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Psychology: Informed Consent Form

Research Title: Factors Influencing Individuals' Decision to Utilize Mental Health in South Texas

Please find attached required Template.

Instructions: Carefully address the directions in that are specified in purple in each section. This document is very important and it represents you, your chair, and the University; therefore, please pay close attention to detail. Ensure there are no spelling or grammatical errors. The form should be written at an eighth grade reading level in layman’s terms. Evaluate the readability using the calculator below, and provide a screenshot of the readability results as a part of your IRB submission.

https://www.webfx.com/tools/read-able/

https://www.online-utility.org/english/readability_test_and_improve.jsp

Please delete these instructions before submitting to the IRB for review.

INFORMED CONSENT FORM

INTRODUCTION

The title of this research study is, “[title of the study]”.

Note: Doctoral learners – please use the following template to introduce yourself – I am “insert your name”, a doctoral student under the supervision of Dr. “insert name of your dissertation Chair” in the College of “insert specific college” at Grand Canyon University. The purpose of this study is to “in no more than 3 sentences, please state your study’s purpose”

RESEARCH

KEY INFORMATION

This document defines the terms and conditions for consenting to participate in this research study.

· How do I know if I can be in this study? Bullet eligibility criteria (inclusion and exclusion) as stated in the IRB application and recruitment materials.

· You can participate in this study if you:

· Inclusion criteria

· You cannot participate in this study if you:

· Exclusion criteria

· What am I being asked to do? If you agree to be in this study, you will be asked to: (List all research activities with duration for each activity).

· What in 1-2 sentences

· When in 1-2 sentences

· Where in 1-2 sentences

· How in 1-2 sentences

Audiotaping: (If applicable)

I would like to use a voice recorder to record your responses. You (can, or, cannot) still participate if you do not wish to be recorded. Briefly describe how the participants’ identity will be protected.

Videotaping: (If applicable)

I would like to use a video camera to record your actions. Because this tape will show who you are, these extra steps will be taken: (describe added security measures, such as how tapes will be securely transported, labeled, stored, deleted, etc.)

You (can, or, cannot) still participate if you do not wish to be recorded. Briefly describe how the participants’ identity will be protected.

· Who will have access to my information? (myself, and/or, my dissertation chair, and/or, other researchers, and/or, my dissertation committee, etc.)

Participation is voluntary. However, you can leave the study at any time, even if you have not finished, without any penalty or loss of benefits to which you are otherwise entitled. If you decide to stop participation, you may do so by: (describe procedure to be followed if the participant wants to leave the study). If so, I (will use, or, will not use) the information I gathered from you.

· Any possible risks or discomforts? State that there are no foreseeable risks or discomforts associated with this study OR list any physical or psychological risks/discomforts. If applicable, explain any procedures that are experimental.

· Any direct benefits for me? State “no” OR state the direct benefits.

· Any paid compensation for my time? State that participants will not get paid for their participation OR explain what they will get and any instructions/information on how and when they will receive their payment/compensation.

· How will my information and/or identity be protected? Will researchers be able to link participant data back to them? Explain if data will have identifiers or not, how will the data be secured and where? How long? Who will have access?

PRESENTATION OF INFORMATION COLLECTED

[In 2-3 sentences, please explain how you will be presenting this data: published? Presented at a conference? Will the data be grouped or will you also include individual data]

NEW INFORMATION

Sometimes during a study we learn new information. This information may come from our research or from other researchers. If new information might relate to your willingness to participate, I will give you that information as soon as possible.

ADDITIONAL COSTS FOR ILLNESS OR INJURY

If you are injured as a result of your participation in this study, treatment will be available to you here: (name and describe the medical location). Additional resources are: (list any that you will provide). Costs that arise from injury or emergency treatment must be paid by you.

TERMINATION OF PARTICIPATION

I may stop your participation, even if you did not ask me to, if: (describe circumstances or signs of distress that would lead researcher to stop participation).

If you decide to stop participation, you may do so by: (describe procedure to be followed if the participant wants to leave the study). If so, I (will use, or, will not use) the information I gathered from you.

PRIVACY AND DATA SECURITY

· Will researchers ever be able to link my data/responses back to me? State “no” or explain how and why.

· Will my data include information that can identify me (names, addresses, etc.)? Answer.

· Will researchers assign my data/responses a research ID code to use instead of my name? State “no” or explain.

· If yes, will researchers create a list to link names with their research ID codes? State “N/A” or explain.

· If yes, how will researchers secure the link of names and research ID codes? How long will the link be kept? Who has access? Approximate destroy date? State “N/A” or explain. Answer each question.

· How will my data be protected (electronic and hardcopy)? Where? How long? Who will have access? Approximate destroy or de-identification date? Answer each question.

· Where and how will the signed consent forms be secured? Explain how secured and if the signed consent forms are stored separately from the data.

FUTURE RESEARCH

[Please change the language in the sentences below to align with your study]

Once identifiers (name, address, etc.) are removed from these data (identifiable private information or identifiable bio-specimens, whichever is applicable) collected for this study,(the de-identified information or bio-specimen, whichever is applicable) could be used for future research studies or distributed to other investigators for future research studies without additional informed consent from you or your legally authorized representative.

STUDY CONTACTS

Any questions you have concerning the research study or your participation in the study, before or after your consent, will be answered by (name of individual, GCU email, and telephone number of PI. The name and contact information of co-investigators can be included as well.)

If you have questions about your rights as a subject/participant in this research, or if you feel you have been placed at risk, you can contact the Chair of the Human Subjects Institutional Review Board, through the College of Doctoral Studies at IRB@gcu.edu; (602) 639-7804.

VOLUNTARY CONSENT

PARTICIPANT’S RIGHTS

· You have been given an opportunity to read and discuss the informed consent and ask questions about this study;

· You have been given enough time to consider whether or not you want to participate;

· You have read and understand the terms and conditions and agree to take part in this research study;

· You understand your participation is voluntary and that you may stop participation at any time without penalty.

Your signature means that you understand your rights listed above and agree to participate in this study

____________________________________________________ ____________________________

Signature of Participant or Legally Authorized Representative Date

INVESTIGATOR’S STATEMENT

"I certify that I have explained to the above individual the nature and purpose, the potential benefits and possible risks associated with participation in this research study, have answered any questions that have been raised, and have witnessed the above signature. These elements of Informed Consent conform to the Assurance given by Grand Canyon University to the Office for Human Research Protections to protect the rights of human subjects. I have provided (offered) you a copy of this signed consent document."

(Your signature indicates that you have ensured the participant has read, understood, and has had the opportunity to ask questions regarding their participation)