residential Graduate Student

|_| Online Undergraduate Student

This research is for:

|_| Class Project

|_| Master’s Thesis

|_| Scholarly Project (DNP Program)

|_| Doctoral Dissertation

|_| Faculty Research

|_| Other:      

If applicable, indicate whether you have defended and passed your dissertation proposal:

|_| N/A

|_| No (Provide your defense date):      

|_| Yes ( Proceed to Associated Personnel Information )

3. ASSOCIATED PERSONNEL INFORMATION (?)

Faculty Chair/Mentor(s):      

School/Department:      

Phone:      

LU/Other Email:      

4. USE OF LIBERTY UNIVERSITY PARTICIPANTS (?)

Do you intend to use LU students, staff, or faculty as participants OR LU student, staff, or faculty data in your study?

|_| No ( Proceed to Funding Source )

|_| Yes (Complete the section below)

# of Participants/Data Sets:      

Department/Source:      

Class(es)/Year(s):      

Department Chair:      

Obtaining permission to utilize LU participants (check the appropriate box below):

SINGLE DEPARTMENT/GROUP: If you are including faculty, students, or staff from a single department or group, you must obtain permission from the appropriate Dean, Department Chair, or Coach and submit a signed letter or date/time stamped email to the IRB indicating approval to use students from that department or group. You may submit your application without having obtained this permission; however, the IRB will not approve your study until you provide proof of permission.

|_| I have obtained permission from the appropriate Dean/Department Chair/Coach and attached the necessary documentation to this application.

|_| I have sought permission and will submit documentation to the IRB once I receive it from the appropriate Dean/Department Chair/Coach.

MULTIPLE DEPARTMENTS/GROUPS: If you are including faculty, students, or staff from multiple departments or groups (i.e., all sophomores or LU Online), the IRB will need to seek administrative approval on your behalf.

|_| I am requesting that the IRB seek administrative approval on my behalf.

5. FUNDING SOURCE (?)

Is your research funded?

|_| No ( Proceed to Study Dates )

|_| Yes (Complete the section below)

Grant Name/Funding Source/Number:      

Funding Period (Month & Year):      

6. STUDY DATES (?)

When do you plan to perform your study? (Approximate dates for collection/analysis):

Start (Month/Year):       Finish (Month/Year):      

7. COMPLETION OF REQUIRED CITI RESEARCH ETHICS TRAINING (?)

List Course Name(s) (Social and Behavioral Researchers, etc.):

     

Date(s) of Completion:      

III. OTHER STUDY MATERIALS AND CONSIDERATIONS

8. STUDY MATERIALS LIST (?)

Please indicate whether your proposed study will include any of the following:

Recording/photography of participants (voice, video, or images)?

|_| Yes |_| No

Participant compensation (gift cards, meals, extra credit, etc.)?

|_| Yes |_| No

Advertising for participants (flyers, TV/Radio advertisements)?

|_| Yes |_| No

More than minimal psychological stress?

|_| Yes |_| No

Confidential data collection (participant identities known but not revealed)?

|_| Yes |_| No

Anonymous data collection (participant identities not known)?

|_| Yes |_| No

Archival data collection (data previously collected for another purpose)?

|_| Yes |_| No

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

|_| Yes |_| No

The inclusion of pregnant women (for medical studies)?

|_| Yes |_| No

More than minimal risk?*

|_| Yes |_| No

Alcohol consumption?

|_| Yes |_| No

Protected Health Information (from health practitioners/institutions)?

|_| Yes |_| No

VO2 Max Exercise?

|_| Yes |_| No

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

|_| Yes |_| No

Use of blood?

|_| Yes |_| No

Total amount of blood:

     

Blood draws over time period (days):

     

The use of rDNA or biohazardous material?

|_| Yes |_| No

The use of human tissue or cell lines?

|_| Yes |_| No

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

|_| Yes |_| No

Use of radiation or radioisotopes?

|_| Yes |_| No

*Note: Minimal risk is defined as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in everyday life or during the performance of routine physical or physiological examinations or tests. [45 CFR 46.102(i)]. If you are unsure if your study qualifies as minimal risk, contact the IRB.

9. INVESTIGATIONAL METHODS (?)

Please indicate whether your proposed study will include any of the following:

The use of an investigational new drug (IND) or an approved drug for an unapproved Use?

|_| No

|_| Yes (Provide the drug name, IND number, and company):      

The use of an investigational medical device or an approved medical device for an unapproved Use?

|_| No

|_| Yes (Provide the device name, IDE number, and company):      

IV. PURPOSE

10. PURPOSE OF RESEARCH (?)

Write an original, brief, non-technical description of the purpose of your research. Include in your description your research hypothesis/question, a narrative that explains the major constructs of your study, and how the data will advance your research hypothesis or question. This section should be easy to read for someone not familiar with your academic discipline:      

V. PARTICIPANT INCLUSION/EXCLUSION CRITERIA

11. STUDY POPULATION (?)

Provide the inclusion criteria for the participant population (e.g., gender, age range, ethnic background, health status, occupation, employer, etc.):      

Provide a rationale for selecting the above population (i.e., Why will this specific population enable you to answer your research question?) :      

Will your participant population be divided into different groups (i.e., experimental and control groups) ?

|_| No

|_| Yes (Describe the groups and explain how groups will be selected/assigned.):      

Are you related to any of your participants?

|_| No

|_| Yes (Explain):      

Indicate who will be excluded from your study population (e.g., persons under 18 years of age):      

If applicable, provide rationale for involving any special populations (e.g., children, ethnic groups, individuals with impaired decision-making ability or low socio-economic status, or prisoners):      

Provide the maximum number of participants you plan to enroll for each participant population and justify the sample size (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, submit a Change in Protocol Form and wait for approval to proceed.):      

ANSWER THE FOLLOWING QUESTION ONLY IF YOU ARE CONDUCTING A PROTOCOL WITH NIH, FEDERAL, OR STATE FUNDING:

Researchers sometimes believe their particular project is not appropriate for certain types of participants. These may include, for example, women, minorities, and children. If you believe your project should not include one or more of these groups, please provide your justification for their exclusion. Your justification will be reviewed according to the applicable NIH, federal, or state guidelines:      

12. TYPES OF PARTICIPANTS (?)

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

|_| Normal Participants (Age 18-65)

|_| Pregnant Women

|_| Minors (Under Age 18)

|_| Fetuses

|_| Over Age 65

|_| Cognitively Disabled

|_| College/University Students

|_| Physically Disabled

|_| Active-Duty Military Personnel

|_| Participants Incapable of Giving Consent

|_| Discharged/Retired Military Personnel

|_| Prisoners or Institutional Individuals

|_| Inpatients

|_| Specific Ethnic/Racial Group(s)

|_| Outpatients

|_| Other potentially elevated risk populations

|_| Patient Controls

|_| Participant(s) related to the researcher

Note: Only check the boxes if the participants will be the focus (for example, ONLY military or ONLY students). If they just happen to be a part of the broad group you are studying, you only need to check “Normal Participants.” Some studies may require that you check multiple boxes (e.g., Korean males, aged 65+).

VI. RECRUITMENT OF PARTICIPANTS

13. CONTACTING PARTICIPANTS (?)

Describe in detail how you will contact participants regarding this study (include the method(s) used—email, phone call, social media, snowball sampling, etc.):      

14. SUBMISSION OF RECRUITMENT MATERIALS (?)

Submit a copy of all recruitment letters, scripts, emails, flyers, advertisements, or social media posts you plan to use to recruit participants for your study as separate Word documents with your application. Recruitment templates are available on the IRB website.

Check the appropriate box:

|_| All of the necessary recruitment materials will be submitted with my application.

|_| My study strictly uses archival data, so recruitment materials are not applicable.

If you plan to provide documents in a language other than English:

|_| I will submit a translated copy of my recruitment materials along with the English version(s).

15. LOCATION OF RECRUITMENT (?)

Describe the location, setting, and timing of recruitment:      

16. SCREENING PROCEDURES (?)

Describe any procedures you will use to ensure that your participants meet your study criteria (e.g., a screening survey or verbal confirmation to verify that participants are 18 or older):      

17. CONFLICTS OF INTEREST (?)

Conflicts of interest are “situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator’s judgement in conducting or reporting research” AAMC, 1990.

Do you have a position of academic or professional authority over the participants (e.g., You are the participants’ teacher, principal, supervisor, or district/school administrator.)?

|_| No

|_| Yes (Explain what safeguards are in place to reduce the likelihood of compromising the integrity of the research, e.g., addressing the conflicts in the consent process and/or emphasizing the pre-existing relationship will not be impacted by participation in the research.):      

Do you have any financial or personal conflicts of interest to disclose (e.g., Do you or an immediate family member receive income or other payments, own investments in, or have a relationship with a non-profit organization that could benefit from this research?) ?

|_| No ( Proceed to Procedures )

|_| Yes (State the funding source/financial conflict and then explain what safeguards are in place to reduce the likelihood of compromising the integrity of the research.):      

VII. RESEARCH PROCEDURES

18. PROCEDURES (?)

Write an original, non-technical, step-by-step description of what your participants will be asked to do during your study and data collection process. If you have multiple participant groups, (e.g., parents, teachers, and students) or control and experimental groups, please specify which group you are asking to complete which task(s). You do not need to list signing/reading consent as a step.

Step/Task/Procedure

Time to Complete Procedure

(Approx.)

Participant Group(s)

(All, Group A, Group B, Control Group, Experimental Group, etc.)

1.      

     

     

2.      

     

     

3.      

     

     

4.      

     

     

5.      

     

     

6.      

     

     

7.      

     

     

8.      

     

     

Note: For complex study designs, additional diagrams, timelines, or figures may be submitted separately.

19. SUBMISSION OF DATA COLLECTION INSTRUMENTS/MATERIALS (?)

Submit a copy of all instruments, surveys, interviews questions, outlines, observation checklists, prompts, etc. that you plan to use to collect data for your study as separate Word documents with your application. Pdfs are ONLY acceptable for proprietary instruments.

Check the appropriate box:

|_| All of the necessary data collection instruments will be submitted with my application.

|_| My study strictly uses archival data, so data collection instruments are not applicable.

If you plan to provide documents in a language other than English:

|_| I will submit a translated copy of my study instrument(s) along with the English version(s).

20. STUDY LOCATION (?)

Please state the actual location(s)/site(s) in which the study will be conducted. Be specific (include city, state, school/district, clinic, etc.):      

Note: Investigators must submit documentation of permission from some research sites to the IRB prior to receiving approval. If your study involves K-12 public schools, district-level approval is acceptable as opposed to submitting separate permission documentation from each school. If your study involves colleges or universities, hospitals, or prisons, you may also need to seek IRB approval from those institutions. You may seek permission prior to submitting your IRB application; however, do not begin recruiting participants. If you find that you need a conditional approval letter from the IRB to obtain permission, the IRB will provide one once you have completed all requested revisions.

VIII. DATA ANALYSIS

21. NUMBER OF PARTICIPANTS/DATA SETS (?)

Estimate the number of participants to be enrolled or data sets to be collected:      

22. ANALYSIS METHODS (?)

Describe how the data will be analyzed:      

Please describe what will be done with the data and the resulting analysis (Include any plans for publication or presentation.) :      

IX. PARENTAL/GUARDIAN CONSENT

23. PARENTAL/GUARDIAN CONSENT REQUIREMENTS (?)

Does your study require parental/guardian consent? (If your participants are under 18, parental/guardian consent is required in most cases.)

|_| No ( Proceed to Child Assent )

|_| Yes (Answer the following question)

Does your study entail greater than minimal risk without the potential for benefits to the participant?

|_| No

|_| Yes (Consent of both parents is required)

X. ASSENT FROM CHILDREN

24. CHILD ASSENT (?)

Is 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.)

|_| No ( Proceed to Consent Procedures )

|_| Yes

Note: If the parental consent process (full or part) is waived (See XIII below) assent may be also. See the IRB’s informed consent page for more information.

XI. PROCESS OF OBTAINING INFORMED CONSENT

25. CONSENT PROCEDURES (?)

Describe in detail how and when you will provide consent/assent/parental consent information (e.g., as an attachment to your recruitment email, as the first page participants see after clicking on the survey link, etc.):      

Unless your study qualifies for a waiver of signatures, describe in detail how and when consent forms will be signed and returned to you (e.g., participants will type their names and the date on the consent form before completing the online survey, participants will sign and return the consent forms when you meet for their interview, etc.):      

Note: A waiver of signatures is only applicable if you will not be able to link participant responses to participants (i.e., anonymous surveys). See section XIV below.

XII. USE OF DECEPTION

26. DECEPTION (?)

Are there any aspects of the study kept secret from the participants (e.g., the full purpose of the study, assignment or use of experimental/control groups, etc.) ?

|_| No

|_| Yes (Describe the deception involved and the debriefing procedures.):      

Is deception used in the study procedures?

|_| No

|_| Yes (Describe the deception involved and the debriefing procedures.):      

Note: Submit a post-experiment debriefing statement and consent form offering participants the option of having their data destroyed. A debriefing template is available on our website .

XIII. WAIVER OF INFORMED CONSENT OR MODIFICATION OF REQUIRED ELEMENTS IN THE INFORMED CONSENT PROCESS

27. WAIVER OF INFORMED CONSENT ELEMENTS (?) |_| N/A

Please indicate why you are requesting a waiver of consent (If your reason does not appear as an option, please check N/A. If your reason appears in the drop-down list, complete the below questions in this section) :

Does the research pose no more than minimal risk to participants (i.e., no more risk than that of everyday activities) ?

|_| No, the study is greater than minimal risk.

|_| Yes, the study is minimal risk.

Will the waiver have no adverse effects on participant rights and welfare?

|_| No, the waiver will have adverse effects on participant rights and welfare.

|_| Yes, the waiver will not adversely affect participant rights and welfare.

Would the research be impracticable without the waiver?

|_| No, there are other ways of performing the research without the waiver.

|_| Yes, not having a waiver would make the study unrealistic. Explain:      

Will participant debriefing occur (i.e., Will the true purpose and/or deceptive procedures used in the study be reported to participants at a later date?) ?

|_| No, participants will not be debriefed.

|_| Yes, participants will be debriefed.

Note: A waiver or modification of some or all of the required elements of informed consent is sometimes used in research involving deception or archival data.

XIV. WAIVER OF THE REQUIREMENT FOR PARTICIPANTS TO SIGN THE INFORMED CONSENT DOCUMENT

28. WAIVER OF SIGNED CONSENT (?) |_| N/A

Please indicate why you are requesting a waiver of signatures (If your reason does not appear as an option, please check N/A. If your reason appears in the drop-down list, complete the below questions in this section) :

Would a signed consent form be the only record linking the participant to the research?

|_| No, there are other records/study questions linking the participants to the study.

|_| Yes, only the signed form would link the participant to the study.

Does a breach of confidentiality constitute the principal risk to participants?

|_| No, there are other risks involved greater than a breach of confidentiality.

|_| Yes, the main risk is a breach of confidentiality.

Does the research pose no more than minimal risk to participants (i.e., no more risk than that of everyday activities) ?

|_| No, the study is greater than minimal risk.

|_| Yes, the study is minimal risk.

Does the research include any activities that would require signed consent in a non-research context (e.g., liability waivers) ?

|_| No, there are not any study related activities that would normally require signed consent

|_| Yes, there are study related activities that would normally require signed consent

Are the subjects or their legally authorized representatives (LARs) members of a distinct cultural group or community in which signing forms is not the norm?

|_| No, the subjects/their LARs are not members of a distinct cultural group or community in which signing forms is not the norm.

|_| Yes, the subjects/their LARs are members of a distinct cultural group or community in which signing forms is not the norm, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Will you provide the participants with a written statement about the research (i.e., an information sheet that contains all of the elements of an informed consent form but without the signature lines) ?

|_| No, participants will not receive written information about the research.

|_| Yes, participants will receive written information about the research.

Note: A waiver of signed consent is sometimes used in anonymous surveys or research involving secondary data. This does not eliminate the need for a consent document, but it eliminates the need to obtain participant signatures.

XV. CHECKLIST OF INFORMED CONSENT/ASSENT

29. STATEMENT (?)

Submit a copy of all informed consent/assent documents as separate Word documents with your application. Informed consent/assent templates are available on our website. Additional information regarding consent is also available on our website.

Check the appropriate box:

|_| All of the necessary consent/assent documents will be submitted with my application.

|_| My study strictly uses archival data, so consent documents are not required.

If you plan to provide documents in a language other than English:

|_| I will submit a translated copy of my consent material(s) along with the English version(s).

XVI. PARTICIPANT PRIVACY, DATA SECURITY, & MEDIA USE

30. PRIVACY (?)

Describe the steps you will take to protect the privacy of your participants (e.g., If you plan to interview participants, will you conduct your interviews in a setting where others cannot easily overhear?):      

Note: Privacy refers to persons and their interest in controlling access to their information.

31. DATA SECURITY (?)

How will you keep your data secure (i.e., password-locked computer, locked desk, locked filing cabinet, etc.) ?      

Who will have access to the data (i.e., the researcher and faculty mentor/chair, only the researcher, etc.) ?      

Will you destroy the data once the three-year retention period required by federal regulations expires?

|_| No

|_| Yes (Explain how the data will be destroyed.):      

Note: All research-related data must be stored for a minimum of three years after the end date of the study, as required by federal regulations.

32. ARCHIVAL DATA (SECONDARY DATA) (?)

Is all or part of the data archival (i.e., previously collected for another purpose) ?

|_| No ( Proceed to Non-Archival Data .)

|_| Yes (Answer the questions below.)

Is the archival data publicly accessible?

|_| No (Explain how you will obtain access to this data.):      

|_| Yes (Indicate where the data is accessible from, i.e., a website, etc.):      

Will you receive the raw data stripped of identifying information (e.g., names, addresses, phone numbers, email addresses, social security numbers, medical records, birth dates, etc.) ?

|_| No (Describe what data will remain identifiable and why this information will not be removed.):      

|_| Yes (Describe who will link and/or strip the data—this person should have regular access to the data and should be a neutral party not involved in the study.):      

Can the names or identities of the participants be deduced from the raw data?

|_| No (Place your initials in the box: I will not attempt to deduce the identity of the participants in this study.):      

|_| Yes (Describe):      

Please provide the list of data fields you intend to use for your analysis and/or provide the original instruments used in the study:      

Note: If the archival data is not publicly available, submit proof of permission to access the data (i.e., school district letter or email). If you will receive data stripped of identifiers, this must be stated in the proof of permission letter or email.

33. NON-ARCHIVAL DATA (PRIMARY DATA) (?)

If you are using non-archival data, will the data be anonymous to you (i.e., Raw data does not contain identifying information and cannot be linked to an individual/organization by use of pseudonyms, codes, or other means.)? Note: For studies involving audio/video recording or photography, select “No”

|_| N/A: I will only use archival data. ( S kip to Media .)

|_| No: My data will contain identifiers. ( Complete the “No” section below .)

|_| Yes: My data will not contain identifiers. ( Complete the “Yes” section below .)

**COMPLETE THIS SECTION IF YOU ANSWERED “NO” TO QUESTION 33**

Can participant names or identities be deduced from the raw data?

|_| No

|_| Yes (Describe):      

Will a person be able to identify a subject based on other information in the raw data (i.e., title, position, sex, etc.) ?

|_| No

|_| Yes (Describe):      

Describe the process you will use to ensure the confidentiality of the participants during data collection and in any publication(s) (i.e., You may be able to link individuals/organizations to identifiable data; however, you will use pseudonyms or a coding system to conceal their identities.):      

Do you plan to maintain a list or codebook linking pseudonyms or codes to participant identities?

|_| No (Justify):      

|_| Yes (Please describe where this list/codebook will be stored and who will have access to the list/codebook. Explicitly state that the list will not be stored with the data.):      

**COMPLETE THIS SECTION IF YOU ANSWERED “YES” TO QUESTION 33**

Describe the process you will use to collect the data to ensure that it is anonymous:      

Place your initials in the box: I will not attempt to deduce the identity of the participants in this study:      

Note: If you plan to use participant data (i.e., photos, recordings, videos, drawings) for presentations beyond data analysis for the research study (e.g., classroom presentations, library archive, or conference presentations) you will need to provide a materials release form to the participant.

34. MEDIA USE (?)

Will your participants be audio recorded?

|_| No |_| Yes

Will your participants be video recorded?

|_| No |_| Yes

Will your participants be photographed?

|_| No |_| Yes

**COMPLETE THIS SECTION IF YOU ANSWERED “YES” TO ANY MEDIA USE**

Include information regarding how participant data will be withdrawn if he or she chooses to leave the study*:      

Will your participants be audio recorded, video recorded, or photographed without their knowledge?**

|_| No

|_| Yes (Describe the deception and debriefing procedures.):      

*Note on Withdrawal: Add the heading “How to Withdraw from the Study” on the consent document and include a description of the procedures a participant must perform to be withdrawn.

**Note on Deception: Attach a post-experiment debriefing statement and a post-deception consent form, offering the participants the option of having their recording/photograph destroyed and removed from the study.

XVII. PARTICIPANT COMPENSATION

35. COMPENSATION (?)

Will participants be compensated (e.g., gift cards, raffle entry, reimbursement, food) ?

|_| No ( Proceed to Risks .)

|_| Yes (Describe.):      

Will compensation be pro-rated if the participant does not complete all aspects of the study?

|_| No

|_| Yes (Describe.):      

Note: Certain states outlaw the use of lotteries, raffles, or drawings as a means of compensating research participants. Research compensation exceeding $600 per participant within a one-year period is considered income and will need to be filed on the participant’s income tax returns. If your study is grant funded, Liberty University’s Business Office policies might affect how you compensate participants. Contact the IRB for additional information.

XVIII. PARTICIPANT RISKS AND BENEFITS

36. RISKS (?)

Describe the risks to participants and any steps that will be taken to minimize those risks. (Risks can be physical, psychological, economic, social, or legal. If the only potential risk is a breach in confidentiality if the data is lost or stolen, state that here.):      

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

|_| No

|_| Yes (Describe.):      

ANSWER THE FOLLOWING QUESTION ONLY IF YOUR STUDY IS CONSIDERED GREATER THAN MINIMAL RISK:

Describe provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the participants (e.g., proximity of the research location to medical facilities or your ability to provide counseling referrals in the event of emotional distress):      

37. BENEFITS (?)

Describe the possible direct benefits to the participants. (If participants are not expected to receive direct benefits, please state “No direct benefits.” Completing a survey or participating in an interview will not typically result in direct benefits to participants.):      

Describe any possible benefits to society:      

Evaluate the risk-benefit ratio. (Explain why you believe this study is worth doing, even with any identified risks.):      

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