POLICY
RESEARCH/INVESTIGATION/CLINICAL TRIALS
POLICY:
The Administrator must approve any research project,
investigational study or clinical trial. Research is defined to
be a systematic investigation designed to develop or contribute
to generalized knowledge. This includes registries,
retrospective, observational or prospective clinical studies,
surveys and laboratory studies.
OBJECTIVE:
Resident rights will be maintained at all times as they
relate to participation in research, investigational or clinical
trials. These rights include informed consent, confidentiality,
and consequence of knowledge.
PROCEDURE:
1. The Administrator, in consultation with the DON and Medical
Director will make determination as to whether a research
activity may be allowed at the facility. A written protocol
of the proposed activity will be available during the decision
making process.
2. Determination will include if the facility staff is competent
to provide the care or treatment outlined in the protocol.
3. The Administrator will assure that the activity does not
violate the organizational Code of Ethics.
4. The Ethics Committee will be consulted in the event that this
represents an ethical dilemma.
5. Once approved, the principal investigator must present the
following information to the Administrator in writing before
beginning the activity:
A. Notification of residents concerning the protocol,
benefits, risks, potential outcomes and consequences
as well as alternative courses of intervention.
B. Signed informed consent of residents involved which is
explained by the primary investigator with a copy
maintained in the resident’s medical record.
C. A statement related to resident maintenance of
confidentiality.
6. Physician orders for care and a copy of any protocol shall be
maintained on the medical record.
7. When the investigation protocol or clinical trial involves
medication administration, the facility will involve the
pharmacist in the discussion as well as in the long term
monitoring of the resident’s outcomes.
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8. The pharmacy will maintain responsibility for procurement and
inventory control of the medication in the pharmacy, while
the medication delivery system shall dictate facility
inventory control. (Ex. Unit dose vs. Bubble pack).
9. The pharmacy will additionally be responsible for returning
unused portions of the medication to the primary investigator
at the completion of the study.
10. Nurses participating in the clinical trial shall meet the
following criteria:
A. Must be permitted by state law to administer the
medication by the prescribed route and have been
authorized to do so by the principal investigator
B. Shall complete an orientation concerning the
medication, administration guidelines, the
pharmacological action and use as well as the
pharmacological monitoring parameters according to
the approved protocol
11. The Administrator, participating residents/subjects or their
family shall be given a copy of the final report of the
outcomes. shall be given progress reports of the activity as
well as a final report of the outcomes.
12. The facility will maintain a research directory of ongoing
research projects at the facility.
13. Approval to publish results of research activities must be
granted by the Board of Directors.
Revised---March 2001
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