The document discusses the roles and responsibilities of medical research ethics committees, emphasizing their importance in safeguarding participant welfare and ensuring ethical standards in research. It highlights the necessity of truth-telling in healthcare, outlining both the benefits and challenges associated with honest communication with patients. Additionally, it addresses cultural concerns in medical research and the critical role of effective communication skills in enhancing patient care and healthcare teamwork.

1. MEDICAL
RESEARCH
PRESENTED BY
Miss. Pooja Deepak Bhandare
Assistant professor
Kandhar College of Pharmacy, Balanthwadi
18-03-2020
1

2. MEDICAL RESEARCH
Ethics committees
Truth telling
Importance of communication
Cultural concerns
Record keeping 2
18-03-2020

3. Ethics committees
• An institution’s Research Ethics Committee (REC) aims to safeguard
the welfare, dignity, and safety of the participants, ensures that
ethically approved research is conducted in line with the approved
protocol.
• The committee play key roles in promoting ethical practices in
biomedical research and in identifying solutions to ensure that the
interests of researchers.
• Functions of ethics committee-
Prior review of human research proposals, scrutinizing the ethical
standards for research conduct in legal framework
Observations to the investigators, to modify the research proposal to
meet the required ethical standards.
 Decision to approve or reject the research proposal.
 Monitoring the conduct of approved research proposals ,ensuring
that their conduct continues to conform to the approved protocol
3
18-03-2020

4.  Resolution, or referral for resolution, of complaints in relation to the conduct of
approved research projects or the conduct of the ethical review of those projects
 Premature termination and/or suspension of the con-duct of a research
proposal whenever it becomes evident that continuing conduct will expose
participants to greater levels of risk than those approved
 Accountability and quality assurance by reporting to the relevant institution
about its performance
Applications to the RECs follow the official review of the proposal, and one of the
following decisions may be sought:
1. Accept without changes
2. Accept with suggested changes
3. Recommend submission to committee of another region
4. Revise and resubmit (with changes)
5. Reject (with reasons)
4
18-03-2020

5. Truth telling-
• In context of healthcare, the duty of a health professional is to be
honest with their patients.
• The General Medical Council (GMC) documents Good Medical
Practice lists in its duties of a doctor, to be honest and open & act
with integrity.
• In studies of health care professional, one main reason for
withholding information from patient is that disclosure would cause
severe distress and this harm the patient.
18-03-2020
5

6. • Reasons for truth telling-
1. Autonomy-is an ethical principle that is widely recognized as
meaning self determination and self governance over ones action.
2. Physical benefit-T.T. about the patients diagnosis and prognosis
supports tolerance of treatment, tolerance of pain and better
outcome.
3. Psychological benefit- they become suspicious and this may result
in them becoming “socially isolated”.
4. Intrinsic good- Communicative conversations dictate that T.T. is a
universal expected rule.
18-03-2020
6

7. Reasons against truth telling-
1. Autonomy –if patient requests not to be told T.T can be forfeited.
2. Physical benefit-the presence or the true nature of medication was
denied because truthful disclosure will cause the patient to refuse to
take the drugs.
3. Psychological benefit-truth disclosure may cause distress,
depression, pain, anger and diminish hope.
18-03-2020
7

8. Cultural concern of medical research-
• Cultural concern is the critical study and analysis of a society
in relation to their cultural habits.
• Culture is a system of societal rules and behavior.
• Cultural competence in research is the ability of researchers
and research staff to provide high quality research that takes
into account the culture and diversity of population when
developing.
• The goal of culturally competent healthcare services is to
provide the highest quality of care to every patients ,
regardless of race, ethnicity ,cultural background or literacy.
18/03/20
8

9. Importance of communication skills in
medical research
• Communication skill:-
• Communication skill is the art of sharing information,
knowledge and ideas from one person to another
effectively. It is very helpful in all fields of life such as in
business, personal life and while applying a job.
18-03-2020
9

10. • Communication skills: The most important skill in the
medicine.
1. To get the most out of the consultation for the patient
foremost and for the doctor.
2. To plan of the communication using of a framework
3. To adopt your style of consulting to meet the needs of the
patient.
4. To handle difficult situations.
5. To have “rescue” plans when thing go wrong
6. To use time efficiently in the consultation.
7. To be able to assess and improve the consultation.
18-03-2020
10

11. Communicationisthemajorpartofthemedicine
• Good communication skill are the integral to the medical and
other health care practice
• Communication is important not only to professional patient
interaction but also the healthcare team
• The benefits of effective communication include good working
relationships and increase patient satisfaction.
• Effective communication may increase patient understanding
of treatment, improve compliance and, in some cases, leads to
improve health.
18-03-2020
11

12. Communicationskills partof your
management
• In order to deliver effective healthcare, doctor are expected to
communicate competently both orally and in writing with a
range of professionals, manager, patient, families and careers.
18-03-2020
12