Application for IRB Protocol Review

Enclosed are materials you will need for the efficient review of your proposed project. Please note that the charge of the Institutional Review Board for the Protection of Human Subjects (IRB) is to ensure the safety, privacy and ethical treatment of human subjects.

There are several key components to the assurance of ethical and humane treatment of participants in research. To facilitate the process of approval of your proposal, the IRB has developed a standard form, which is online for your use. You will note that page 1 asks for basic information about the proposed study. Page 2 lists questions to which the investigator must respond. These questions address the nature of the proposed project and the nature of the participation asked of subjects. While specific instructions for completing the application are included in the form, it is important to note that the investigator must provide a copy of the intended informed consent form to be inserted at designated location. An example of such a form is part of the online application. Deadlines, dates of meetings and additional information which may be helpful to you can be found on-line .

First review the IRB powerpoint to become familiar with the purpose and process of the Wesley College IRB. Read and follow the instructions carefully. Please submit one typed electronic copy of thecompleted application.Include within the application all information and supporting documentation.

Please submit your materials to theIRB Chair. The Office of Academic Affairs provides information on the current IRB chair.

Although not a requirement, the researchers are invited to attend the IRB meeting during the time of the review of their application. Advisors of student researchers are also encouraged to attend.

Complete all sections. For areas that are not applicable to the research indicate in that area N/A.

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Institutional Review Board – Human Subjects Protection Committee

For IRB use only:

Log Number
IRB Recommendation
Formal letter notification date

1.Principal Investigator (primary person conducting the research Choose an item..

Name: Click here to enter text.Department:Click here to enter text.

E-Mail Address: Click here to enter text.

Current Address:Click here to enter text.

Phone where you can be reached during the day: Click here to enter text.

2.Co-Investigator: Choose an item.

Name: Click here to enter text.Department: Click here to enter text.

Email Address: Click here to enter text.

Phone: Click here to enter text.

3. If you are a student, provide the following:

Faculty Sponsor: Click here to enter text.Department: Click here to enter text.

Faculty Sponsor Email Address: Click here to enter text.

4.Project Title: Click here to enter text.

5. Check only one: Choose an item.

6. Dates during which project will be conducted: From Click here to enter text.To Click here to enter text.

5.Has this project previously been considered by any IRB? Yes ☐

No ☐

If yes, give approximate date of review. Click here to enter text.

6. PROPOSED RESEARCH PROJECT

  1. Purpose of the study-State concisely and realistically what the study is intended to

accomplish.

Click here to enter text.

  1. Background-Briefly state the background of the study, including some relevant references

and identify the main question the current study is intended to address.

Click here to enter text.

  1. Characteristics of the Subject Population-The following information should be provided:

1.Age Range-What is the age range and why was it chosen?Click here to enter text.

2.Sex-What is the sex of the subjects? If there is a restriction, provide the rationale.Click here to enter text.

3.Number-What is the estimated number of subjects?Click here to enter text.

4.Inclusion Criteria-How did you obtain potential subjects and how will you contact

them?Provide a copy of any planned advertisements.Click here to enter text.

  1. Methods and Procedures: Provide a step-by-step description of each procedure, including the frequency, duration, and location of each procedure. Attach copies of any instruments to be used, such as surveys, rating scales, or questionnaires.

Click here to enter text.

  1. How will confidentiality of the data be maintained? Click here to enter text.
  1. Describe all known and anticipated risks to the subject.Click here to enter text.

Check the box that best indicatesthe nature of risk for the research:

"Minimal risk" means that the risk of harm anticipated in the proposed research is not more likely than those risks encountered in daily life, or during routine physical or psychological examinations/tests. ☐

“High risk” means that the proposed research can cause physical or psychological harm. ☐

  1. Describe the anticipated benefits to the subjects, and the importance of the knowledge that may reasonably be expected to result from the research.Click here to enter text.

7. Consent form is attached. ☐

8. Copy of the questionnaire or other survey instruments used for the research are attached. ☐

9.Additions to or changes in procedures involving human subjects as well as any problems connected with the use of human subjects once the project has begun must be brought to the attention of the IRB.

I agree to provide whatever surveillance is necessary to ensure that the rights and welfare of the human subjects are properly protected. I understand that I cannot initiate any contact with human subjects before I have received approval/or complied with all contingencies made in connection with the approval. I understand that as the principal investigator I am ultimately responsible for the welfare and protection of human subjects and will carry out the project as approved.

Click here to enter text.Click here to enter text. Signature of Principal Investigator/Program Director Date

8.Approval by Faculty Sponsor (REQUIRED FOR ALL STUDENTS):

I affirm the accuracy of this application, and I accept the responsibility for the conduct of this research and supervision of human subjects as required by law.

Click here to enter text. Click here to enter text.

Signature of faculty sponsorDate

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Title of Research: Click here to enter text.

INFORMATION AND CONSENT FORM

Introduction:

You are invited to participate in a research study investigating Click here to enter text.This study is being conducted byClick here to enter text.,Choose an item.at Wesley College under the supervision ofClick here to enter text., a faculty member in the Department ofClick here to enter text.. You were selected as a possible participant in this research becauseClick here to enter text.. Please read this form and ask questions before you agree to be in the study.

Background Information:

The purpose of this study is toClick here to enter text.. Approximately Click here to enter text.people are expected to participate in this research.

Procedures:

If you decide to participate, you will be asked to Click here to enter text.. This study will take approximately Click here to enter text.

Risks and Benefits of being in the study:

The study has Click here to enter text.risks. (Risks must be explained, including the likelihood of the risk. Describe discomforts and inconveniences the subjects may reasonably expect. If the subjects will be told of significant physical or psychological risks to participation, they also must be told under what conditions the researcher will terminate the study.)

The benefits to participation are Click here to enter text. (State benefits. If there are no direct benefits to the subjects, state "There are no direct benefits to you for participating in this research."). (If applicable, describe appropriate alternative procedures that might be to the subject's advantage, if any. Any standard treatment that is being withheld must be disclosed.)

Confidentiality:

Any information obtained in connection with this research study that can be identified with you will be disclosed only with your permission; your results will be kept confidential. In any written reports or publications, no one will be identified or identifiable and only group data will be presented. (If it applies to your study, include ways in which you will maintain confidentiality, e.g. “No one in the daycare center will know your child’s results.” If you release information to anyone for any reason, you must state the persons or agencies to whom the information will be furnished, the nature of the information to be furnished, and the purpose of the disclosure.)

We/I will keep the research results in a locked file cabinet in (state where) and only I (or the researcher(s) named in this form) and our/my advisor will have access to the records while we/I work on this project. We/I will finish analyzing the data by (specify the ending date of your research). We/I will then destroy all original reports and identifying information that can be linked back to you. (If tape or video recordings are made, explain who will have access to them, if they will be presented to others for educational purposes, and when they will be erased or destroyed.)

Voluntary nature of the study:

Participation in this research study is voluntary. Your decision whether or not to participate will not affect your future relations with (the name of any other cooperating institution or) Wesley College in any way. If you decide to participate, you are free to stop at any time without affecting these relationships.

Contacts and questions:

If you have any questions, please feel free to contact me, Click here to enter text., at Click here to enter text.You may ask questions now, or if you have any additional questions later, the faculty advisor, Click here to enter text., will be happy to answer them You may keep a copy of this form for your records.

This project has been approved by the Wesley College Institutional Review Board for the Protection of Human Subjects

Statement of Consent:

You are making a decision whether or not to participate. Your signature indicates that you have read this information and your questions have been answered. Even after signing this form, please know that you may withdraw from the study at any time.

______

I consent to participate in the study. (If you are video- or audio-taping your subjects, include a statement such as "and I agree to be videotaped.")

______

Signature of ParticipantDate

______

Signature of Parent, Legal Guardian, or WitnessDate

(if applicable, otherwise delete this line)

______

Signature of ResearcherDate

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FOR COMMITTEE USE ONLY

This project:

poses minimal risk.

poses greater than minimal risk.

is Exempt from Continuing Review.

requires Expedited Review.

requires full IRB Review.

SignatureDate

IRB:

Approved to Proceed Disapproved______

SignatureDate

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