IRB FAQs

Frequently asked questions relating to the IRB

1. Does my master’s thesis/doctoral dissertation require IRB review?
2. I plan to conduct my research at another institution. Does Missouri State University's IRB need to review my research proposal?
3. Do student projects require IRB review?
4. My research involves tissue/specimens. Do I need IRB review?
5. Do I need to notify the IRB every time I make a change to the study?
6. Which module in the CITI training should I take?
7. How do I know if my research is covered by HIPAA?
8. How do I renew my study approval?
9. What if my study has expired?
10. How long does data collected from a human research project need to be maintained by the PI?
11. What if I want to conduct a pilot study?
12. I have IRB approval from another institution. Do I have to submit a full IRB proposal to Missouri State's IRB?
13. I am not a MSU student, staff, or faculty member, but I wish to conduct research at Missouri State. Do I need MSU IRB approval?

Answers

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

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

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

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

3. 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 ORC 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 the definition of student project, and therefore, would require IRB review.

4. 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.

5. 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.

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

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

7. 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 ORC for further information on revised authorization/consent form.

8. 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 30 days before the expiration date. Renewals must be submitted through Cayuse IRB.  If your original application was submitted on paper, you must create a new submission in Cayuse IRB.

Studies that have expired due to submissions past the expiration date are subject to full review with a new application to the IRB.

9. 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. The ORC will be pleased to provide necessary assistance to secure approval for this project with minimum delays.

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.

10. 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 at least three(3) 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.

11. What if I want to conduct a pilot study?

Pilot studies designed to determine the feasibility of conducting a larger study usually do not require IRB approval. Pilot studies typically address issues regarding research design, instrumentation or methods of data collection. Studies qualify as pilot studies if:

1. they are small in scale (i.e. <10 subjects);

2. their purpose is to refine data collection procedures instrumentation or research design;

3. there is minimal risk to participants;

4. no sensitive data is collected;

5. no vulnerable populations are involved; and

6. there is no intent to publish or disperse the pilot study data and thus no intent to contribute to generalizable knowledge.

12. I have IRB approval from another institution. Do I have to submit a full IRB proposal to Missouri State's IRB?

Research conducted at Missouri State University that has been reviewed and approved by another qualified IRB may qualify for Single IRB Review. The Principal Investigator must complete a Request for Single IRB Review through the Cayuse system.  The request can be made on the General Information tab of the application.

13. I am not a MSU student, staff, or faculty member, but I wish to conduct research at Missouri State. Do I need MSU IRB approval?

It depends. Please contact the Office of Research Administration to discuss your research.  Email: IRB@missouristate.edu