Institutional Review BoardApplication Packet

AY 2016-17

Committee Members:James Fuller

Susan Gavin (chair)Cathy Harner

Julie LittleHadley Mitchell

Joseph PakMatt RenfrowPatricia Stan

Bill Toll

IRB Application

IntroductionTaylor University is committed to the protection and ethical treatment of human subjects in the research process. To fulfill this commitment, Taylor University established the Institutional Review Board (IRB) to review ALL research conducted by or on Taylor University constituents. For example research conducted by faculty, students or staff and research conducted on faculty, students, staff or alumni. Taylor University’s IRB is federally registered with the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP). This registration allows Taylor’s IRB to provide Federal Wide Assurances (FWA) for research projects involving human subjects. Taylor’s registration number is FWA00016004. All principal investigators must complete the CITI certification for Social and Behavioral (or Biomedical) Human Subject basic refresher course. A copy of the certificate must accompany this application.

To access CITI training: Go to www.citiprogram.org<http://www.citiprogram.org

o If you have never used CITI click register in the upper right corner of CITI home page. Proceed to step 1.

o If you have used CITI before log in and go to Taylor University courses then add a course. Skip to Step 7.

Step 1 - Select Taylor University (your organizational affiliation) Step 2 - Enter your personal information (first and last name, email address) Step 3 - Create a username and password, and a security question Step 4 - Continue answering questions regarding gender, etc. Step 5 – the answer is No Step 6 – must enter TU email address, department and role in research (i.e. student

researcher – undergraduate) Step 7 - check social and behavioral human subjects – basic course

Review and Approval processAll proposals reviewed will be classified into one of three categories as established by OHRP. A brief description for each category follows. For more detailed information, please visit the OHRP web site at http://www.hhs.gov/ohrp/policy/index/index.html.

Exempt – The proposal is reviewed only by the chair and determined that it is exempt from further review. Examples would include, but not limited to the following: Research involving the use of educational tests, survey procedures, observation of public behavior or the collection or study of existing data. Although a research project may include the methods listed above, it does NOT automatically make it exempt. It is possible further review is required.

Expedited – The proposal is reviewed by two members of the IRB. Proposals that would require expedited review include, but are not limited to the following:

Collection of data from voice, video, digital, or image recordings made for research purposes

Collection of data through noninvasive procedures such as blood pressures, pulse rates, ultrasound, Doppler blood flow and EKGs

Full – The proposal is reviewed by the full IRB. Proposals that would require full review include, but are not limited to the following:

Research involving vulnerable subjects including children

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IRB Application

Research that exposes subjects to more than minimal risks Research that is particularly private or sensitive in nature

Regardless of the level of review, the IRB considers the following issues about your research:This list is drawn from the National Institutes of Health IRB protocols.

1. The proposed research design is scientifically sound & will not unnecessarily expose subjects to risk.

2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result.

3. Subject selection is equitable.4. Additional safeguards required for subjects likely to be vulnerable to coercion or undue

influence.5. Informed consent is obtained from research subjects or their legally authorized

representative(s).6. Risks to subjects are minimized.7. Subject privacy & confidentiality are maximized.

It is the goal of the IRB to complete the review process within one week of submission, however, this may not be possible for proposals that require a full review. It is extremely important that all information is provided that is requested. Incomplete proposals will be returned and will delay the review process.

SubmissionTo submit a proposal to the IRB, you must complete and submit a complete research proposal that includes the following:

Name of the Primary Investigator and all secondary investigators If you are a student conducting the research, you MUST list and have approval from a

sponsoring faculty member. Description of the project’s

o Goalso Designo Hypotheses and/or research questionso Locationo Procedures ando How the data will be obtained

Description of participant population(s) Description of how the data will be analyzed and disseminated Identification of Risks to Participants Attach a copy of the Informed Consent form Attach complete copies of any interview or questionnaire instruments that will be used Attach copy of NIH certification

InstructionsTo submit a proposal application to the IRB:

Complete all sections of this proposal application by editing the document with Microsoft Word.

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Print off and sign the assurances section (page 3). If you are a student conducting the research you MUST have a faculty sponsor sign this form. Scan the signed form and save as a .pdf, .tif or .gif file type.

Review IRB check list to ensure you have addressed all areas of the proposal requirements E-mail the complete proposal and all associated files (including all protocols, consent forms,

cover letters, etc. and assurances signature page) to IRB@taylor.edu.

Proposals will be reviewed in the order submitted. Once the review is completed, you will receive notification from the IRB indicating if the proposal was approved and the level of review.

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IRB Application

Request for IRB Review of Research Involving Human Subjects

Taylor University institutional policy and federal regulations require that research projects involving human subjects be reviewed to consider:

1. The rights and welfare of the individual(s) involved2. The appropriateness of the methods used to secure informed consent3. The balance of risks and potential benefits of the investigation

All research involving human subjects should complete this application. Please send this form with any supporting documentation to IRB@taylor.edu. Questions may be directed to IRB@taylor.edu.

Section A: Applicant Information and Assurances

Title of Proposed ResearchPrimary Researcher’s Name and relationship to TUAnticipated Start Date of Project

Anticipated Ending Date

Email Phone

Department

Co-Researcher(s) if applicable and relationship to TUFaculty Sponsor for student researchSource of funding if applicable

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IRB Application

Researcher Assurance:

I certify to the following:1. The research will not be initiated until written approval is obtained from the IRB.2. I have completed the appropriate training for human subjects protection through CITI or other

appropriate program.3. The proposed research includes only those activities described in this application.4. I will obtain prior written approval for modifications to this project, including but not limited to

changes in procedures.5. I will report to the IRB any unanticipated problems and adverse effects, as well as my findings

during the course of the study that may affect the risks or benefits to the subjects.6. I agree to keep records of IRB approved documents and to retain research data with appropriate

confidentiality.7. I understand that this research is subject to continuing review and approval by the IRB.8. The information on this application is correct.

______________________________________________ Date __________________________Researcher #1

______________________________________________ Date __________________________Researcher #2

______________________________________________ Date __________________________Researcher #3

______________________________________________ Date __________________________Researcher #4

Faculty Advisor Assurance: (Student research only includes graduate students)I have examined the proposal, and I assume the roles and responsibilities required to oversee the conduct of this research, prevent harms to subjects and foster benefits to the subjects. I will report any significant and relevant changes in the research proposal, adverse events, or incidents to the IRB. I have also received certification for human subjects’ research and can confirm that the students have received appropriate certification.

____________________________________ _______________________________ ________________Faculty Name (print) Signature Date

Instructions:Once signatures have been obtained, please scan this page and submit it with the completed application to IRB@taylor.edu.

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Section B: Project Description

Briefly, but completely, answer the following questions. Please keep the use of technical phrasing and/or jargon to a minimum. Explain in terms or phrases that may be unclear to those who would be reviewing your material and who are not in your field. [Please type your information into this Word document. Simply keep typing and use as much space as needed]

You MUST respond to ALL questions

1. Describe the project’sa. Goals

b. Design

c. Hypotheses and/or research questions,

d. Location (Where will the study be conducted?)

e. Procedures, and

f. How data will be obtained

2. Describe your participant population(s). Include (a) age, sex, and approximate number (b) inclusion/exclusion criteria if any. (c) method of recruiting, and (d) inducement to participate.

3. Describe how data will be analyzed and disseminated.

4. Describe security procedures for privacy and confidentiality. Describe how all data collected will be handled and stored—and when, if ever, forms, or identifiers will be destroyed such that the participants’ confidentiality or anonymity will be protected.

IF THIS PROPOSAL IS USING EXISTING DATA or DATA SETS SUCH AS NSSE OR HERI ONLY YOU MAY STOP HERE. ALL OTHERS COMPLETE QUESTIONS 5-7 AND THE INFORMED CONSENT

FORM.

5. Identification of Risks to Participants. Remember there are always risks, even if it is exposure to the normal risks of everyday life.

a. Please describe any foreseeable risks (physical, emotional and social) to the participants. Include any methods or devices that will be used to limit participant risk. Describe any distress that might be caused by the research. If distress is a possible outcome, describe the planned procedures for debriefing the participants after the research is conducted.

b. If you would like to request a waiver of written informed consent, please explain how the use of written consent would impede the research or needlessly jeopardize the participant’s confidentiality. Explain how you will guarantee that oral consent has been

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secured. Researchers proposing to use oral consent must provide a copy of the consent document that will be read to participants.

c. Please describe the consent process by explaining when and how the participant’s consent will be obtained. Describe additional steps that will be taken to ensure the participant’s right to withdraw without penalty at any time and to guarantee their privacy and ensure confidentiality. Attach the consent form to this application. If participants include minors (under 18) or other populations who may not be able to give consent for themselves, describe how parents/guardians will be informed of the study and give their consent. If the research is part of an in-school or institutional study, what will teachers, officials or administration be told about the study, and how will their permission be obtained? (See sample consent form).

6. Describe how medical services will be provided if the subject suffers adverse health effects as a result of the research and who will bear the cost.

7. Attach complete copies of any interview or questionnaire instruments that will be used.

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Section C: Informed Consent checklist

When using humans as research subjects you must first obtain their informed consent. Use this checklist to effectively create an informed consent form.

A statement explaining the purpose of the research

A statement of the expected duration of the subject’s participation

A description of the procedures to be followed

A description of any reasonable foreseeable risks or discomforts to the subject, including invasion of privacy

A description of any benefits resulting from the research, either to the subject or others

A statement that informs the subject of his/her right not to be a subject in a research project that is also a teaching exercise

A statement informing the subject about how his/her anonymity will be guarded, e.g., that their confidentiality will be protected by assigned code numbers, be limitations of who has access to data, by data storage in locked cabinets, by locked computer files, etc.

A statement that the subject’s participation is voluntary, and that his/her refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

If written informed consent is required, a place for the subject to sign and date the form and a statement that the copy of the signed consent form will be given to the subject for his/her records

If the subject is a minor or is not capable of giving consent, a statement of parental/guardian responsibility in consenting to the subject’s participation in the study with a place for the parent/guardian to sign and date the form in addition to the participant’s signature

The name, address, email, and telephone number of the principal investigator of the research project, and his/her affiliation with Taylor University. If the principal investigator is a student, the name, email and telephone number of the faculty advisor is also required

A statement informing the subject that inquiries regarding the nature of the research, his/her rights as a subject, or any other aspect of the research as it relates to his/her participation as a subject can be directed to Taylor University’s Institutional Review Board at IRB@taylor.edu or the Chair of the IRB, Susan Gavin at 756-998-5188 or ssgavin@taylor.edu

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IRB Application

TAYLOR UNIVERSITY

INFORMED CONSENT

[Insert Title of Study (must match Title on Proposal)]You are invited to participate in a research study of [Insert general statement about study]. You were selected as a possible subject because [Explain how the subject was identified]. We ask that you read this form and ask any questions you many have before agreeing to be in the study.The study is being conducted by [Indicate the investigators’ names and University/Departmental affiliation]. It is funded by [Indicate study sponsor, if any, and state if the sponsor].STUDY PURPOSEThe purpose of this study is to [Explain why the research is being done using language understandable to the subject, e.g., eighth grade level.].NUMBER OF PEOPLE TAKING PART IN THE STUDY:If you agree to participate, you will be one of [Insert single number if the study involves only on site or local and national numbers if a multi-center study. It may also be appropriate to clarify the number of subjects in different cohorts or groups, if applicable] subjects who will be participating in this research.PROCEDURES FOR THE STUDY:If you agree to be in the study, you will do the following things:[Explain in language understandable to the subject all procedures/tests, including surveys, focus groups, audio or video taping, assignment to study groups, administration of study medications, x-rays, blood draws, study visits, etc., which will be employed in the study. Clarify where the procedures will be performed, how frequently they will be performed, and the expected amount of time each procedure and/or visit will last. Also clarify the total duration of the study. Identify which procedures are experimental and which are standard procedures. (If blood is to be drawn, explain how and from where the blood will be drawn, e.g., “from a vein in your arm.” Indicate the total number of times blood will be drawn, the amount of blood to be drawn each time, and the total amount of blood to be drawn over the course of the study. Translate the amount to be drawn to common measurement terms, such as teaspoonfuls or cupfuls)].RISKS OF TAKING PART IN THE STUDY:While on the study, the risks [side effects, and/or discomforts] are:[List in language understandable to the subject the risks, side effects, and/or discomforts of each of the procedures to be employed in the study including physical, psychological, social, and legal. Include risks and side effects of all medications to be given to subjects for the purpose of the study. The likelihood of the risks and/or side effects should also be included. Examples of possible risk/side effect statements include:The risks of completing the survey are being uncomfortable answering the questions.The risks of completing the interview include possible loss of confidentiality.The risks of drawing blood include pain, bruising, and rarely, infection.The side effects associated with take [Insert study medication] are mild diarrhea, confusion, sleepiness, depression, and headaches. In rare instances, hair loss, rash, decrease in the number of red blood cells and blood platelets (which could cause fatigue) could occur.

If appropriate, add the following statement: There also may be other side effects that we cannot predict.]

[Explain measures that will be employed to minimize the risks and side effects listed above.

Examples include:While completing the survey, you can tell the researcher that you feel uncomfortable or do not care to answer a particular question.

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Explain any psychological, social, or medical services that may be required because of research participation such as counseling, social support services or medical services. (If there are significant psychological risks to participation, the subject should be told under what conditions the researcher will terminate the study). While you are receiving [Insert study medication], you will be questioned weekly about possible side effects; you will also be monitored by the blood tests we are obtaining.]

BENEFITS OF TAKING PART IN THE STUDY:

The benefits to participation that are reasonable to expect are [describe any direct benefit to the subject or benefit to others, which may reasonably be expected from the research. If there is no direct benefit to the subject, state this. Note: payment to subjects is not considered a benefit of participating in the study and should not be listed in this section. Rather it should be listed under a separate Payment section.]

ALTERNATIVES TO TAKING PART IN THE STUDY:

Instead of being in the study, you have these options: [List appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subjects. If the only other alternative is not participating, this should be stated.]

CONFIDENTIALITY

Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality. Your personal information may be disclosed if required by law. Your identity will be held in confidence in reports in which the study may be published [Include the following statement, if applicable, “and databases in which results may be stored.” If tape recordings or videotapes are made, explain who will have access, if they will be used for educational purposes, and when they will be destroyed.].

Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the study investigator and his/her research associates, the Taylor University Institutional Review Board or its designees, the study sponsor, [Inset sponsor name], and (as allowed by law) state or federal agencies, specifically the Office for Human Research Protections (OHRP) etc., who may need to access your research records.

COSTS

Taking part in this study may lead to added costs to you or your insurance company. You or your insurance company will be responsible for the following costs: [list the procedures, tests, office visits, medications, etc. for which the subject or the subject’s insurance is responsible. If appropriate, state that all standard of care procedures, drugs, tests, etc. will be the responsibility of the subject or his/her insurance and clarify what is considered standard or care procedures.]. You will not be responsible for these study-specific costs: [list the procedures, drugs, tests, visits, medications, etc. for which the study will pay. If appropriate, include the following statement: “If during the study, [name of study drug] becomes commercially available, you may have to pay for the amount of drug needed to complete the study.”]

PAYMENT

You [will/will not] receive payment for taking part in this study. [Describe the details and any conditions of payment. If subjects will not be paid, this should be stated.]

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COMPENSATION FOR INJURY

[If a source of funds for payment of treatment costs is NOT available, include the following statement:]

In the event of physical injury resulting from your participation in this research, necessary medical treatment will be provided to you and billed as part of your medical expenses. Costs not covered by your health care insurer will be your responsibility. Also, it is your responsibility to determine the extent of your health care coverage. There is no program in place for other monetary compensation for such injuries. If you are participating in research which is not conducted at a medical facility, you will be responsible for seeking medical care and for the expenses associated with any care received.

[If a source of funds for payment of treatment costs IS available, the source and conditions for payment of those costs should be identified.]

FINANCIAL INTEREST DISCLOSURE

[If an investigator has a financial interest in this research, insert the following statement:]

One or more individuals involved in this research might benefit financially from this study. The Institutional Review Board (an ethics committee which helps protect people involved in research) has reviewed the possibility of financial benefit. The Board believes that the possible financial benefit is not likely to affect your safety and/or the scientific integrity of the study. If you would like more information, please ask the researchers or study staff.

CERTIFICATE OF CONFIDENTIALITY

[If a certificate of confidentiality has been obtained for this study, include the required informed consent language found in the approved certificate of confidentiality.]

CONTACTS FOR QUESTIONS OR PROBLEMS

For questions about the study or a research-related injury, contact the researcher [Insert name of investigator] at [Insert telephone number]. If you cannot reach the researcher during regular business hours e.g. 8:00AM-5:00PM), please call [Insert applicable information]. After business hours, please call [state alternate number and person/title the subject should request, e.g. on-call physician].

In the event of an emergency, you may contact [Insert name of investigator] at [List 24-hour emergency number].

VOLUNTARY NATURE OF STUDY

Taking part in this study is voluntary. You may choose not to take part or may leave the study at any time. Leaving the study will not result in any penalty or loss of benefits to which you are entitled. You decision whether or not to participate in this study will not affect your current or future relations with [Insert appropriate entity, e.g. hospital, University, professor]. [If withdrawal from the study prior to completion could pose risk to the subject, stat what those risks might be and how orderly termination will occur.]

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[If appropriate, include the following statement:] You participation may be terminated by the investigator without regard to your consent in the following circumstances: [State when and why study participation may be terminated and how orderly termination will occur.]

[If appropriate, include the following statement:] You will be told about new information that may affect your health, welfare, or willingness to stay in the study. This study may be terminated by [Insert sponsor/investigator as appropriate] if [State reason for possible premature termination].

(As appropriate – Use the following section and appropriate paragraph.)USE OF SPECIMENS

[If specimens obtained as part of the study will be used for commercial use, include the following statement:]As this is a research institution, specimens obtained in medical situations may later be used for research purposes. The investigator intends to include specimens taken from you along with other specimens that may also be used in an attempt to develop products to be sold, and it is not the intention of the investigator to enter into an agreement with you to become partners in sharing the profits or losses in the sale of those products.

SUBJECT’S CONSENT

(This section should be in first person.) In consideration of all of the above, I give my consent to participate in this research study.

I will be given a copy of this informed consent document to keep for my records. I agree to take part in this study.

Subject’s Printed Name: ______________________________________

Subject’s Signature: ________________________________________ Date: ______________

Printed Name of Person Obtaining Consent: ______________________________________

Signature of Person Obtaining Consent: _____________________________ Date: _______________

If the study involves children who will be providing their assent on this consent document, rather than on an assent document, use the following signatures:

Printed Name of Parent: ______________________________________

Signature of Parent: _______________________________________ Date: ______________

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Section D: Application check list

The following elements must be included (if applicable) in submitted proposals to be evaluated by the Institutional Review Board:

Completed proposal application (Section A)

Completed AND signed assurances page (page 4). Please scan the signed document for electronic submission

Completed project description (Section B). Be sure to answer ALL applicable questions. If items are left blank, it may delay the processing of your submission

Appropriate informed consent form (Section C)

Letters of permission – e.g. Conducting research at another institution or work place environment or providing permission to use a survey instrument or other copyrighted material.

Copies of ALL instruments to be used including cover letters or introductory emails.

Copies of CITI training certificates.

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