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Informed Consent and
Participants’ Safety
Who/What Ensures Clinical Trial Participants’ Safety?
Most clinical research is federally regulated and has built in safeguards to
protect participants’ rights and welfare:
- Researchers must follow strict ethical and scientific principles to protect
patients and obtain valid results.
- Sponsors must adhere to Good Clinical Practice, an international standard for
human trials that requires drug companies to obtain informed consent, have
trials vetted by independent ethics committees, provide on-site monitoring, and
give treatment for adverse effects both during and after trials.
- The FDA inspects clinical trial sites to “protect the rights and welfare of
volunteers and verify the quality and integrity of data submitted for review.”
- Every trial follows a controlled protocol, or study plan, that explains what
will be done and why (e.g. number of participants, drug dosages, medical tests
to be administered, etc.) and has been approved by the study sponsor, the
medical center or clinic where the work will be done.
- As a clinical trial progresses, researchers report results at scientific
meetings, to medical journals, and to various government agencies.
“Between the FDA, the help of other government agencies, Institutional Review
Boards, the required monitoring of studies by industry and private sponsors, and
the required oversight and reporting by investigators and their staff, a lot of
people are looking out for the research participant's safety." says David A. Lepay, M.D., Ph.D., director of the FDA's Good Clinical Practice Program.[6]
Investigational New Drug Application (IND)[5]
Before a clinical trial can begin enrolling participants, sponsors must obtain
FDA approval of an (IND) application to advance to human trials. The decision is
based on preclinical data showing that the product will not expose human
participants to unreasonable risks in limited, early-stage clinical studies. The
IND application highlights:
- “Any serious, unexpected adverse experience associated with use of the drug.”
- “Any finding from tests in laboratory animals that suggests a significant risk
for including reports of mutagenicity, teratogenicity, or carcinogenicity.”
- “Any risks of particular severity or seriousness anticipated on the basis of
the toxicological data in animals or prior studies in humans with the drug or
related drugs.”
- “Identification of all safety reports previously filed with the IND concerning
a similar adverse experience, and analyze the significance of this in light of
the previous, similar reports.”
- Previous safety problems identified in other countries during the clinical
trial or marketing stages, or withdrawal of the drug from market.
- “The pharmacological and toxicological effects of the drug in laboratory
animals and, to the extent known, in humans, based on which the sponsor has
concluded that it is reasonably safe to conduct the proposed clinical
investigations. The kind, duration, and scope of animal and other tests required
varies with the duration and nature of the proposed investigations.
- “… information relating to safety and efficacy in humans obtained from prior
clinical studies.”
- “A description of possible risks and side effects to be anticipated on the
basis of prior experience with the drug under investigation or with related
drugs, and of precautions or special monitoring to be done as part of the
investigational use of the drug.”
During the course of the study, sponsors must update the FDA should any new
safety information become available. Sponsors may withdraw treatments from
clinical trials at any stage; the FDA cannot dictate whether or not a clinical
trial should continue.
Institutional Review Boards (IRBs)
approve protocol
Comprised of lay people with varying backgrounds and experts, IRBs review
research protocols and related materials to protect research participants’
rights and welfare, making sure they are fully informed and have given their
written consent before studies begin. IRBs examine protocol to ensure that:
- It does not present an undue or unnecessary risk to the patient.
- Participants are treated humanely and ethically.
- Risks are minimal compared with potential benefits of the treatment.
- Design is consistent with sound scientific principles, ethical norms,
regulatory requirements, institutional commitments and regulations, applicable
law, standards of professional conduct and practice, and community attitudes.
- Informed consent document includes all required elements.
- Inclusion and exclusion criteria identify the appropriate people as eligible
for the trial.
IRBs have the authority to approve, require modifications to secure approval, or
disapprove research.
“It's important that we have the rapport with the public that allows them to
trust us with this program,” says Bernard A. Schwetz, D.V.M., Ph.D., acting
director of the Office for Human Research Protections in the Department of
Health and Human Services. “Without people willing to participate, there won't
be any clinical trials.” [6]
Informed consent process
The FDA requires that potential clinical trial
participants receive, and review at their leisure, all
relevant study information before deciding whether or
not to enroll. The written information must be
understandable to every participant, and should include
details about the trial’s purpose, duration, procedures,
potential risks and benefits, and alternative therapies,
as well as key contacts and the rights of study
participants.
The informed consent process allows the researcher and patient to exchange
information and ask questions. Patients invited to enter a trial are not
obligated to join, but can consent to participate if they find the potential
risks and benefits acceptable. Participants must sign a consent form prior to
enrollment and before any study procedures can be performed. Consent is entirely
voluntary, and participants can leave a study at any time, without penalty.
Researchers may terminate participation without participants’ consent if a trial
is not working or if an unexpected change occurs in the health status of a
participant.
Sources
- The Center for Information
and Study on Clinical Research Participation (CISCRP); Results of the New National Survey
of Public Perception, conducted in December 2004
- The Center for Information
and Study on Clinical Research Participation (CISCRP); Results of the New National Survey
of Public Perception, conducted in December 2004
- National Survey Shows that two-thirds of Americans Think that Clinical
Research Studies are Safe ; CISCRP press release 12/23/04
- Activa Therapy New Hope for
Parkinson’s Program Clinical Trials —
The Pursuit of Science
-
FDA Guidance for Industry – PreMarketing Risk Assessment
-
Clinical testing with
Humans, by Carol Rados.
NurseTown.com, Jobs for Healthcare Professionals
- National Coalition for PKU & Allied Disorders, Human Subjects Research
Protection
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