The APT Foundation, Inc has incorporated into its policies and
procedures the following
administrative policy.
General Policy
Statement
The
APT Foundation, Inc (hereafter “APT”) fosters a research environment that
promotes integrity. Research misconduct is contrary to the interests of APT,
the health and safety of the people it serves, public trust, and the agencies
that fund research. To that end, APT adheres to the Public Health Service (PHS)
Policies on Research Misconduct as articulated in the Department of Health and
Human Services (DHHS) Code of Federal Regulations (42 CFR Parts 50 and 93)
based on the final rule effective June 16, 2005. Although based on this PHS
report and other sections of the CFR (e.g., 45 and 48) related to fiscal
improprieties, ethical treatment, criminal matters and other personnel actions,
APT policies and procedures apply to all research conducted in APT facilities
or involving APT patients or staff regardless of source of funding.
APT investigates all
allegations to the fullest extent possible regardless of the date of their
occurrence. APT investigates all allegations regardless of their perceived level
of intentionality, knowledge, and recklessness of allegation. Subsequent
findings may consider issues related to length of time elapsed between the
occurrence and allegation of misconduct as well as the degree of willful
wrongdoing versus honest error. The primary purpose of APT’s inquiry is to determine
whether an allegation has been made in good faith and whether there is sufficient
evidence to support a referral of this case to the U.S. Office of Research
Integrity (ORI) or other external investigation body.
The Human
Subjects Protection Administrator
or Chief Executive Officer will be responsible for submission
of an annual report on possible research misconduct on March 1 through the
ORI web site at http://ori.hhs.gov.
Aggregated information will be sent at any other time upon request from ORI. All
research records and investigations related to an allegation of research
misconduct will be maintained in a secure location for a period of no shorter
than 7 years. APT will maintain the confidentiality of these records and the
proceedings to the extent permissible by law.
All parties involved
in an allegation of research misconduct (complainants, respondents, witnesses,
investigative team members) are protected against retaliation for “good faith”
cooperation with this process. “Bad faith” cooperation is not protected and
refers to errors of omission or commission that are attributed to dishonesty (i.e.,
a reasonable person would not believe in the truth of the allegation given
evidence available at the time of the complaint) or attributed to the influence
of personal, professional, or financial conflicts of interest with those
involved. APT will make appropriate effort to restore the reputation of the
respondent when the allegations are not supported and all other parties when an
allegation has been made in good faith.
APT will submit
appropriate reports to ORI or other investigative or oversight body that
describe the process followed in conducting an inquiry, the evidence on which
the conclusions of the inquiry are based, and if a finding of research
misconduct is made, the administrative actions that are taken against the
respondent. All information provided by the complainant and the respondent will
be maintained by APT and may also become part of evidentiary hearing or the
research record itself.
These policies are
distributed to all persons conducting research in APT facilities or involving
APT patients or staff. These policies are also available to all APT staff and
patients and the public-at-large. APT will inform all research employees and
affiliates about the official who is designated to receive allegations and the
procedures for individuals to make an allegation of research misconduct
involving research. In addition, APT will inform all employees and affiliates
that they have the option of reporting any allegation or evidence of research
misconduct directly to the ORI rather than to the designated misconduct policy
and procedures official at APT. Information related to this policy will be
posted on the APT website. APT
employees and affiliates will work closely with ORI, other federal
offices, and other external funding sources to fully explore the allegation or
evidence of misconduct in research.
Definitions
Research misconduct
involves significant disregard for the ethical principles governing research
with human participants. The PHS definition of Research Misconduct is more
narrowly focused on “fabrication, falsification, or plagiarism in proposing,
performing, or reviewing research, or in reporting research results.” The APT
Foundation conceptualizes research misconduct more broadly as involving one of
the following areas: 1) fraud (similar to the PHS definition above); 2)
negligence; 3) abuse.
“Fraud” refers to the
fabrication (making up and reporting this data), falsification (manipulating
data in an inaccurate manner), plagiarism (appropriating other’s ideas,
methods, words, or findings without appropriate credit), or other serious
misrepresentation of research findings, scholarly contribution, personnel
credentials, or financial/accounting procedures.
“Negligence” refers
to the careless or reckless disregard for the safety, privacy, or rights of
human participants in research.
“Abuse” refers to the
intentional highly inappropriate, coercive, or harmful verbal, physical, or
sexual interaction between a research staff and a study participant.
Research misconduct
is determined to have occurred when the alleged behavior(s): a) represent a
significant departure for accepted research practices (i.e., fraud, negligence,
abuse); b) are committed intentionally, knowingly, or recklessly, AND; c) are
proven by a preponderance of evidence.
For the purpose of
this policy, the term “complainant” refers to any individual(s) (whether
affiliated with APT or not) making an allegation of research misconduct toward
another individual(s) involved in research occurring within APT operated
facilities or involving APT patients or staff. The individual against whom
research misconduct is being alleged will be referred to as the “respondent.”
A “research team”
will refer to the principal investigator, co-investigators, key personnel,
collaborators, and all full-time, part-time, per hour/diem, or voluntary staff
involved in a research project toward which an allegation of research
misconduct has been made.
An “inquiry team”
will refer to the local ad hoc committee constituted for the purpose of
evaluating the merit of the allegation and deciding the next step of
investigation and reporting process. An
“investigation team” will refer to an external group (typically ORI) conducting
an investigation of alleged research misconduct.
Procedure for
Reporting and Investigating Research Misconduct
1. A written or verbal allegation by a
complainant is submitted to the APT Chief Executive Officer (CEO) or, if the
CEO is a member of the research team under allegation, the Board President may
be contacted directly. Either of these individuals will confirm the identities
of the complainant, respondent(s), and the composition of relevant research
team.
2. The CEO will assign the case to the Human
Subjects Protection Administrator
as the initial investigator for this allegation. If the Human
Subjects Protection Administrator
has a conflict of interest, then the Chief Operating Officer (COO) will serve
as the investigator. If all parties are in substantial conflict with either the
complainant or the respondent, then the case will be referred immediately to
the Yale Human Investigations Committee (HIC) and ORI for investigation.
3. Within 24 hours of
the reported allegation, the case investigator and another member of APT Senior
Management who is not a member of the research team will schedule a joint
meeting with the person(s) making the allegation. This meeting will be held within
1 week of the allegation report. The purpose of this meeting is to collect
sufficient information to determine whether research misconduct potentially exists
and whether it involves fraud, negligence, abuse, or a combination of these
behaviors. After private deliberation by the two senior managers, the person
making the allegation will be informed of the nature of any immediate or
anticipated action and their rights, responsibilities, and protection (e.g.,
whistleblower status) in moving forward. Specifically, the complainant will be
informed of their protection from retaliation if their allegation has been made
in “good faith,” but that such protections do not extend to allegations made in
“bad faith” (i.e, allegations judged as being made with dishonesty and malice
with no reasonable appearance of evidence).
The complainant will be asked to honor the confidentiality of any
investigation proceedings.
4. If a decision to
investigate further is made, then ORI will be informed within 24 hours. ORI
also will be contacted as necessary throughout this local inquiry phase,
specifically around discussions to request outside investigation and any
decisions made about the case, including its closure for whatever reason. One
of the APT inquiry officials will notify ORI by phone (240-453-8800), fax:
(301-594-0043), or email (askORI@osophs.dhhs.gov.) about all significant
decisions involved in this case.
5. Within 24 hours of
the initial report to the ORI that a local inquiry will be initiated, the two
APT senior managers will personally deliver or send my certified mail written
notification to the respondent of the inquiry. At this time, these two managers
will make every effort to obtain custody of all research records and evidence
needed to conduct the research misconduct proceedings. Original or source
documents will be collected except for research records of currently active
participants whose source documents may be photocopied. All such records and
evidence will be inventoried and sequestered in a secure location. The
respondent will be provided copies of or supervised access to any of the
sequestered materials for the purpose of preparing a defense against the
allegation. Additional records may be taken into custody as the inquiry
proceeds. All records will remain in the custody of APT until they are
requested by ORI, their custody is transferred to another covered institution
(most typically
6. Within 24 hours of sequestering the research
records and informing the respondent, the case investigator will schedule a
meeting of a local inquiry team that will consist of the following: 1) APT
Senior Management representative; 2) APT Board of Director representative or legal
counsel as indicated; 3) Yale HIC Community Programs Liaison or his/her designee;
4) CMHC Risk Management representative or his/her designee; 5) Yale Human
Resources representative or Corporate Counsel as indicated; 6) Scientific
Expert. All members of this inquiry team must be free of conflicts with both
the complainant and the respondent. The first meeting of this team will occur
no later than one week of the sequestering of records. Any of these individual also
may request additional parties to join this team. If all potential members of
this inquiry team are considered to be compromised by conflicts of interest,
then the case will be referred immediately to ORI for investigation.
7. The overall
objective of the first meeting of the investigative team will be to determine
whether: a) the allegations are without merit and the case should be closed
without prejudice to the respondent; b) the veracity of the allegations is
unclear and requires further local inquiry before determining whether a report
to ORI should occur; c) there is evidence or substantial reason to suspect the
allegation has merit and the inquiries will be reported to the ORI for formal
investigation. Thus, the agenda of this meeting will be four-fold: a) Hear a
summary of the complaint and the facts collected to date regarding the
allegation; b) Decide by simple majority vote whether any immediate action must
be pursued (e.g., protocol suspension, criminal complaint, suspension of all
research activities, termination of employment); c) Decide who will serve as
the lead agency for the local inquiry, specifically whether this will be APT or
Yale University or whether an immediate request for external investigation by
ORI is necessary; d) Assuming that a local inquiry by the team will proceed,
determine a schedule of meetings with the complainant(s), respondent(s), and relevant
witnesses. The results of this meeting will be communicated in writing to the complainant
and respondent.
8. Both complainant and respondent will be asked
to supplies the names and contact information for all parties with information
relevant to the case. If a local inquiry proceeds, the inquiry team will
interview all people reasonably identified as having knowledge relevant to the inquiry.
All significant issues and leads will be pursued relevant to the inquiry. All
witness interviews will be tape recorded and transcripts will be created that
will be corrected by witnesses. All recordings and transcripts will become
parts of the record of the investigation. All local inquiry meetings are
considered confidential and closed to the public. Disclosure of any information
from these proceedings is limited to those who have a need to know to carryout
the research misconduct proceeding. The confidentiality of research participant
identities must be maintained to the extent allowable by law.
9. The local inquiry
team will determined the extent of research activity that will be allowed for
the respondent and his/her research team(s) during the different phases of the
investigation. If any decision is made to suspend any aspect of research
operations, this decision will be communicated immediately to the funding
agency and the reason and anticipated duration of this suspension.
10. At the end of the
local inquiry, a draft report will be provided to both complainant and
respondent within 30 days. All parties will have opportunity to respond in
writing to this report within 30 days unless a written request for an extension
is approved by the inquiry team. Comments by all parties will be considered
when revising the report. A final “inquiry report” will be completed within 30
days of receipt of all comments.
11. The final
“inquiry report” report will be sent to ORI along with any other information
specified by ORI (see Subpart C of 42 CFR 93.309, 93.313, and 93.315) within one
week of its completion. This mailing will include the following information: a)
inquiry report; b) final institutional actions; c) institutional findings; d)
institutional administrative actions. Any planned decision to close the case
before completing a full investigation will be discussed with ORI before
issuing a report. At the request of ORI, any and all records related to the
inquiry will be transferred to the custody of HHS.
12. Respondents have
the right to a fair hearing to contest findings of the local inquiry or ORI
investigation under Subpart E of 42 CFR 93
The APT
Foundation, Inc certifies that this statement will be a permanent amendment to its
research policies and its procedures for responding to allegations of research
misconduct.
___________________________ ____________________
Lynn M Madden, M.P.A Date
Chief Executive Officer
The APT Foundation, Inc
203-781-43600
lmadden@aptfoundation.org