EXPEDITED Procedures

IMPORTANT ANNOUNCEMENT regarding research with minors involving online surveys:

The MTSU IRB is currently reviewing requests to administer online surveys to minors only through the full committee review.  Also, please be advised that the IRB is currently reviewing a policy procedure in compliance with Children's Online Privacy Protection Act (COPPA - 1998). Approvals to allow such interventions are granted only on a case-by-case manner.  Importantly, requests to waive parental consent for studies conducted through online means are not entertained until further notice.  

 

SUMMARY

This page is expected to provide the researchers with an outline of the necessary documents and paperwork to be completed in conjunction with the EXPEDITED procedures for obtaining IRB approval .  Note that most of the procedures, requirements, documentation and formatlities between the Expedited and a Full Review process are very similar.

 

  • Allow a minimum of 4 business days BEFORE you call us regarding the status of your petition
  • Please allow at least 2 weeks for protocols to be reviewed AFTER your application is complete
  • During the months of September-October and February-March, expect a minimum processing time of 3 weeks
  • The expedited review mechanism may take more than usual time for studies that involve special cases such as studies involving protected minorities, children, prisoners and etc. 

 

DEFINITION

An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

The studies that  (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure (45 CFR 46.110 and 21 CFR 56.110). The research activities listed in the protocol application SHOULD NOT BE DEEMED to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

Please be aware that the categories in this list apply regardless of the age of subjects, except as noted.  The expedited review procedure may not be used for classified research involving human subjects.

The expedited review procedure MAY NOT BE used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Importantly, OHRP requires that the IRB mandate the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

Click here to read more about the OHRP's regulatory policy and guidelines for expedited review processes

 

RESEARCH CATEGORIES REVIEWED UNDER THE EXPEDITED MECHANISM

 

A short-form description of the categories under with expedited protocols are reviewed and approved is listed below (Click here for full description of the categories):

  1. Clinical studies of drugs and medical devices only certain specific condition met
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
  3. Prospective collection o biological specimens for research purposes by noninvasive means.
  4. Collection of data through noninvasive procedures
    1. Many studies conducted at the MTSU HHP Department may come under this category
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior
    1. NOTE - Many of the MTSU research may come under this category
  8. Continuing review of certain types of studies that were previously approved by the convened IRB
  1. Continuing review of research, not conducted under an investigational new drug application or investigational device 

*** IMPORTANT - Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).

 Source: 63 FR 60364-60367, November 9, 1998.  Click here to read more about the OHRP's research categories and recommendations to IRBs

NEW EXPEDITED APPLICATIONS

 

Essential Forms and Attachments

  • Expedited Application Form
  • Informed Consent Form (Expedited)
    • Click here to watch an OHRP video on obtaining informed consent
  • When conducting research with children:
    • For children 0-12 years 
    • For participants between 12-18 years
      • Combined Parental consent - Child assent form - IRBF010d
      • Parental consent only - IRBF010e - Contactirb_information@mtsu.edu
      • Child assent only - IRBF010f - contact irb_information@mtsu.edu
    Research with Minors - Please note that the parents have to provide active consent for allowing their children to participate in most of the studies unless determined otherwise by the IRB.  An "opt-out" clause for consent will no longer be accepted by MTSU IRB.
    • Ensure the investigator fills the APPENDIX B of the expedited application
    • Visit Working with Minors page for more information
  •  Recruitment details (flyer, email transcript, etc.)
  • CITI training certificate if new to MTSU - click here to know more about how to obtain your certification
    • Students must complete "students in research" module in addition to other training courses
    • All of the investigators must complete "Research with Children" and "Research in Public Elementary and Secondary Schools" modules
  • Survey Instrument(s)

Other Essential Documents to be submitted with the application

  • Permission letter(s) if the study is conducted at a non-MTSU facility
    • Studies that would take place outside MTSU will require appropriate permission letters from the facility
    • For instance, researchers conducting studies with school children would require a letter of support on official stationary from the school's administration
    • Send scanned PDF of the letter by email for IRB review and keep the original for your records
  • Mutual agreements and approvals
    • This is similar to the permission letter described above, but the difference being the research is not only conducted by MTSU representative(s) but also include workers from other Institution.  
  • ADVERSE EVENT NOTIFICATION
  • Other study-specific documents

 

  • Be advised that the IRB and the Office of Compliance may direct you to provide other types of documents not mentioned above to determine compliance.  

  • All essential and additional materials should be emailed to irb_submissions@mtsu.edu.

  • INCOMPLETE APPLICATIONS WILL NOT BE REVIEWED

  • The 2-3 weeks review timeline will not start until the prereview is successfully completed.

 

DOCUMENT SUBMISSION

The Office of Compliance now follows an updated process by which documents are received for IRB review.  The following two email accounts are designated to correspond with the researchers:

Please click here for an overview the most recent document submission process

 

REVIEW PROCESS

Administrative Actions (PREREVIEW):

The application and the supporting documents will be administratively prereviewed for completeness.  Incomplete applications will be sent back to the researcher(s) without any administrative action.  Complete applications will be assigned a new IRB ID which will resemble ##-2###.  The researchers will be corresponded by email if further information is needed.  

IRB Member Review:

Subsequent to the administrative actions, the application materials will be forwarded to a suitable IRB member or its representative.  Although every effort will be made by the Office of Compliance to designate reviewers who have the necessary working knowledge on the subject matter of the application.  The researchers should however prepare the application in simple language such that a reviewer with a different field of expertise would also understand.  The reviewer will directly correspond with the researchers and may request more information needed to make a determination.   After the review process, the reviewer may either determine that the proposed study can be approved under one of the research categories  mandated by the OHRP.  Or, the reviewer may refer the study for a full committee review.

Secondary Review (if necessary):

In the event that the primary reviewer determines the protocol may not comply within the requirements of the expedited mechanism, then the application will be administratively sent for a secondary review.  The Office of Compliance will send appropriate notification to the researcher on the status of the application should the second reviewer also determines that the study needs to be reviewed by the full committee.  However, if the second reviewer recommends approval under the expedited mechanism , then the IRB Chair will be requested to review the study to make a final decision.  

 

PROTOCOL APPROVAL

The researchers will receive an Expedited Approval Notice from the Reviewer or the Office of Compliance.  It is important that the researchers store the document in a safe location along with their study-related documents.  The approval notice should be sent to appropriate funding agency by the researcher.  Each protocol approved under the expedited mechanism can be kept active for up to THREE (3) years.  However, the PI or the faculty advisor (if the PI is a student) has to submit a Continuing Review 3-4 weeks prior to the annual expiration date noted in the approval notice.  Expired protocols cannot be renewed or continued.  Therefore it is vital that the researchers obtain approval for continuation prior to the expiration date.  A protocol can be continued twice and after the third year a new application needs to be submitted.  

 

POST-APPROVAL  PROCEDURES  &  OBLIGATIONS

The applicant of the protocol or the faculty advisor (if the applicant is a student) must assume full responsibility that the study will be conducted in the guidelines listed by the research team in the protocol.  Any alteration to the protocol can be done only after obtaining written approval from the IRB or the Office of Compliance.  Starting from August, 2015, major changes to the procedures and the instruments will not be allowed and the researchers will be directed to complete a new application.  The following are a few procedures and obligations for the researchers in order to keep the protocol active.  Depending on the type of protocol, additional restrictions and obligations may be imposed.

Data Storage

The PI or the faculty advisor (if the PI is a student) has to take responsibility of the data collected during the study.  All confidential materials need to be secured as proposed in their application.  The researchers have to notify the Office of Compliance if there are any breaches or any change of storage location is anticipated.  A suitable course of action would be determined upon the researchers' notification.  It is mandatory that the researchers store the data in a secure place for up to three (3) years after the study has ended.  After this storage time, the investigators MAY destroy the data such that the confidentiality will not be lost.  

In addition to the research data, the investigator who is charged with the institutional responsibility is also required to maintain records on the co-investigator(s) of the study, such as role of the investigators, training information & expiration, list of co-investigators and other activities.  It is also important  to record  the dates of addition/removal of the co-investigators to ensure the protocol is always conducted by researchers whose training is up-to-date..

Amendments to Existing Expedited Protocols

Currently the "Addenda policy" is being revised and the proposal under review. Please contact the office of compliance (irb_information@mtsu.edu) for additional information on creating addendum requests.

1. Minor Amendments

Policy in preparation - Addition/removal of investigators, small extensions of participant number and correcting typographical errors to the previously approved documents.  

2. Major Amendments

Policy in preparation - addition of a new location for conducting the research activity, minor changes to the instruments, amendments to the informed consent, procedural changes and etc. 

Closing an Expedited Protocol

An existing protocol can be closed at any time by filing a final report.  The investigators however should remember that the data collected when the protocol was active needs to be stored in a secure location for up to three (3) years after the final report has been approved and acknowledged.  The data and the location may be subject to OHRP audit any time during this period.   Changes in location of the storage of sensitive data also needs to be notified to the IRB.  This is true even after the protocol has been closed or has expired.  

>> Adverse Event Notification <<

All adverse events, such as study-related injuries to the participants and other types of harms that may have happened to the human subjects need to be reported to the Offfice of Compliance within 48 hours by emailing compliance@mtsu.edu.  Other adverse events could include compliance breaches or inadvertent/intentional deviations in the protocol should also be reported. Any event that could potentially place the participant at risk will be deemed as "adverse" and MUST be reported. Subsequent to notifying compliance@mtsu.edu by email,, the researcher MUST submit an Adverse Event Form by providing specifics on the event and what course of action was taken to mitigate the risk(s).  The "Adverse Event Form" needs to be completed and submitted within seven (7) days of the event to irb_submissions@mtsu.edu.  

Investigator Change Notification

All addition and removal of investigators should be reported to the Office of Compliance prior to commencing research.  The PI or the faculty advisor (if the PI is a student) should submit an Addendum Request to initiate the addition/removal of investigators.   Additionally, the new investigator who will be added to the protocol should have completed proper CITI training at the time of the request.  Data collected by an individual who is not included in the protocol would not be permissible and may lead to the cancellation of the protocol.  

Progress Report and Continuation Review Request

Typically, most IRB approvals for expedited and full member review mechanisms are given for up to one year.  At the end of the first year, the investigators can either opt to close the study or to continue the protocol for an additional year.  If they choose to close the study, then they will follow the process described above on how to submit a final report.  If they wish to continue the study, then they have to submit a request for Continuing Review.  The application for a continuing review should be received by the Office of Compliance at least three (3) weeks before the date of initial expiration in order to process the extension in a timely fashion.  A continuing review request may be submitted twice for the life of a protocol.  After three years, the protocol will automatically expire and a new application needs to be filed.

A PROTOCOL CANNOT BE EXTENDED ONCE IT EXPIRES.  

 

 

OTHER ACTIONS

Denial of Approval:

A protocol may be denied approval due to either noncompliance or the proposed study may not qualify to be reviewed under the expedited mechanism.  In both cases, the IRB in cooperation with the Office of Compliance will make every effort to help the researchers to address the compliance concerns.  In rare instances, where the proposed study could not be achieved under the set forth criteria, the researcher will be asked to resubmit a fresh application to be reviewed under he full committee review mechanism

Refer to Full Committee:

As explained above, a study may not qualify for IRB's expedited review mechanism  will have to be reviewed by entire committee.  

Deferral:

In very rare cases a protocol may be deferred by the MTSU IRB.  There may be many specific reasons why such a decision has been arrived.  Nonetheless, a protocol that has been deferred cannot be resubmitted or be approved for human participation.  Be advised that the protocols deferred by the IRB cannot be overturned by any other agencies or individuals within MTSU.  By law, the OHRP requires the IRB to act independent and the MTSU offers its fullest support to the Committee.  

Appeal Process:

As stated above, all IRB decisions are final and cannot altered.   A researcher may nonetheless appeal a decision by making a written request with proper justification to the Chair of IRB (Click here for a list of current IRB members).  The decision of the IRB Chair may convene a special meeting or bring the protocol up for a vote in an upcoming IRB meeting.  Once the IRB votes to defer the protocol, then the decision cannot be appealed under any circumstances.  The researchers must be aware that involving MTSU Administration or ranking officials to influence an IRB approval process is a violation of University's Federal-Wide Assurance and PHS policies governing human subject research.  In contrast however, an authorized Institutional Official reserves the right to cancel a protocol that has been previously approved by the IRB.

 

 

 

 

 

The following process is currently under review

Amendments TO AN EXISTING EXEMPT PROTOCOL

 Starting from August 2015 (Protocols starting with 16 or later), amendments to exempt protocols will be restricted to only minor changes.  The changes include minor typographical changes to the protocol/instrument/informed consent.  Other allowed changes would be addition or removal of investigators.  The Office of Compliance will no longer be able to complete major changes in the instruments or the protocol that have originally been approved as exempt.

Completed amendment request forms should be sent to irb_submissions@mtsu.edu.