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Informed Consent Template Instructions

Please read the following instructions carefully. Modify this template for use in your own research and submit the final version to the IRB for review and approval along with your protocol submission. Other templates are provided on the IRB Forms page of the WVU Office of Human Research Protection (OHRP) website. New Rule Consent Criteria can be found on the site as well. If you have any questions, please contact the WVU OHRP at 304-293-7073 or at IRB@mail.wvu.edu.

Anything in red should be completed with information specifically for your study. Purple text provides instructions for specific sections and identified required and additional elements of informed consent that are required when appropriate.

When finished, please remove the remaining instructions including the purple text and make all of the red text black to match the rest of the document.

Text not applicable to your study and highlighting of text should be removed from the template before submitting it for review. Ensure to remove all tracked changes noted in your final version. Note: Submitting a tracked change word version of the ICF as well as the final pdf version of the ICF is advantageous for a prompt review.

Remove this instruction page from the final version of your Informed Consent Form (ICF).

Save and upload the final version as a pdf document.

Upon review and approval, the system will watermark each page of the PDF file. The watermark will contain the approval date and the expiration date, along with the protocol number.

Key Information Page:This should be a concise summary of the important information, about your study, that a participant would want to know.

This is a required section of all informed consent forms for protocol approved by the IRB following January 21, 2019 Common Rule update.

This summary should not be longer than a single page.

Detailed Informed Consent Form:

The WVU Protocol Number must be in the header of the Consent Form. If the research has another protocol tracking number, you may place it underneath the WVU Protocol Number.

Consent Forms should be written between a 6th and 8th grade reading level.

If there is no sponsor for the research, please remove the ‘Funding Source or Sponsor’ section in the header of Consent Form or list the applicable Department providing support for the project.

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Key Information for:Insert Title (or Short Title) of Study

You are being asked to participate in the research described below. This page provides key information that may help you to make this decision; more detailed information can be found after this section.

Why is this research being done and what is involved?

In this section, briefly describe (in lay terms):

The purpose of the study What the participant is asked to do (For example: You will be asked to complete a survey, attend

a focus group, and complete a follow-up survey.) How long it will take them to complete the research study.

Do I have to participate and what are the risks involved?

Participation in this research study is completely voluntary and you are free to withdraw from the research at any time. If you do not wish to participate, please discuss alternatives with the (pick one: researcher or study doctor) or refer to the “Alternatives” section in the consent form. State whether there is a benefit to the subject. If there is no direct benefit to the subjects, use this text: You may or may not directly benefit from participating in this research.

Risks from participation in this study include State the most important reason(s)/risk(s) why a participant may NOT want to volunteer for this study considering the participant’s perspective.

Who can I talk to if I have questions or concerns?

If you have any questions or concerns about this research or would want to withdrawal from the study, you can contact Study Contact Name at business hours contact information from the Dept. of insert dept. name of contact at West Virginia University.

For more information, please see the Informed Consent Form.

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Informed Consent for Research | More than Minimal Risk

Principal Investigator (PI) | Click here to enter text.

Department | Click here to enter text.

Co-Investigator(s) | You can remove this field as necessary or enter Co-Is.

Sponsor or Funding Source | Click here to enter text.

WVU IRB Protocol # | Click here to enter text.

Study Title | Click here to enter text.

Introduction

You have been asked to participate in this research study, which has been explained to you by an authorized member of the research team. This study is being conducted by insert PI names and degrees in the Department of insert PIs WVU Department at West Virginia University, along with insert Co-I names and degrees. (If applicable) Funding for this research is provided by [insert funding source]. Replace the last 2 sentences of this paragraph with those below, if the research is a thesis project.

This research is being conducted to fulfill the requirements for a [insert degree] in [subject] from the Department of _______________ at West Virginia University. This research is being conducted under the supervision of insert PI name and degrees.

Purpose

Be sure that the Purpose is written in lay terms with no technical terms or jargon. If it is necessary to use such wording, be sure to define the term in language that is easily understood by people with no experience in your field. Identifying that the study involves research and the purpose of the research are required elements of informed consent.

The purpose of this study is define the purpose of the study in lay terms. WVU expects to enroll approximately number of subjects enrolled by WVU researchers/sites subjects. A total of approximately insert aggregate number of subjects subjects, at all sites, are expected to participate in this study. Notifying subjects of the approximate number of subjects to be involved in the study is an additional element of informed consent.

Description of Procedures

Identifying the procedures or activities to be followed is a required element of informed consent.

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Be sure that the procedures or activities are written in lay terms with no technical terms or jargon. If it is necessary to use such wording, be sure to define the term in language that is easily comprehended by ordinary people with no experience in your field.

Identify and describe the experimental procedures or activities in detail. Use a separate paragraph for each element/step of the treatment(s) or activities. The description should include a timeline and be explained in chronological order of treatments, procedures, and/or activities that are specific to the research. Visuals or diagrams are helpful to enhance subject understanding.

An explanation of any other investigational procedures or activities must be included as well. This should include any interviews or questionnaires that may be conducted, or any other forms of data collection on top of the experimental treatment or activities. If interviewing or administering surveys, be sure to include a sentence telling the participant they will see the questions prior to signing the consent form and that they do not need to answer each question. Identifying any experimental procedures or activities is a required element of informed consent.

If multiple visits or interactions, please give an approximate time of how long each visit will take and the length of time to complete the study in total. Notifying subjects of the expected duration of participation in the research is a required element of informed consent.

This study involves identify and describe investigational procedures in a way that is easily understandable and with appropriate detail and will take approximately state how long it will take to participate in the study for you to complete.

As applicable, please describe all standard of care procedures or normal activities that will occur separately from the investigational procedures or activities (those that are done specifically for the research). The standard procedures or activities are those activities done regardless of the research.

Risks and Discomforts

Enter a description of any risks or discomforts that the subject may have from participating in the study. When available – provide a table or listing of risks/side effects, categorized by “More Likely”, “Less Likely”, and “Rare”.

State whether you are researching a sensitive topic (i.e. suicide, sexual history, criminal activity). Put the counseling or other referral list in this section.

Notifying subjects of any reasonably foreseeable risks or discomforts due to their participation in the research is a required element of informed consent.

An additional element of informed consent includes notifying subjects that the research may involve risks which are currently unforeseeable. If applicable, include the statement that the particular treatment or procedure may involve risks to the subject (you) which are currently unforeseeable (21 CFR 50.25(b)(1).).

In addition, there is always the risk of uncommon or previously unknown side effect(s) or event(s).

An additional element of informed consent includes notifying subjects that the research may involve risks to the embryo or fetus, if the subject is or may become pregnant, which are currently unforeseeable.

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As applicable, include language with regard to risk to an unborn child and pregnancy considerations for both male, who may father and child, and female participants.

Radiation Risk

Include if radiation is utilized in the study: The amount of radiation (x-rays and scans to assess your disease) that you are exposed to in this study is considered standard of care for your disease. The risks of these procedures will be explained to you by your doctor and staff involved in your care. Risks from radiation exposure are cumulative (they increase) over time.

Alternatives

Notifying subjects of any appropriate alternative procedures or courses of treatment that might be advantageous is a required element of informed consent. The alternative is not to participate in the study. If there are other alternatives for the participant to consider, include them in this section.

You do not have to participate in this study.

Remove the following statement if there are no other applicable alternatives: Alternatives that could be considered in your case include:

State whether there are an appropriate alternative procedures or courses of treatment, if any, that might be advantageous to prospective subject (21 CFR 50.25(a)(4)).

Benefits

Notifying subjects of any benefits to the subject or to others which may reasonably be expected from the research is a required element of informed consent.

State whether there is a benefit to the subject as it relates to the purpose of the study. For example, “Your health may improve as a result of this drug therapy, but since it is not known whether this therapy will be effective in your case, you may not receive any benefit or your condition may worsen.” Please keep in mind that payments for participation are not considered a benefit to the subject and should be addressed in the Financial Considerations section of this document.

If there is no direct benefit to the subjects, use this text: You may or may not directly benefit from participating in this research. The knowledge gained from this study may eventually benefit others.

Financial Considerations

For clinical research, you may direct participants to consult with their insurance carrier prior to entering the research study. Investigators must clarify who pays for, or who is responsible for, any costs incurred as a result of participation in the research. Notifying subjects of any additional costs that may result from participation in the research is an additional element of informed consent.

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Use one of the following two paragraphs:

[There are no special fees for participating in this study, but any expense associated with current therapy or treatment of side effects will be billed to you or to your insurance company.]

[The study sponsor, {insert sponsor name}, will pay for {insert procedures sponsor will pay for} that would not be part of current therapy for your disease or condition. If you are assigned to the experimental therapy, the cost will be paid by {insert sponsor name} the study sponsor.]

If you are planning to pay or compensate participants, explain fully and clearly what they will be paid, how they will be paid, and any intervals of payments. Also include if subjects will be paid and the amount they will be paid if they do not complete the entire study. This is additional element of informed consent.

The participant will be compensated <enter the dollar amount paid or the compensation> for each visit.

The participant can earn up to <enter the total amount that participants can earn>.

If the participant does not complete the study, compensation will be <enter the text>.

For information regarding the method of payment, contact the Principal Investigator.

Unless the study is confidential, due to the sensitive nature of the research or has been awarded a Certificate of Confidentiality, you must inform subjects that they may be asked to provide their Social Security Number and verification of U.S Citizenship or Permanent Resident Status to receive payment.

Your information may be provided to the appropriate parties for billing and/or payment purposes. Please be advised that any compensation received for participation in a research study, including a gift card, is considered taxable income and must be reported to the Internal Revenue Service (IRS).

If you are targeting WVU employees or WVU study employees are research subjects, please include the following language in the consent form: If you are a WVU employee or a WVU student-employee, you are required to report the total amount of compensation received for your participation in a research study to the WVU Tax Services Office upon receipt of payment.

If you are targeting students: For departments with an IRB approved Extra Credit Policy – PI’s may offer extra credit to students within their department for participating in research. If this is applicable, it should be included in this section.

Your data, health information, research results, specimens, genomic data [only include as appropriate], or any and all other information related to this research study used in this research study may contribute to a new discovery or treatment.  In some instances, your data, your health information, your research results, your specimens, these discoveries or treatments, or any other information related to this research study, even if identifiers are removed, may be of commercial value and may be sold, patented, or licensed by the investigators and West Virginia University for use in other research or the development of new products.  You will not retain any property rights nor will you share in any money or commercial profit that the

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investigators, West Virginia University, or their agents may realize. This is an additional element of informed consent.

Confidentiality

Clearly explain the extent, if any, to which the confidentiality of records identifying the subject will be maintained. Disclose any limits of confidentiality (i.e. sending recordings to a transcription agency, sharing records with study sponsor, mandatory reporting, and any possibility of loss of confidentiality due to media attention.) This is a requirement of informed consent.

Any information about you that is obtained as a result of your participation in this research will be kept as confidential as legally possible. Your research records and test results, just like hospital records, may be subpoenaed by court order or may be inspected by the study sponsor or federal regulatory authorities, including the Food and Drug Administration (FDA), without your additional consent.

In addition, there are certain instances where the researcher is legally required to give information to the appropriate authorities. These would include mandatory reporting of infectious diseases, mandatory reporting of information about behavior that is imminently dangerous to you or to others, such as suicide, child abuse, etc.

This sentence should be kept only if these are a part of your study; if not, remove this sentence. Audiotapes or videotapes will be kept locked up and will be destroyed as soon as possible after the research is finished.

In any publications that result from this research, neither your name nor any information from which you might be identified will be published without your consent.

One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens is a required element of informed consent.

1) A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent.

OR

2) A statement that the subject’s information or biospecimen collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

For research involving biospecimens, please include whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequencing of that specimen). This is an additional element of informed consent.

Genetic Information Nondiscrimination Act (GINA) (Please remove this section if not applicable.)

(For more information about GINA, please visit the Office for Human Research Protections Guidance.)

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A Federal law, called the Genetic Information Nondiscrimination Act (GINA), generally makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. This law generally will protect you in the following ways:

Health insurance companies and group health plans may not request your genetic information that we get from this research.

Health insurance companies and group health plans may not use your genetic information when making decisions regarding your eligibility or premiums.

Employers with 15 or more employees may not use your genetic information that we get from this research when making a decision to hire, promote, or fire you or when setting the terms of your employment.

All health insurance companies and group health plans must follow this law by May 21, 2010. All employers with 15 or more employees must follow this law as of November 21, 2009. Be aware that this Federal law does not protect you against genetic discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

West Virginia's genetic discrimination laws protect patients from discrimination by health insurers or employers. This means that a health plan or insurance company cannot raise your rates based on genetic information about you or commit any other form of illegal discrimination, nor can employers in West Virginia use your genetic information to inform decisions related to hiring or firing you.

Certificate of Confidentiality (CoC) (Please remove this section if not applicable.)

(For more information about CoCs, please reference the National Institutes of Health Certificates of Confidentiality Kiosk.)

This research is covered by a Certificate of Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or use information, documents, or biospecimens that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, or local law that requires disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as allowed by federal regulations protecting research subjects. 

Use the following language as applicable: The Certificate cannot be used to refuse a request for information from personnel of the United States federal or state government agency sponsoring the project that is needed for auditing or program evaluation by name the agency which is funding this project or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or your involvement in this research. If you want your research information released to an insurer, medical care provider, or any other person not connected with the research, you must provide consent to allow the researchers to release it.

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Language such as the following should be included if researcher intends to disclose information covered by a Certificate, such as potential child abuse, or intent to hurt self or others in response to specific federal, state, or local laws. The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of list what will be reported, such as child abuse and neglect, or harm to self or others. 

Language such as the following should be included if researcher intends to disclose information covered by a Certificate, with the consent of research participants. The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to in this informed consent document restate what will be disclosed, such as including research data in the medical record.

ClinicalTrials.gov (Please remove this section if not applicable.)

This section is required for controlled drug/device trials (except Phase 1 drug trials) and pediatric device surveillance trials. For information regarding an Applicable Clinical Trial (ACT), please refer to the following link: https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf.

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. (Required for FDA regulated research.)

HIPAA Authorization (Please remove this section if PHI is not involved in this study.)

We know that information about your health is private. We are dedicated to protecting the privacy of that information. Because of this promise, we must get your written authorization (permission) before we may use or disclose your protected health information or share it with others.

You can decide to sign or not to sign this authorization section. However, if you choose not to sign this authorization, you will not be able to take part in the research study. Whatever choice you make about this research study will not have an effect on your access to medical care.

Persons/Organizations Providing the Information

Specify as appropriate

Patient (data are from the participant)/West Virginia University Hospitals/ WVU Medicine/ WVUHS (data are from records)

Persons/Organizations Receiving the InformationAdd applicable information and/or delete any information that does not apply.

The research site(s) carrying out this study. This includes UHA or UHA Affiliates, WVU, WVU Hospitals, West Virginia University Health System (WVUHS). It also includes each site’s research and medical staff.

Health care providers who provide services to you as part of this research study.

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Laboratories and other people and groups that look into your health information as part of this study in agreement with the study protocol.

If applicable, The United State Department of Health and Human Services (which includes the National Institutes of Health (NIH), Food and Drug Administration (FDA)) and other groups that have the right to use the information as required by law. (Required for FDA regulated research.)

(If applicable,) Foreign Regulatory Agencies (Sponsor name, if applicable) and the people and companies that they use to oversee, manage, or

conduct the research. The members and staff of any institutional review board that oversees this research study. The West Virginia University Office of Human Research Protection and the West Virginia

University Office of Sponsored Programs. Enter your own Research Unit or Department (if applicable)

The Following Information Will Be Used

Specify the PHI that is viewed or recorded for the study and delete any sections that do not apply.

Information from your existing medical records, and new information about you that is created or collected during this study, such as: history and physicals, clinic visit notes, nursing and staff notes, laboratory results, x-rays, EKG results, demographic data, pulmonary tests, imaging scans, and study forms.

The Information is Being Disclosed for the Following Reasons

Add applicable information and/or delete any information that does not apply.

Review of your data for quality assurance purposes Publication of study results (without identifying you) Other research purposes such as reviewing the safety or effectiveness of the study drug and other

products or therapies; conducting performance reviews of the study drug; evaluating other products or therapies for patients; developing a better understanding of disease; improving the design of future clinical trials

You may Cancel this Authorization at Any Time by Writing to the Principal Investigator

Enter the PI name and full contact information (specifically a mailing address). Only written cancelation of Authorization is permissible.

If you cancel this authorization, any information that was collected already for this study cannot be withdrawn. Once information is disclosed, according to this authorization, the recipient may re-disclose it and then the information may no longer be protected by federal regulations.

(Keep this paragraph, as appropriate) You have a right to see and make copies of your medical records. You will not be able to see or copy your records related to the study until the sponsor has completed all work related to the study. At that time, you may ask to see the study doctor’s files related to your participation in the study and have the study doctor correct any information about you that is wrong.

This authorization will expire at the end of the study unless you cancel it before that time (or has a specific expiration date).

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Voluntary Compensation

More than Minimal Risk studies are required to specify whether medical treatments or compensations are available if injury (from participating in the research) occurs and, if so, what the treatments consist of, or where further information may be obtained.

There is no money set aside to help treat you if you get hurt or sick in this study. The study doctor and WVU or its partners do not have special funds to pay for research related injuries if they occur.

Please utilize Option 1 or Option 2 as applicable template wording:

1) If the sponsor is paying for treatment as a result of injury due to the research, please use the following language.

If you are injured as a result of this research, treatment will be available.  [Sponsor] will pay for this care.  There is no commitment to provide any compensation for research-related injury. You should realize, however, that you have not released this institution from liability for negligence. Please contact the investigator, [name] at [phone number] if you are injured or for further information.

OR

2) If the sponsor is not paying, and the insurance company or subject will be billed, include the following language.

If you are injured as a result of this research, treatment will be available.  This care will be billed to you or your insurance company.   There is no commitment to provide any compensation for research-related injury. You should realize, however, that you have not released this institution from liability for negligence. Please contact the investigator, [name] at [phone number] if you are injured or for further information.

Providing information of who to contact in the event of a research related injury is a required element of informed consent.

Voluntary Participation

Notifying subjects that “participation is voluntary” and “refusal to participate or discontinuation of their participation will involve no penalty or loss of benefits to which the subject is otherwise entitled” is a required element of informed consent.

Participation in this study is voluntary. You are free to withdraw your consent to participate in this study at any time. Notifying subjects how they should terminate their participation in the study is an additional element of informed consent. (If applicable,) If you choose to withdraw your participation from the study, the data collected on you up until that time remains a part of the study database and may not be removed. No additional information will be added to the study database after your withdrawal. (Required for FDA regulated research.) Notifying subjects of what will occur if they decide to withdraw their consent is an additional element of informed consent.

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If recruiting students: Refusal to participate or withdraw will not affect your class standing or grades and will involve no penalty to you. If recruiting employees: Refusal to participate or withdraw will not affect your employee status at West Virginia University.

Refusal to participate or withdraw will not affect your future care or status at West Virginia University.

In the event new information becomes available that may affect your willingness to participate in this study, this information will be given to you so that you can make an informed decision about whether or not to continue your participation.

Notifying subjects of new findings that may relate to the subject’s willingness to continue participation will be provided to the subject is an additional element of informed consent. Also, including a statement regarding whether clinically relevant research results, including individual research results, will or will not be disclosed to subjects, and if so, under what conditions is an additional element of informed consent. Please also address incidental findings, noting if and under what circumstances, those findings will be given to participants.

Please use or modify the following language based on your study:

Incidental FindingsGenerally, tests done for research purposes are not meant to provide clinical information. Because the investigators will not have access to information that identifies you, the research findings will not be provided to you.

If there are any known circumstances where the investigator will terminate a subject’s participation without the subject’s consent (i.e. they miss the first 3 out of 7 sessions), it should be stated here. This is an additional element of informed consent.

Contact Persons

If you have any questions, concerns, or complaints about this research, you can contact Name of PI/Co-I/Study Personnel at business hours contact information. (If applicable) You can also contact Co-I/Study Personnel at business hours contact information (phone #). Providing subjects with information on how to contact the investigator for question, concerns, or complaints is a required element of informed consent.

If you are hurt from being in this research, you should contact Name of PI at business hours contact information (phone #). If injury occurs outside of business hours and is related to your participation in this research, please contact Name of PI/Co-I/Study Personnel at phone #.

For information regarding your rights as a participant in research or to talk about the research, contact the WVU Office of Human Research Protection (OHRP) at (304) 293-7073 or by email at IRB@mail.wvu.edu. Providing subjects with information on how to contact someone independent of the investigator for question, concerns, complaints, and subject rights is a required element of informed consent.

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Future Contact (Please remove this section if not applicable.)

Future research may be conducted for which you are eligible. If you are interested in being contacted for future research, please indicate so by completing this section.

☐ Yes, I want to be contacted if future research studies, for which I am qualified, become available.

☐ No, I do not want to be contacted if future research studies, for which I am qualified.

Signatures and Authorization – (Remove Authorization information if HIPAA is not included.)

You have been given the opportunity to ask questions about the research (if applicable) and your authorization of HIPAA, and you have received answers concerning areas you did not understand. Upon signing this form, you will receive a copy.

Participant SignatureI willingly consent to participate in this research (if applicable) and authorization of HIPAA.

Signature of Subject or Subject’s Legal Representative

Printed Name Date

Consenting Individual SignatureThe participant has had the opportunity to have questions addressed. The participant willingly agrees to be in the study.

Signature of Person Obtaining Informed Consent

Printed Name Date

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