| 10.
Monitoring the conduct of research |
 |
10.1
National ethics body
Ideally,
there should be a national ethics body to monitor Research Ethics
Committees which should possess powers to sanction investigators
who deviate from ethical standards in their research. Ideally
too, the various professional councils of South Africa should
consider health research in the same way that they consider
any other activity of investigators, and discipline registered
health professionals who have been found guilty of professional
misconduct because of improper financial arrangements and scientific
misconduct, for instance.
In addition
to these influences on the investigator, there are the constraints
provided by law. For example, any procedure carried out on a
person without consent may be construed as an assault. In addition,
delictual liability may ensue from treatment without informed
consent.
10.2
Particular role of the Research Ethics Committee
10.2.1
Proposed research
| 10.2.1.1 |
The
Research Ethics Committee probably achieves its principal
influence merely by its existence. The knowledge that it
is necessary to present an account of the intended research
to an independent body, including professional peers and
lay people, and of the concern that the Committee has for
the interest of the participants, exerts a major controlling
influence on the design of the study from the outset. The
ethos of the Committee should be to help, not hinder investigators.
|
| 10.2.1.2 |
Ways
in which the Committee can increase its influence when
this seems necessary include:
-
interviewing investigators in person;
-
sanctioning a limited pilot study with the requirement
that the experience gained should be reported to the
Committee before more extensive approval is given;
- insistence
that the investigator should submit the Participant
Information Sheet for approval by the Committee, in
order to exert greater influence over the extent and
quality of the information made available to participants;
-
scrutiny by Research Ethics Committees of the Consent
Form that will be used in order to ensure that participants
are given adequate information before giving their consent.
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10.3
Research in progress
Research
Ethics Commitee responsibilities continue while research is
in progress.
10.4
Ownership of results of research
10.4.1
Intellectual property rights
| 10.4.1.1 |
For
the purposes of this section the term Intellectual Property
Rights (IPR) shall mean provisional patent applications,
granted patents, trade marks, copyright, inventions, design
rights (registered and unregistered), expertise, know-how,
confidential information and all other intellectual property
rights of whatever nature anywhere in the world. |
| 10.4.1.2 |
It
is the policy of the MRC that all IPR which result from
funding provided by the MRC should be fully developed and
made available to the public as a whole. For this to occur,
investigators and inventors should disclose to the MRC all
research results which, in their opinion, may amount to
IPR in order to allow the MRC to decide whether it wishes
to protect and commercialise that IPR. |
| 10.4.1.3 |
It
is also MRC policy that all investigators and inventors
who have developed IPR should assign that IPR to the MRC
if requested to do so, and sign all necessary documentation
to effect transfer. |
| 10.4.1.4 |
In
the South African Medical Research Council Act, No 58 of
1991, Section 16 states that the rights in all inventions
and in all improvements in respect of processes, apparatus,
machines made by employees of the MRC, persons assisting
the MRC with any investigation or research, and persons
who are in receipt of MRC bursaries or grants-in-aid, automatically
vest in the MRC unless otherwise agreed to by the MRC Board.
Most educational institutions have put in place intellectual
property policies which state that all IPR developed by
their investigators belong to the educational institution.
It should also be noted that the MRC has entered into agreement
with a number of educational institutions, providing for
the joint ownership of IPR and for sharing the proceeds
of commercialisation of those rights. |
| 10.4.1.5 |
Part
of the proceeds from the commercialisation of IPR which
originate from MRC-funded research should be used for the
advancement of MRC research. The MRC has a royalty sharing
scheme which states that these proceeds shall be shared
as follows: one third to the investigator or inventor, one
third to the MRC Centre/Unit/Group (if applicable) and one
third to the MRC technology transfer office. |
| 10.4.1.6 |
Investigators
should not enter into material transfer agreements or confidentiality
agreements without the prior consent of the MRC, as these
agreements potentially have a bearing on the ability of
the MRC to commercialise IPR. |
| 10.4.1.7 |
In
the event that the MRC carries out research on behalf of
another person, government or administration, the IPR deriving
from that research shall belong to the MRC unless it is
otherwise agreed. |
| 10.4.1.8 |
In
most cases, industrial sponsors will not spend the time
and effort required to get a product to the marketplace,
without assurance of a monopoly and formal protection under
IPR. Publication of certain technical information may destroy
its commercial value and prevent formal protection under
IPR. However, it is part of the function of the MRC to disseminate
information and make it available to the public. Investigators
should therefore reach prior agreements with industrial
sponsors, allowing for the publication of research results
after a short delay that will allow the sponsor to study
(and possibly modify) the proposed disclosure, and to ensure
that it will not result in the loss of IPR. Research Ethics
Committees have a duty to ensure that research involving
patients is conducted in an atmosphere which is as free
as possible from commercial bias, and they should not approve
proposals in which industrial sponsors seek to impose more
restrictive conditions than the above, on the publication
of research results. |
| 10.4.1.9 |
The
MRC may apply for a patent as assignee of an invention under
the Patents Act, No 57 of 1978, or apply for a design as
assignee of the design under the Designs Act, No 195 of
1993. In terms of the Copyright Act, No 98 of 1978, the
author of an original work is the owner of the copyright
in that work, unless the work was created by an employee
during the course and scope of employment, in which case
it belongs to the employer. The MRC has an intellectual
property policy which states that copyright in all original
works created by persons employed or funded by the MRC,
belongs to the MRC. The MRC may assign the copyright in
a work back to its creator if it feels that there is no
commercial value attached to that copyright. |
10.5
Research results
10.5.1
Responsibilities of investigators
Investigators
have responsibilities to share possible benefits of research
results with participants.
10.5.2
Rights of participants to results of research
In
studies that involve sustained co-operation on the part of participants,
it is good practice to make arrangements to inform them of the
outcome of the research, in broad terms, and to combine this
with a letter of thanks or a small gift in the case of children.
The benefits
of research are to be made available to the research population
and the local communities from which they were drawn, and adequate
reports of the research must be made publicly accessible within
a reasonable period of time.
All research
participants should be informed of the outcome of the research
in which they were involved.
Where communities
or groups within a society are researched, they should be told
the results of the study - for example, on hereditary diseases
prevalent within their group. The participants have a right
to be informed of new findings that may affect their rights,
and they have a right to direct access to their original clinical
records. (Refer to the provisions of the Promotion of Access
to Information Act, No 2 of 2000, which applies to public bodies
such as the MRC, for example. Patients have this right except
where, in the view of the clinician practitioner concerned,
disclosure is likely to cause serious harm to their physical
or mental health or well-being, in which case proper counselling
should be given.)
10.5.3
Should research results form part of hospital or clinical practice
records?
Information
that emerges in the course of research and is likely to assist
the diagnosis or treatment of the participating patient, should
be made available without delay to the clinician having overall
responsibility for the patient's care. There is no need for
all results of research investigations to be recorded in hospital
or clinical practice records.
10.5.4
Disposal or continued storage of identifiable results
When
the research is complete, the need for continued security and
confidentiality remains.
10.6
Legal implications and arrangements for compensation
(See Appendix IV for compensation guidelines.)
10.6.1
Introduction
The
risk of injury, whether physical or psychological, occurring
as a result of participation in research is generally low, but
cannot be completely eliminated. Whatever the motives of the
participant in agreeing to take part in research, there is an
element of benefit to society, and it seems fair that society
should bear some of the risk in financial terms. The participant's
expectation that injury will be compensated is reasonable, and
we believe that it has public support. It is recommended that
investigators or sponsors of research take out professional
indemnity insurance to cover themselves against eventual liability
for claims arising from research activities.
10.6.2
Arrangements for compensation
| 10.6.2.1 |
Where
the research involves invasive procedures or exposure to
drugs or other products, there is a real risk of injury.
Formal arrangements for compensation are necessary. |
| 10.6.2.2 |
In
the event of significant injury, the participant should
be entitled to receive compensation regardless of whether
or not there was negligence or legal liability on any other
basis. The spirit of the guidelines of the Association of
the British Pharmaceutical Industry (Appendix IV), should
be followed. These are fair, no-blame compensation guidelines
that do not infringe upon the legal rights of research participants.
|
10.7
Publication and authorship24-30
10.7.1
Introduction
Those
engaged in research have a moral obligation to share their findings
with other investigators, clinicians and society, for the mutual
benefit of all. There are personal pressures on investigators
to publish, and institutions in South Africa also benefit from
the volume and quality of their research output.
Essential
requirements for publication are that the research has been
ethical from the beginning, through an institution's Research
Ethics Committee review of the protocol, that results have been
honestly gathered and reported and that due credit has been
given to collaborators. Research results are usually published
in scientific journals after peer review. In this process, reviewers
appointed by an editor judge the quality of the research and
the conclusions reached.
Ethical
conduct in publishing is a mutual responsibility of authors
and their parent institutions, of editors and of journal publishers.
10.7.2
Authors
Authorship
of a paper should be settled as early as possible, the main
criterion being public accountability for content of the paper.
The assignment of authorship may cause problems. Loose assignment
of authorship degrades the value of the effort put in by those
who truly qualify as authors. Those who genuinely deserve authorship
should not be deprived of it. Open communication among all the
individuals involved in research is a guarantee of serving the
best interests of all. The MRC endorses the recommendations
of the International Committee of Medical Journal Editors,24,25
which are reproduced below.
10.7.2.1
Guidelines on authorship
10.7.2.1.1
International Committee of Medical Journal Editors24,25
Each
author should have participated sufficiently in the work to
take public responsibility for the content. This participation
must include:
- conception
and design, or analysis and interpretation of data, or both;
- drafting
the article or revising it for critically important intellectual
content;
- final
approval of the version to be published. Participation solely
in the collection of data does not justify authorship. All
elements of an article (i, ii and iii above) critical to its
main conclusions, must be attributable to at least one author.
A paper with corporate (collective) authorship must specify
the key person responsible for the article; others contributing
to the work should be recognised separately. Editors may require
authors to justify the assignment of authorship.
10.7.2.1.2
Acknowledgements of intellectual contributions that fall short
of authorship24,25
At
an appropriate place in the article (title page, footnote, or
appendix to the text, as required by the relevant journal) one
or more statements should specify:
- contributions
that need acknowledgement but do not justify authorship; such
as 'advice', 'critical review of study proposal', 'data collection',
'participation in clinical trial'. Such persons must have
given their permission to be named;
- acknowledgements
of technical help;
- acknowledgements
of financial and material support;
- financial
relationships that might lead to a conflict of interests.
10.7.2.1.3
Information to be included in the covering letter24,25
Manuscripts
must be accompanied by a covering letter. The covering letter
must include:
- information
on prior duplicate publication or submission elsewhere of
any part of the work;24
- a statement
of financial or other relationships that might lead to a conflict
of interests;
- a statement
that the manuscript has been read and approved by all authors;
- the
name, address, and telephone number of the corresponding author,
who is responsible for communicating with the other authors
about revisions and final approval of the proofs;
- a clear
statement regarding the ethics approval of the research including
the ethics clearance number.
The manuscript
must be accompanied by copies of any permission to reproduce
published material, to use illustrations of identifiable persons,
or to name persons for their contributions.
10.7.2.1.4
Other guidelines
Data
reported must be factual, not plagiarised, altered or selective.
It should be published in as concise a form as possible, without
repetition in several journals (multiple publication) or subdivision
into multiple small units ('salami' publication). Where others'
work is quoted, credit must be given through reference to the
parent work. Unsubstantiated or exaggerated claims must be avoided.
Release of research findings should be via professional biomedical
journals, not non-refereed 'lay' publications, in order to avoid
misleading sensationalism.28
Anonymity
of research participants and confidentiality of their details
must be maintained. Any proprietary interest in a drug, treatment
or institution must be clearly divulged.
It is a
responsibility of each research team head to ensure that no
fraudulent publications emanate from the team. Should fraudulent
publication occur the responsibility is shared by all the authors.
10.7.3
Editors, peer reviewers and publishers
| 10.7.3.1 |
Editors
have an obligation to treat all contributors equally and
fairly. They have a responsibility to inform contributors
of editorial policy (for example, via 'Instructions to Authors')
as well as of reasons for rejection of articles.29,30 Acceptance
or rejection of articles should be on scientific grounds
only. Clearly prejudiced or politically biased reviewers'
reports should be ignored, and the future use of such reviewers
evaluated. Editors also have a responsibility to obtain
a clear statement on ethics clearance of research submitted
for publication, and to include this statement in the published
work. |
| 10.7.3.2 |
If
fraud is suspected, it must be speedily and vigorously investigated
and authors' home institutions and funding bodies informed.
If fraud is proven, this must be openly recorded and previous
work questioned. |
| 10.7.3.3 |
Peer
reviewers must respect and maintain the confidentiality
of the unpublished information to which they have privileged
access. There must be no theft of data, no plagiarism or
deliberate delay in evaluation. Personal prejudices or bias
must not be allowed to influence acceptance or rejection
of articles. Reports to editors should be clear and professional.
Where possible, suggestions should be made to improve the
chances of publication of an article. Should a reviewer
feel uncomfortable about evaluating a manuscript because
of personal beliefs, the manuscript should be returned promptly
to the editor, without review. |
| 10.7.3.4 |
Journal
publishers should ensure that their publications conform
to the highest ethical standards, and should support editors'
attempts to maintain these standards. |
10.7.4
Ownership of data
Current
opinion is that the sponsoring or employing institution owns
the data and must hold the original data, should an investigator
leave, so that the data are available for scrutiny. These should
be kept for a minimum of five years after publication of an
article. Copies of all data may be taken by the researcher with
the permission of the sponsoring institution.
10.8
Liaison with the public media
This
section is included for the benefit of MRC-supported investigators
and it serves as a guideline for correct procedures rather than
ethical practices.
The MRC
maintains responsible co-operation with all public news media
in order to communicate scientific information and to cultivate
understanding and appreciation of MRC activities and of clinical
research in general.
It is expected
that Directors of MRC-supported units or centres, and short-term
investigators who are supported by the MRC, should co-operate
with the media at all times and to the best of their ability,
for the sake of clinical research. Non-MRC personnel should
be careful to follow procedures laid down within their host
institutions, whereas MRC personnel may liaise with the public
news media only with the permission of the President of the
MRC or the President's nominee.
Cognisance
should be taken of the 'Ingelfinger rule' when reporting research
results: clinical research should not be reported in the scientific
or lay press prior to publication in an appropriate peer-reviewed
journal.28
The Corporate
Communication Division at Head Office is available to any MRC
staff member or any affiliated researcher for advice and guidance
regarding contact with the media. They have produced communication
guidelines, Communication Guidelines of the Medical Research
Council, 2001.
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