Questions relating to the Institutional Review Board:

1. What is an IRB (Institutional Review Board)?
2. How does Missouri State University define research?
3. When do activities involving human subjects need IRB review?
4. How does Missouri State University define human subjects?
5. Does my master’s thesis/doctoral dissertation require IRB review?
6. I plan to conduct my research at another institution. Does Missouri State University's IRB need to review my research proposal?
7. Does Institutional Research require IRB review?
8. Do student projects require IRB review?
9. What are the IRB meeting dates?
10. My research involves tissue/specimens. Do I need IRB review?
11. Do I need to notify the IRB every time I make a change to the study?
12. What do I include with my IRB submission?
13. What type of reviews does the IRB conduct?
14. What is the process for submission to approval of proposals to the IRB?
15. How long does it take to get a study approved by the IRB?
16. How do I fill out the IRB Application forms?
17. I have some questions about my IRB submission. Who can I talk to?
18. Do I need to take/complete a training program/class to conduct human research at Missouri State University?
19. Which module in the CITI training should I take?
20. How do I know if my study is regulated by Missouri State University’s HIPAA requirements?
21. How do I know if my research is covered by HIPAA?
22. What are my responsibilities as a human subject researcher?
23. What is a consent form?
24. How can I waive consent procedures from my research proposal?
25. How does Missouri State University define an enrolled subject?
26. What constitutes as non-compliance for Human Subject Research?
27. How do I renew my study approval?
28. What if my study has expired?
29. How can I close my study when I am finished?
30. How long does data collected from a human research project need to be maintained by the PI?
31. Can the IRB suspend a research project?
32. This FAQ has not been completely helpful. Can I get additional help from the Office of Sponsored Research and Programs?
33. What are some of the common mistakes to avoid?

Common Acronyms and Abbreviations:

FDA:       Food and Drug Administration
CITI:       Collaborative Institutional Training Initiative (University of Miami)
IRB:        Institutional Review Board
HIPAA:   Health Insurance Portabilty and Accountability Act
HS:         Human Subjects
OSRP:   Office of Sponsored Research and Programs
PI:           Principal Investigator  
NIH:        National Institute of Health
DHHS:    Department of Health and Human Services 

---

(Note: Links within the answers open a new window)

1.  What is an IRB (Institutional Review Board)?

The IRB reviews research studies involving human subjects. The IRB is federally mandated to ensure that proper safeguards are in place to protect human subjects enrolled in research studies.

2.  How does Missouri State University define research?

A systematic investigation designed to develop or contribute to generalizable knowledge.
Generalizable Knowledge is further defined as any information generated from data collected to describe, inform, generate or test hypotheses that will be shared with others in any public or semi-public venue other than closed meetings and/or the classroom setting.  This may include dissemination of information through more traditional, formalized means such as journal publications or conference presentations.  It also includes dissemination through things like local or state newsletters or posting on the Internet such that a wider audience could access the information freely. 

[Top of Page]

3.  When do activities involving human subjects need IRB review?

Any activity that meets the federal definition of both “Research” and “Human Subjects” or the Food and Drug Administration (FDA) definition of “Clinical Investigation” requires review and approval by the Missouri State University IRB.

Activities that meet this definition constitute research for purpose of the policy and procedures, whether or not they are supported or funded under a program which is considered research for other purposes.  For example, some demonstration and service programs may include research activities.

[Top of Page]

4.  How does Missouri State University define human subjects?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) data through intervention or interaction with the individual, or (b) identifiable private information.

Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (e.g., cognitive experiment).

Interaction includes communication or interpersonal contact between investigator and human subject (e.g., a telephone interview).
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which he or she can reasonably expect will not be made public (e.g., a medical record).  Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human participants.

[Top of Page]

5.  Does my master’s thesis/doctoral dissertation require IRB review?

Graduate work (thesis or dissertation) which involves research on human subjects requires IRB Review.

[Top of Page]

6.  I plan to conduct my research at another institution. Does Missouri State University’s IB need to review my research proposal?

If you are completing the study as Missouri State student or Missouri State faculty member, your research should receive review by the Missouri State IRB.

7.  Does Institutional Research require IRB review?

Institutional research is a study that is designed to obtain information to assist in the administration of the University. Institutional research provides information for administrative planning, policy making, decision making, and includes examinations of institutional effectiveness.  Institutional research is specifically defined as those data collection and interpretation efforts that:

(a) will not be shared outside of the University environment;

(b)will not be disseminated to other professionals or the public in any forum;

(c) presents no more than “minimal risk” (as defined by Federal regulation);

(d) is not intended to produce “generalizable knowledge”; and,

(e) contains no identifiers in the data that might compromise an individual’s confidentiality. Institutional efforts meeting this definition are not subject to the IRB policy and procedures.

[Top of Page]

8.  Do student projects require IRB review?

Student projects or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of research. Course instructors are encouraged to call the IRB or OSRP if they have any questions.

Student project means a study in which a student investigator (individually or as part of a group) gathers or analyzes information in a systematic manner, primarily for pedagogical purposes. It is not intended to contribute to generalizable knowledge and is not to be presented outside the class in which the research is being done or published/disseminated (including publication on the Internet) in any way, presented, archived, or compiled with similar research for later publishing or presentation. Research conducted for a senior project, master’s thesis or seminar project does not fall under this definition.

 

9.  What are the IRB meeting dates?

The IRB Meeting dates and locations can be found on OSRP website or from your IRB College Representative.

10.  My research involves tissue/specimens. Do I need IRB review?

If the study meets the definition of “research” and “human subjects”, the study requires IRB review.

11.  Do I need to notify the IRB every time I make a change to the study?

Yes. All changes (including study personnel changes) to a study must be approved by the IRB.

12.  What do I include with my IRB submission?

The items to be included are;

1. Application form
2. Human Subjects Protection Cover sheet
3. CITI Certificate of training
4. HIPAA Certificate of training (if applicable)
5. Copy of your proposal
6. Brief statement of your project goals
7. Protocol
8. HIPAA Plan (if applicable)
9. Benefits of research/study
10. Risks and Analysis
11. Procedues to reduce/minimize risks
12. Procedures for obtaining Informed Consent

(See IRB Application Process)

[Top of Page]

13.  What type of reviews does the IRB conduct?

The IRB conducts the following reviews:

• Initial IRB Review for new protocols. Review types include Exempt, Expedited or Full.
• Modification Review for changes made to IRB approved studies
• Continuation Review is usually an annual review conducted by the IRB for ongoing approved studies.
• Review of Unanticipated/Anticipated Problems/Adverse Events associated with the study.

[Top of Page]

14.  What is the process for submission to approval, of proposals to the IRB?

The process for submission to approval is;

• Complete CITI training (and HIPAA training if applicable)
• Submit your application (proposal) to your Faculty (PI) advisor (attach copies of CITI and HIPAA certificate of training)
• Faculty advisor sends accepted proposal to the respective IRB College Representative
• If IRB College Representative approves application, proposal is sent to the IRB Chair
• Once proposal is approved by the IRB Chair, it is sent to OSRP. (If not approved, it is sent back to the Faculty advisor)
• OSRP receives the approved proposal and sends approval letter to faculty advisor, co-workers(student, staff, faculty), copied to IRB College Rep. and Chair

15.  How long does it take to get a study approved by the IRB?

The time to get a study initially approved depends on the type of review conducted by the IRB and if applicable, the amount of time it takes for the investigator to respond to the IRB’s requested revision(s). Currently the average times is 7 days through campus mail.

16.  How do I fill out the IRB Application forms?

These are MS Word or Adobe PDF documents that can be downloaded from OSRP website, and filled on your computer or by hand. All forms must be filled completely before the IRB office will accept the proposal.

17.  I have some questions about my IRB submission. Who can I talk to?

Contact your college IRB member, the IRB Chair or the Office of Sponsored Research & Programs,( OSRP @ 836-5972 or sponsoredresearch@missouristate.edu).

18.  Do I need to take/complete a training program/class to conduct human research at Missouri State University?

Yes, All investigators, and study personnel who interact and/or intervene with Human subjects or handle personally identifiable data of a human subject must be trained in the protection of human subjects. The training comprise the CITI and HIPAA training.

19.  Which module in the CITI training should I take?

If your reesarch involves biomedical/medical information then you take the Biomedical training, otherwise you take the Social and Behavorial training.

20.  How do I know if my study is regulated by Missouri State University’s HIPAA requirements?

Studies are regulated by the Missouri State University HIPAA Privacy Rule if the investigator obtains protected health information from a University covered entity department.

21.  How do I know if my research is covered by HIPAA?

HIPAA is applicable to you if your college or department uses Protected Health Information in connection with certain covered transactions. Legal counsel with guidance from Deans and other Missouri State officials have determined which colleges and departments engage in covered transactions and thus are covered by HIPAA. Because of its size and the diversity of its activities, the Missouri State University is designated as a hybrid entity which means that some departments/colleges are regulated by HIPAA and others are not. An entity, or its covered departments or colleges, that is regulated by HIPAA is called a Covered Entity (CE).

If you are employed in a Missouri State Covered Entity component and create, access or share Protected Health Information, HIPAA applies to your research.

If in your research you collect Protected Health Information from a Missouri State Covered Entity and your department/college is deemed outside of the Covered Entity, HIPAA applies to your access of the Protected Health Information.

Researchers not in the Covered Entity may need an authorization form:

• to access PHI for their study; or,
• if they are conducting part of their study in the Covered Entity.

Please contact the Office of Sponsored Research and Programs at 417-836-5972, or e-mail SponsoredReserach@missouristate.edu for further information on revised authorization/consent form.

22.  What are my responsibilities as a human subject researcher?

The PI has primary responsibility for all aspects of the protection of human participants on a given project, including compliance with all Federal and University policies and procedures, and that all research associates involved in a PI’s project also comply with said regulations, policies, procedures and guidelines.

23.  What is a consent form?

A consent form is a written document that explains the research study to potential subjects. This document is signed by the subjects and must contain information/statements to ensure that subjects are fully informed about the study. (see templates) The Investigator should use the template when developing a consent form. Please note that the IRB may waive consent procedures for some research proposals.

24.  How can I waive consent procedures from my research proposal?

The IRB may waive the requirement for a signed informed consent form if the following requirements are met:

• the research involves no more than minimal risk to the participants;
• the waiver or alteration will not adversely affect the rights and welfare of the participants;
• the research could not practicably be carried out without the waiver or alteration; and
• whenever appropriate, the participants will be provided with additional pertinent information after participation.   

25.  How does Missouri State University define an enrolled subject?

The IRB considers a subject enrolled in a study when the subject signs a consent document.  Any screening or testing done for research purposes to determine subject eligibility should not be conducted prior to the subject agreeing and documenting their consent to participate in the research (except where waiver approved).

In cases where the IRB approves a waiver from the requirement for obtaining informed consent and/or a waiver from the requirement for documentation of informed consent, any individual on whom data has been collected should be counted as an enrolled subject.

[Top of Page]

26.  What constitutes as non-compliance for Human Subject Research?

Non-compliance includes, but is not limited to:

• Misuse or nonuse of approved informed consent procedures
• Failure to submit protocols in a timely manner
• Breaking confidentiality, unless required by law (e.g., child abuse)
• Unapproved subject recruitment activities
• Failure to secure confidential records in the required manner
• Failure to report problems involving physical or psychological injury to participants or others
• Failure to report risks to participants or others that exceed the protocol as approved
• Report from a subject of abuse by the PI or research staff
• Conducting research involving human participants that has never been approved by the IRB
• Initiating changes to research protocols involving human participants without prior IRB approval
• Continuing research activities beyond the IRB approved end date

Even though these types of events must be reported, the PI is encouraged to contact the IRB Chairperson and OSRP if anything occurs that causes concern regarding the protection of human participants.

27.  How do I renew my study approval?

If the IRB has not approved continuing review past the expiration date, new subjects should not be enrolled until the IRB approves the project for another year.  The renewal must be submitted at least 21 days before the expiration date. Periodic reports that have expired during the review process are considered active and the review is continuing. Studies that have expired due to submissions past the expiration date are subject to full review with a new application to the IRB.

28.  What if my study has expired?

The continuation of research after the expiration date is a violation of the regulations [21 CFR 56.103(a)]. Therefore, all research activities pertinent to the study should stop and no new enrollment should occur. You may submit a new application for the continuation of the project, which will go through full IRB review. OSRP will be pleased to provide necessary assistance to secure approval for this project with minimum delays.

If you were actively pursuing renewal with the IRB at the time of expiration, and the IRB believed that there was an overriding safety or ethical concern, the IRB would have permitted continuation of the study for a brief time to complete the review process. All IRB protocols are approved for one year or less depending upon the level of risk. Continuing reviews are required at a frequency determined by the IRB at the time of approval to ensure the rights and welfare of research subjects.

29.  How can I close my study when I am finished?

You do not have to wait for the end of your study approval period to close out your study if you have completed the research.  You MAY NOT CLOSE a study if ANY human subjects are still active, even for only one more visit or for any type of follow-up or information gathering or statistical analysis. If a study was closed because of sponsors decision, please inform the OSRP right away. If a study is going to be closed because of, for example, an investigator leaving the institution, you are then required to inform the sponsor, the IRB, and OSRP.

30.  How long does data collected from a human research project need to be maintained by the PI?

IRB policy requires investigators to maintain their research records (includes data collection form(s) including source documents and case report form (s) for five years after completion of the study. For research which falls under authority of other agencies or statutes with longer research record retention requirements, the longer retention period applies.

Investigators are responsible for ensuring that research involving humans conforms to generally accepted scientific principles, and that it is based on a thorough knowledge of the scientific literature and other relevant sources of information. The methods to be used should be appropriate to the objectives of the research and the field of study.

31.  Can the IRB suspend a research project?

The IRB Chairperson may suspend a study at any point after receiving information regarding unacceptable and uncorrectable levels of risk or harm to the participants or others or serious disregard on the part of the researcher to the policy and requirements of the IRB. The Chairperson will promptly notify the PI(s), as well as the OSRP, in writing of this decision and the reason(s) for suspension of approval.  The OSRP will notify OHRP and funding agency (if applicable) of the suspension or termination of approval.

Furthermore, the IRB Chairperson will convene a meeting of the IRB to discuss the suspension of IRB approval and the IRB will decide whether;

(1) IRB approval should be reinstated with or without modifications,

(2) suspension of IRB approval should be continued, or,

(3) IRB approval should be terminated.  The PI will be informed, in writing, of the outcome of the IRB meeting.

32.  This FAQ has not been completely helpful. Can I get additional help from the Office of Sponsored Research and Programs?

The Office of Sponsored Research and Programs will provide assistance when help is needed. You can contact the office at (417) 836-5972 or e-mail at sponsoredresearch@missouristate.edu.