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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.
Reporting Adverse Events
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).
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 Human and Animal Protections Research Office at (410) 455-2737 or HARPO@umbc.edu.
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 subject safety. An event is considered serious and must be reported when the participant experiences an unusually strong response, recurring problems, and/or death.
For the social and behavioral sciences, what does "serious," "unexpected," etc. mean?
source of definition: FAQS re Adverse Event Reporting, Social and Behavioral Sciences Institutional Review Board, University at Buffalo, The State University of New York, http://cas.buffalo.edu/dean/hsrc/
An investigator must use his/her expertise along with the known risks associated with study participation and will be asked to provide their opinion as to whether the proposed changes to the protocol or consent forms are required.
Click to download the Adverse Event Report
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.
Reports of adverse events occurring on UMBC protocols should be submitted to the IRB Chair within five (5) days of occurrence, after first awareness of the problem. 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:
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:
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 Human and Animal Protections Research Office Administrator 3. the Associate 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 seriousness of the violation.
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 Office for Human Research Protections. 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.
Annual Continuation and Approval
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 and full board approved human subject protocols at UMBC are approved for a total of five years. A protocol is initially approved for a period of up to 12 months. Four (4) continuations or renewals may be requested, each for a period of up to 12 additional months.
Continuing review of research previously approved by the IRB at a convened meeting may be performed by the IRB where, at the time of renewal, the research: is permanently closed to the enrollment of new subjects, all subjects have completed all research related interventions, and the research remains active only for long-term follow-up of subjects; had no subjects ever enrolled and no additional risks were identified; where the remaining research activities are limited to data analysis.
OR
the research, where the IRB has determined and documented at a convened meeting, involves no greater than minimal risk and no additional risks have been identified.
The Human and Animal Protections Research Office will send the principal investigator an Annual Continuation Report Reminder in advance to the expiration of approval for a protocol approved via expedited 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 Human and Animal Protections Research Office at least four (4) weeks prior to the current protocol end date.
Click to download the Annual Continuation Report
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.
Prior to the end of the fifth year of the protocol, the Human and Animal Protections Research Office 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 Human and Animal Protections Research Office.
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 Human and Animal Protections Research Office (HARPO@umbc.edu).
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 Human and Animal Protections Research Office 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 Human and Animal Protections Research Office.
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 Human and Animal Protections Research Office.
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 Human and Animal Protections Research Office 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 Human and Animal Protections Research Office, 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.
Protocol Modifications
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 in writing 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 will be notified of approval of requests for minor changes in approximately one (1) week following submission.
Click to download the Protocol Modification Request
Determining whether a modification request should receive expedited or full convened committee review can be difficult. Most modifications will be handled through expedited review regardless of whether the original application was reviewed by the full board or expedited. However, modifications that substantially change the study design or that change the risk to subjects may require review by the full IRB. The IRB chair will make the decision about the type of review. The following definitions* may be helpful to investigators to determine the level of approval to pursue; investigators are encouraged to contact the Human and Animal Protections Research Office (HARPO@umbc.edu) with any questions prior to submitting the 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.
Minor Changes
Definition: Minor changes have no substantive effect upon an approved protocol or reduce the protocol risk already approved by the IRB Examples of minor changes are: 1) Changes in contact names, addresses, telephone numbers, advisor, ending date, adding a researcher, etc. 2) Scientific and/or therapeutic changes that leave the research population at the same or lower risk than risk(s) already approved 3) Changes in the consent form that reflect changes in scientific/therapeutic changes noted above 4) Adding additional subjects of the same type of population indicated in the original protocol 5) Changing the title of the protocol
Major Changes
Definition: Major changes are changes that may increase the research population's risk or are of questionable risk. Examples of Major Changes are: 1) Adding a subject population different from those already approved 2) Adding questions to a questionnaire 3) Changing consent procedures which involves the reconsenting of subjects 4) Changing the location of the research from that which has already been approved for projects other than no risk survey/interview research. 5) Adding an element that may breech the confidentiality of the subject 6) Adding a deceptive element to the research or changing the debriefing procedures for already approved deception 7) Changing the way subjects are compensated for participation in research - such as increasing the amount, changing from a lottery to cash, etc.
*(definitions adapted from Kent State University - Human Subjects Review Board)
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
Protocol Monitoring (PAPM)
The University of Maryland Baltimore County is required by federal regulation to exercise "appropriate oversight mechanisms" to insure that the institution's policies and procedures designed for protecting the rights and welfare of human subjects are being effectively applied in compliance with the Office for Human Research Protections (OHRP) approved Federalwide Assurance (FWA).
In essence, the University is required to perform post approval protocol monitoring (PAPM) to protect research participants, to educate researchers about human subject protection issues and to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities. A report of the PAPM review will be provided to the members of the Institutional Review Board.
The Human and Animal Protections Research Office make arrangements to meet personally with the investigator and/or research staff to examine the investigator's protocol file. Investigators should plan to allow for least one (1) hour for the Human and Animal Protections Research Office to conduct the review; while the investigator’s presence is not required, it will be helpful to be present to answer any questions. Student investigators and faculty advisors should meet prior to the review to make arrangements for a meeting time and access to the protocol files.
The Human and Animal Protections Research Office will examine the following items in the protocol file:
The investigator's data storage medium will be examined to determine if the appropriate measures are undertaken to ensure confidentiality and minimize risk to participants. Applicable items to be reviewed include the use of a secured location (lock and key system), an updated firewall or virus protection program and secure data tracking systems.
Maintaining confidentiality of data sources is important while the study is active. Data should be stored in a secured location and identified by code numbers only. A master list must be kept in a separate location from the data, with only the investigator and his/her designee responsible for access to the data If audio- and video-tapes have been used in the study, the recommended length of time to keeping tapes is three years beyond the completion of the study. However, data from audio- or video-tapes should be transcribed as soon as possible; once accomplished, these tapes should be erased or destroyed. The results of the review must be kept in the investigator's protocol file. In addition, retention of signed consent forms and other relevant documents or the location of where these are maintained for at least five 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.
___________________________________________________________________________________________________________________________ Didn’t find what you needed? Contact the HARPO staff at 410-455-2737, HARPO@umbc.edu or Instant Message to AIM Screen name HARPO246 |
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