Clin Eval 45（3）2017

Invited lecture

Ethics and regulations of clinical researchin South Africa ＊1
Ames Dhai
Steve Biko Centre for Bioethics, University of the Witwatersrand, Republic of South Africa

Abstract
This is the record of lecture of Professor Ames Dhai, at the seminar titled “Japanese new law onclinical research and human research ethics in South Africa: Development and ethical partnership toward
global health”, organized by “Clinical Research Risk Management Study Group”, co-organized by “Clinical
Evaluation (Rinsho Hyoka Kankokai Inc.)”, supported by “Japan Pharmaceutical Industry Legal Affairs
Association (JPILA)” and “Japanese Association of Pharmaceutical Medicine (JAPhMed)”. The seminar washeld on September 29, 2016, at Venue: Mitsui Sumitomo Insurance, Tokyo, Japan.
She introduced her contribution to set up the Centre with the name of Steve Biko, a prominent humanrights activist, who was killed at 31 years of age, in the apartheid regime, as he struggled for “black
consciousness” and establishment of equality and freedom of black people.
After the abolishment of apartheid in 1994, South African Constitution was established. It defines the“Bill of Rights” which clarifies that everyone has the right to bodily and psychological integrity, including
the right not to be subjected to medical or scientific experiments without their informed consent. This isbased on the United Nationʼs International Covenant on Civil and Political Rights as agreed in 1966.
She also introduced South Africaʼs regulatory framework of research ethics to protect human andanimal research subjects, including ICH-compatible GCP regulations for clinical trials. Her lecture provided
much of insights and wisdom for the Japanese to learn true meaning of ethics, human rights and research
regulations in the international context.
Key words
bioethics, human rights, South Africa, apartheid, clinical trial
Rinsho Hyoka（Clinical Evaluation）．2017；45：W15−W35．

＊1

The record of the lecture on September 29, 2016, at Venue: Mitsui Sumitomo Insurance, Tokyo, Japan.
− W15 −

臨床評価45 巻 3 号

2017

Professor Ames Dhai, M.D., MBChB, FCOG, LLM,
PG Dip Int Res Ethics, PhD
Director of the Steve Biko Centre for Bioethics at
the Faculty of Health Sciences, University of the
Witwatersrand, Johannesburg, the Republic of South
Africa.
She established the Centre in 2007. The Centre,
which runs Masters and PhD programs in Bioethics and
Health Law, has local and international recognition as aleading Centre in these disciplines and in 2013 wasawarded the World Medical Association Co-operating
Centre and the South African Unit of the UNESCO
International Network in Bioethics status. Professor
Dhai serves on several policy making bodies in the country and is a Past President of the South African Medical
Association. She also serves regularly as a consultant /expert advisor for the World Health Organisation, andis on the WHOʼs African Advisory Committee for HealthResearch and Development. She served on the World
Medical Associationʼs (WMA) Working Group on Health Databases and Biobanks where she was involved in developing
international policy. She participated in the WMAʼs Working Group on amendments to the Declaration of Helsinki and inactivities of the Institutes of Medicine (USA), and the National Academies of Sciences (USA). Professor Dhai is an ethicist
of international standing who can be credited with entrenching bioethics as an integral aspect of health sciences in South
Africa. She started off her career as a medical doctor, specialised in Obstetrics and Gynaecology, and then went on tograduate with a Masters in Law and Ethics.
Source: https://www.wits.ac.za/staff/academic-a-z-listing/d/amesdhaiwitsacza/
The photograph is at the time of lecture in Tokyo, September 29, 2016

words on this as well.

1．Origin and overview of Steve
Biko Centre for Bioethics

Steven Bantu Biko was the father of the black
consciousness movement (Fig. 1). He was born in
1946, but had a very short life. At 31 years of age,

I will talk about research ethics and why it is

he was killed by the apartheid regime, because heimportant to think about ethics when we are doing

was trying to conscientize us into believing in our-clinical research. I will talk about some tragedies

selves as black people who were equal to anyone

and scandals, both international and locally rele-else in the country. I met Steven in my first year ofvant in South Africa. I will look at some interna-

medical school at university. At that stage, Steventional ethics and regulatory instruments together

was already banned by the South African govern-

with our South African regulatory instruments. I

ment and had been placed under house arrest in awill highlight some of the gaps that we have inprovince a distance away from us. Despite theSouth Africa with regards to participant protec-

house arrest and banning, he managed to cometion, what are some of our most relevant in terms

across to the university to get us to believe in our-of our governmentsʼ instruments. Currently, there

selves that as black people we were equal to anyone

is a reawakening of discussion of what should theelse in the world. He influenced our lives and ourstandards of care be in clinical trials and what

thinking greatly. When I was asked to set up a cen-should the post-trial access be ‒ I will say a few

tre for bioethics, I was really happy that the uni-

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Clin Eval 45（3）2017

Fig. 1and resuscitate him and get him to a point where

Steven Bantu Biko

they could start the interrogation again. During hislast incarceration, he had terrible head injuries asa result of the brutality of the South African
regime. When the doctors were called in to look athim, he already had concussions, but they failed totake his condition seriously. They did not even do aproper medical examination. They failed to institute care in his best interests. They wrote false
medical certificates which conveyed false information. They allowed Steve to be examined in thepresence of the security police. How does that align

Steven Bantu Biko
18 December 1946 - 12 September 1977

with respecting the privacy and confidentiality ofyour patient?

versity was supportive of the name of the centre,
which is the Steve Biko Centre for Bioethics.

Basically, they subordinated the welfare of theirpatient to the interest of the security policy, andWhy did I think about the Steve Biko Centre foryet when we take our Hippocratic Oath, we pledge

Bioethics? Steven Bikoʼs name serves as a constantthat the welfare of our patients and the best inter-reminder to us as medical people as to how low weest of our patients should be our first consider-

can stoop when it comes to recognizing our patients

ation. In the apartheid era, doctors took this oath,and doing whatever is in the best interest of our

but they didnʼt apply them. The interest of thepatients (Table 1). Biko was detained in a jail whereapartheid state was the doctorʼs first consider-

he was subjected to harsh brutal treatment by theation. They transported him under very sick condi-

South African police during his interrogation.

tion from one prison to a central security prison

South African doctors were called in to assess his

about 12,000 kilometers away. He received inade-medical condition. The police would torture andquate medical care in that prison as well. So, it isdamage Steve to a point whereby he would not be

not surprising that he succumbed and he was pro-able to respond, and then the doctors would come innounced dead after a day at the prison. At that

Table 1

Biko ‒ improper care

� Doctors failed to regard Bikoʼs condition seriously� Inadequate medical examination
� Failure to provide nursing care
� Failure to observe Biko closely� Wrote a false medical certificate and also conveyed incorrect information
� Allowed Biko to be examined in the presence of the security police�� Transported a very sick patient under extremely unsatisfactory conditions
without a medical attendant� Transferred a patient without a referral note
� Received inadequate care in Pretoria prison− W17 −

臨床評価45 巻 3 号

2017stage, we had very little bioethics teaching in the

We have a strong staff component, both Council

country. Bioethics was specifically not allowed infunded, that is, university funded, and grant funded,

the medical school that I went to. It was the only

and we have got a set of honorary lecturers as well.

black medical school. It was University of Natal-

Some of the activities that we are involved in isBlack Section. If black students were taught bio-teaching, research in bioethics and health law. We

ethics, it could “start us thinking” and we would

do a considerable amount of academic advocacy.

start demanding a realization of our human rights.

When we are not happy with whatʼs happening with

It was the apartheid governmentʼs decision never toregard to the ethical treatment of patients in theallow us to have any involvement in bioethics.

country, through the position of academia, we put

However, on the evening that Biko died, as students

into motion our agency as advocates for ourat the University of Natal we put together the very

patients. We also do consultations, both clinicalfirst faculty bioethics lecture, and it was planned

and non-clinical, for university staff and the greaterfor 6 oʼclock that evening. After all was done inSouth African community should there be any con-getting the speakers together and getting the lec-

cerns that they may have in bioethics.

ture off the ground, at 5:30pm the lecture wasbanned by the South African government.

The teaching that we do includes undergraduate
and postgraduate teaching. We have the regulator

However, we have risen above that. Post-1994,

for clinicians in the country, the Health Professions

we have got a centre for bioethics in Steveʼs name,Council of South Africa (HPCSA). The Centre wasand it is one of the leading centres in the country.

active in contributing to the development of a core

The entrance to Steve Biko Centre for Bioethics
in the “Health Science Building” with the nameof Professor Phillip Vallentine Tobias.
Photo: Chieko Kurihara, May 11, 2016.

When Steve Biko Centre for Bioethics was established in 1994
at the University of the Witwatersrand, Professor Dhai wasdesignated as the director of the centre.
The photo panel of an educational TV series in 2002 titled“Tobiasʼs Body” guided by Professor Phillip Vallentine Tobias,
at the entrance of Steve Biko Centre for Bioethics, with thewords of Professor Tobias: “The so-called race of mankind aresimply a variety of different sorts of surface anatomy. What is on
the surface is just a frill of variation.”
Photo: Chieko Kurihara, May 11, 2016.

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Clin Eval 45（3）2017

curriculum in bioethics, human rights and health

2．Research ethics: objectives,components, and challenges

law by the HPCSA. The HPCSA has mandated
every faculty of health sciences in the country toensure that at least 10% of the core curriculum inhealth sciences training is a combination of bioeth-

By way of introduction to research ethics, I

ics, human rights, and health law. This has to be

would like to quote Leon Kass, a very renowned

taught vertically through the study years, and it

ethicist. In one of his publications, he said, “Themust be examinable as well. That is where we arebenefits of biomedical progress are obvious, clear

with our undergraduates. To incentivize our stu-and powerful. But the hazards are much less welldents, the Centre managed to get some funding, andappreciated.” That is the reason we need to have

we have a bioethics prize now that is awarded toregulatory controls and ethical controls, because

the health science student with the highest aca-

the hazards are not really appreciated when it

demic marks in bioethics every year across all thecomes to biomedical progress. What are the objec-

disciplines. In terms of the postgraduate programs,

tives of ethics? We talk about ethics all the time,

we have short courses of competency in bioethics,

but what does ethics really mean? It is how wehuman rights, and health law. We have also estab-ought to be acting in a given situation. Ethics pro-lished a Masters program in this discipline. Morevides us with strong reasons for acting in a par-recently, we developed a PhD program, whichticular way. It involves a critical reflection ofstarted in 2010, and we have graduated three so far

morality. The intention of ethics is to safeguard

and we hope to graduate about two a year. Of course,

human dignity, to promote justice, equality, truth,

we do a lot of Continuing Professional Development

and trust. This is so pertinent in our South African(CPD) to graduates for bioethics.

context, especially considering the situation that
we had in apartheid and the situation that continues− W19 −

臨床評価45 巻 3 号

2017

Centre Staff
� University Council Funded
Professor Ames Dhai - Director
Dr Kevin Behrens - Senior lecturer
Ms Jillian Gardner - Lecturer
Dr Christopher Wareham - Lecturer
Ms Tebogo Dithung - Centre Administrator
Ms Samkelo Nsibande - Projects Co-ordinator� Sessional − Grant Funded
Professor Peter Cleaton-Jones - Research Ethics
Advocate Yolande Guidozzi - Lecturer
Dr Norma Tsotsi - Lecturer
Dr Anthony Egan - Lecturer
MS Lizeka Tandwa - Research Assistant� Honorary Lecturers
Dr Louise Bezuidenhout
Dr Graham Howarth
Professor Trevor Jenkins

The Human Research Ethics Committee (Medical) at one of its monthly meetings

at the moment in our country. In terms of ethics,

context of South African vulnerability and ourregulations, and laws, it is very important for eth-apartheid legacy.

ics to inform laws and regulations rather than laws

In terms of ethics, we focus on principle-based

and regulations to inform ethical guidelines.

ethics in research. We look at

Whenever I do a talk, I am asked, “But you arebasically boils down totalking about ethics? Yes, we should be considering

ticipants are involved in research, they need tothis, but what does the law say?” Itʼs not what does

make a full informed consent, and their

the law say, but how has ethics informed the law -, which. When par-has to be protected. When it comes tothat should be the question.

, that is,,

What is ethics in research? It is simply about

it translates in research ethics to the benefits of

how we can ensure that people that are vulnerable

research outweighing any perceived harms. It is

are protected from exploitation and other forms ofimportant to realize that there is a dissymmetry inharms. What we see in ethics in research, is that

this when you look at risks. The risks are now

there is an evolving language where we move fromimmediate within the research context for futurea passive subject to an active participant. We lookbenefits, and itʼs important that the participant

at person-centered ethics in research as well, justunderstands this. When it comes tolike we have patient-centered ethics in the health-research, it is important to discuss what thecare context. This is especially pertinent in the− W20 −

inwill be especially if itʼs international

Clin Eval 45（3）2017

collaborative research. Would one have the same

documents will have quasi-legal status. Oftentimes,

standards within your research site as compared toresearchers will come to us and say that this is athe sponsor companyʼs site? Or would you have a

guidance document; it does not have a clout of thelower standard? If you demand the same standard,law. We would say, no, itʼs got quasi-legal standing,

how would that pan out, especially when you con-because itʼs a response to our Constitution and oursider that that standard may not be the standard of

National Health Act. Therefore, you are legallycare within the country, because if one insists on an

bound to the ethics within the documents.

outside standard, if that standard is proven, then

Basically, when it comes to research ethics, there

the research is proven to be beneficial. What if

are two components: regulatory and ethical. But,

your country cannot afford to give that as the stan-when we look at health research, there are many

dard of care thereafter in line with the Declaration

challenges to health research, but all these chal-of Helsinki in terms ofand standard

lenges hinge around one question and that singleof care. There are no clear-cut answers. While wequestion is whether the demands and goals of sci-do have guidelines, we try to look at each situationence and biomedical research can be pursued withon an ad-hoc basis and say to ourselves what would

full protection of the rights and dignity of thethe best situation be for participants and communi-

research participant and communities. This is aties in terms of this particular dilemma for us inreal dilemma. The dilemma is intensified when weSouth Africa. There are also issues in terms of

think about the goals of medical research. The

justice when it comes togoals of medical research is to promote well-being. Prior to 1994, that was totallyfor humankind. How do you arrive at this balance?

ignored. If you were involved in research as a black

3．Tragedies and scandals

participant, if you got injured as a result of being
in the research, there was not much in terms ofcompensation and you got into the healthcare sec-

Let me describe this with some of the realities

tor, which was a very skeletal healthcare centre

that we see. An Italian Researcher Giuseppewith very little to offer black South Africans andSanerilli. Around 1893, he thought that he had dis-then you became a victim of that situation.

covered the organism that caused Yellow Fever. He

I have already said that ethics is not a law. Itʼs a

injected a whole lot of subjects with this organism,

distinct entity. Ethics unfortunately is constrained

and needless to say, several died and others becameby the law, but I would always say to the lawyers

very sick. There was huge mortality and morbidity.

and they get very unhappy with me is that the law

At that time, there was no telephone or internet,

is the minimum standard, and ethics must rise above

but there were sailors going from shore to shore.

the law should the law demand you to do anything

Very soon in the 1890s, the world woke up in shock

unethical. Lawyers are not happy to hear this, but

because researchers were using human beings as

it is very important that lawyers must be bound byguinea pigs. Thatʼs where the guinea pig terminol-

ethics as well. Very important is if ethics informs

ogy started. Next example is about gypsy twins.

the law, then ethics is imbedded in the law. Any

This was an atrocity committed during the WWII.

regulations or guideline documents that come out of

We have read a lot about the atrocities committed

the law, because the law will state that you needby Hitler amongst the Jews, but Hitler also wanted

guidelines and regulations in A, B, and C, thoseto get rid of gypsies that were living in Germany− W21 −

臨床評価45 巻 3 号

2017

because he wanted a pure Aryan race. His idea of

results, he showed that 75% of his participants

pure Aryan race was fair skin, blue eyes, blondwere white women and 25% were black African

hair. These gypsy twins had been captured during

women, but when they went through his documents,

the WWII. His chief scientist, Dr. Mengele, anes-

it was reverse ‒ 75% were African women with nothetized them, then injected potassium chloride

informed consent and 25% were white. When they

into their hearts killing them off, and removed theirlooked at follow-up, they couldnʼt trace theseeyes and shipped them off to Berlin for study,

women, so many of them were probably dead.

because he wanted to know how one could study the

There was a disciplinary hearing. He lost his job

natural processes, and tamper them towards what

and was stripped off his professorship. He wasthey wanted in terms of an Aryan race.

blacklisted. He cannot do research in the country at

The story about an ex-professor Werner Bezwoda

all. He was reported to our Health Professions

is also well known. He was a professor of oncology

Council, which is our regulatory board, and theyat University of the Witwatersrand. In 1999, hesuspended him from practice for a few years. He iswent to the European Oncology Society where he

now back in private practice, but it hurt the repu-

presented some very good oncology research results

tation of South Africa and our institution. Because

on breast cancer. Then, in 2000, he presented inof this, we made sure that we tightened our regula-

America to the International Society of Oncologists.

tions on health research.

It was chemotherapy coupled with stem cell rescue.

This is a picture of demonstrators at an interna-

His results were so good that oncologists thattional HIV/AIDS conference. It was at the time ofattended his conferences went back to their prac-pre-exposure prophylaxis trials. There were threetices and tried the regimes that he had showed,

countries involved, two in Africa and one in the

only to find that their patients were doing worse or

East. The reason for the demonstrations was there

they were dying.

wasnʼt adequate informed consent, or proper stan-

The International Oncology Society asked him

dard of care. In terms of access for the communi-

for his data, because it could be that we had someties, there wasnʼt anything brought in. Governments

specific nuances in Africa whereby our patientswere not aware of the exact ethical implications,were surviving but patients in the west were not,and based on these demonstrations, the three gov-

and he did not give them data. Because the data wasernments stepped in and shut down the trials pre-not forthcoming, a group from International

maturely.

Oncology Society came through to South Africa

We have had many international problems,and engaged with the dean of the medical school

African together with South African problems. I

and then got into Prof. Bezwodaʼs site only to findam sure you will agree with me when I say ethics inthat he had fabricated his results. He did not evenresearch was “born in scandal,” and it is now reared

have a proper protocol. This research did not

and nurtured in protectionism＊2.

undergo research ethics review, although they had
a strong research ethics committee in the institution already at that stage. When he presented his＊2Levine C. Has AIDS changed the ethics of human subjects research?
167-73.
− W22 −. 1988; 16(3-4):

Clin Eval 45（3）2017

the Singapore Statement, and this is important his-

4．International ethics andregulatory instruments

tory that should not be forgotten.

5．South African ethics andregulatory instruments

We have some pertinent international instruments and guidelines starting from Nuremberg
Code 1947 moving into the International Covenant

What about South African Instruments andon Civil and Political Rights 1966, where specifi-

Guidelines? Because of our history together withcally informed consent is mentioned＊3. Then there

the fact that lots of clinical research is done inis the Declaration of Helsinki 1964. Itʼs beenSouth Africa, we have a tier-sort of ethical regula-

updated seven times, and the latest version is in

tory legal protections. We are protected by the Bill

2013. One may ask, if the principles of ethics donʼtof Rights of the Constitution of South Africa.

change, why do you have to be updating something

Then, we have our National Health Act, which is an

all the time? That is because with the rapid advance-

act of parliament. In terms of Chapter 9 of ourment of science and technology, scientific processes

National Health Act, itʼs specific to the formation

change. Therefore, while the principles remain theof a National Health Research Ethics Council thatsame, the application of the principles may differ.

has to put together guidelines for good practice. So

Then there is the CIOMS guidelines, the ICH-GCP

the GCP guidelines together with the Ethics inwhich has been mentioned already, and of course,

Health Research Guidelines are a result of theSingapore Statement on Research Integrity (2010).

work done by the National Health Research Ethics

This is specifically to safeguard against scientificCouncil. I was deputy chair of that Council for 2

misconduct. Japan was quite a catalyst when it

years and was also involved in the interim council

came to the Singapore Statement, because my very

that worked to put in together these guidelines. We

first trip to Japan was around 2008-2009 where

also have our Health Professions Council of Souththe Ministry of Science and Technology hosted theAfrica Guidelines that has three booklets on Ethics

OECD countries. The huge concern at that stagein Research; one is general research. Should there

was the fabrication, falsification, and plagiarism

be any infringement of the ethics, then thethat we were seeing in science. At that meeting, I

researcher gets reported to the Health Professions

represented the South African Department ofCouncil and is either fined or goes up for a full

Science & Technology. That meeting was the cata-inquiry and may be suspended or lose his or her

lyst for the very first international symposium on

registration with the Council.

research integrity which took place in 2009 in

Here are some pictures of the reality of South

Portugal. From then, the Statement was born.

Africa that we live in. We have very, very high

Between 2009 and 2010, the Statement was being

levels of poverty. In Africa, most of our popula-

worked on, finalized, and launched in the Secondtions are vulnerable. We have little or no health-World Conference on Research Integrity in 2010 incare for our patients. There are failing or failed

Singapore. So, Japan has played quite a big role inhealth systems. There are low levels of literacy. You＊3International Covenant on Civil and Political Rights. 1966: “No one shall be subjected to torture or to cruel, inhumanor degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medicalor scientific experimentation”.
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臨床評価45 巻 3 号

2017

can see a classroom there filled with many stu-

comes to research? Itʼs the right to equality, so no

dents. How does one learn in a classroom like that?

vulnerable group should be subjected to research

Very little clean drinking water. The shacks arefor the value of beneficial few, those who can man-the types of dwellings that we have. In the far right,

age to afford the interventions proven useful by thethere is a child sitting in an open toilet. Where isresearch. There should be equitable distribution ofhuman dignity? These are the conditions in Africa

the risks and benefits of research throughout ourthat we as advocates for our patients have to fightcommunities. Our research participants need to beagainst. We have had transition and we have hadtreated in a dignified way. They have a right to life.

change, but there has not been adequate change for

They cannot be subjected to experimentation where

those that do not have. Here, we have huge con-they could die. We had the example of Professor

trast, vast disparities, no equality. At the same

Werner Bezwoda at my own medical school where

Cape Town, we have got Khayelitsha, so two dif-the right to life was possibly infringed. There is

ferent states of living a few kilometers away fromalso the right to privacy and the right of freedom

each other. Again, one type of classroom for learn-of belief and opinion. In other words, freedom ofing, another type of school for learning. You canreligion, if a research participant has a particular

see the disparities that we have. That is why it isviewpoint. For example, if they are going to do thisso important for us that are involved in protection-

research on sterilization or abortion, and it is

ism to ensure that our participants who come fromagainst their religious beliefs to be involved inthese communities are protected in research.

something like this, itʼs important to respect thatand not to force them to be part of the research

6．South African ethics andregulatory instruments:
Bill of Rights (Table 2)

project. Also access to information, the participants need to know what the participation entails
and what has happened to the data that they havegiven you on the research side. What are the results

In terms of Bill of Rights of our constitution,
when we look at Section 12, “Everyone has theof the research? How are the results going to benefit them at all?

right to bodily and psychological integrity, which

7．South African ethics andregulatory instruments:
National Health Act andNational Health Research
Ethics Council

includes the right ... not to be subjected to medicalor scientific experiments without their informed consent.” This is very similar wording to the International Covenant on Civil and Political Rights in the
country. In terms of South Africa, we have gone along way. The South African government has done
a lot in that many of us do have civil and political

In terms of our National Health Act, we have arights at the moment. I would not have been at thedefinition of health research. Any health research

University of the Witwatersrand Medical School ifthat falls under this definition must be reviewed

we had not had the transition. There has been a lot

and approved by a research ethics committee, which

done for us, but there hasnʼt been much done foris both registered and accredited by the Nationalsocioeconomic rights and that is a huge problem.

Health Research Ethics Council. Health research

What are some other applicable rights when it

is defined as any research which contributes to the− W24 −

Clin Eval 45（3）2017

Table 2South African instruments and guidelines for health researchBill of Rights of the Constitution of South Africa� 12(2)
Everyone has the right to bodily and psychological integrity, which includes the right ...
(c) not to be subjected to medical or scientific experiments without their informed consent.
� Some other applicable rights:
9 - Equality;
10 - Human dignity;
11 - Life;
14 - Privacy;
15 - Freedom of religion, belief and opinion;
32 - Access to information
National Health Act (No.61 of 2003)
� “health research” includes any research which contributes to the knowledge of:the biological, clinical, psychological, social processes
improved methods for provision of health services
human pathology
the causes of disease
the effects of environment on human bodythe development of new applications of pharmaceuticals, medicines, related substances
the development of new applications of health technology
National Health Research Ethics Council (NHA - sec 72(2))
� determine guidelines for the functioning of health research
� ethics committees,� register and audit health research ethics committees,� set norms and standards for conducting research on humans and animals, including norms andstandards for conducting clinical trials,
� adjudicate complaints about the functioning of the health research ethics committees,� refer to the relevant health professional councils any violations
� institute disciplinary actions,� advise the national department and provincial departments on any ethical issues concerning
research.
Clinical Trials (NHA - sec 71)
� “... a systematic study involving human subjects that aims to answer specific questions about thesafety or efficacy of a medicine or method of treatment.”
Health Research Ethics Committees (NHA)� 73(1) Institutions at which health research is conducted, to establish / have access to healthresearch ethics committee, registered with the NHREC.
� 73(2) A health research ethics committee must (a) review research proposals to ensure that research will promote health, contribute to theprevention of communicable or non-communicable diseases and or disability or result in cures(b) grant approval for research where proposals meet the ethical standards
Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa
Ethics in Health Research: Principles, Processes and Structures Ethical and Legal Guidelines for Biotechnology Research in South Africa (DST) - 2006
Health Professions Council of South Africa Ethical Guidelines− W25 −

臨床評価45 巻 3 号

2017

knowledge of biological, clinical, psychological, andany violations that are reported to the Nationalsocial processes; improved methods for provision

Health Research Ethics Council, these can also beof health services; human pathology; causes of dis-referred to the relevant health professional coun-ease; effects of environment on human body; devel-

cils. For example, if someone is registered with theopment of new applications of pharmaceuticals,

Health Professionals Council, they can be referred

medicines, related substances; and development offor disciplinary action. The National Healthnew applications of health technology. You can see

Research Ethics Council is also mandated to advise

it is very broad. It is not only drug development,

our national department of health and provincial

but it is a wide range. It includes social sciences

departments on any ethical issues concerning

type of research which has an implication on healthresearch. It has got quite a heavy mandate.

as well.

8．South African ethics andregulatory instruments:
clinical trials and HealthResearch Ethics Committee

In terms of our National Health Act, there is aneed for a National Health Research Ethics Council.
It is mandated by the Act. The National HealthResearch Ethics Council has already been established. There was an interim council followed by
the appointment of a full council. The council has

In terms of our National Health Act, a clinicaljust completed its third term. I served on two terms

trial is defined as “a systematic study involving

as deputy chair, the first and second term, together

human subjects that aims to answer specific ques-with being a member in the interim Research Ethics

tions about the safety or efficacy of a medicine orCouncil. I took a break in the third term. While I

method of treatment.” You can see, it is not

am sitting in Japan, I got a call from our Director

restricted to drug development, but any method ofGeneral of Health asking whether I would chair thetreatment, because you have quite a bit in terms of

new Council that is about to be established. I am

psychology trials where they try to check what thestill thinking about it because itʼs a lot of work, andbest method of treatment would be. In terms of theit will be quite a challenge. But the job of a National

Act, 73(1) states that institutions where research

Health Research Ethics Council as per the Act is

is conducted must either establish or have accessto determine guidelines for the functioning ofto health research ethics committee, which are reg-

health research ethics committees, to register andistered with the NHREC. That is clear-cut, blackaudit health research ethics committees - and they

and white, and we have been functioning in that way

have done so already, and currently, we have about

since 2004. In terms of what a research ethics com-

38 research ethics committees that have been reg-mittee must do, itʼs built into an act of parliament.

istered in the country and already audited - to set

This is what I meant when I said law can be influ-

norms and standards for conducting research on

enced by ethics. A research ethics committee must

humans and animals, including norms and standards

review research proposals to ensure that researchfor conducting clinical trials and that is why we dowill promote health, contribute to the prevention of

the GCP guidelines as well. Why animals? There iscommunicable or non-communicable diseases and or

lot of phase I research that is informed by animal

disability or result in cures. It tells you the type oftrials. We need some protection for the animals as

research as well that you are expected to look at,well, so this is why we have this. Should there be

and the research ethics committee grants approval− W26 −

Clin Eval 45（3）2017

for research where proposals meet the ethicalrevised guidelines, we were already ready. So, we

standards. I have not gone into the detail, butreview and approve biobanks. This is a highly spe-

Chapter 9 of the Act stipulates how informed con-cialized committee that looks at genomics andsent is to be obtained from the research partici-

genetics research and reviews and approves any

pants. It divides the informed consent to adults andresearch that involves a biobank.

minors. There are a number of stipulations which I

9．South African ethics andregulatory instruments:
other oversight committees

havenʼt gone into in the interest of time.
Here is my university. It has the oldest research
ethics committee in Africa established in 1966 verysoon after the first Declaration of Helsinki in 1964
and also as a response to the very first article by

We have other oversight bodies. A very impor-Beecher in early 1966 which exposed a whole lot oftant oversight body is the Medicines Control

ethics violations in research＊4. Beecher reviewed aCouncil. Itʼs a regulatory body and a government

number of trials that had been published in high-body that you would have. It applies standards asranking peer-reviewed scientific journals. He

laid down by an act of parliament, which is thelooked at 54, but the journal article only consid-

Medicines and Related Substances Act, which gov-

ered 22 trials because of space limitations as well.

erns the manufacture, distribution, sale and mar-Soon after that, the University of the Witwatersrandketing of medicine. The Medicines Control Council

established its research ethics committee and here

has got an arm called the Clinical Trials Committee.

we are. As a research ethics committee, we meet

When you have a clinical trial for drug develop-

once a month and review our research ethics trials

ment, the actual applications that the sponsor willvery much in line with our country level guidelines

send in parallel, one would be to the Medicines

and where our country level guidelines are defi-

Control Council who will look at the scientificcient, we use the Declaration of Helsinki to rise

aspects of the research, although they are now

above the country level guidelines.

looking at ethics as well, which is very good, andIn terms of Research Ethics Oversight, we havethe other body would be the research ethics com-gone beyond just the research, but also we look at

mittee. This is to avoid delays. When we look at thebiobanks. Our research ethics guidelines weretrials, if we do approve, we give conditional approv-

revised in 2015 to include biobanks. In terms of theals. The Research Ethics Committee will say,guidelines any new repositories or biobanks must

approved conditional to Medicines Control Council

have prior research ethics committee approval.

approval, or Medicines Control Council will say

Before that stipulation in 2013, the research ethics

approved conditional to Research Ethics Committee

committee at my university took OECD guide-approval. As soon as the two approvals come

＊5

lines

and started working on guidelines forbiobank approval. We established a Biobanks

through, they will get a final unconditional
approval.

Ethics Committee, and I chair that ethics committee. When the stipulation came through in our＊4＊5Beecher HK. Ethics and clinical research.
. 1966; 274(24): 1354-60.
OECD guidelines on human biobanks and genetic research databases. 2009.
− W27 −

臨床評価45 巻 3 号

2017

We go to the higher standard that is the Helsinki,

10．South African regulatory gaps
and current standards of carediscussion

which makes it a responsibility of sponsors,researchers, and host country governments to provide post-trial access of medications. The Helsinki
Declaration states that this information has to be

What are some of our gaps or problems in terms

disclosed during the informed consent process.

of regulations and ethics in terms of our latest

In terms of the Standard of Care, the Helsinki

2015 edition of our Department of Health Guidelines

states that testing is to be done against those offrom the National Health Research Ethics Council,

best proven interventions except where none exists＊6“Principles, Processes and Structures (PPS)”or where there is compelling scientific/method-(Table 3). I will say I wasnʼt part of that develop-

ological reason, one would employ a placebo in thement. It was when I stepped down. There are huge

control arm. Our research ethics guidelines at the

problems with the latest guidelines. I will just talkmoment looks at reimbursements for participationon three or four. It says right at its preamble thatin trials and says that we need to pay our research

it will not deal with clinical trials (CTs) and yet it

participants. This can be calculated against the

makes reference to CTs throughout the document.

current hourly rate for unskilled labor in market-

It does not take into account the National Healthplace of $1.5 per hour. We have concerns with that.

Act definition of CTs. When it comes to science

How do they work this out? They view labour law

type of research, these researchers are now con-

to work it out, but what they have done in the pro-fused what guidance documents to follow. It does

cess is commoditized and commercialized thenot mention anything about post-trial provisions or

researcher-participant relationship. We feel that it

about standards of care. All it says is for theseis important that research participants do not bear

aspects look at GCP guidelines, and our old GCP

the costs of being involved in research. They need＊7

guidelines is of 2006 . Because of issues of HIV,to be reimbursed for transport, meal, and out-of-

standards of care and post-trial provisions are spe-

pocket expenses. This needs to be calculated on ancific to HIV in that GCP document, but researchad-hoc basis with some guidance, but not stipula-

has moved in the interim, and this has not beention of this.
Currently

updated to take into consideration other aspects ofwork-in-progress,

ourMedicines

research, which are not HIV specific. What ourControl Council is also very worried about post-

research ethics committees do is we look now at thetrial access, especially with the problems we have

Declaration of Helsinki. Our guideline documents

in our guidelines. It has put together a document

are silent on post-trial provisions and standard ofthat is undergoing consultation at the moment.

care, and we say what does the Helsinki stipulates.

What this document says is very clearly the first＊6＊7

Department of Health, Republic of South Africa. Ethics in Health Research: Principles, Processes and Structures,
second edition. 2015. Available from: http://www.sun.ac.za/english/faculty/healthsciences/rdsd/Documents/Ethics/
DoH%202015%20Ethics%20in%20Health%20Research%20-%20Principles,%20Processes%20and%20Structures%20
2nd%20Ed.pdf
Department of Health, 2006. Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participantsin South Africa. Department of Health: Pretoria, South Africa. 2006. Available from: http://www.sun.ac.za/english/
faculty/healthsciences/rdsd/Documents/Ethics/DoH%20(2006)%20Guidelines%20for%20Good%20Practice%20in%20
Conduct%20of%20CTs.pdf− W28 −

Clin Eval 45（3）2017

Table 3

Regulatory gaps in PPS and MCC Document (guidelines)

Principles, Processes and Structures (PPS)
1.1.14 “This document does not deal with clinical trials which form the subject matter of the Department of
Healthʼs Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South
Africa, 2nd edition (2006) or its successor. However, this document includes guidance on insurance against
research-related bodily injury, including in clinical trials.”→ PPS does not deal with clinical trials, yet reference to CTs throughout document.
3.1.7 “Reimbursements and inducements for participantsParticipants should not have to incur expenses to take part in research. Consequently, researchers should
budget to reimburse expenses incurred by participants for travel, refreshments and also for inconvenience,
depending on the circumstances. If no travel or other expenses are incurred, reimbursement is not required
unless an inconvenience reimbursement is justifiable.
A fair rate of reimbursement should be calculated using the Time, Inconvenience and Expenses (TIE)
method to determine the cost to participants for time expended, inconvenience and refreshments associatedwith research participation. This method costs expenses at the current hourly rate for unskilled labour inthe market place ＊ , regardless of whether the participant is employed. See NHREC (2012) Payment of trial
participants in South Africa: ethical consideration for Research Ethics Committees.”＊ There is a footnote to indicate current hourly rate for unskilled labour in market place of R15-R25/ hour→ commodification & commercialising researcher-participant relationship.
MCC Document (Not finalized yet)
� In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as a beneficial
in the trial.
� This information must also be disclosed to participants during the informed consent process.
� The issue of post-trial access has become very important as many patients on clinical trials who benefit
from study treatment cannot access their treatment independently once the trial is completed.
� This is particularly important in patients with serious illnesses requiring lifesaving therapy or treatments providing significant symptom relief which is not available from other therapies.
� As participants in clinical trials have contributed significantly to the study sponsors in many ways,
there is an obligation on the part of the sponsor to continue to provide study medication at no cost to
all participants who are still benefiting.
MCC Document - Guidelines (Not finalized yet)
� All patients, private and public on medication on clinical trials must be provided with post trial accessof their medication without any cost to them as long as they benefit from the medication and where
withdrawal is likely to lead to deterioration of the individual health status as assessed by the investigator.
� Upfront submission of a roll-over trial protocol to provide post trial access is recommended.
� Care must be taken to prevent gaps in patient treatment between the original and roll-over protocols.
� Details of post-trial access should be included in the clinical trial form 1, and informed consent
document/patient information leaflet.
� Public sector patients cannot obtain many registered medicines due to cost and essential medicines list
constraints making it essential for such patients to receive therapy post-trial until the medication isavailable to public sector patients and not just until it is commercially available.

two bullet points are in line with the Helsinki whichvery important in our country, because many

allows for the provisions for post-trial access andpatients on clinical trials who benefit from study

disclosure during informed consent. It goes on fur-treatment are not able to access their treatment

ther to say that the issue of post-trial access is

independently once the trial is over. This is par-− W29 −

臨床評価45 巻 3 号

2017

ticularly important in patients with serious ill-patient treatment between the original trial and thenesses requiring life-saving therapy or treatmentsroll-over trials. There has got to be continuity ofproviding significant symptom relief, which is notgetting that intervention. They also say all theseavailable from the therapies. As participants indetails must be included in all the documents includ-

clinical trials have contributed significantly to theing the informed consent document. Then, anotherstudy sponsors in many ways, there is an ethicalstipulation it makes is that public sector patientsobligation on the part of the sponsor to continue tocannot obtain many registered medicines. It can

provide study medication at no cost to all partici-

have a drug and it gets registered, but it does notpants who are still benefiting. This is the real

become part of the standard of care, and this is

stringent route that we have gone in the country,

because of cost, itʼs too expensive, and we have an

but itʼs still under discussion waiting to be final-

essential medicines list, which will have certain

ized.

number of medications only. It is constrained in

The guidelines go further to state all patients,that the intervention that has been proven to bewhether private or public on medication, and theeffective may not be part of that essential medi-

situation in South Africa is we donʼt have anycines list at that stage, and therefore, it is essential

national health insurance or universal healthcare

for such patients in the public sector to receive theas yet. We are very much like the United States

therapy post-trial until the medication is available

where the rich can afford healthcare and poor go toin the public sector, not only until it is commer-

state health facilities. All patients must be pro-cially available. Because these are some of thevided with post trial access of their medication

things that the pharmaceutical industry has been

without any cost to them. As long as they are ben-trying to do and saying, we will provide post-trial

efiting from the medication, they must be provided,

access until it becomes commercially available, but

because if we are going to withdraw the treatment,

transactional cost wonʼt make it possible for those

this could lead to deterioration in their health. If

that cannot afford and so this would take care of all

the sponsor feels that rather than providing post-that.

trial access, have a phase IV post-marketing trial,

I must tell you that IPASA (Innovative Pharma-(the roll-over trial), then there is an expectation

ceuitical Association of South Africa) is not happy

that there must be an upfront submission at thewith this guideline, and so they are in the process

time of submitting the phase III, submit the phaseof preparing a very strong response against this.

IV of the roll-over trial. It is very important theyalso said that care must be taken to prevent gaps in− W30 −

Thank you very much for your attention.

Clin Eval 45（3）2017＜ Q&A ＞
Organizer (Chieko Kurihara) Thank you verymuch Professor Dhai, we learned so much fromSouth Africa, where peopleʼs history and social
background is much different from ours, and people
have developed basic structure of research ethics
and regulations, as well as principles and practice.
In Japan, the issues of drug promotion-oriented
clinical researches conducted by companies led toproposal of the Clinical Research Act. Companies
and researchers should rethink about their targetof research and development, learning from thesociety where people who need drug cannot accessto their essential drugs and where people havedeveloped such robust research ethics framework.
This is my motivation of proposal and planning of

Yuzo Nabeoka, one of the organizers of
this seminar, a member of ClinicalResearch Risk Management Study Group.

todayʼs seminar.
Organizer (Yuzo Nabeoka) Earthʼs atmosphereis becoming hot and communicative disease isincreasing. Some pharmaceutical companies pro-environmental impact it has together with thevide free license to research for this kind of dis-

impact on health has become a bioethical issue asease. It will be good opportunity for the Africanwell. It is very important for us in our institutions

people to develop evidence for this kind of disease,in Africa and throughout the globe to develop thesenot only for African people but also for the world.

public-private partnerships and work together

Dhai

The whole issue of climate change andbecause after all itʼs one common goal.

Chieko Kurihara, at the time of introductory presentation before Professor Dhaiʼs lecture, as amember of Clinical Research Risk Management Study Group.
− W31 −

臨床評価45 巻 3 号

2017

Professor Dhai, during the lecture.

Q

Is Medicines Control Council only involved

Committee ‒ Humanities/Non-Medical. They would
look at all research that does not fall under thein new drug review?
The Medicines Control Council in terms

definition of health research as per the Nationalof the Medicines and Related Substances Control

Health Act. Oftentimes, from the humanities disci-

Act will be involved in new drug review, or newplines, you will find that research is sent to us atapplications for a drug that is already registered

the medical school, because of the impact on health.

but not for that particular application. Itʼs justWe see a lot of social sciences and lot of psychol-

involved in that. The National Health Researchogy research. If there is maybe an engineering type

Ethics Council is involved in all types of health-of research, the Humanities Committee may look at

related research as per the definition of thethat to ensure that the science is good and there is

National Health Act.

going to be no adverse effect on humanity as well.

Dhai

Q

How many ethics committee do you have in

Committee.

your university?
Dhai

Then, we have got one Animal Research Ethics
Q

In my university in terms of research, wehave three research ethics committees. Itʼs a very

How often do the Ethics Committee forClinical Research meet?
Dhai

large university, 35,000 students, 5,000 staff mem-

We meet once a month. We have two arms

bers. We have one called Human Research Ethicsof that ethics committee. We have the industry

Committee ‒ Medical. This is the Committee that I

relatedserve on that has been established since 1966.

research. We have about 10 clinical trials a month

Later on in time in the early 2000s, there was thefrom the industry related research and we haveestablishment of the Human Research Ethics

between 80 and 90 research projects a month, which− W32 −

researchandtheinvestigator-driven

Clin Eval 45（3）2017

are new protocols, investigator-driven, and thistrial by each chair, but the trial is also sent out tocould be highly complex research funded by inter-the entire research ethics committee together withnational research organizations to simple retro-

two in depth reviewers from the committee. It takes

spective studies done by students. Thatʼs the entire

a long time. We are in the process of going elec-

80 or 90, sometimes going to a 100 just before antronic, so we are expected to review on a laptop.

exam period. What happens is we have two sepa-

But I wil say, no, you send me a paper copy, becauserate administrative bodies. One administrative body

I take it home and I wake up at 3 oʼclock in thethat looks at the clinical trials, because you needmorning to do my reviews. You donʼt get paid extra,

much more there. You need the serious adverse

because you are balancing your faculty commit-

events committee. You need to monitor the data

ments between the reviews and some of us are pas-

safety monitoring board reports and the monitor

sionate about what we do. We have been activists

reports etcetera. So, the admin is quite heavy

during the apartheid regime, and we continue being

there. The medical school formed a Section 21

activists, and this is my time of activism and con-company thatʼs not a non-profit organization com-

tribution to the needs of our country. It takes mepany, and it works on those clinical trials indepen-

sometimes 2 or 3 hours to review one thick inves-

dently of our research office. They charge fortigator brochure and then read it alongside ourreview of trials and that is why it can put so muchresearch ethics application, but then I am given two

into administration. There is a payment for amend-or three a month to look at, and then I am given

ments as well. If you send in a trial that is very

about six investigator-driven trials to look at. Whatbadly written and, that requires lots of amend-

we also do is we have a process of expedited review.

ments, and we say to you, you have got to rewrite

All retrospective studies will be reviewed by ourand resubmit, you pay again as if you are submit-

overall chair, Professor Cleaton-Jones, together

ting a brand new trial. Itʼs a high amount. They may

with one other. Usually the studentsʼ studies get

pay over a 10,000ZAR, which is 10,000ZAR,

done through an expedited route, so it does notdivided by seven, and you will be able to accountcome to us, and co-chairs will chair all the overall

for Yen.

ones, but again in our investigator-driven trials

But for our investigator trials, there is no pay-depending on the expertise and the background ofment at all, because this is covered by amongst oth-the individual, each investigator-driven research isers, fees and indirect costs from grants. We did notalso reviewed by two in-depth reviewers. In terms

have top-heavy support for our admin for ourof our guidelines, research ethics committee mem-investigator-driven trials and the range. With a lot

bers and researchers now have to have researchof advocacy to the university there has been quite

ethics training on a 3-year basis. Itʼs when you area change, and you will find that the Centre has

looking at it, not only do you ask in terms of theextended to include research ethics administration

science, but you also ask about the ethics, itʼs got

and from one admin person we are now into three.

to be from an informed perspective. When the audit

Q

How long does it take to review such num-

happens, then the National Health Research Ethics
Council looks at the research ethics committee

bers of clinical trials?
The process is the chairs, we have one

membership and looks to see whether all of us dochair and four co-chairs, and we divide the trials

have research ethics training and when was the lastamongst us so there is an in depth review of eachtraining. There is also a need for all of us to have

Dhai

− W33 −

臨床評価45 巻 3 号

2017

The left is Hiroshi Watanabe, Hamamatsu University School of Medicine/National Center
for Global Health and Medicine, an invited chairperson for Professor Dhaiʼs lecture.

GCP training which is different as well.
Q

Beecher exposed in his article in 1966. It was

Why did it take such a long time, 17 years,

because of this, but together with , the history ofafter Nuremberg Code was published until 1964

the World Medical Association, which first started

when Helsinki Declaration occurred?

off as a doctor grouping looking at clinical care, inDhai

I wish I could put up my other set ofthe late 1940s. Soon after the Nuremberg, earlyslides and take you through post-Nuremberg to

50s, they got together in Paris and felt that it was

Helsinki. The attitude from the west was that thedoctors that were involved in the Nazi war atroci-

Nuremberg Code was for a particular type ofties as well, and therefore, something had to beresearch. It was for a barbaric, autocratically run

done for research. It was an international declara-

country, which was Germany. It was not for people

tion. It took many years to get consensus between

from the west. There were attitudes against thethe different national medical associations. Itʼs

Nuremberg Code right from the outset. The othervery, very interesting, if you are going to the World

thing is researchers in the past were self-regulat-

Medical Association to look at how challenging thising, so they didnʼt feel the need to have someone towhole process was, but they eventually got there in

actually pressurize them into thinking ethics. They

1964.

felt they were managing well without this. However,

Chairman (Hiroshi Watanabe) Today in thewhat happened was between the Nuremberg Codefirst part of this seminar we discussed various

and the Helsinki, there were many atrocities in theissues of clinical research in Japan, and then in thewest that started surfacing. If you look at it, there

second part we learned from Professor Dhai about

is the Willowbrook Trials, hepatitis transmission

research ethics from international perspective. We

experimentation, where those that were mentally

appreciate that she appraised the contribution ofchallenged were institutionalized and were madeJapan in the process of development of “Singapore

the subject of research. In fact, there were aboutStatement on Research Integrity” initiated by

54 atrocities within the United States itself that

OECD. We learned much about the situation in− W34 −

Clin Eval 45（3）2017

South Africa, where people have struggled with

We wish to continue partnership with Professor

various social issues. We also learned that such

Dhai and the people who are engaged in medicine

experience of the people has led the development ofand medical ethics. Thank you very much.

robust thinking of research ethics and regulations.
Program of the seminor

Japanese new law on clinical research and human research ethics in South Africa
Development and ethical partnership toward global health
Sept 29, 2016, Thursday, 15:00-18:00
Venue: Mitsui Sumitomo Insurance, 14F 1402-03
Agenda:Japanese new law on clinical research is going to be issued to regulate clinical research to find safety or efficacy of medicinal
product. Especially the research of unauthorized products or research funded by a company is to be strictly regulated by thislaw, with additional requirement of prior submission to regulatory authority. The law will also install legal framework of ethics
committee. Furthermore, the law requires information of company’s research funding to be disclosed to public. Such regulatory
framework was proposed responding to recent affairs of scientific misconducts and retractions of papers from high-impact
factor journals, as the results of some of inappropriate relationship among academic researchers and companies. The new law is
expected to restore confidence of Japanese research and to contribute to healthcare improvement.
On the other hand, in South Africa, as the consequence of abolishment of apartheid and as the conquest of liberty of people,
they established in 1996 the Constitution to assure human dignity and to prohibit human experimentation without informed
consent. Their GCP regulation under pharmaceutical law covers clinical trial not limited to such trial aiming at product approval.
In recent world trend to promote international collaborative clinical development toward global health, we should finddesirable and ethical path of drug development for people most in need, and how funding should be designed. We would like to
provoke discussion as the first step toward ideal and ethical international partnership toward global health.
Lectures:Dr. Yuso Tomohira, Japan Pharmaceutical Industry Legal Affairs Association (JPILA)“Japanese new law on clinical research and future perspective” (in Japanese)
Prof. Ames Dhai, Steve Biko Centre for Bioethics, University of the Witwatersrand“Research regulation and bioethics in South Africa” (in English)
Chairpersons:Prof. Hiroshi Watanabe, Department of Clinical Pharmacology and Therapeutics,
Hamamatsu University School of Medicine/National Center for Global Health and Medicine
Dr. Takayoshi Tokuyasu, Japan Pharmaceutical Industry Legal Affairs Association (JPILA)(English-Japanese explanation (not direct interpretation): Chieko Kurihara)
Organized by: Clinical Research Risk Management Study Group
Co-organized by: Clinical Evaluation (Rinsho Hyoka Kankokai Inc.)
Supported by: Japan Pharmaceutical Industry Legal Affairs Association (JPILA);The Japanese Association of Pharmaceutical Medicine (JAPhMed)

Acknowledgment
The organizers of this seminar “Clinical Risk Management Study Group” would express our gratitude for the courtesyof Professor Kazutaka Shimoda, Chairman of the Department of Psychiatry, Dokkyo Medical University, as the Presidentof the 23rd- Annual Conference of the Japanese Society of Transcultural Psychiatry, held on October 1-2, 2016, to support
invitation of Professor Dhai to have another lecture in this Conference and permit to provide her lecture at this seminar.
We also appreciate Mitsui Sumitomo Insurance, Inter-risk Study Institute, and Rinsho Hyoka Kankokai (Clinical Evaluation)
to support the seminar in Tokyo.

(Published November 30, 2017)− W35 −