Application

You need a detailed consent form to give people or their representatives the information they need to decide if they want to join your research. You'll find a consent template on the next page. Using our template can help avoid extra paperwork and delays in approving the study.

The contents of the consent template have been organized to facilitate understanding. Consent documents should be written in plain language, excluding technical terms, and generally at an 8th-grade reading level. The reading level can be higher if the planned participant population tends to have a higher literacy rate than the general population. For more information on plain language, go to http://www.plainlanguage.gov/ .

Please note the following:

1. The regulations require consent forms to contain a concise and focused presentation of the key information that is most likely to help potential subjects understand why they might or might not want to participate in a study. The key information must be presented first and must include the following:

a. Identification of the project as a research study and that participation is voluntary

b. Purpose of the research, duration of participation, and a description of research procedures

c. Foreseeable risks or discomforts

d. Expected benefits to subjects or others

e. Alternative procedures or treatments that might benefit the subject

2. Text in [brackets] represents information about your study that you must add.

3. A forward slash (/) indicates that you must select an option specific to your study (e.g., “will/will not” or “I/we”) and remove the remaining option(s).

4. Additional instructions or sample text are provided in boxes.

5. Before you submit your consent document to the IRB, delete this cover page, all brackets, and the boxes. You’ll also need to remove any extra spaces created when the boxes were removed.

6. Please follow the instructions in blue below, revising or providing the information in red. You will need to remove the instructions as you go, including these instructions. The font color of your completed document should be black.

7. The finished document should reflect what you will give to prospective participants.

8. If your study involves multiple types of participants who will complete different procedures (e.g., teachers who will be interviewed and take part in a focus group and administrators who will complete a survey), you will need to create different consent forms for each participant group.

9. When you save your newly created consent documents, please use a file name that clearly identifies the document and the intended audience (e.g., consent(teachers), etc.).

For questions about consent, please contact the IRB at [email protected].

Consent

Provide your study title, ensuring it matches the title you listed on your IRB application. Regarding co-investigators, list any individuals assisting you with your research. If you are a student, do not list your faculty sponsor as a co-investigator. Only list a faculty member if they will be part of a study team.

Title of the Project: [Title]

Principal Investigator: [Your Name, [List your role/affiliation with LU.] [Student/Graduate Student/Doctoral Candidate/Faculty Member/etc.], [Provide the name of your academic school or department (e.g., School of Education, Psychology Department, etc.).] [___], Liberty University

[ Co-investigator(s): Name(s), credentials, institutional affiliation]

Key Information about the Research Study

This is the key information section described beside number one on the previous page. Please complete each bullet point by inserting the required information.

You are invited to participate in a research study. To participate, you must be [List your participant criteria.] [e.g., 18 years old or older, a college student who has completed at least 30 credit hours, etc.].

Things you should know:

· The purpose of the study is to [brief, concise study purpose]. If you choose to participate, you will be asked to [brief, concise study procedures]. This will take approximately [time estimate].

· [Retain and complete the following sentence if your study procedures will involve greater than minimal risk. Otherwise, you may remove it.] Risks or discomforts from this research include [brief, concise description of risks or discomforts].

· [Brief, concise description of potential direct benefits to subjects or statement that subjects are not expected to receive direct benefits].

· Taking part in this research project is voluntary. You do not have to participate, and you can stop at any time.

Please read this entire form and ask questions before deciding whether to participate in this research.

What is the study about and why is it being done?

In one to two sentences and plain language, please list the purpose of your study. Do not include details about your procedures as they will be discussed below.

The purpose of the study is [study purpose].

What will happen if you take part in this study?

* Next, list your study procedures and include expected time estimates for each. You may provide an overall time estimate for total participation at the end of your procedures list if your study involves multiple procedures that will take place during a single visit (e.g., Exercise Science projects).

* If you plan to implement an intervention using a control and experimental group(s), you must notify your participants of how groups will be assigned (randomly or otherwise) and that participants may or may not receive the intervention as part of their participation. If control group participants can receive the intervention after the study has concluded, provide related information.

* If you choose to withhold information about study groups and group assignments, your study will involve deception, and you will need to note this on the Consent page of your IRB application and potentially create and submit a debriefing statement for IRB review.

* For qualitative studies, if participants will be asked to review their interview transcripts, the developed themes, etc. to check for accuracy or confirm agreement (i.e., member checking), please list this as a procedure and include a time estimate. If you use the term member checking, include a description for participant understanding.

* Screening is not considered a study procedure, so it should not be listed below.

* Please do not list reading/signing the consent form as a procedure.

* If your study will involve the collection of photographs/video/artifacts (pictures, drawings, etc.) of or from participants, and you plan to include the photographs/video/artifacts or images of the artifacts in your paper/thesis/dissertation/publication or as part of a future presentation(s), your participants will need to sign a release form allowing you to do so.

If you agree to be in this study, I will ask you to do the following:

1. [First task/procedure (e.g., Participate in an in-person, audio-recorded interview that will take no more than 1 hour.)] [ Be sure to include a time estimate, and if applicable, information about any plans to record (audio/video) participants.]

2. [Second task/procedure (or delete this text)] [ Be sure to include a time estimate, and if applicable, information about any plans to record (audio/video) participants.]

3. [Additional tasks/procedures as needed (or delete this text)] [ Be sure to include a time estimate, and if applicable, information about any plans to record (audio/video) participants.]

How could you or others benefit from this study?

* Select the appropriate option below. Participants should not expect to receive a direct benefit simply from taking a survey or participating in an interview; however, they may receive a direct benefit if the study procedures involve a teaching or therapy intervention, the opportunity to obtain training they would not receive if they did not participate, etc.

* You will also need to provide information about the expected benefits to society/your discipline/the literature.

[Option 1: No Direct Benefits] Participants should not expect a direct benefit from participating in this study.

[Option 2: Direct Benefits] The direct benefits participants should expect from participating in this study include [description of the expected benefits].

Benefits to society include [description of expected benefits to society/your discipline/the literature].

What risks might you experience from being in this study?

* Select the appropriate option below, considering that risk can be psychological, physical, legal, social, and economical.

* No study is without risk, but studies involving data collection through surveys or interviews are generally considered minimal risk, so option 1 should be retained.

* Individuals participating in studies involving physical activity may risk injury, but if the participants are healthy and fit, such risks are still considered minimal. For this scenario, option 2 should be retained and completed.

* For guidance regarding procedures involving greater than minimal risk (Option 3), please contact the IRB.

[Option 1: Minimal risk] The expected risks from participating in this study are minimal, which means they are equal to the risks you would encounter in everyday life.

[Option 2: Minimal risk, but the possibility of psychological stress exists.] The expected risks from participating in this study are minimal, which means they are equal to the risks you would encounter in everyday life. The risks involved in this study include [Describe any risks, including the likelihood of them occurring.] [(e.g., the possibility of psychological stress from being asked to recall and discuss prior trauma.)]. To reduce risk, [I/the study team] will [Describe the steps you will take to mitigate the risks.] [(e.g., monitor participants, discontinue the interview if needed, and provide referral information for counseling services.)].

[Option 3: Greater than minimal risk] The risks involved in this study include [Describe any risks, including the likelihood of them occurring.] [risk information]. To reduce risk, [I/the study team] will [Describe the steps you will take to mitigate the risks.] [___].

[If your study will involve direct communication with participants and you are a mandatory reporter, this must be disclosed as a risk to participants. Please include the following language:] [I am a mandatory reporter. During this study, if I receive information about child abuse, child neglect, elder abuse, or intent to harm self or others, I will be required to report it to the appropriate authorities.]

How will personal information be protected?

Please read the below definitions before completing this section:

*Anonymous means you, the researcher, cannot link your data (e.g., survey responses, grades, etc.) to the specific participants who provided or are associated with the data.

* Confidential means you can link individual participants to the information they provide or are associated with, but you will not disclose participant identities or how named or identifiable individuals responded.

The records of this study will be kept private. [Include the following sentence if the data will NOT be anonymous.] [Published reports will not include any information that will make it possible to identify a subject.] Research records will be stored securely, and only the researcher[s] will have access to the records.

[Include the following in this section:]

· [Based on your study procedures and the above definitions, retain the applicable statement, and remove the inapplicable statement. If your study will involve both anonymous (e.g., an anonymous online survey) and confidential data (e.g., an interview and focus group), retain both statements and specify which forms of data will apply to each (e.g., Participant responses to the online survey will be anonymous.).] Participant responses [will be anonymous./will be kept confidential by replacing names with pseudonyms/numbers.]

· [Retain the following sentence if you plan to conduct interviews.] [Interviews will be conducted in a location where others will not easily overhear the conversation.].

· [Retain the following information if you will be conducting a focus group(s).] [Confidentiality cannot be guaranteed in focus group settings. While discouraged, other focus group members may share what was discussed with persons outside of the group.]

· [Include the following sentence if the data will NOT be anonymous and the possibility of using the data for future research or sharing the data with another/other researcher(s) exists. If neither is the case, you may delete it.] [Data collected from you may be [used in future research studies] [and/or] [shared with other researchers]. If data collected from you is reused or shared, any information that could identify you, if applicable, will be removed beforehand.]

· [Describe how and where data will be stored, who will have access to it, and if and how the data will be disposed of. If you will have both electronic and hardcopy data, include information associated with both.] Data will be stored [on a password-locked computer/in a locked [drawer/file cabinet]/etc.]. The [researcher/the researcher and members of [his/her] doctoral committee/the study team/etc.] will have access to the data. [After [three/five/seven] years, [all electronic records will be deleted] [and/or] [all hardcopy records will be shredded.]/Data will be retained indefinitely.] [ Note: Data should be retained for at least three years after the completion of your study.]

· [Include the following if you will record participants. Describe where and for how long recordings will be stored, who will have access to them, and when they will be erased.] Recordings will be stored [on a password-locked computer/etc.]. The [researcher/the researcher and members of [his/her] doctoral committee/the study team/etc.] will have access to the recordings. [After [three/five/seven] years/once participants have reviewed and confirmed the accuracy of the recording transcripts], [the recordings will be [deleted/erased.]/Recordings will be retained indefinitely.]

How will you be compensated for being part of the study?

* You may delete this section if participants will not be compensated, and you prefer not to mention the possibility of compensation on this form.

* Please note, compensation is to reimburse participants for their time, effort, or actual costs (e.g., fuel used to travel to and from an interview) spent completing your study procedures.

* If you plan to compensate participants, include payment/reimbursement/incentive information here. If participants will receive class points or some other token, include that information here.

* Include information about when participants will be compensated, the conditions of payment, and whether monetary benefits will be pro-rated if a participant does not complete the study. Because participation in research is voluntary and participants have the right to end their participation during the study if they so choose, if a study involves more than one procedure, compensation should be prorated or even staggered (e.g., $5 to $10 per procedure as opposed to receiving a single payment of $20 or $25 after all procedures are completed.)

* If you are conducting an anonymous, online survey and plan to request participant email addresses using a platform that will pull participants’ email addresses from the survey for compensation and provide them to you in a separate data sheet from the survey responses, include details about how this will occur.

* If you will provide your participants with a meal, snack, or refreshments, include related information below.

Participants [will/will not] be compensated for participating in this study. [If participants will be compensated, include payment/reimbursement/incentive information. Otherwise, remove the remaining information in this paragraph.] [After the [survey/interview/focus group/each procedure/etc.] participants will receive [a $__ [Visa/Amazon/etc.] gift card/three Psychology activity credits/etc.]. [If participants will not be compensated for each procedure, but compensation will be pro-rated, include the following sentence.] [Any participant who chooses to withdraw from the study after beginning but before completing all study procedures will receive [a $__ [Visa/Amazon/etc.] gift card/etc.] [If you will be conducting an anonymous survey and plan to compensate participants, include information about how you will do so without linking participants to their data. Examples include using a survey platform that you can program to pull participant emails from the compensation response field and provide them to you in a separate data form from the survey responses, including a link at the end of the study survey to a separate survey where participants will enter their email addresses for compensation, or including instructions at the end of the survey for participants to email you if they wish to be compensated. ] [Email addresses will be requested for compensation purposes; however, they [will be pulled and separated from your responses by the survey software/will be collected through a separate survey from the study survey/will be collected by email after the survey] to maintain your anonymity.]

What are the costs to you to be part of the study?

Delete this section if it does not apply to the study.

To participate in the research, you must pay for [expected costs (e.g., parking)].

Is the researcher in a position of authority over participants, or does the researcher have a financial conflict of interest?

Include the above heading and applicable below statement if you are in a perceived or actual position of authority over your planned participants (e.g., You are a school principal, and participants will be teachers in the same district.), or you or the organization funding the study may receive a direct financial benefit from the study results (e.g., Delete this section if it does not apply to your study.

[Option 1: Professional/Grading Authority] The researcher serves as [a teacher/professor/supervisor/etc.] at [organization/school/etc.]. [Retain and revise the following sentence if your data collection will be anonymous. Otherwise, remove it.] [To limit a potential or perceived conflict, [Retain the applicable option.] [data collection will be anonymous, so I will not know who participated/a research assistant will ensure that all data is stripped of identifiers before I receive it.] This disclosure lets you decide if this relationship will affect your willingness to participate. No action will be taken against an individual based on his or her decision to participate or not participate in this study.

[Option 2: Financial Interests] The researcher has a financial interest in the outcome of this study. The researcher [Retain the applicable option.] [is a [paid/unpaid] board member of the sponsoring organization/has stock in the sponsoring organization/is listed on a patent associated with this study/has received honoraria or travel reimbursement from the sponsoring organization during the last 12 months]. This study is funded by [sponsoring organization/firm/etc.]. [Sponsoring organization/firm/etc.] will provide [equipment/etc.] for the study. This disclosure is made so you can decide if this relationship will affect your willingness to participate or not in this study.

Is study participation voluntary?

The voluntary participation wording is required for all research. Please review the options in red and select the appropriate options based on your study design.

Participation in this study is voluntary. Your decision whether to participate will not affect your current or future relations with Liberty University [Include the name(s) of any other institution(s) associated with your study from whom you had to gain permission or IRB approval.] [or _____]. If you decide to participate, you are free not to answer any question or withdraw at any time [Insert the following statement if you are only conducting an anonymous survey:] [before submitting the survey] [Delete the statement if your data collection includes additional/other procedures than an anonymous survey.] without affecting those relationships.

The researcher[s] conducting this study [is/are] [your name and the name(s) of any co-researcher(s)]. You may ask any questions you have now. If you have questions later, you are encouraged to contact [him/her/them] at [phone number and/or email]. You may also contact the researcher’s faculty sponsor, [name], at [email].

If you have any questions or concerns regarding this study and want to talk to someone other than the researcher[s], you are encouraged to contact the IRB. Our physical address is Institutional Review Board, 1971 University Blvd., Green Hall Ste. 2845, Lynchburg, VA, 24515; our phone number is 434-592-5530, and our email address is [email protected].

Disclaimer: The Institutional Review Board (IRB) ensures that human subjects research will be conducted ethically as defined and required by federal regulations. The topics covered and viewpoints expressed or alluded to by student and faculty researchers are those of the researchers and do not necessarily reflect the official policies or positions of Liberty University.

Your Consent

Retain the applicable option from the below choices.

[Option 1: Anonymous Data Collection] Before agreeing to be part of the research, please ensure you understand the study. [You will be given a copy of this document for your records/you can print a copy of the document for your records.] If you have any questions about the study later, you can contact the [researcher/study team] using the information provided above. Although you are not required to sign a consent form, if you prefer to do so, please contact the researcher.

If option 1 applies, remove the remaining contents of this document.

[Option 2: All Other Research] You agree to participate in this study by signing this document. Make sure you understand what the study is about before you sign. You will be given a copy of this document for your records. The researcher[s] will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information provided above.

I have read and understood the above information. I have asked questions and have received answers. I consent to participate in the study.

If you will be recording or photographing participants, retain the below checkbox and permission statement and remove the listed methods that do not apply to your study. If you will NOT be recording your participant(s), please remove the checkbox and permission statement.

|_| The researcher has my permission to [Retain the applicable recording information in red and delete the methods you will not use.] [audio-record/video-record/photograph] me as part of my participation in this study.

____________________________________

Printed Subject Name

____________________________________

Signature & Date

Legally Authorized Representative Permission

Delete this section if it does not apply to your study. A legally authorized representative (LAR) is a family member or other individual with the legal authority to make decisions on the part of an adult who is incapable of doing so because of a physical condition or cognitive disability.

By signing this document, you agree to the person below participating in this study. Make sure you understand what the study is about before you sign. You will be given a copy of this document for your records. The researcher[s] will keep a copy with the study records. If you have any questions about the study after you sign this document, you can contact the study team using the information provided above.

I have read and understood the above information. I have asked questions and have received answers. I agree for the person named below to take part in this study.

If you will be recording or photographing participants, retain the below checkbox and permission statement and remove the listed methods that do not apply to your study. If you will NOT be recording your participant(s), please remove the checkbox and permission statement.

|_| The researcher has my permission to [Retain the applicable recording information in red and delete the methods you will not use.] [audio-record/video-record/photograph] the person named below as part of their participation in this study.

_________________________________________________

Printed Subject Name

_________________________________________________

Printed LAR Name and Relationship to Subject

_________________________________________________

LAR Signature Date