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Post Approval Administration

One major investigator responsibility is to be compliant all IRB policies, decisions, conditions, and requirements. This means ensuring that the research is implemented as specified in the approved IRB protocol. Review the below topics to view what is required after the IRB provides approval.

Annual Continuation and Approval
Protocol Modifications
Reporting Adverse Events
Protocol Deviations and Violations
Closing a Protocol
Protocol Files

Annual Continuation and Approval

Expedited Review Protocols

The IRB is responsible for the continuing review of research to ensure that the rights and welfare of human participants are being protected. Special attention will be paid to determine whether new information or unanticipated risks were discovered during the research.

All expedited approved human subject protocols at UMBC are initially approved for a period of up to 12 months. At that time, investigators must file an Annual Continuation Report requesting a renewal for a project. The annual review date is an anniversary date that is one calendar year later than the date on the original IRB letter of approval. Research cannot continue beyond the one-year period without IRB approval.

As a courtesy to principal investigators, the ORPC will send an Annual Continuation Report Reminder in advance to the expiration of approval for a protocol approved via expedited review. It is the principal investigator’s responsibility to submit a continuing review application before expiration of IRB approval, and in ample time for IRB review.. Federal regulations make no provision for any grace period allowing the research to continue beyond the expiration date of the IRB approval. Therefore, continuing review and re-approval of research must occur on or before the date when the IRB approval expires. The request and all supportive materials including current and/or modified consent documents, questionnaires, measures, survey instruments and advertisements/recruitment letters, must be submitted to the ORPC at least four (4) weeks prior to the current protocol end date.

The IRB may grant a one-time exception to the permanent closure of the study to allow for reactivation of a study’s approval. Information about this request may be found here.

Click to download the Annual Continuation Report for Expedited Review protocols

Full Board Review Protocols

As stated above, the IRB is responsible for the continuing review of research to ensure that the rights and welfare of human participants are being protected. Special attention will be paid to determine whether new information or unanticipated risks were discovered during the research.

All full board approved human subject protocols at UMBC are initially approved for a period of up to 12 months, unless otherwise specified by the IRB A continuation or renewal may be requested, each for a period of up to 12 additional months, unless otherwise specified by the IRB. Full board approval of protocols are for a total of five (5) years, after which a new protocol must be submitted to determine that the rights and welfare of human participants continue to be protected.

Note: Full board reviewed and approved studies may only be renewed by expedited review if the research is permanently closed to enrollment, all subjects have completed the research related intervention and the research remains active only for long term follow-up. Please contact the ORPC with any questions.

As a courtesy to principal investigators, the ORPC will send an Annual Continuation Report Reminder in advance to the expiration of approval for a protocol approved via full board review.  The principal investigator, however, is responsible for timely submission of a continuation request. The request and all supportive materials must be submitted to the ORPC at least four (4) weeks prior to a scheduled IRB meeting.

Click to download the Annual Continuation Report for Full Board Review protocols

With either approval, a protocol period lapses when no continuation request has been submitted prior to the expiration date. As such, no protocol activity may continue, including contact with participants and the use and analysis of collected data. If this occurs, the protocol will be administratively closed by the IRB; investigators listed on this protocol will not have new submissions reviewed until a closure report is received.  The process for submitting a new protocol is required to resume project activities.

Exempt Protocols

Under the Exempt category, the principal investigator is not required to submit a renewal request. If for any reason the status of the protocol changes and it is believed that the protocol is no longer exempt from IRB review and approval, please contact the ORPC at compliance@umbc.edu.

Protocol Modifications

Most modifications may be approved administratively or may be handled through the expedited review process. Please review the below definitions to determine what type of change you wish to pursue. Any proposed change to an already approved human subject research protocol, measures, or informed consent document during the period of IRB approval must be submitted using the below form to the IRB immediately for review and approval. An investigator cannot initiate the procedures/changes stated in the amendment until IRB approval has been obtained. An amendment to the protocol does not change the approval date. Investigators are encouraged to contact the ORPC (compliance@umbc.edu.) with any questions. Investigators will be notified of approval of requests for changes in approximately one (1) week following submission.

Examples of minor changes

  1. Administrative changes
  2. Minor consent form changes
  3. Minor changes to recruitment procedures, recruitment materials or submission of new recruitment materials to be used in accordance with approved recruitment methods
  4. Minor changes to study documents such as surveys, questionnaires or brochures
  5. New study documents to be distributed to or seen by subjects that are similar in substance to those previously approved
  6. Changes in payment to subjects or the amount subjects are paid or compensated that are not significant enough to affect the risk/benefit ratio of the study
  7. Decrease in the number and volume of sample collections as long as they do not negatively alter the risk/benefit ratio of the study
  8. Editorial changes that clarify but do not alter the existing meaning of a document
  9. Addition of or changes in study personnel
  10. Addition of a new study site
  11. Translations of materials already reviewed and approved by an IRB

Examples of  major changes

  1. Changes that adversely affect the risk/benefit ratio of the study or specifically increase the risk to subjects
  2. Changes in inclusion/exclusion criteria that impact the risk/benefit ratio of the study
  3. Significant changes in study design, such as the addition of a new subject population or the elimination of a study arm
  4. New risk information that is substantial or adversely affects the risk/benefit ratio of the study
  5. Significant changes to the study documents to be distributed to or seen by subjects
  6. New study documents to be distributed to or seen by subjects that include information or questions that are substantively different from materials already approved by the IRB

Exempt Protocols

Changes to exempt studies do not need review unless the change would make the study non-exempt.

Click to download the Protocol Modification Request

Please highlight any proposed wording changes in the application form, consent documents, recruitment fliers, etc. by highlighting in yellow and underlining and attach those changed documents to this form. This will assist the reviewer with understanding the changes investigators are planning to make. Please review these instructions when submitting a modification of protocol documents to the IRB.

Note about changes to informed consent

Federal regulations (46.116 General requirements for informed consent) do not require reconsenting of subjects who have completed their active participation in the study, or of subjects who are still actively participating, when the proposed change will not affect their participation. However, when changes do occur in the conditions or the procedures of a study which alter how consent was previously obtained, the investigator should once again seek informed consent from the subjects. Those subjects who are presently enrolled and actively participating in the study should be informed of the change and reconsented if it might relate to the subjects’ willingness to continue their participation in the study. If reconsenting in necessary, investigators must submit a Request for Modification to a Protocol form as well as an Addendum to Informed Consent form.

Click to download the Addendum to Informed Consent Form

Reporting Adverse Events

Investigators are responsible for prompt reporting to the IRB of “any unanticipated problems involving risks to subjects or others…” (45CFR46.103.b (5)).  The IRB maintains responsibility for initial assessment of the risk/ benefit ratio in a research activity involving human participants. During the course of the project, investigators are required to promptly inform the IRB of any unanticipated negative effect or undesirable experience that is possibly, probably or definitely related to study procedure(s).

Although adverse events occur most commonly in the context of biomedical research, adverse events can occur in the context of social and behavioral research. Adverse events are not necessarily physical in nature; attention must be paid to psychological harm (such as depression, thoughts of suicide, etc), threats to privacy or participant safety. Events can occur which are unexpected and result in new circumstances that increased the risk of harm to subjects without directly harming them. The event may also present unanticipated risks to others (e.g., the sexual partners of the subjects, individuals the subject may come in contact with, family members, research personnel, etc.) in addition to the subjects.

In each case, while the event may not have caused any detectable harm or adverse effect to subjects or others they nevertheless represent unanticipated problems and should be promptly reported. The investigator must also include a description of any corrective actions that have been initiated in the conduct of the research to prevent a reoccurrence of the problem or to protect research participants from potential or further harm.

Only unexpected adverse events that are related to the research need to be reported.  An event is “related to the research procedures” if in the opinion of the principal investigator, it was more likely than not to be caused by the research procedures or if it is more likely that not that the event affects the rights and welfare of current participants. If this relationship can be definitively ruled out, then the adverse event should not be reported to the IRB.  If in doubt, it is best to err on the side of caution by contacting the ORPC at (410) 455-2737 or compliance@umbc.edu.

Reports of adverse events occurring on UMBC protocols should be submitted to the ORPC using the Adverse Event Report form within five (5) days of occurrence of any

  • actual unforeseen harmful or unfavorable occurrence to participants or others that relates to the research protocol (injuries, psychological events)
  • unforeseen development that potentially increases the likelihood of harm to participants or others in the future
  • problem involving data collection, data storage, privacy or confidentiality
  • complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team
  • protocol violation (meaning an accidental or unintentional change to an IRB approved protocol) that harmed participants or others or that indicates participants or others may be at increased risk of harm

ORPC staff will review the Adverse Event Report form for completion and forward to the IRB Chair for review, and if necessary, forward for review at a convened IRB meeting.

The IRB will determine if the study and/or consent form should be updated, and/or currently enrolled subjects should be informed of the new information to determine whether they wish to continue. If risks to subjects have changed such that the study must be stopped, all enrollment must cease and the research project placed on hold pending resolution by the IRB.  Investigators will be notified of the appropriate changes to make for submission to the IRB for review and approval – usually submitted in the form of an amendment.. If the event is considered serious or life threatening, proper notification will be made by the principal investigator, via the IRB chair, to the UMBC Institutional Official and to all applicable Federal agencies.

Protocol Deviations and Violations

.As stated in the federal regulations ( 45 CFR 46.113), all protocol deviations and/or instances of noncompliance with IRB regulations must be reported to the IRB by the principal investigator as soon as the violations are discovered. The IRB has the authority to suspend or terminate approval of research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects. The IRB also has “sanction,”  “suspend,” or “terminate” approval if there has been serious or continuing non-compliance with the policies, requirements or determinations of the IRB.

Investigators not in compliance with IRB procedures will not be able to process new protocols or renew current projects until all concerns have been addressed and the investigator sends a letter to the IRB Chair acknowledging the error that was made.

Minor Protocol Deviations

As stated in the Researcher’s Guide, investigators are responsible for conducting human with participants in compliance with federal regulations and UMBC’s policies and procedures. Failure to comply with these administrative regulations may result in an individual investigator’s ability to conduct research but can also affect the ability of all others at UMBC to perform human participant research. Non-compliance with regulations may be seen as protocol deviations. Deviations generally do not have substantive effects on the safety or well-being of research participants; do not affect the value of the data collected (meaning the violation does not confound the scientific analysis of the results); do not result from willful or knowing misconduct on the part of the investigator(s); and do not violate any ethical principles.

Common deviations in investigator compliance include:

  • unreported changes in the IRB approved protocol or consent documents
  • misuse or non-use of the IRB approved informed consent documents
  • lapse in obtaining approval for continuing review
  • failure to obtain IRB approval prior to starting research activities
  • failure to file protocol modifications.

Problems such as these are often caused by an investigator failing to communicate effectively with the IRB.  When such instances are discovered, the IRB will act promptly to halt the research, ensure remedial action regarding compliance with federal and institutional human participant protection requirements.

Deviation Reporting Procedure

Investigators can almost always avoid protocol deviations by being aware of the IRB requirements and following the approved protocol.  If a protocol deviation does occur, an investigator must immediately submit a protocol deviation reporting form to the IRB for review immediately upon discovery. This form will serve as the documentation for modifying the particular protocol; investigators must await IRB approval before implementing anticipated changes or modifications.

Click to download the Protocol deviation reporting form

Following the review of the reporting form, the IRB chair will notify the investigator in writing of the need to meet discuss the deviation and develop a plan to avoid such actions in the future. The results of the meeting will determine what must be done (if anything) to correct the conditions that lead to the deviation and what (if anything) must be communicated to the research participants. Participant enrollment may be suspended pending resolution of the problem or concern. The IRB chair will present a summary of the deviation, process, facts, and conclusions at the next scheduled convened IRB meeting.

Protocol Violations

Protocol violations emerge when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reports may come from a variety of sources: participants, community members, research staff, etc. Reporting of violations will be made, in writing, to the IRB Chair; all reports will be held in the strictest of confidence and discussed within the confines of the fact-finding committee.

Protocol violations are those that:

  • are un-approved by the IRB that caused substantive harm to research participants
  • cause damage to the scientific integrity of the data collected
  • result from evidence of willful or knowing misconduct on the part of the investigator
  • impact on ethical principles

Violation Investigation Procedure 

Incidents of alleged or known protocol violations may be investigated by the IRB via the following steps:

The IRB chair will create a fact finding committee, composed of:

1. the IRB Chair

2. the ORPC Administrator

3. the Assistant Vice President for Research

4. two or more representatives from the PI’s department or discipline, and

5. a representative from the UMBC Legal Counsel.

This committee will analyze all information gathered regarding the protocol violation and compare it to the approved protocol.  When necessary, the committee will consult with experts in the specific discipline of research in order to make definitive, unbiased and educated decisions regarding the violation. A conclusion will then be made regarding the reporting of the incident to the Office for Human Research Protections (see Guidance on Reporting Incidents to OHRP).

If the hearing committee finds any of the protocol violations criteria noted above, the IRB Chair will immediately suspend the protocol. (Note: this does not preclude the IRB chair from suspending the protocol in advance of the hearing if, in the chair’s assessment, the conditions in 45 CFR 46.113 have been met and warrant an emergency protocol suspension). If suspension of the protocol results from harm to the enrolled research participants, the IRB chair will request that the PI’s department chair assign PI duties to another qualified person. (Note: This change of PI also requires approval of the grant sponsor). In this situation the official action will be the suspension of the investigator (45 CFR 46.109 (d)).

Depending on the nature or the seriousness of the violation, the committee may elect to direct the IRB to audit all protocols that involve the investigator in question. If the findings of the hearing committee support research misconduct, the Vice President for Research will be notified. A summary of the violation, process, facts, and conclusions will be presented at the next scheduled IRB meeting. The IRB chair will notify the investigator in writing with copies to the PI’s department chair, the appropriate dean, the Vice President for Research, and the ORPC. If an investigator disagrees with the findings or requirements of the Committee, investigators have the right to appeal the committee’s decision to the Vice President for Research.

Closing a Protocol

All expedited and full board approved human subject protocols at UMBC are approved for a total of five years. Prior to the end of the fifth year of the protocol, the ORPC will send the investigator a notice of closure, stating the requirements for closing the protocol and submitting a new protocol for continuing the research project. Investigators, whose externally funded projects are not being renewed, may request a one-time, six month extension to complete data analysis and prepare a report for the funding agency. Requests must be made in writing to the IRB at least sixty (60) days prior to the termination of the project and submitted to the ORPC.

As the activities of a research project come to an end, the principal investigator is responsible for submitting a closure report, indicating any research findings and/or outcome of the project. A closure report is also required if the investigator is leaving the university. The investigator must sign the closure report. In cases where the investigator is a student, the faculty advisor must cosign the report. Attach copies of any results, reports, articles (etc.) deemed necessary to support the closure of the protocol and forward to the ORPC.

When is a protocol officially closed?

The procedure differs depending upon whether the study is minimal risk or higher. In cases where the project is minimal risk or less, protocol closure may occur when data collection is completed, when basic data analyses are completed and when all contact with participants has ended. The basic data analyses should allow the investigator to conclude with reasonable certainty that there are no further impacts from the study on the participants. If the investigator has stated in the protocols or informed participants that identifying information, which could be linked to participants, this deletion must be made prior to closing a protocol.  Note that a protocol closure does not affect an investigator’s ability to write articles or publish. However, it does stop any ongoing or future contact between the investigator and participants. All linkages to participants should be destroyed. Should the investigator decide future contact is needed with the participants or collect additional data, he/she must notify the IRB. The use of previously collected data from previously approved from an officially closed protocol may require the submission of an exemption application. Please consult the ORPC with any questions.

Students completing research for their thesis or dissertation must, upon completion of the project activities (as defined above), submit a closure report.

Click to download the Closure Report

If a principal investigators does not respond to a continuation (renewal) request by the date the protocol is due to expire, the IRB, via the ORPC, will administratively close the protocol. No protocol activity may continue, including contact with participants, the use of and/or the analysis of subject records and collected data.

Reopening a closed protocol

On occasion a principal investigator may make a request to the IRB to reopen a research study that was administratively closed (due to failure of the investigator to provide a proper continuing review form) or was appropriately closed  (study was properly closed with submission of a closure report) in order to continue with the research.
To reopen the study, investigators should submit a brief cover letter to the IRB Chair, referencing the approval number and protocol title, requesting that the study be re-opened. The following information must be provided:

  • an assurance that no participants have been enrolled during the time the study was not approved, that data collection during this unapproved time was discontinued and this is a continuation of the same study
  • details of all pertinent information as to why this needs to be re-opened
  • any amendments or changes in the study protocol, personnel, or consent documents (using the previously approved format)
  • any documents relating to unanticipated events (i.e. Adverse Events)
  • if participants need to be notified, indicate how this will be accomplished and by whom. Provide any documents—letters, email notifications, etc.

Requests to reopen a study must be made within 30 days of the notice of administrative closure or submission of the protocol closure report.

Note:

Investigators may conduct data queries after closure without reopening the study. Such queries occur without IRB approval if both of the following apply:

1. The data being queried is limited to that originally collected for the study as specified in the consent and authorization forms signed by subjects and/or the study protocol. No new data may be collected after study closure without prior IRB approval

AND

2. The data being queried is limited to the original timeframe during which data was collected for the study. No data outside the original timeframe for data collection can be queried after study closure without prior IRB approval.

Protocol Files

A protocol file must be maintained with the investigator’s office or department with the following information:
1.All correspondence between the investigator and the IRB as well as any communications regarding the study from a sponsor;
2.Copies of the signed Consent Form obtained from all participants or information as to where these documents can be found;
3.Any data derived from the study;
4.Progress reports;
5.Reports of all adverse incidents and any follow-up to adverse incidents; and,
6.Current contact point for the investigator (address and telephone number) should the investigator no longer be associated with UMBC.

The investigator is responsible for maintaining a protocol file that includes all correspondence between the IRB and principal investigator. In addition, retention of signed consent forms and other relevant documents or the location of where these are maintained for at least five (5) years past completion of the research activity for adult subjects and, for minor subjects, at least three years after reaching the age of 18, whichever is longer.

 

 

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