| 6.
Conduct of research |
 |
6.1
Responsibility for overall care of patients
| 6.1.1 |
In
most cases the person who approaches the patient to be recruited
should be the clinician responsible for the routine clinical
care of the patient. Where patients are the research participants,
the investigator conducting the research project may or
may not be the same person as the clinician responsible
for their overall care. It may therefore happen that changes
in management will be undertaken only with reluctance, for
fear of disturbing the research procedure. Alternatively,
the usual clinician may not realise that he or she retains
overall responsibility for care, being under the illusion
that the researcher had taken over this role. Proper communication
is essential between all health care workers and investigators
who share responsibility for the care of the patient.
|
| 6.1.2 |
It
is important that the ordinary requirements - clinical and
other - are not neglected as a consequence of the involvement
in research, and that the identity of the person in overall
clinical charge of the patient's care is clear. This person
should know about the research and be in agreement with
it. If there is any likelihood that the patient might be
confused about which clinician is responsible for overall
care, this should be made clear on the Participant Information
Sheet.
|
6.2
Responsibility in the conduct of multicentre studies
In
multicentre studies it is particularly important that the person
responsible for the overall clinical care of the patient should
be closely concerned with, or informed of, the running of the
research project. His or her agreement should be obtained. This
avoids uncertainty on the part of others in the clinical team,
if there seems to be conflict between the apparent demands of
the research protocol on the one hand, and the interests of
the individual patient on the other. The patient's interests
take precedence at all times.
6.3
Delegation and research conducted by non-medical health-workers
Where
research activities will be delegated by the investigator, the
Research Ethics Committee should be satisfied that the investigator
will delegate only to individuals with the necessary skills
and experience.
Research
ideas and projects increasingly emanate from non-medical groups
of health workers. In many instances the responsibility for
the conduct of the research may be entirely that of the investigating
health worker. In most instances, however, it may be necessary
to obtain the consent of the relevant clinician for any planned
research intervention to ensure that this is appropriate to
the patient's state. The collection of samples (or information)
from patients should be supervised by the relevant clinician
or a skilled person nominated by the clinician.
All research
involving patients must be referred to a Research Ethics Committee.
In some cases, class approval may be given in advance to applications
for minor research or a series of studies of a particular type
to be carried out as a regular feature of a research or training
programme. Even in these circumstances, the Committee will wish
to be informed of each individual study by title at least.
6.4
Responsibility for the welfare of research workers and laboratory
personnel
| 6.4.1 |
The
Research Ethics Committee should stress the importance of
safeguarding the welfare of all personnel participating
in research. The primary investigator must formulate and
apply safety rules and guidelines for the handling of all
hazardous materials. The provisions of the Occupational
Health and Safety Act, No 85 of 1993, regarding a safe working
environment, should be adhered to. |
| 6.4.2 |
Arrangements
for compensation in the event of injury should be dealt
with as outlined in the recommendations of Good Clinical
Practice.9 Occupational injury should also be compensated
in accordance with the Occupational Injuries and Diseases
Act, No 130 of 1993. |
6.5
Adequacy of facilities to carry out research
Where
there is doubt about the appropriateness of the facilities in
which research will be done, a site visit by representative
members of the Research Ethics Committee may be necessary.
6.6
Participant privacy and confidentiality
The
right to privacy - which includes autonomy over personal information
- is a common-law and constitutional right. It means, for example,
that clinicians have a duty to ensure that information concerning
their patients remains confidential. Failure to safeguard information
may render a clinician liable for breach of confidentiality.
Legal exceptions may be imposed in terms of the law, as where
clinicians may be obliged to disclose information regarding
notifiable diseases. Disclosure may also be made where the patient
concerned has consented to disclosure.
| 6.6.1 |
It
is essential that information about a research participant,
whether a patient or a healthy volunteer, should be regarded
as completely confidential. This is the case where the information
is derived from the medical records or from research activity.
Sensible precautions should be taken to preserve confidentiality.
|
| 6.6.2 |
Ideally,
no names of persons participating in a study should be on
a research record. All participants should be coded, and
only these codes used to identify individuals and to prevent,
for example, double entries. The principal investigator
must take responsibility for keeping a control list of names
and codes, and see that confidentiality is maintained. The
key to the code should be kept secret by the investigator.
Where identifiers are needed to link data to a patient or
other participant, they should be kept separately from patient
records. On completion of the research, these identifiers
should be destroyed, and in all further analysis the codes
should be used to distinguish data. |
| 6.6.3 |
When
the research is complete, the need for confirmed confidentiality
and security of information remains. |
| 6.6.4 |
Information
about persons participating in a study may be released to
a third party only with the consent of the participant or
someone legally capable of consenting on the participant's
behalf. |
| 6.6.5 |
Care
must be taken to ensure that confidentiality about the identity
of participants will be preserved, through the use of coding,
for example, when the results of research are published.
|
|
