1. The document discusses the ethical issues involved in a proposed clinical trial of a new hip prosthesis implant. It outlines ethical concerns regarding animal studies, randomized controlled trials, and the selection of surgeons to implement the new implant. 2. Randomized controlled trials pose ethical challenges as they involve depriving some subjects of potentially beneficial treatment. Placebo effects and ensuring informed consent from subjects are also discussed. 3. Surgeon selection, competence, communication and avoiding harm to patients are important ethical principles to consider regarding the surgical procedures for the new hip implant.

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Case Study:
Proposed Clinical trial of New hip prosthesis

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Ethical Issues in Clinical Trial of Hip Implant
Clinical situations and decisions involves a combination factual concerns and ethical issues. Ethical
values are part of many decisions taken by clinical investigators. The decision comprise ethical
component and scientific component. According to the degree of simplicity, decision can be classified
as easy decision, difficult decision. Hence , it becomes important explain the reasons for ethical
aspects of clinical decision along with the scientific decision. Valid reasoning is important . Valid
reasoning comprises of providing definition, elucidating a concept, identifying similarities and
making distinction between two concepts. . Clinical trials investigate topics of clinical relevance, and
clinical relevance is intimately related to biological relevance. The ultimate goal in this field of
clinical research is to develop a new compound that is biologically active, acceptably safe, well
tolerated, and useful in the treatment of biological states that are, or may become, of clinical concern.
Individual variation also plays the important role in prospective controlled randomized study. Reason
for this, every subject do not responds to the same medical implant in the same way on account of
variation in sex, age, weight and ethnicity. For hip implant , it is necessary to explain ethical aspects
associated with surgery, implant design. Framework of ethics includes pre operative investigation of
implant, involvement of animal studies. Ethical issues arises due to surgical procedures for hip
implant, material selection and response to material. The incidence of hip fractures is increasing due
to the ageing population. The world-wide annual number is estimated to rise from 1,7 millions in
1990 to 6,3 millions in 2050 [5]. The mean cost of the initial hospitalisation for the fracture was $
9,534. The mean costs of the medical services during the one year follow-up period were $ 13,470 for
the hip fracture patients and $ 6,170 for a matched control group. This brings the importance of hip
surgery and associated surgical techniques for its proper application. Hip implant professionals
increasingly find themselves confronted with moral questions and ethical dilemmas. Clinical
investigators brings to situation that requires a choice between options that are or seem equally
unfavourable or mutually exclusive. Application of advances in medical and health care, science, and
technology, combined with the desire to enhance public health efforts, has led to the establishment of
a number of international ethical codes and guidelines. The statements of medical ethics require the
physician to do what is best for the patient and place the interests of patient before the interests of the
clinical investigators. The purpose of ethics associated with clinical trials is to protect and defend
human self respect and rights of patients. Adherence to ethical standards can significantly facilitate a
pleasant environment for both patients and medical workers. Medical ethics must be understood as an
applied professional concept that is separate from the concept of avoiding doing harm to patients.
Given case hip implant includes clinical trial conducted on two hundred patients with hip arthritis
suffering from non- inflammatory degenerative disease resulted in deformity and loss of function.
Hence it belongs to phase II of clinical research trials in which group of people suffering relevant
condition are involved in study to assess efficacy and adverse effects. Following ethical issues arises
from this hip implant clinical trial;
 Animal Experimentation
 Randomized control trial
 Surgeon selection to implement new hip implant
 Other ethical issues

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Ethical issues related to animal studies:
Difference in anatomy of Human and Rabbit. The physical and biological characteristics studied in
animals are not truly identical to human disease but are limited representations of them and in most
cases, animal studies do not assess the role of naturally occurring variation and its effects on
phenotypes. According to Animal ( Scientific Procedures ) Act, project licence for use of animals in
clinical trials will be granted only
 if the purpose of experiment cannot be achieved by any other reasonable and practicable
method.
 Minimum number of animals with the lowest degree of neurophysiology will be used
 Procedures will cause minimum distress or suffering to the animals.
 Anaesthetic will be used to avoid any interference with the objective of the experiment.
Further, the concept of sentience becomes especially important to elaborate the ethical issues related
animal experimentation. Sentience is the capacity to perceive or feel things. There is no verbal
evidence that animal posses sentience as human [7]. However, behavioural and physical similarities
between animal and human are limited. There should be checklist to determine whether a non-human
animal has the capacity for pain, stress and anxiety.
Fig.1.1. Ethical issues associated with animal experimentation
Animal studies can be allowed if there exists no substitute to study safety of new implant .If the goal
of biomedical experimentation is the understanding and treatment of human clinical concerns, then
the current special importance given to animal models, constructed under multiple artificial
conditions, should be replaced by more relevant alternatives and a return to an emphasis on clinical
research and public health attention to preventative measures [8]. Obvious and subtle differences
between humans and animals in terms of physiology, anatomy, and metabolism make it difficult to
apply data derived from animal studies to human conditions. For example, Acetaminophen is
poisonous to cats but is a therapeutic in humans; penicillin is toxic in guinea pigs but has been an
invaluable tool in human medicine. Furthermore , movement patterns in animal does not replicate to
human ; in the same manner range of motion in Rabbit hip joint is different than that for human .
Potential impact on the species and ecosystem must be considered.
Ethical issues associated with Randomised controlled trial:
In Randomized control trial , a group of subjects receives new hip implant under investigation and
others receive another implant with assured safety and performance. But in this case ethical question
Ethical
issues:
Animal
Studies
Sentience
Difference in
phenotype
Degree of
harm

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arise such that if the new hip implant is promising , we are keeping away subjects with established
implant from potential benefit and if established hip implant is known to be effective , we are
depriving subjects on the new implant of potential benefit.
Randomised controlled trials (RCT) are ethical only if the equipoise is exists that means knowing of
the best treatment. Clinical equipoise exists only if in comparing treatment A and B
 The clinical community agrees there is no convincing evidence that A is better or less toxic
than B
 There is no superior therapy C, unless good reason exists to reject C
Hence, doubt about which hip implant (either new or existing one) is superior justifies giving subjects
an equal chance to get either one; no one is being assigned to treatment low level of quality [9].
Information about which treatment the subject is receiving may be important in managing an adverse
event or a medical emergency, consistent with a concern about safety and health and prosperity of
subjects.
According to declaration of Helsinki 2000 Article 17 “Physicians should abstain from engaging in
research projects involving human subjects unless they are confident that the risks involved have been
adequately assessed and can be satisfactorily managed. Physicians should cease any investigation if
the risks are found to outweigh the potential benefits or if there is conclusive proof of positive and
beneficial results. Hence, it becomes important to take all precautions while performing clinical trials
on human [11].
Declaration of Helsinki 2000 Article 29“The benefits, risks, burdens and effectiveness of a new
method should be tested against those of the best current prophylactic, diagnostic, and therapeutic
methods. This does not exclude the use of placebo, or no treatment, in studies where no proven
prophylactic, diagnostic or therapeutic method exists.”
Randomization control trial results in placebo effect:
As the subjects will be randomized in to receive either new hip implant or the established hip implant
, this could be result in placebo effect. The placebo effect confronts investigators with two ethical
concepts that are to relieve their patients‟ suffering and to tell their patients the truth. In clinical trial,
when subjects are warned that they may receive a placebo, the placebo effect is reduced considerably.
Hence the key ethical issue is whether it is acceptable for doctors to prescribe a placebo to their
patients without telling them that it is one, so as to preserve its potential effectiveness. Some
physicians think that nothing justifies lying to a patient. In their view, using a placebo without telling
the patient may undermine the patient‟s trust and compromise the clinician - patient relationship.
Another example of the risks they cite is that to put a placebo in execution to a patient who is
suffering from depression, and then commits suicide because he or she has not received proper
treatment. In short, according to this position, which is often taken by the organizations that oversee
medical research, a study in which some patients receive nothing but a placebo is acceptable only if
the disease being treated is relatively benign and the drug being tested is designed to relieve its
symptoms or shorten its duration, or if the disease is a serious one for which there is not yet any
effective treatment [10].
The process of exposing subjects to risks in order to collect data introduces the possibility of
exploiting subjects for the benefit of future patients. Clinical research involves medical devices such
as hip implant about which limited information is available . Hence research comprise uncertainty

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about risk and benefits. The potential risks to individual subjects are minimized, the potential benefits
to individual subjects are enhanced, and the potential benefits to individual subjects and society are
proportionate to outweigh the risks. Hip replacements are one of the great successes of modern
medicine, but a combination of inadequate regulation and limited commercialism has caused actual
and potential harm for large numbers of patients .
Clinical research poses three types of net risks: absolute, relative, and indirect. Absolute net risks arise
when the risks of an procedure are not well justified by its potential clinical benefits. Clinical research
also poses absolute net risks when it offers a chance for clinical benefit which is not sufficient to
justify the risks faced by the subjects. Relative net risks arise when the risks of a research intervention
are justified by its potential clinical benefits, but the intervention's risk-benefit profile is less
favourable than the risk-benefit profile of one or more available alternatives. For in given hip implant,
risk- benefit profile of new implant may be less effective than as compared to existing hip implant.
This increases relative net risk in clinical trial. Investigators propose a randomized-controlled trial
to compare an new Hip implant against an expensive and somewhat more effective implant. Such
trials make sense when, in the absence of a direct comparison, it is unclear whether the increased
effectiveness of the more expensive implant justifies its costs. In this case, receipt of the cheaper
implant would be contrary to subjects' interest in comparison to receiving the more expensive implant
. The trial thus poses relative net risks to subjects. Indirect net risks arise when a research
intervention has a favourable risk-benefit profile, but the intervention diminishes the risk-benefit
profile of other interventions provided as part of or in parallel to the study. Individuals who recognize
that they face a risk may become frightened; they also may take costly or burdensome measures to
protect themselves .In order to understand the risk and benefits associated with research ;specific steps
to be followed. Identification of risk and within the context of good clinical practice, minimized by
using procedures which are consistent with sound research design and which do not unnecessarily
expose subjects to risk, and whenever appropriate, by using procedures already being performed on
the subjects for diagnostic or treatment purposes. Potential benefits focus on the benefits to individual
subjects, such as health improvements, because the benefits to society through the generation of
knowledge are assumed if the research is deemed to be of value and valid. The specification and
enhancement of potential benefits to individual subjects should consider only health-related potential
benefits derived from the research. Changes that could enhance potential benefits for individual
should determined by research team. If the potential benefits to subjects are proportional to the risks
they face, as generally found when evaluating phase 2 and 3 research which include large number
group of people, then the additional social benefits of the research, assured by the fulfilment of the
value and validity requirements, imply that the cumulative benefits of the research outweigh its risks.
Ethical issues associated with surgeon and surgical procedures:
In hip implant surgery , surgical complications have been an inevitable part of surgical practice. To
benefit patients and reduce the possibility of complications, surgeons must be competent and
knowledgeable. This encompasses both surgical technique and the ability to recognize the limits of
their professional competence. When new hip implant design is introduced , it is new for experienced
as well as newly recruited surgeon. Hence in such case the skills possessed by the surgeon are
compromised. A surgical complication is any undesirable, unintended, and direct result of surgery
affecting the patient [2]. It becomes important to focus on key ethical issues relating to surgical
complications. During the 1970s, Tom Beauchamp and James Childress introduced the highly
influential „„Four Principles‟‟ approach to medical ethics. Their conceptual framework relies on the

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application of four basic moral principles that, alone or in combination, help identify and resolve
ethical issues in clinical trials. 5. According to this , four principles of surgical ethics to followed .
Respect for autonomy: In health care, respect for autonomy requires doctors to respect a competent
patient‟s deliberated wishes and provide adequate information to support patients in their decision-
making.
Beneficence :This refers to the Hippocratic commitment to benefit patients by acting in their best
interests. Because the conception of what constitutes benefit (and harm) varies from person to person,
this principle usually requires respecting patient autonomy.
Nonmaleficence: This principle refers to the moral obligation not to cause harm to patients. Surgery,
with its necessary incision, could be seen to defy this principle. Indeed, all attempts to benefit patients,
whether through words, drugs, or procedures, carry risks of harm. Hence nonmaleficence is best
described as the obligation to avoid causing net harm to patients and should be considered in
conjunction with the principle of beneficence.
Justice :In health care ethics, the principle of justice primarily refers to the obligation to distribute
scarce health care resources fairly. It also includes the obligation to respect people‟s human rights and
to respect morally acceptable laws.
Ideally, the surgeon tailors the information to the needs and circumstances of the individual patient.
For example, a surgeon should be particularly thorough when discussing the possible complications of
replacing hip implant with a professional hand surgery with a sleight-of-hand magician. Regarding the
surgeon selection for new implant , more experienced surgeons are likely to have lower complication
rates than less experienced surgeons [3] . As per the principle of beneficence , the most experienced
surgeon, or at least the one with the best track record should allowed to perform the surgical
procedure. Skilled surgeon should be allotted for such surgery includes new hip implant who has
technical ability, recognition of the limits of one‟s competence, the ability to exercise good judgment,
adequate self-care and attention towards strict infection control measures, mechanical checks of
systems and equipment, quality improvement, and continuous professional development. This
contribute to reducing the occurrence of surgical complications [12]. Surgeons should communicate
appropriately not only to patients but also to the other members of the team, from the anesthetist to the
operating theatre assistant. During clinical trial, if not proper skilled surgeons are involved it arises
chances of fear, frustration, or anger can lead individuals to make errors in the surgical procedures.
Also, it is necessary for surgeon to explain the detailed surgical plan to all of his team members
otherwise improper communication such as unclear or insufficiently detailed instructions, can also
lead to misunderstandings and reductions in efficiency among the surgical team.

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Ensuring Informed consent from Subjects
In order to get valid consent from subjects it is important present information to all subjects in simple
way and inform them about their voluntary rights related to consent. Valid consent comprises
informed , competent and voluntary. This contributes to requirements of valid consent from subjects
involved in clinical trial.
Table.1.1 Important aspects of valid consent:
Informed consent Clinician discloses detailed information to the subject
Competent consent Consent subject with reasoning capacity
Voluntary consent Consent with no pressure on subject to make decision
Informed consent: True informed consent requires that patient does not agree but specifically
authorizes doctor to make decisions and choose plan for clinical trial. Informed consent includes the
need to respect persons and their autonomous decisions. Giving information to all subjects which
includes study design, experimental methodology , operation execution and statistical analysis.
Consent must be specific to treatment and procedure for which patient is assigned and rights delivered
to subjects . Clinical investigator should provide the available statistical data to the all subjects; for
example ten or twelve percent of all hip implant undergone early revision. Subjects undergoing trial
should be allowed to see evidences containing certain characteristics of material and design of
previous implant which have shown earlier failure rates. This consent can be obtained by giving
detailed information to all subjects related to clinical trial and allow them to ask queries in order to
clear their difficulties.
Competent consent: Subject giving consent should be capable of thinking. Clinical investigator can
assess the reasoning capability of subject . Ethical research requires subjects or their authorized
representatives to provide valid informed consent. For this , it is important to focus on potential
capacity of the subject to give informed consent. Clinical investigators should approach the potential
subjects who are at increased risk for lacking the capacity to give valid informed consent. More
frequently, it is found that individuals with no known loss of ability to think fail to give valid consent
only because they fail to understand essential elements of informed consent. Competent individuals
who do not understand the essential elements of informed consent, like incompetent individuals who
cannot understand these elements, are at increased risk for making decisions [13]. A person‟s
competence to make decision depends not only on the person but also on environment. According to
Health Care Consent Act section 4 (1) A person is capable of consenting to a treatment if the person is
able to: (a) “understand” the information that is relevant to making a decision about the treatment, and
(b) “appreciate” the reasonably foreseeable consequences of a decision or lack of decision [15]. To
appreciate the clinical treatment, he or she needs the ability to weigh the information in the ntext of
his or her life circumstances. In order to respect patient autonomy properly, clinical investigators
should try to enable patients to have competence to make decisions .If capacity of subject is
fluctuating means it depends on time of the day , it is necessary to discuss treatment when subject is at
its best.
There exists different ways to assess the capacity to consent to treatment. Clinical investigators can
check subjects status by following questionnaire such as
 Does the person understand the condition for which the specific treatment is being proposed?
 Is the person able to explain the nature of the treatment and understand relevant information?

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 Is the person aware of the possible outcomes of treatment, alternatives or lack of treatment?
 Are the person‟s expectations realistic?
 Is the person able to make a decision and communicate a choice?
 Is the person able to manipulate the information rationally?
Voluntary consent: Subject must not pressurised to give consent. tconsent must be freely given. The
patient must not be pressured into giving consent. This would include pressure from hospital staff, a
medical practitioner or family. Pressuring a patient into making a quick decision could be considered
as forced decision. Clinical investigator can allow subject to think on the clinical trial and should ask
to have discussion with any other clinician
Counselling subjects clinical trial:
Counselling subjects by clinical investigators to inform the advantages and purposes of clinical trials
help them to make valid decision relating to clinical trial.
Subjects need to understand a realistic assessment of benefits and risks when hip implant arthroplasty
is properly performed . Medical team can make attempt to explain how the benefits of such clinical
trial sufficiently outweighs the risks. All subjects informed about all important randomization and
suspension of knowledge about the treatment. The content of basic information depends on the
particular circumstances, the severity of the condition, and the procedure‟s risks [4]. On occasion,
during the process of obtaining consent, a surgeon confirms to the patient that he or she will be
performing the operation, even though parts of the operation are performed by a junior surgeon. This
makes the strong relation between surgeon and subject.
One difficulty relates to the degree of disclosure necessary to satisfy the consent conditions. It is
neither practical nor desirable to list all possible complications to a patient. Not only would such a
disclosure be time-consuming, but providing too much information can reduce rather than enhance a
patient‟s autonomy by confusing the patient [17].
Furthermore, excessive information about theoretical complications may frighten the patient into
refusing operations that may in reality be relatively low risk and highly beneficial. Clear
understanding of information requires a combination of good judgment and communicative ability.
Assessing subject about understanding of the information:
After explaining the detailed information about the treatment to all subjects, they should be given
sufficient time to understand and deliberate and consult with others . When subject shows a desire to
enrol, it is important for clinical investigator to formally assess the whether they understand the study
.Those who are confirmed with proper understanding of the treatment would be allowed to sign the
consent form. In order to all potential subjects‟ actual consent will require a scored and validated post
decision questionnaire (PDQ) that can be adapted to individual studies. For example questions
including basic of hip implant design, characteristics of materials used, risk associated with implant,
possible changes in quality of life could be helpful to assess whether the subject has adopted all
information regarding the clinical trial [14]. A post decision assessment would allow investigators to
focus any necessary educational interventions to the essential elements of informed consent that
individuals fail to understand the first time.

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Clinical investigator can assure subjects about the medical confidentiality. It can achieved through the
trusted subject – clinician relationship. Clinical investigators should make implied promise to subjects
that their information will be kept confidential.

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ABC Orthopaedic Health Care
Informed Consent Form provided to you consists of two parts:
1. Information Sheet
2. Certificate of Consent
You will be given a copy of the full Informed Consent Form after the post discussion questionnaire.
Information Sheet
Introduction
In this interesting field of orthopaedics our company is on the march of introducing new Hip implant
made of different material. Successful results obtained for this new material from laboratory tests
conducted on Rabbit model encouraged our team to implement into actual human trial. We are
inviting you to be major part of clinical trial conducted for this implant. You will be receiving the
detail information explaining the each aspects of implant procedure in information sheet provided in
simple terms. We request you to read all data provided and feel free to ask any queries related to it.
You are allowed to elect your consultant on your comfort basis to have open discussion and we
welcome your suggestions.
Purpose of the research
Osteoarthritis is common disorder characterized by degradation of bones. It is the most common cause
of joint damage requiring hip replacement. It usually presents as swelling, pain, inflammation, and
increasing loss of physical ability to move. These symptoms may occurred in adults over the age 45.
Damage to the hip joint from a fall, automobile accident, or workplace or athletic injury may trigger
the process of cartilage breakdown in the hip joint. If this continues , it may leads to loss of blood
supply to tissue. If not treated; in later stage it may affect other healthy parts of body and becomes
permanent loss of functionality. Present treatment for this disease includes surgical procedure which
fixes two bones together with screws and plates. Also there exists non-surgical treatments such as
medication to alleviate the pain. But these treatment limits the range of motion of joint bone and
person may have reduced length of bone as a result.
We want test the efficacy and safety of this new hip implant .New implant has been found to possess a
effective solution for bone degradation with no toxic , injurious response to body part in previous
study performed on Rabbit model. In present clinical trial we plan to see effect of this new implant on
patient with bone diseases.
Information obtained from these clinical trial will be beneficial to other patients suffering from same
problems.We have obtained permission from the Institutional Ethics Committee for conducting this
study.

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Participant selection
Our clinical team will recruit two hundred patients with non- inflammatory degenerative disease
suffering from pain, deformity and loss of function which are not recovered through medical
treatment. Patients from six different orthopedic centre will be allotted for clinical trial of new hip
implant. All patients are selected on basis of level of damage to hip joint.
Procedures and Protocol
We will divide two hundred patients into two groups to implement randomized procedure of cinical
trial. Each group will be asked to have pre-operative drug to modulate immune response against
foreign material to which they will be exposed.
During treatment one group will receive new hip implant and other will be provided with the existing
hip implant. Which hip implant group will be assigned to will be determined purely by chance; it is
called randomization. Randomization improves the scientific quality of research.
Database for all information will be maintained throughout the procedure and will be kept
confidential. All patients will be under consistent monitoring of health care professionals.
Implant design: Newly designed implant comprise two components. One is cemented ; which are
attached to existing bone with cement . Cement material acts as glue and attaches artificial joint to
bone. Uncemented part is attached using a porous coating that is designed to allow the bone to adhere
to the artificial joint. Material used have found no adverse effects during previous studies conducted
on Rabbit model which ensures its biocompatibility.
Following are the steps involved in surgical procedure.
1.Before the surgery , selected patient will undergo primary tests such as X-ray to get perfect status
of hip joint
2.Surgeon will observe patient for a period of two days during which he/she will be given medication.
3.Patient will be required to follow instructions for diet and any required precautions.
4.Patient will be given general anesthesia during complete surgery
5.After the surgery, patient will receive medicine to control pain and prevent blood loss.
6.Patient will have sessions of physical therapy to restore strength, mobility and fitness to continue
daily activities.
7.Clinical team will ask patients to visit for every six months for first two years of surgery.
8.During clinical visits ,clinician will assess the hip implant response with respect to pain, mobility
and ensures the patients satisfaction. Position of hip implant will be checked with the medical imaging
through X- ray and reported to the patient about their progress.
9.Health care professionals will prescribe some instructions such as weight management and level of
activities to be performed. Overall duration of clinical trial will last for ten years.

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Risks
As patient is subjected to new hip implant, he/she could be confronted with few risks associated with
the implant. Risks includes hip dislocation. Particles of implant material worn off joint surface and
absorbed by surrounding tissues and it could be result in swelling around the joint. Small chances of
blood clot in leg are possible. It also possible blood loss requiring transfusion with its low risk of
disease transmission. However, treatments are available for such risks arises during hip implant
surgery.
Benefits
Hip implant will assure you benefits which weigh more over the risks. Benefits of new hip implant
includes:
•Reduced bone degradation
•Reduced pain
•Restoration of function
•Improved quality of life
Reimbursements
Patients will receive reasonable amount of money for compensation for travel. This amount hass been
approved by ethics committee of institution.
Confidentiality
The medical research institute assure that all database including medical and personnel information
will be kept confidential. Clinical team members and health care professional are allowed to access
the information for clinical purposes. Information will not open to ordinary people at all. All access
will assigned to the surgeon and related clinical members.
Right to Refuse or Withdraw
The participation in this research is purely voluntary and patients have right to withdrawfrom this
study at any time during the course of the study. However, itis advisable that you talk to the research
team prior to stopping the treatment.Patient can continue their follow up sessions of associated
clinical outcome even after withdrawal from the study.
Who to Contact
If any further information and counseling needed related to this clinical trial , please contact on the
following contact details:
Principle Investigator: Dr. Adam .M
Department of Orthopedics Surgery
Edward Street, London, United Kingdom Fax:07405235648 Ph: 07423568974

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Questionnaire
The questionnaire includes ten questions, which belong to all aspects of the clinical trial. Please,
choose the correct answer and circle the corresponding letter.
1. The right to withdraw your valid consent is given to you at which time point of the clinical trial?
a) Before hip replacement surgery
b) Between hip replacement surgery and first follow-up appointment
c) Never
d) At any point you want
2. How long will the clinical trial last?
a) 3 years
b) 5 years
c) 10 years
d) 15 years
3. Which of the following medical conditions is excludedfrom the clinical trial?
a) Pain
b) Recent joint infection
c) Deformity
d) Loss of Function
4. . How frequently do participants need to attend follow-up appointments within the first two years?
a) 3 month
b) 6 month
c) 8 month
d) 12 month

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5. Which of the following medical conditions is included intothe clinical trial?
a) Metabolic Disorders
b) Recent high doses of therapeutic radiation
c) Tissue Disorders
d)Hip deformity
6. Who influenced your decision to participate in this clinical trial?
a) Family members
b) Nobody
c) Friends
d) Clinicians
7. Which of the following risks is not associated with hip implant procedures?
a) Early implant failure
b) Risk of infection
c) Toxicity
d)Vision disorders
8. Which of the following group of persons is not enabled to access personal data from participants of
this clinical trial?
a) Surgeons
b) Nurses
c) Administrative staff members
d) Public people
9. Which of the followingtreatments is not an alternative treatment to hip replacement surgeries?
a) Administration of medications
b) Blood platelet procedures

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c) Medication to restore hip function totally
d) Physical therapy to restore motion partially
10. Which property of the new hip implant distinguishes it from existing hip implant devices?
a) Material
b) Design
c) Target audience
d) Mode of fixation
11. Which of the following benefits is not associated with hip replacement procedures?
a) Reduced sensation of pain
b) Improvement in joint mobility
c) Improvement in quality of life
d) Total restoration of hip motion

16. 16
Certificate of Consent
This section can be written in the first person. It should include a few brief statements about the
research and be followed by a statement similar to the one in bold below. If the participant is illiterate
but gives oral consent, a witness must sign. A researcher or the person going over the informed
consent must sign each consent.
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask
questions about it and any questions that I have asked have been answered to my satisfaction. I
consent voluntarily to participate as a participant in this research and understand that I have the right
to withdraw from the research at any time without in any way affecting my medical care.
Name of Participant__________________
Signature of Participant ___________________
Date ___________________________
Day/month/year
If illiterate
A literate witness must sign (if possible, this person should be selected by the participant and should
have no connection to the research team).
I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that the individual has given consent
freely.
Print name of witness_____________________ AND Thumb print of participant
Signature of witness ______________________
Date ________________________
Day/month/year
I have accurately read or witnessed the accurate reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I confirm that the individual
has given consent freely.
Print Name of Researcher________________________
Signature of Researcher _________________________
Date ___________________________
Day/month/year

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