Policy and Procedures for Investigating Allegations of Non–Compliance with Human Subjects Regulations
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INTRODUCTION
The University of Minnesota Institutional Review Board: Human
Subjects Committee (IRB) has responsibility to oversee the use of human
subjects in research for this institution in order to protect the safety
and welfare of the research subjects. This responsibility includes authority
under the federal regulations as follows:
Suspension or termination of IRB approval of research
An IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's requirements
or that has been associated with unexpected serious harm to subjects.
Any suspension or termination of approval shall include a statement
of the reasons for the IRB's actions and shall be reported promptly
to the investigator, appropriate institutional officials, and the department
or agency head. 45 CFR ñ 46.113.
To exercise this statutory authority, the IRB shall review
all allegations of Non–Compliance with human subjects regulations and
review any study that has been associated with unexpected serious harm
to research subjects. The IRB will follow these policies and procedures
for conducting an inquiry and investigation into allegations of Non–Compliance
and in reviewing incidents of unexpected serious harm to subjects.
The IRB will take appropriate action to insure the safety and welfare
of human research subjects. These actions may range from corrective
or educational measures for the researcher to terminating IRB approval
for all active studies of a research. Further, the IRB may suspend approval
of research projects at any time during an inquiry or investigation
to assure the protection of human subjects.
This policy includes written procedures for reporting actions to appropriate
University and federal government officials as required by federal regulations.
APPLICATION
These policies and procedures apply to all research activities of
faculty, staff, students and others who are involved in research that
falls under the jurisdiction of the IRB.
DEFINITIONS
Director shall mean the Director of the IRB: Human Subject
Committee. The Director has the responsibility of directing the case
from the inquiry process through disposition of the case.
Executive Committee shall mean the chairs and vice-chairs of
the five IRB committees, as well as staff support from the IRB office.
Executive Council shall mean at least three members of the
Executive Committee whose role is to receive and act upon recommendations
from the advisory panels (i.e., Inquiry, Investigation and Appeals)
involved in the process. The Executive Council carefully weighs the
recommendations received from each of the bodies, but retains final
decision making authority at each stage of the process. The Executive
Council and the three advisory panels reporting to it may be advised
by legal counsel throughout the process.
Inquiry Panel shall mean three members of the Executive Committee
whose charge is to review the initial allegation of Non–Compliance,
the response from the researcher and any other appropriate materials
and to issue a recommendation to the Executive Council as to whether
an investigation is warranted.
Investigation Panel shall mean an ad hoc committee of at least
five IRB members established by the Executive Council to investigate
the allegation of Non–Compliance. To assure continuity and avoid duplication
of efforts, one of these panelists will be a member who served on the
Inquiry Panel. All other members will be IRB members outside the Executive
Committee whose areas of expertise are suited to reviewing the complaint
and are of study. The Investigation Committee will issue findings and
recommendations of the Executive Council.
Appeals Panel shall mean three members of the Executive Committee
who have not served on any other panels involved in the process (i.e.,
Inquiry, Investigation or Executive Council) and whose charge is to
review an appeal by the researcher and issue a recommendation to the
Executive Council as to whether reconsideration of its decision is warranted.
Non–Compliance shall mean conducting research involving human
subjects in a manner that disregard or violates federal regulations
governing such research. This can include, but is not limited to, failure
to obtain IRB approval for research involving human subjects, inadequate
or non-existent procedures for informed consent, inadequate supervision
in research involving experimental Non–Compliance Investigation Policy
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drugs, devices or procedures, failure to follow recommendations made
by the IRB to insure the safety of subjects, failure to report adverse
events or proposed protocol changes to the IRB, and failure to provide
ongoing progress reports.
PROCESS FOR HANDLING ALLEGATIONS OF NON-COMPLIANCE
Submission of an Allegation
There are two ways allegations of Non–Compliance may be submitted:
- Any individual or organization may submit a written complaint or
allegation of Non–Compliance to the IRB.
- The IRB itself may initiate a complaint based on information available
to the IRB (e.g., deficiencies noted in IRB files, media or scholarly
reports of research activity subject to IRB jurisdiction).
INQUIRY
A. Purpose
In the inquiry stage, factual information is gathered and expeditiously
reviewed to determine if an investigation of the complaint is warranted.
An inquiry is not a formal hearing or an in-depth analysis of the allegations;
it is designed to separate allegations deserving further investigation
from those that are frivolous, unjustified or related to minor infractions.
B. Process
Whenever an allegation or complaint of Non–Compliance is made, the
Director will forward the allegation to three members of the Executive
Committee who will serve as an Inquiry Panel. The Director also will
send written notice of the allegations to the researcher and request
a response from the researcher within 10 working days. If the Complaint
raises issues of safety and welfare for research subjects that are apparent
upon initial review, the Director also will give the researcher notice
of an opportunity to address in his/her response the possible summary
suspension of the researcher's project(s).
The Inquiry Panel will review the allegation of Non–Compliance, the
response from the principal investigator and any other information necessary
to determine whether an investigation is warranted. The Inquiry Panel
may interview the researcher and others, but is not obligated to do
so. It may be necessary to secure critical data or materials at the
outset of an inquiry to protect the integrity of those data or materials
or records. The IRB maintains the authority to secure such materials
at any time during an inquiry or investigation.
C. Recommendations and Outcome
At the conclusion of the inquiry phase, the Inquiry Panel will
make a recommendation to the Executive Council. Possible recommendations
include: 1) dismissal of the allegation or complaint as unjustified;
2) referral of the matter to another more appropriate system within
the University for resolution (e.g., Grievance, Student Conduct Code,
Academic Misconduct, Animal Care); 3) resolution through corrective
or educational measures where the violation of human subjects regulations
is minor or inadvertent; and 4) a formal IRB investigation where the
allegation or complaint appears founded and is of a serious nature.
The Executive Council will promptly act upon the recommendations of
the Inquiry Panel and notify the researcher in writing of the outcome
of the inquiry phase. This notice will include a statement of the reasons
for the Executive Council's decision. Depending on the nature of the
allegations and the extent of the review required, the inquiry phase
is expected to be completed within thirty days. The Executive Council
may grant an extension of this time frame if warranted.
SUSPENSION AND REPORTING
At any time during the inquiry or investigation process, the IRB may
determine that it is necessary to suspend accrual of research subjects
or suspend approval of research project(s) to assure the protection
of human subjects. The authority to suspend research rests with the
Executive Council; both the Inquiry and Investigation Panels may recommend
suspension of the Executive Council. If suspension is warranted, it
normally will occur at the end of the inquiry phase. Except in cases
of imminent harm to research subjects, the Executive Council will not
suspend approval of research studies until the researcher has had an
opportunity to respond to the initial allegation of Non–Compliance.
When the Executive Council makes a decision to suspend approval of
research, it will notify the Vice President for Research and other appropriate
University officials. These may include the researcher's department
head, the senior administrative officers, and officials of the Fairview
University Medical Center (FUMC ) if FUMC patients are involved. The
Vice President for Research, who serves as the authorized institutional
official, will send written notice on behalf of the IRB to the following
entities, as required under federal regulations:
- the Federal Office for Protection from Research Risks (OPRR);
- the Federal Food and Drug Administration (FDA) if the suspension
of research approval involves an investigation drug or device;
- the OPRR and FDA as applicable, if the matter involves the non-submission
of a project which should have been reviewed by the IRB, and the researcher's
failure to do so has resulted in unanticipated risks to human subjects
or serious or continuing Non–Compliance with IRB requirements;
and
- external and internal sponsors funding a study under suspension.
Reports will be filed within five working days of suspension.
In some cases reporting to professional licensing boards or state
agencies also may be required. These reports will be made by the Executive
Council or other appropriate University officials.
INVESTIGATION
A. Purpose
The purpose of the investigation is to explore the allegations by
assembling and examining relevant information. The Investigation Panel's
charge is to generate a report that summarizes the information it considered,
its conclusions as to whether there was Non–Compliance with human subjects
regulations and recommendations for action. During n investigation,
additional information may emerge that justifies broadening the scope
of the investigation beyond the initial allegations. The researcher
shall be informed if new and different allegations are discovered during
the course of the investigation.
B. Process
The investigation will be conducted by an ad hoc panel of at least
five IRB members established by the Executive Council (the "Investigation
Panel"). One of the panelists shall be a member of the Inquiry Panel.
All other members will be IRB members outside the Executive Council
whose areas of expertise are suited to reviewing the complaint and area
of study. Depending on the nature and scope of the complaint, IRB members
may be relieved of their regular IRB duties during the investigation
so as not to be overburdened.
The Investigation Panel may use any and all materials and reports
gathered during the inquiry phase, but is not limited by actions or
conclusions of the Inquiry Panel. The Investigation Panel may obtain
documents and other records relevant to the investigation, such as researcher
records, medical charts, grant applications and other scientific or
scholarly data. The Investigation Panel may interview any persons who
may have information relevant to the complaint. All interviews will
be tape recorded. The Panel may draw on the resources of the institution
or external consultant to assist in the review of issues which require
expertise beyond or in addition to that available on the Investigation
Panel.
The researcher under investigation will be given an opportunity to
submit written comments and appear before the Panel on at least one
occasion prior to the Panel issuing its report. The researcher may offer
relevant information to the Panel and suggest other individuals to be
interviewed. The researcher also may be accompanied by an advisor, including
an attorney, at any time the researcher appears before the Panel. The
researcher shall give the Panel notice of the advisor's participation
at least 48 hours prior to any interview.
At the conclusion of its investigation, the Investigation Panel will
prepare a report summarizing the information it considered and outlining
its conclusions and recommended actions. The Investigation Panel will
forward a copy of this preliminary report to the researcher and give
the researcher ten working days in which to submit comments to the report.
The Investigation Panel will review any comments received from the researcher
and decide based on these comments whether to modify its preliminary
report. When finalized, the Investigation Panel will send the Executive
Council its report with any comments received from the researcher. Depending
on the case, the investigation phase is expected to be completed within
60 working days. The Executive Council may grant extensions if warranted
and may request interim reports.
C. Outcome
The Executive Council will base its decision on the report of the
Investigation Panel and any comments submitted by the researchers. Actions
the Executive Council may take with respect to the investigation include,
but are not limited to: 1) dismissal of the complaint as unjustified;
2) remediation or educational measures; 3) increased reporting by the
researcher of his/her human subjects researcher activities; 4) restrictions
on research practice, such as limiting the privilege to minimal risk
or supervised projects; 5) suspension of approval for one or more of
the researcher's studies; 6) termination of approval for one or more
of the researcher's studies; and 7) referral to other University officials
or committees for possible further review and action by those bodies.
The Executive Council will issue the final investigative report and
send it to the researcher. The decision becomes final within five working
days of release unless the researcher files a written statement of appeal
within that time frame.
APPEALS/RECONSIDERATION
A. Purpose
The purpose of an appeal is to give the researcher an opportunity
to request reconsideration of the Executive Counsel's decisions under
certain limited circumstances. Grounds for appeal are limited to: 1)
new information not reasonably available during the investigation; 2)
material failure to follow these policies and procedures; and 3) sanction
exceeds the severity of the violations. No other grounds will be considered.
B. Process
The Appeals Panel will be comprised of three Executive Committee members
who have not served on any other panel involved in the process (i.e.,
Inquiry or Investigation Panels, Executive Council). The Appeals Panel
will review the written statement of appeal by the researcher and make
a recommendation at to whether the Executive Council should reconsider
any aspect of its decisions based on the ground outlined above. In reaching
this recommendation, the Appeals Panel may seek a response from the
Investigation Panel. The decision whether to forward a request for reconsideration
should be made within 10 working days.
If the Appeals Panel denies the appeal, the Executive Council's prior
decision become final. If the Appeals Panel recommends reconsideration,
the Executive Council re-opens the case. When the Executive Council
re-opens the case, it may choose to reconvene the Investigation Panel
or reconsider the matter on its own. The Executive Council, or the Investigation
Panel, if reconvened, will offer the researcher the opportunity to appear
personally to present the appeal.
Upon reconsideration, the Executive Council determines whether to
modify or uphold its original decision. This action is final. Consistent
with the IRB's regulatory authority, no other entity within the University
may override an IRB decision which limits, imposes conditions or in
any way restricts a researcher's privileges. The reconsideration phase
is expected to be completed within 30 working days.
DISSEMINATION OF FINDINGS
At the stage when the Executive Council's decision becomes final (i.e.,
5 working days after its original decision if there is no appeal; upon
a decision by the Appeals Panel to deny the appeal; or upon the Executive
Council's final determination if the case is forwarded for reconsideration),
the Executive Council will release its findings to the researcher and
to appropriate University and governmental officials as required under
federal regulations. The same guidelines as set forth above for reporting
suspensions will apply. Further, it may be necessary to inform these
same officials of the status of the proceedings while they are pending.
Decisions whether to release the IRB's findings to the public will be
made by institutional officials outside the IRB in conformance with
the Minnesota Government Data Practices Act. The IRB will not initiate
any public disclosure of findings.
A. Resources
The Executive Council, Inquiry, Investigation, and Appeals Panels
shall have access to the necessary resources and staff to conduct a
thorough and fair review of allegations. Internal and external consultants
may be called to assist in the review.
B. Coordination with other Investigative Processes
Some complicated cases require review by other institutional or external
entities. The IRB will cooperate in the review of allegations of academic
misconduct, financial mismanagement, FDA inspections, etc. In cases
that appear to involve academic misconduct, the Investigation Panel
may report allegations of such misconduct to appropriate institutional
officials. Where academic misconduct and IRB investigations are pending
against the same researcher, the IRB will participate in a close coordination
of processes to avoid duplication of effort and minimize competing use
of resources.
C. Conflict of Interest/Commitment
As with all IRB processes, any IRB panel member or Executive Committee
member who has a conflict of interest or commitment relating to the
matter under review will excuse himself/herself from the proceedings
and an alternate will be designated by the senior chair. It is permissible
to allow substitution of non-Executive Committee members for conflict
of interest/commitment concerns at any stage in the establishment of
the inquiry or investigative review panels.
D. Confidentiality for Complainants and Witnesses
Generally, the researcher under review should have access to the identity
of complainant(s) and others who provide information. However, if such
individuals are in a status subordinate to the researcher and wish to
maintain their anonymity, the IRB will make every effort to protect
their identifies while at the same time affording the researcher access
to the substance of the allegations and information presented against
him/her. The IRB cannot guarantee absolute anonymity.
E. Retaliation
Reviewing complaints and allegations of Non–Compliance is critical
of the IRB's ability to protect human subjects. A climate free of fear
of sanction is required to foster appropriate reports and ensure a fair
review of allegations. Retaliation against good faith "whistle blowers"
is illegal and will not be tolerated at this institution. Whistle blowers
who report IRB related concerns may utilize other mechanisms at the
University for protection from retaliation.
March 1996 amended to change UMHC to FUMC (5/97)
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