1.  Where is the IRB administrative office?

Wickes Hall 314

2.  Who do I contact if I have questions?

IRB Manager Julie Decker, (989) 964-4941, jadecker@svsu.edu or IRB Chair Maric Cassar, (989) 964-4779, irbchair@svsu.edu.  You can also come to IRB Office, hours 8:00 a.m. - 4:30 p.m. Monday through Friday

3.  What rules must the IRB follow?

Federal guidelines "The Common Rule (45 CFR 46)" is the foundation for IRB rules.

Additional rules/laws are applied by the state of MI

4.  What guidelines does the IRB follow?

The institutional IRBPoliciesAndProcedures (38kB)

1. When is IRB review required?
   • Any study that requires human participants and meets the definition of “Research”
   • Research is defined by federal regulations as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge". 
   • Generalizable knowledge draws conclusions from information obtained to apply to populations outside of the study (professional association) usually through publication and or presentation
     
     
2. What are the different types of IRB review?
   • Full Board protocols
     • High level of risk to participants (above minimal risk)
     • Research is identifiable and sensitive
     • Research does not fit any of the Expedited categories
   • Expedited protocols
     • Minimal risk to participants
     • Research is identifiable and sensitive and falls within one of the expedited categories (1-7)
   • Exempt from full board review protocols
     • Less than minimal risk to participants
     • Research that is identifiable but not sensitive
     • Research that is sensitive but not identifiable
     • Research that is not sensitive and not identifiable
   • Nonhuman Participant Research
     • Research that involves no interaction with an individual and only de-identified data.  UNCG researchers have no access to identifying information
     • Research that is designed to preserve a historic event only and there is no attempt to draw generalized conclusions from data collected
       
       
3. How long does the initial review process take?
   • A full board review protocol takes approximately six weeks if  well written and the protocol is complete
   • An Expedited review protocol takes approximately one month if well written and the protocol is complete
   • An Exempt from further review protocol takes approximately two weeks if  well written and the protocol is complete
   • A Determination of not Human Participant Research takes approximately one week if well written and the protocol is complete
     
     
4. What if I don’t get approval from the IRB prior to conducting my study?
   • Individuals that do not acquire IRB approval prior to data collection are noncompliant and are liable for any and all negative outcomes
     
     
5. When does a study require full board review?
   • When research involves highly sensitive information/methodology and vulnerable populations with a lot of serious risks to participants
   • When research does not fit in one of the expedited categories
   • When research does not have clear benefits but does have a clear high level of risk
     
     
6. What happens with my protocol once I send it to the ORC?
   • 1^st The protocol is logged into the database
   • 2^nd The protocol is initially reviewed
   • 3^rd An approval is issued for (Exempt/Non Human Participant Research) or the protocol is forwarded to the IRB chair 

1. How long are IRB approvals valid?
   • The approval period of an exempt protocol is 3 years
   • The approval period of an nonexempt protocol is determined by the IRB but not more than one year
     
     
2. How will I know when its time to renew my project?
   • Renewal reminder notices are sent out 30 and 60 days in advance to the PI named on the protocol
     
     
3. What happens if I miss my renewal deadline?
   • All research activities must cease until approval is obtained
     
     
4. How long does the renewal process take?
   • If all documents are sent along with the renewal the review and approval process takes approximately two weeks
     
     
5. If I submit a modification during my approval period does that count as a renewal of my protocol?
   • No, a modification change components of the currently approved protocol not the approval period

1. When is a modification necessary?
   • A modification is necessary whenever a PI deviates from the approved protocol
     
     
2. Can I make changes to my protocol and inform the IRB later?
   • No, the IRB must approve any changes prior to implementation
     
     
3. Are all modification viewed the same by the IRB?
   • There are two types of modifications minor and significant (see examples below)
     
     

Significant Changes

1. Working with kids in standardized school and wanting to add kids from a school for adjudicated youth (Alternative Schools)
2. Working with pregnant women and wanting to add pregnant minors.
3. Incorporating invasive measures to a study such as therapy that could lead to depression or rekindled psychotic disorders
4. Adding a site to conduct research that the PI has a clear conflict of interest
5. Adding procedures that include the use of Personal Health Information (PHI)
6. Adding procedures for data collection that involve student rights (FERPA)
7. Changing survey procedures from anonymous survey to collecting identifiers (this could mean a new IRB application)

Minor Changes

1. Increasing the sample size for a study
2. Changing the stimuli for an experimental study (e.g., memory lists of words to memory lists of pictures, as long as the pictures are of the same caliber or similar response)
3. Requesting additional contact information (email or fax number)
4. Changing PI of equal capabilities or adding students to a project
5. Adding sites to collect data of same caliber (another high school in the USA not a high school from overseas)

All minor changes must meet both of the following criteria:

• All added procedures involve no more than minimal risk
• All added procedures fall into categories (1)-(7) of research that could be reviewed using the expedited procedure

4. If my protocol was initially reviewed by the full board do all of my modifications need to go back to the full board?
   • For each modification the IRB will make a determination if the change will require review by the full board review

1. Why do I have to get informed consent?
   • Informed consent assures that prospective human participants will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate
     
     
2. Are there different ways that I can obtain informed consent?
   • The long form (STRONGLY RECOMMENDED)
   • The short form with oral presentation
     
     
3. What information needs to be in the informed consent form?

(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the participant;

(3) a description of any benefits to the participant or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the participant;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation will be made and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research participants' rights (Eric Allen , Director of Office of Research Compliance, 256-1482); and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

4. Do I have to get the informed consent signed and dated?
   • In most cases yes the informed consent document has to be signed and dated
   • The IRB can determine if the research meets the criteria for waiving documentation (signed informed consent)
     
     
5. Is it possible to get a waiver of informed consent or elements of informed consent?
   • In most cases some form of informed consent is required
   • The IRB can determine if certain elements of informed consent can be waived or the entire process of obtaining informed consent
     
     
6. Where can I find samples of informed consent forms?
   • The ORC website under IRB forms
     
     
7. Would you like a sample approved consent form or IRB application?
   • Contact the IRB representative in your department to obtain a copy of one of their approved studies. If you do not haven IRB representative on the list, please contact the ORC for assistance.

1. What options do I have for obtaining my training? CITI (online module)
   
   
2. Which CITI modules are accepted by the IRB?
   Most investigators should complete either the "Biomedical Research Investigators" or the "Social & Behavioral Research Investigators" curriculum, depending on the type of research conducted (click How to access Basic and Refresher Courses in CITI (16kB) (18kB) to learn how to access courses required for IRB review).  Investigators who are conducting FDA research should also complete "Good Clinical Practice" curriculum.  Additional curricula, such as "Students conducting no more than minimal research" and "Research with data or laboratory specimens only" might be useful for introducing students to ethical research issues, but do not qualify as sufficient training for human-subjects research undergoing IRB review. Those who wish to know more about the IRB, are contemplating serving on the IRB, or are actively serving on the IRB should complete the "IRB Members" curriculum.
   
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3. How long is my training certificate valid?
   3 years
   
   
4. Does everyone on a research project need a certificate of training?
   Yes, the Principal Investigator, Faculty Advisor, and any other researchers listed on the IRB Application must complete training.

1. Can children consent to participate in research?
   • No, children give their assent to participate in research
     
     
2. How old does a child have to be in order to give assent?
   • 5 years old
     
     
3. Are the elements of informed consent the same as those for assent?
   • For the most part yes but the age and cognitive abilities of the kid may merit a wavier of some of the elements
     
     
4. Do I have to obtain permission from the child’s parent before working the child?
   • Yes, parental permission should be obtained prior to the child assent
     
     
5. Do both parents have to sign the informed consent form?
   • Only when the research is of high risk and/or there is not direct benefit to the child
     
     
6. Is it possible to get a waiver of child assent?
   • Yes, but the PI should provide adequate justification to the IRB
     
     
7. Is it possible to get a waiver of parental permission?
   • Yes, but the PI should provide adequate justification to the IRB

1. Do I have to have an interpreter if I plan to work with non-English speaking people?
   • No, however it is required that you have adequate plans to communicate with non-English speaking populations
     
     
2. Can the IRB waive certain requirements for conducting research with illiterate or deaf populations?
   • Yes, however the PI must provide a plan to ensure that the participants understand what is going on in the research project
     
     
3. If there are language barriers what information do I need to submit to the IRB?
   • Typically all research related documents must be translated into the appropriate language
   • A plan to communicate information as appropriate to the population

1. If I conduct research in the school system do I need approval from the district or just the school in which I plan to conduct the research?
   • All school systems don’t follow the same rules regarding conducting research in their school and the PI should discuss the policy with the school.  Some school systems require an independent review of the research by a research review committee similar to an IRB.  While others only need the principal to review and approve the research.
     
     
2. If both the school system and SVSU IRB need to review the protocol, who do I submit to first?
   • This decision is up to the investigator, however SVSU recommends the PI submit the protocol to either SVSU or the school system for review first, but not simultaneously.
   
   
   

Do individuals that are not currently employed or enrolled at SVSU need IRB approval before conducting the study?

• Most studies can be conducted at SVSU without IRB approval but clearance must be obtained through the IRB
• The IRB will review the research and make a determination

If I am leaving the university and I have an open protocol, what should I do?

The PI will need to complete a IRB Renewal/Close-out Form (116kB)and submit it to the IRB. If leaving the university to work or attend another institution, then the PI/Student will need to seek approval for that study at the new institution since SVSU will no longer be responsible for the protocol 

What should a PI do if a participant is physically injured, suffers personal loss, or psychologically traumatized when participating in an approved research study?

The PI is responsible for reporting any unexpected project outcomes or events to the IRB. See the Adverse Event Tree for guidance on how to report an event.

Does a pilot study always have to go through IRB approval?

No, a pilot study doesn’t always need to go to the IRB for approval, however:

• There can be no mention of SVSU IRB in the consent forms.
• There can be no language that indicates that there was IRB approval or that the IRB condoned the study.
• The study results cannot be presented as research data.