BEFORE SUBMITTING YOUR PROTOCOL FOR IRB REVIEW, MAKE SURE YOU HAVE INCLUDED THE FOLLOWING (IF APPLICABLE):

____Survey, Questionnaire or Interview Questions

____Consent and Assent forms

____Recruiting materials

____Permission letters from participating institutions

____Signed Investigator Assurance form

____Clear, concise description of procedures to be used (Feel free to also attach any proposals that may further explain your project.)

Additionally, these assurances must be made:

____All personnel listed must have completed IRB/Human Subjects Training. If not, your application cannot be approved until the training has been completed. See our website for training dates and times. http://www.msstate.edu/dept/compliance/irb/irbregistration.htm

____If applicable, the advisor has thoroughly reviewed this application to ensure readability and accuracy.

PLEASE NOTE:

· THE DETERMINATION OF THE IRB WILL BE COMMUNICATED TO YOU IN WRITING. SUBMISSION OF AN APPLICATION TO THE IRB DOES NOT EQUAL IRB APPROVAL. YOU MAY NOT BEGIN THIS RESEARCH UNTIL YOU HAVE IRB APPROVAL.

· If your research has not yet received funding needed to create instruments and other associated materials, provide a timeline of when those items will be developed. Your application will be reviewed for “118 designation”(see http://www.msstate.edu/dept/compliance/irb/irbawardchanges.htm for more details).

If you have any questions, please feel free to contact our office at 325-5220 or by email at jmiller@research.msstate.edu or tarwood@research.msstate.edu.

Send to:

IRB

Campus Mailstop 9563

PO Box 6223, Mississippi State, MS 39762

8A Morgan Street

INVESTIGATOR'S ASSURANCE

Mississippi State University

Institutional Review Board

Project Title:

As Primary Investigator, I have ultimate responsibility for the performance of this study, the protection of the rights and welfare of the human subjects, and strict adherence by all co‑investigators and research personnel to all Institutional Review Board (IRB) requirements, federal regulations, and state statutes for human subjects research. I hereby assure the following:

The information provided in this application is accurate to the best of my knowledge.

All named individuals on this project have been given a copy of the protocol and have acknowledged an understanding of the procedures outlined in the application.

All experiments and procedures involving human subjects will be performed under my supervision or that of another qualified professional listed on this protocol.

I understand that, should I use the project described in this application as a basis for a proposal for funding (either intramural or extramural), it is my responsibility to ensure that the description of human subjects use in the funding proposal(s) is identical in principle to that contained in this application. I will submit modifications and/or changes to the IRB as necessary to ensure these are identical.

I and all the co‑investigators and research personnel in this study agree to comply with all applicable requirements for the protection of human subjects in research including, but not limited to, the following:

· Obtaining the legally effective informed consent of all human subjects or their legally authorized representatives, and using only the currently approved, consent form (if applicable); and

· Making no changes to the approved protocol or consent form without first having submitted those changes for review and approval by the Institutional Review Board; and

· Reporting serious and unexpected adverse effects to IRB Administration verbally within 48 hours and in writing within 10 days of occurrence, and all other unexpected adverse events in writing within 10 days of occurrence; and

· Promptly providing the IRB with any information requested relative to the project; and

· Promptly and completely complying with an IRB decision to suspend or withdraw its approval for the project; and

· Obtaining continuing review prior to the date approval for this study expires. I understand if I fail to apply for continuing review, approval for the study will automatically expire, and study activity must cease until IRB current approval is obtained.

· Your study and any associated records may be audited by the IRB to ensure compliance with the approved protocol.

Name of Primary Investigator / Researcher:

Signature:

I assume responsibility for ensuring the competence, integrity and ethical conduct of the investigator(s) for this research project. The investigator(s) is/are fully competent to accomplish the goals and techniques stated in the attached proposal. Further, I certify that I have thoroughly reviewed this application for readability and accuracy and the study is clearly described herein.

Name of Advisor:

Signature:

THE MISSISSIPPI STATE UNIVERSITY INSTITUTIONAL REVIEW BOARD

FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH

Protocol Submission Form

PRINCIPAL INVESTIGATOR / RESEARCHER INFORMATION

Name: Dr./Mr./Ms.

MSU Net ID:

Daytime Phone Number:

Mailing Address:

If on-campus, provide Mailstop

City/State/Zip:

E-Mail Address:

Department:

IRB and Human Subjects Protections Education completed on ______________

FACULTY ADVISOR (Faculty member supervising the student for this project)

If you are a student, you must have an advisor for this project.

Advisor:

MSU Net ID:

Daytime Phone Number:

Advisor=s E-Mail Address:

Department:

Campus Mail Stop:

IRB and Human Subjects Protections Education completed on ______________

ADDITIONAL INVESTIGATORS / RESEARCHERS

Will additional researchers be involved with this project? If so, list them along with their Net ID, phone number, address, and email address. Indicate the date in which they completed IRB and Human Subjects Education.

TITLE of project:

Is this an original submission or a revision?

If this is a revised application, please list the docket number assigned to the first submission of the study.

PROJECT PERIOD: from _______________ to ________________

Includes both data collection and data analysis

*NOTE: Beginning date cannot predate IRB approval date. If you intend to begin immediately upon IRB approval, list beginning date as “upon IRB approval”.

STUDY FUNDING

Provide information about how the study costs will be supported

____Department funds ____Personal Funds ____No cost study ____Other, specify:

____External Funding

Agency:

SPA Proposal or Fund/Account Number:

PI of Award (if different than Principal Investigator/Researcher listed above):

Address each of the following items in YOUR written Protocol.

I. Personnel & Qualifications

NOTE:

· In this section, the principal investigator is to describe the qualifications of all researchers involved in the study to perform the responsibilities assigned.

· As principal investigator, it is your responsibility to ensure that all individuals conducting procedures described in this application are adequately trained prior to involving human participants.

· All personnel listed on this application are required to successfully complete the MSU IRB & Human Subjects training course or an MSU IRB approved alternative. APPROVAL WILL NOT BE GRANTED UNTIL ALL INDIVIDUALS HAVE COMPLETED THIS TRAINING.

· As personnel change, you must submit a modification request to the IRB for approval before they can work with human subjects or identifiable or confidential information.

A. Including yourself, provide the name of each individual who will be responsible for the design or conduct of the study, have access to human participants, or have access to identifying or confidential information.

B. For each person identified above, identify his/her role in the project and clearly state the procedures or techniques he/she will be performing.

C. For each person identified above, describe his/her level of experience with the procedures or techniques he/she will be performing.

D. Indicate where each of the personnel listed received training to perform the identified procedures and who supervised or provided the training.

E. Explain how these skills/abilities will be periodically reviewed.

II. Research Protocol

1. SITE OF WORK:

List each site where the research procedures will be performed. If any of the sites are off-site (i.e. not at MSU or MSU remote or branch sites), please provide information about that site (address, type of business/institution, etc.). If a cooperating institution (school, hospital, prison, etc.) is involved, append letters that have been prepared on the official letterhead of the cooperating institution and signed by an authorized representative.

2. Brief description of the GENERAL PURPOSE of the project.

3. In your view, what BENEFITS may result from the study that would justify asking the subjects to participate?

4. Give details of the PROCEDURES that relate to the subjects' participation. If the procedures are in an existing document (for example, a grant or dissertation proposal), you may want to attach the document or the pertinent parts of the document. Be sure to reference the attachment.

5. List ALL vulnerable subject populations to be included and additional precautions being taken to ensure their protection.

Examples include Minors (under age 18), College students, Prisoners, Employees, Pregnant women/Fetuses, Adults with Cognitive Impairments, Substance abusers and Non-English Speaking people

6. How will the subjects be selected and recruited?

Append copy of letter, advertisement, and transcript of verbal announcement if applicable.

7. What inducement will be offered?

Provide justification for any inducement other than those of trivial benefit.

8. How many subjects will be used? List any salient characteristics of subjects (e.g.., age range, sex, institutional affiliation, other pertinent characterizations.)

9. Number of times researchers will interact with each subject?

10. What will the subjects do, or what will be done to them, in the study?

APPEND COPY OF QUESTIONNAIRES OR TEST INSTRUMENTS, DESCRIPTION OF PROCEDURE TO BE CONDUCTED ON THE SUBJECT. If the procedures involve observation, please include the type of behavior or action you expect to observe and record. If the procedures involve an interview, attach a sample of questions you plan to ask.

11. How do you intend to obtain the subjects' INFORMED CONSENT?

N/A is not an acceptable answer to this question.

If in writing, attach a copy of the consent form. If not in writing, include a written transcript of what is to be said to the subject(s), and justify the reason that oral, rather than written, consent is being used. Each subject should be fully informed by written or oral statement that indicates at a minimum: the purpose of the project, the benefits to be derived, a full description of the procedures to be carried out in which the subjects are involved, the amount of time that is required of subjects and who to contact with questions.

Is it clear to the subject that their participation is fully voluntary? Is it clear to the subjects that they may withdraw at any time? Is it clear to the subjects that they may refuse to answer any specific question that may be asked of them? Is it clear to the subjects who to contact in case of research-related questions? If the subjects are minors, you must obtain minor assent in addition to parental consent. Please attach assent form/procedure.

12. Assessment of RISK

Do you see any chance that subjects might be harmed in any way? Do you deceive them in any way? Are there any physical risks? Psychological? (Might a subject feel demeaned or embarrassed or worried or upset?) Social? (Possible loss of status, privacy, reputation?) How will you control for the risks you’ve identified?

13. How do you ensure CONFIDENTIALITY of information collected?

At a minimum, provide the following information:

Who will have access to the data? Where will data be stored? Where will signed consent forms be stored (be specific regarding location)? What identifiers (direct or indirect) will be collected? What purpose do the identifiers serve? When will identifiers be removed or “de-linked” from the data? (Identifiers include a code number, which may be linked to another document containing names or other identifying information.) Will the data be retained or destroyed? If the data will be destroyed, how and at what point in time (be as specific as possible)?

14. Are approvals needed from another MSU regulatory committee (i.e. IACUC for animals or IBC for infectious agents or recombinant DNA)? If so, please attach approval letter(s) from appropriate committee(s). If approval has not yet been obtained, where are you at in the approval process?