(Statement Approved by the AANS Board of Directors on 04/25/08)
The neurosurgeon's relationship with industry, when properly structured, is
an appropriate, beneficial, and collaborative partnership to improve patient
care. Neurosurgeons are necessary collaborators with industry for technical
innovation by providing ideas and feedback, conducting research trials, serving
on scientific advisory boards, and serving as faculty to teach the use of new
technology related to neurosurgical practice. Neurosurgeons with innovative
ideas to improve patient care rely on industry to bring their creative ideas
to practical application in the healthcare market. The collaborative relationship
between neurosurgeons and industry must be structured to avoid pitfalls of
improper inducements or incentives.
Therefore, the following guidelines are promulgated and in order to clarify
the proper relationships between neurosurgeons and industry.
As part of their professional commitment to excellence in patient care, neurosurgeons
must maintain specialized knowledge and skills through continuing medical education
programs, seminars, and professional meetings. These professional functions
may be sponsored by medical device manufacturers, pharmaceutical companies,
and other businesses, which serve an important role supporting continuing medical
education (CME) activities and the development of new technologies that contribute
to improved patient care. A collaborative effort between neurosurgeons and
industry ensures that patients have optimal surgical outcomes through the invention
and testing of new technology, research and evaluation of existing technology,
as well as continued education of neurosurgeons in applications of technology
in surgical care.
Neurosurgeons must be aware of potential conflicts of interest with patient
care when pursuing academic or commercial ventures. There may be contractual
or other remunerative relationships between physicians and industry, and these
relationships have a potential for creating bias. A potential conflict of interest
exists whenever professional judgment concerning choices in patient care has
a reasonable chance of being influenced by self-interest of the neurosurgeon.
The self-interest is often financial in nature. Financial relationships are
those in which the neurosurgeon benefits by receiving a salary, royalty, intellectual
property rights, consulting fee, honoraria, ownership interest (i.e., stocks,
stock options or other ownership interest excluding diversified mutual funds)
or other financial benefits. Financial benefits are usually associated with
roles such as employment, management position, independent contractor (including
contracted research) consulting, research or education support, fellowship
funding, speaking and teaching, membership on advisory committees or review
panels, board membership, and other activities from which remuneration is received
When such conflicts exist, medical or surgical care decisions may be distorted
by personal interests. Disclosure of any potential conflict of interest is
required in communications to patients, the public and colleagues. The primary
goal of surgical care must be benefit to the patient and must not be compromised
by neurosurgeons' personal interests. Neurosurgeons, as with all physicians,
have an ethical obligation to present themselves and the services they provide
to patients, as well as any potential conflicts of interests, in a clear, understandable,
and accurate manner.
Those who have payment or contractual relationships with industry are required
to disclose them prior to any educational presentation. According to the Accreditation
Council for Continuing Medical Education, (ACCME) circumstances create a conflict
of interest when an individual has an opportunity to affect CME content about
products or services of a commercial interest with which he/she has a financial
relationship. In accordance with ACCME Standards for Commercial
Support, all disclosure information must be provided to CME activity participants
prior to the beginning of the CME activity. Speakers, authors, committee members,
or others in the planning process who have the ability to influence and/or
control the educational content must disclose their financial relationships.
When faced with a potential conflict of interest that cannot be resolved,
a neurosurgeon should consult with the appropriate committee in an institutional
or professional society to determine whether a conflict of interest exists
and how to address it.
It is important that deliberate steps be taken to avoid inappropriate influence
from industry in organizations, sponsored educational meetings, research patient
and public education initiatives, and interactions with patients in order to
preclude biased promotion or support of medical devices, procedures or practice
These guidelines have been formulated as a guide to the relationship between
the specialty, neurosurgeons and the medical industry.
Ethical Guidelines which form the foundation to the guideline on neurosurgeon-industry
conflict of interest:
The physician-patient relationship is the central focus of all ethical concerns.
A neurosurgeon shall, while caring for and treating a patient, regard his
or her responsibility to the patient as paramount.
A neurosurgeon shall prescribe drugs, devices, and other treatments on the
basis of medical considerations and patient needs, regardless of any direct
or indirect interests in or benefit from industry.
The practice of medicine may present potential conflicts of interest. When
a conflict of interest arises, it must be resolved in the best interest of
the patient. If the conflict of interest cannot be resolved, the neurosurgeon
should notify the patient of his or her intention to withdraw from the relationship.
A neurosurgeon shall, when treating a patient, resolve conflicts of interest
in accordance with the best interest of the patient, respecting a patient's
autonomy to make healthcare decisions.
When a neurosurgeon has a financial interest (as defined in Appendix A) that
is related to any aspect of a patient's evaluation and care, a potential conflict
exists which should be disclosed to the patient. It is unethical for a neurosurgeon
to receive compensation of any kind from industry in exchange for using a particular
device or medication in clinical practice. Reimbursement at fair market value
for documented administrative costs in conducting or participating in a scientifically
sound research clinical trial is acceptable.
A neurosurgeon who has influence in selecting a particular product or service
for an entity (organization, institution) shall disclose any relationship with
industry to colleagues, the institution and other affected entities.
A neurosurgeon shall enter into consulting agreements with industry only when
such arrangements are established in advance and in writing to include evidence
of the following:
- Documentation of an actual need for the service;
- Proof that the service was provided;
- Evidence that physician reimbursement for consulting services is consistent
with fair market value; and
- Not based on the volume or value of business he or she generates for the
corporate industrial entity.
A neurosurgeon shall participate in or consult at only those meetings at which
CME is awarded when they are conducted in clinical, educational, or conference
settings conducive to fair, balanced, and accurate exchange of information.
A neurosurgeon shall accept no financial support from industry to attend industry-related
social functions without a related educational element.
A neurosurgeon who is attending a CME activity shall accept no industry financial
support for attendance at a CME activity. Residents and neurosurgeons-in-training
may accept an industry grant to attend a CME activity if they are selected
by their training institution or CME sponsor and the payment is made by the
training program or CME sponsor. Bona fide faculty members at a CME
activity may accept industry-supported reasonable honoraria, travel expenses,
lodging and meals from the conference sponsors. Industry shall have no involvement
in the selection of faculty, topics, location, or venues for CME events; that
is the sole responsibility of the sponsoring organization.
A neurosurgeon, when attending an industry-sponsored non-CME educational activity,
shall accept only tuition, travel and modest hospitality, including meals and
receptions; the time and focus of the activity must be for education or training.
When appropriate, faculty may receive a reasonable honorarium, which may include
reasonable travel expenses.
A neurosurgeon, when attending an industry-sponsored non-CME educational activity,
shall accept no financial support for meals, hospitality, travel, or other
expenses for his or her guests or for any other person who does not have a bona
fide professional interest in the information being shared at the meeting.
A neurosurgeon, when reporting on clinical research or experience with a given
procedure or device, shall disclose any financial interest in that procedure
or device if he or she or any institution with which he or she is connected
has received anything of value from its inventor or manufacturer.
A neurosurgeon who is the principal investigator shall make his or her best
efforts to ensure at the completion of the study that relevant research results
are reported truthfully and honestly with no bias or influence from funding
sources, regardless of positive or negative finding.
For purposes of these guidelines:
- "Industry" includes pharmaceutical, biomaterial, and device manufacturers.
- "CME activities" refer to educational activities that meet the requirements
of and have been approved by the Accreditation Council for Continuing Medical
- A "conflict of interest" occurs when a neurosurgeon or an immediate
family member has, directly or indirectly, a financial interest or positional
interest or other relationship with industry that could be perceived as influencing
the neurosurgeon's obligation to act in the best interest of the patient.
A "financial interest," "financial arrangement," "financial inducement," or
"financial support" includes, but is not limited to:
- Compensation from employment;
- Paid consultancy, advisory board service, etc.;
- Stock ownership or options;
- Intellectual property rights (patents, copyrights, trademarks, licensing
agreements, and royalty arrangements);
- Contracted research, general research support, fellowship funding;
- Paid expert testimony;
- Honoraria, speakers' fees;
- Meals and hospitality
A "positional interest" occurs when a neurosurgeon or family member is an
officer, director, trustee, editorial board member, consultant, or employee
of a company with which the neurosurgeon has or is considering a transaction
or financial arrangement.