Medical Research Ethics

/
1990

2002
2006
2013
tahergamal@mans.edu.eg
01224112728
Dr.Taher Gamal - Prof. of ophthalmology - Mansoura medical school -Egypt

Independent Ethics Committee (IEC) =

=Research Ethics Committee (REC)

,Ethical Review Board (ERB) =
,Institutional Review Board (IRB) =
====================================================
A committee that has been formally designated
to Approve, Monitor, and Review biomedical
and behavioral research involving Humans
with the aim to protect rights and welfare
. of research subjects
Regulations have empowered committees to
, Approve
require Modifications
or Disapprove

History of research ethics:

During World War II from 1939 - 1945
A number of German doctors had been forced to carry out painful
experiments and often fatal performed on thousands of prisoners without
their consent. As development and testing of drugs and methods of
treatment of injuries
and illnesses and immunization vaccines for the prevention and treatment
of infectious diseases as Malaria and typhus, tuberculosis, typhoid, yellow
fever and inflammation of the liver contagious. Experiences of the
bone test effectiveness of real estate (Sulfanilamide). Prisoners were
subjected to mustard gas & phosgene

:
1945 -1939
.


.( ).

.
20 1945
1 .1946

12


-1 1947
-2 1964
-3 1979
-4
1949

1947 -1
Nuremberg Code of Ethics- 1
(Germany)
A set of research ethics principles
for human experimentation
set as a result of
Subsequent Nuremberg Trials
.at end of Second World War
Includes 10 Points

1964 -2
Declaration of Helsinki- 2
(Finland)
A set of ethical principles
human experimentation regarding
developed for medical community
. by World Medical Association (WMA)
It is widely regarded as the cornerstone
.research ethics document on human

1979 -3
Belmont Report- 3
) Belmont ,Maryland -USA(
A report created by
National commission for protection
of human subjects of biomedical
. and behavioral research

 -4

CIOMS Report- 4
Council for International Organizations of Medical Sciences

, International, Non-governmental
Non-profit Organization
Established Jointly By
WHO = World Health Organization
and
= UNESCO
United Nations Educational, Scientific & Cultural Organization

. in 1949

CIOMS Guidelines
Ethical justification & scientific validity of biomedical research . 1
involving human subjects
Ethical review committees. 2
Ethical review of externally sponsored research. 3
Individual informed consent. 4
: Obtaining informed consent. 5
Essential information for prospective research subjects
: Obtaining informed consent. 6
Obligations of sponsors and investigators
Inducement to participate in research. 7
Benefits and risks of study participation. 8
Special limitations on risk when research involves individuals. 9
. . . who are not capable of giving informed consent
Research in populations and communities with limited. 10
resources

CIOMS Guidelines
Choice of control in clinical trials. 11
Equitable distribution of burdens and benefits in selection of . 12
groups of subjects in research
Research involving vulnerable persons. 13
Research involving children. 14
Research involving individuals who by reason of mental or. 15
behavioral disorders are not capable of giving adequately
.informed consent
Women as research subjects. 16
Pregnant women as research subjects. 17
Safeguarding confidentiality. 18
Right of injured subjects to treatment and compensation . 19
Strengthening capacity for ethical and scientific review and. 20
biomedical research
Ethical obligation of external sponsors to provide health-care . 21
services cioms




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2
3
4
5
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650
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 12000
Webometric
Ranking of World Universities
1
358
911
1223
1493

Harvard
Cairo
Mansoura
Alexandria
Banha
10

1
2
8

 Research Ethics


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Research Ethics Logo

Lotus flower which represents

Purity and Perfection

"
Ethical considerations discussed
aim for Pure and Perfect research design


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(2


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82 2002


(1
(2 ) (
(3
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Ethical Considerations for Scientific Research
Truthfulness .1
Expertise 2
Safety 3
Trust 4
Consent 5
Withdrawal 6
Digital Recording 7
Feedback 8
False Hope / 9
Vulnerability 10
Exploitation 11
Anonymity 12
Animal Rights 13

1- (Truthfulness)
Must be movable search results honestly, and be honest with
borne, and not to supplement any missing information or
incomplete depending on what you think has happened, do not try
to enter data based on the results of theories, or other persons.
-1


.

2- Experience (Expertise)
Must be the work being done in the research appropriate to your level of
experience and your training, first prepare the initial work and then try to
understand the theory accurately before they apply the concepts or
procedures, and the person will be an expert in the field of search the
best assistant for you to choose the things that you should consider.

-2


.

3- (Safety)
Do not expose yourself to the risk of physical or moral, and take
precautions preparations when testing the whole, do not try to implement
search in environments that may be hazardous aspects of geological,
weather, social, or chemical, and that the safety of the target of the
search is also important, not make them feel ashamed or their exposure
to risk in the subject of research.

-3



.

4- (Trust)
Try to build a relationship of trust with those who work with them,
so you get greater cooperation and the results were more
Accurate, nor exploit the trust of the people who study them.
-4

.

5- (Informed Consent)
Always make sure you have the prior approval of
those who would like to work with them during the
period of the research, it should be aware that
individuals be schooled they are under study, for
example, if you need access to the property of others
you have to get their consent to it, failure to initial
planning and good for your search may oblige you to
search for other site and start again.
= -5

6- (Withdrawal)
People have the right to withdraw from the study at any time, always
remember that the participants are often volunteers and should be
treated with respect and that the time which spend for your search can
be used in the work of another, more profitable and useful to them, and
for this reason you should expect the withdrawal of some of the
participants, and better for you to begin your search largest possible
number of individuals to put them under study, so that you can continue
with a group large enough to make sure that your search results
meaningful.

-6





.

7- (Digital Recording)
Not logged votes or take photos or shoot video without the
consent of the target of the search, and get prior approval
before the start of any recording, do not try to use cameras or
tankers voice hidden for recording sounds and movements of
the target, and must be aware that the request for approval after
the imaging is unacceptable.

-7




.

8- (Feedback)
If you can give feedback to the target of the search, then do, you
may not be able to provide participants with the report in full, but
to give them a summary or some phrases and recommendations
may be important to have and meet the required purpose, and is
very important to offer them images and sounds or printed texts of
the statements that they said already before publishing, so it was
not the target of any bodily or mental harm because of your
interpretation of what they said or did, make sure you always take
prior approval before publishing.
-8

9- (False Hope)
Do not make the target think through questions that
things will change because of your search or project
conducted by, and do not give promises outside the
scope of your search or your salad or your position or
your influence.

/ -9

10- Vulnerability
))Taking into account feelings of others
Some may be more likely to target a feeling of
defeatism or surrender because of the age factor,
; disease or inability to understand or express
. you must take into account their feelings

-10

: ) (
) ( - )
( - - - -
.

11- Exploiting positions (Exploitation)

Not exploited for the benefit of your search
positions; not explain what you notice what
. others say or indirectly serve until the search

-11

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12- Confidential information (Anonymity)

You have to protect the identity of the target at all
times not give names or hints lead to the disclosure of
their true identity, and this can be achieved by
converting names to numbers or symbols with making
sure everything related to the destruction of the
. identity of the target after the end of the study

-12

13- (Animal Rights)

If your studies related to animals, there are ethical considerations
in this regard, you should be taken into account; since you have
treated the animal and sponsorship appropriate care by a sense
of the extent of the pain and discomfort he has, this is in line with
the requirements of the objectives of any study or research you
do, you should be looking for advice from teacher supervisor and
the person expert in the field of research conducted before
starting any study requires the presence of animals, whether in
. the laboratory or in the field of study

-13

Principles of Ethical Research

Research should be Designed, Reviewed .1

and Undertaken to ensure Integrity and Quality
-1

Research Staff and Subjects .2
must be informed fully about the Purpose , Methods and intended
possible Uses of research, What Participation in research entails
.and what Risks, if any, are involved

( ) .2

.

Confidentiality of information supplied by research .3

subjects & Anonymity of Respondents must be
respected

. 3

Research participants must participate in a .4
Voluntary Way, Free From Any Coercion

.4
.

Harm to research participants .5

must be avoided

.5
Independence of research must be clear, and .6
any Conflicts of Interest
or Partiality must be Explicit
.6


Unethical Deviations

1-Publishing the same paper in two

different journals without telling
editors
1

2-Submitting the same paper to
different journals without telling the
editors
2

3-Not informing a collaborator of your

intent to file
a Patent in order to make sure that you
are the sole inventor
3

4-Including a Colleague as an author on
a paper in return for a favor even
though the colleague did not make a
serious contribution to the paper
-4

5- Discussing with your colleagues

Confidential Data from a paper that you
are reviewing for a journal
5

6- Trimming Outliers from a data set
without discussing your reasons in
paper
6

7-Using an Inappropriate Statistical

Technique
in order to enhance significance of
research
7

8-Bypassing Peer Review Process and
announcing your results through a Press
Conference without giving peers adequate
information to review your work

9-Conducting a Review of the Literature that fails to

Acknowledge the contributions of other people in the
field or relevant prior work

9

10-Stretching the truth on a Grant Application
in order to convince reviewers that your
project will make a significant contribution to
the field
10

Stretching the truth on- 11

a Job Application or Curriculum Vitae
11

Giving the same research project to-12
Two Graduate Students
in order to see who can do it the
fastest
12

13- Overworking , Neglecting , or

Exploiting
Graduate or Post- Graduate
Students
-13

14-Failing to keep good research
records
-14

15-Failing to Maintain Research

Data
for a reasonable period of time
- 15
( 5)
16- Making Derogatory Comments and
Personal Attacks
in your review of author's submission

-16
( )

17 - Making Significant Deviations from the

research protocol approved by your
institution's Animal Care and Use Committee
or Institutional Review Board for Human
Subjects Research
without telling the Committee or the Board
- 17

18- Not reporting an Adverse Events

in a human research experiment
( )-18

Wasting animals in- 19

research
19
20- Exposing Students and Staff
to biological risks in violation of
your institution's Biosafety Rules
-20

21- Rejecting a manuscript for

publication without even reading
it
-21

22- Sabotaging someone's

work
-22

23- Stealing Supplies, Books, or

Data
-23

24- Rigging an experiment

so you know how it will
turn out

-24

25- Making Unauthorized Copies

of
Data , Papers , or Computer
Programs
-25

26- Deliberately Overestimating
the Clinical Significance of a New
Drug
in order to obtain economic
benefits

-26
) (

Research Publications

1.Honesty
Honesty and Integrity is a duty of each
Author , Expert-Reviewer and
Member of Journal Editorial Boards.
: -1

2.Review Process
Review process contributes to the Quality
Control and it is an essential step to ascertain
the standing and Originality of the research.
: -2

3.Ethical Standards Journal Editorials

presented some experience of
Unscrupulous activities.
: -3

4.Authorship
Who may claim a right to authorship ?
In which order should authors be
listed ?
: -4

:Author must have

, Contributed to design of study- 1
, Acquisition of data- 2
Analysis and interpretation- 3
Provided critical revision of article- 4
Provided final approval of version to publish - 5

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-1 Resident
-1Demonstrator
-1 Tutor
-2Lecturer
-3 Assistant Professor
-4 Professor

Composition of
Research Ethics Committee
=REC

Research Ethics Committee (REC)

Multidisciplinary, independent , body charged with
reviewing research involving human participants to
ensure that their dignity, rights and welfare are
protected.The independence of a REC is founded on its
membership, on strict rules regarding conflict of
interests, and on regular monitoring of and
.accountability for its decisions

( )

1) Research Ethics Committee

Must have at least Five members.
1- 5
2) Research Ethics Committee Members must have
Enough Experience, Expertise & Diversity
to make an informed decision on whether
Research is Ethical Informed Consent is Sufficient,
and Appropriate Safeguards Have Been Put In Place.

2-

3) If works with studies that include Vulnerable Populations, REC

should have members who are familiar with those groups. It is
common for REC to include Advocate for Prisoners when
considering research that involves them.

- 3
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4) Research Ethics Committee should include both
Men and Women, as long as they aren't chosen
specifically for their gender.

4-

5) Members of Research Ethics Committee

Must not be all of the same profession.

-5
6) Research Ethics Committee must
include at least One Scientist
and at least One Non-scientist.

-6

7) Research Ethics Committee must include at least

one person who is not affiliated with institution
commonly called :"Community Member"
- 7
) )
8) Research Ethics Committee may include
Consultants in their discussions to meet requirements
for expertise or diversity, but Only Actual REC Members
May Vote.
)( -8

6/6/2006
=Medical Schools
Medicine + Dentistry + Pharmacy + Nursing

Faculty of Medicine

. .

Faculty of
Dentistry

Faculty of
Pharmacy

Faculty of
Nursing

Faculty of Veterinary
Medicine

Faculty of Law


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()

:
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Researches
.Master Ship Thesis = M.S

.Philosophy Doctorate Thesis = Ph.D
Academic = Basic sciences
( )
.Medical Doctorate Thesis = M.D
Clinical (Medicine & Surgery)
( )
.Researches = R

.Research Projects = R.P
Sponsored From Pharmaceutical companies
Or / STDF = Science & Technology Development Fund

( )

Mansoura
Faculty of Medicine

10/5/2009
School of Medicine

MMREC



)(

Proposal of Research Protocol

Protocol Components
Title : without abbreviations
Capitalized as sentence : First letter only
:Authors
=Principal Investigator = PI
Resident or Visitor resident=
Demonstrator or Clinical Demonstrator=
Assistant Lecturer = Tutor=
: Supervisors
Professor - Assistant Professor - Lecturer
Introduction : Brief 1-2 pages
Aim of research : Problem + Solution
: Place of research
Hospital Department Laboratory Radiology unit
- Operating room - Outpatient
Total Duration MS = 1 Year. MD = 2 Years
Benefits
Possible Side effects

Protocol Components
: Study Design
Prospective / Retrospective / Prospective & Retrospective
Subjects = Patients + Volunteers (Control Group)
Total number : Each group > 10
Patients : Adults or Children -- Males or females
: Inclusion criteria
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: Exclusion criteria
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: Or Experimental Animals
; Type of animaWeight of animalSex : Male - FemaleAge-

Protocol Components
Methods of research
Non Invasive: Examination- Investigation- Radiological
Invasive
Endoscopy Catheters Blood sample - Biopsy=
-Clinical Examinations:1-2-3
-Clinical Investigations:1-2-3
-Laboratory Investigations:1-2-3
Medical Imaging Investigations ( X-ray CT MRI MRA US )
Treatment
Drugs ( By any route)
or Materials
Sutures + Dyes + Implants + Prosthesis + Nails=
Operations
Preoperative
Surgical Procedure
Postoperative

.Curriculum Vitae = C.V

Name:
:Birth date & place
Address:
Home phone:
mobile Phone:
:e-mail
:Academic Job
Resident Visitor Resident -Demonstrator Clinical Demonstrator
Tutor = Assistant Lecturer
:Scientific Degree
M.B., B.Ch = Bachelor of Medicine & Surgery
M.S. = Master Ship
M.D. = Medical Doctorate
Ph.D. = Philosophy Doctorate
:Title of Thesis
: Publications

Application Forms
Human Research

5+4+3+2+1

Invasive Techniques
Medical procedure Piercing skin
or Passing inside any body cavity using
Needle
or Scalpel
or Catheter
or Endoscope inside body
or Administration of any Drugs
or Administration of Medical Preparation

Non Invasive Techniques

Medical procedure without penetration of skin
:Or touching mucous membranes of body as
Measuring Pulse- 1
Visualization of Ear Drum- 2
Visualization of Nasal Mucosa- 3
Auscultation of Heart Beats- 4
Auscultation of Respiratory Sounds- 5
Measure of body Temperature- 6
Measuring Blood Pressure- 7
Audiometry- 8
Examination of Mouth- 9
Electro-Cardio- Graphy = ECG- 10
X-Ray Radiology- 11
Computerized Tomography = CT- 12
Magnetic Resonance Imaging = MRI- 13
Dressing of Wounds- 14
Swab of Eye Discharge- 15
Swab of Nasal Discharge- 16
Examination of Sputum- 17
Examination of Urine- 18
Examination of Stool- 19
Examination of Semen- 20
Examination of Menstrual Blood- 21
Examination of Discharge from Skin Ulcers & Wounds- 22

:Human Participants (or Subjects) Including

Living Human Beings( Patients + Volunteers)- 1
=Human Tissues- 2
) Biopsy or Fine Needle Aspiration Biopsy

Human beings who have recently died- 3

Cadavers ,Body Parts (Organs)
Embryos = until 8 weeks & Fetuses = > 8 weeks- 4
Human Data and Records (Paper or Computer)- 5
Bodily Fluids ------------------------------------------------- - 6

Invasive Body Fluids

Aqueous Humor
Vitreous Humor
Bile
Blood
Endolymph
Gastric Juice
Peritoneal Fluid
Pleural Fluid
Vaginal Secretion
Cerebro Spinal Fluid

Non Invasive Body

Fluids
Breast Milk
Earwax
Saliva
Sebum
Semen
Sweat
Tears
Vomit
Urine

Omar

Aly

Omar

Omar

Aly

Aly

Informed Consent Form

1- Name of Institution
2- Title of Project
3- Principal Investigator
4- Other Investigators
5- Participants Names
Purpose of Research- 6
Procedures- 7
Time Duration of Procedures and Study- 8
Discomforts and Risks- 9
Potential Benefits- 10
Statement of Confidentiality- 11
Costs for Participation- 12
Compensation for Participation- 13
Research Funding- 14
Voluntary Participation- 15
Contact Information for Questions or Concerns- 16

Application Forms
Experimental Animal Research
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Aly Anwar

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Phases of clinical research

Clinical Trial Phases
Pre- Clinical studies
In Vitro ( Laboratory Test Tube )
Electron microscopy- Microbiology
Chemical pathology -Parasitology-Virology
Clinical biochemistry-Toxicology -Immunology
In Vivo ( Animal ) Experiments

Pre-clinical studies
In Vivo = Animal Testing

)Experimental Animals(
Mice
Rats
Guinea pigs
Rabbits
Testing of drug in animals, to gather information
of
Efficacy, Toxicity & Pharmacokinetic

Clinical Trial Phases = Clinical Human Studies

Phase 0 - Phase I - Phase II A - Phase II B

Phase III - Phase IV

:
.

100 - 20

300 - 20

3000 - 300

= = =

Phase 0 study
Human Micro dosing Study=
Sub therapeutic doses of study drug
to a small number of subjects (10 to 15)
, Gives no data on safety or efficacy
: being by definition
A dose too low to cause any therapeutic effect
Primary goal
Pharmacodynamics
and Pharmacokinetics
Particularly
oral bioavailability
and half-life of the drug

Phase I trials
. First stage of testing in human subjects
Normally, a small (20-100) group
of healthy Volunteers will be selected
Primary goal
Testing of drug on healthy volunteers for
Dose-ranging
Either
Single Ascending Dose (SAD) studies
Or
Multiple Ascending Dose (MAD) studies

Single Ascending Dose = SAD

1-Small groups of subjects given a single dose of drug
while they are observed and tested for a period of time.
2- If they do not exhibit any adverse side effects, and
pharmacokinetic data is roughly in line with predicted
safe values,
3- Dose is increased, and a new group of subjects is
then given a higher dose.
4- This is continued until pre-calculated
pharmacokinetic safety levels are reached,
or intolerable side effects start showing up
(at which point drug is said to have reached
Maximum Tolerated Dose (MTD).

Multiple Ascending Dose = MAD

1- Studies are conducted to better understand
Pharmacokinetics & Pharmacodynamics of
multiple doses of drug.
2- In these studies, a group of patients receives
multiple low doses of drug,
while samples (of blood, and other fluids) are
collected at various time points and analyzed to
understand how drug is processed within
body.
3- The dose is subsequently increased for
further groups, up to a predetermined level.

Phase II Trial
Performed on larger groups ( 100 300 )
Primary goal
Testing of drug on patients to assess efficacy
and safety
Phase IIA Trial
To assess dosing requirements
). How Much Drug Should Be Given(
Phase IIB Trial
To study efficacy
How Well Drug Works At Prescribed Dose (s)(

Phase III
, Randomized , controlled
Multicenter trials
on large patient groups (10002000 )
depending upon
Disease / medical condition studied
Primary goal
Testing of drug on patients to assess
Efficacy
and Safety

Mansoura Medical Centers

Phase IV
Post Marketing Surveillance (PMS)
Practice of monitoring safety of
Pharmaceutical drug
or Medical device
after it has been released on market
and is an important part of science of
. Pharmaco vigilance
Post marketing surveillance can further
Refine, or Confirm or Deny , safety of a drug after it is
used in general population by large numbers of people
.who have a wide variety of medical conditions
Primary goal watching drug use in public

 82 2002


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