Research Ethics, Governance, Oversight And Public Interest

Authors: Abu Bakar Suleiman, Joon-Wah Mak.

ABSTRACT

A better educated public has started to challenge the way decisions are made in medical research activities. Although Institutional and National Guidelines on Research are in place, there are fears that Institutional Review Boards (IRBs) and funding agencies are only fairly active in scientific and ethical reviews of research proposals but not on oversight of projects after their initiation. These issues are integral to good research governance and researchers and custodians of research ethics must ensure that public interest is not compromised.

Medical progress is based on research including human experimentation carried out according to guiding principles as enunciated in the Declaration of Helsinki (2000), but the quality of compliance with the Declaration is an important issue.

Better choice and appropriate training of members of IRBs to improve the quality of decision making and governance processes are urgently needed. Competency in evaluation of proposals requires not only the appropriate scientific knowledge but also access to relevant preclinical and other data. Unfortunately, the completeness and quality of such data may not be adequate.

Public interest demands that injury to trial subjects in clinical trials is minimized if not avoided completely. Unfortunately this is not always possible with trials where novel biological modes of action are tested. A more robust evaluation mechanism for project approval may minimize but not completely avoid injury to subjects; thus insurance cover to provide care and compensation to subjects must be compulsory.

The decision to approve or reject a project must be based on the balance of potential risks and benefits, taking into consideration justifiable distributive risks to target communities and populations. Economic considerations should never be the primary focus, especially when there are real concerns that the migration of early phase clinical trials including vaccine trials to developing countries is based on the perceived less stringent ethical requirements and oversight there.

Keywords: Declaration of Helsinki, ethics, Institutional Review Boards, research governance, research oversight.

Citation: IeJSME 2008: 2 (Suppl 1): S35-S38

DOI: https://doi.org/10.56026/imu.2.Suppl1.S35

Dilemma of Pregnant Ladies with Breast Cancer

Authors: Zainur Rashid Z, S Sulaiha S A, Lew K G, Nurhana S.

ABSTRACT

Gestational breast cancer (GBC) or pregnancy-associated breast cancer was defined as breast cancer diagnosed during pregnancy and within 1 year of delivery. Breast cancer is the second commonest cancer after cervical seen in pregnancy and lactation. Nevertheless, the incidence is low and accounts for approximately 1 in 3000 of pregnancies. A delay in diagnosis is common and 70% to 89% of patients with operable primary lesions already have positive axillary lymph nodes. Breast cancer identified during pregnancy can be extremely distressing for the mother despite it has similar course of disease and prognosis seen in non-pregnant women of the same age and stage of disease. Diagnostic and treatment options should be carefully decided to prevent further harm to the mother or any potential risk to the developing fetus.

Keywords: Breast cancer; Pregnancy; Diagnosis; Management.

Citation: IeJSME 2009: 3 (2): 3-7

DOI: https://doi.org/10.56026/imu.3.2.3

Medical Informatics For Medical Students And Medical Practitioners

Author: Jai MOHAN

ABSTRACT

The importance of incorporating medical (or health) informatics into the education of medical students and medical practitioners is being increasingly recognised. The advances in information and communication technology and the pervasion of the Internet into everyday life have important implications for healthcare services and medical education. Students and practitioners should learn to utilise biomedical information for problem solving and decision making based on evidence. The extensive introduction of electronic health information systems into hospitals and clinics and at the enterprise level in Malaysia and elsewhere is driving a demand for health professionals who have at least basic skills in and appreciation of the use of these technologies. The essential clinical informatics skills have been identified and should be incorporated into the undergraduate medical curriculum. It is recommended that these be introduced in stages and integrated into existing programmes rather than taught as a separate module. At the same time, medical schools should support the integration of e-learning in the educational process in view of the numerous potential benefits.

Keywords: Medical informatics, medical students, information & communication technology.

Citation: IeJSME 2010: 4 (1): 2-6

DOI: https://doi.org/10.56026/imu.4.1.2

Bacillus Thuringiensis Parasporal Proteins And Their Effect On Human Cancer Cells : An Overview

Author: Shin Yee Rebecca Wong

ABSTRACT

Bacillus thuringiensis is an anaerobic, spore forming bacterium that produces various toxic proteins both during its vegetative stage and sporulative stage. During its sporulative stage, it produces parasporal proteins that have long been used in the agriculture fields as insecticides. Although anticancer effect of Bacillus thuringiensis parasporal proteins can be dated back to the 1970s, research in this area went through a giant leap in the late 1990s, with much of the work being done in Japan. It has been found that some strains of non-insecticidal Bacillus thuringiensis produce parasporal proteins that exhibit anticancer activity. Due to their selectivity against human cancer cells but not normal cells, some of these proteins have been extensively studied for their anticancer effect and the mechanism of action by which these proteins kill cancer cells have also been widely explored in Japan and Malaysia with sporadic reports from other parts of the world. The abundance of these bacilli in nature and their selectivity have made them potential candidates for cancer treatment. However, literature on the in vivo effect of these proteins is scarce. Since different Bacillus thuringiensis strains produce different cytotoxic proteins with wide variations in their anticancer effect and mechanism of action, further investigations are necessary and their effect in vivo must be well established before they can be used in human subjects.

Keywords: Bacillus thuringiensis, Non-insecticidal, Non-haemolytic, Parasporal proteins, parasporin, Anticancer activity.

Citation: IeJSME 2010: 4(2): 3-9

DOI: https://doi.org/10.56026/imu.4.2.3

Severe Respiratory Sequelae Of H1N1: Clinical Features, Management And Outcome – A Review

Authors: Ismail A Hamid, Marzida Mansor, Gracie Siok Yan Ong, N M Kumar.

ABSTRACT

Since the outbreak of the novel influenza H1N1 in April 2009 in Mexico, more then half a million cases have been recorded with more then 6000 deaths. In contrast to seasonal flu, this virus appears to have a predilection for the young, obese and pregnant. It’s most important and almost fatal complication is Acute Respiratory Distress Syndrome (ARDS). Intensive care units (ICU) around the world have scrambled to upgrade various treatment modalities including high frequency oscillation ventilation, inotropes, antivirals and antibiotics in an effort to reduce the mortality arising out of this complication. More importantly, this complication appears reversible if adequate and early therapy is instituted. In particular, rescue therapies that allow the lung to rest appear to have brought success in some clinical settings. This article describes the experiences of seven centers that have used various modalities as rescue therapy in patients having Acute Respiratory Distress Syndrome (ARDS). The experiences in 13 patients at the University of Michigan, 58 in Mexico, 168 in Canada, 180 patients at Leicester UK, 194 in Australia and New Zealand and case reports from Hong Kong and Singapore are described.

Keywords: H1N1, ARDS, ventilation, ECMO.

Citation: IeJSME 2010: 4(2): 10-17

DOI: https://doi.org/10.56026/imu.4.2.10

Issues in Management of Acute Appendicitis in Pregnancy

Authors: Sivalingam Nalliah, Lionel Wijesuriya, Subramani Venugopal.

ABSTRACT

Acute appendicitis is an infrequent yet the commonest surgical emergency in pregnancy occurring in about 1:1500 pregnancies. The classical abdominal pain in the right lower quadrant of the abdomen is the only reliable clinical sign. Delay in diagnosis is attributed to presence of symptoms commonly seen in pregnancy like nausea and vomiting and difficulty in localizing abdominal pain due to displacement of the appendix with advancing gestation. Perforated appendix and generalized peritonitis impacts adversely on pregnancy contributing to increases in miscarriage, pre-term delivery, fetal loss and even maternal mortality. Imaging studies like abdominal ultrasonogram, helical computerized tomography and magnetic imaging have been utilized to complement clinical suspicion and decrease ‘negative appendectomies’ but robust data on their routine use is awaited. Although the laparoscopic approach is a useful diagnostic and therapeutic tool in early pregnancy, its use as the primary approach for appendicectomy in pregnancy requires further evaluation as increases in the incidence of fetal loss of 5.6% has been reported compared to 3.1% in open access surgery.

Keywords: Acute appendicitis in pregnancy, diagnosis, imaging, surgical approaches, perinatal outcome.

Citation: IeJSME 2011: 5 (1): 2-9

DOI: https://doi.org/10.56026/imu.5.1.2

Industry and Cosmetic Uses of Talc with their Implication on Health

Author: Davendralingam Sinniah

ABSTRACT

Talc’s softness, whiteness, lamellarity, inertness and affinity for organic chemicals make it valuable for industrial and domestic applications. The largest consumers are the paper and ceramic industry; only 5% is used as cosmetics. It is also used for preserving animal feed, and a carrier for drugs, insecticides, pesticides and chemicals. Talc was introduced as baby powder in 1894 and advertised aggressively worldwide. Widespread and indiscriminate use soon raised concerns about its implications for health. The IARC found that talc containing asbestiform fibres is carcinogenic to humans, but inadequate evidence to implicate talc not-containing asbestiform fibres. Pulmonary manifestations of talc inhalation include talcosis, talcosilicosis, and talcoasbestosis. Drug-users administering talc-adulterated oral medications intravenously develop pulmonary granulomas, fibrosis and irreversible pulmonary hypertension. Worldwide reports reveal talc inhalation is fatal to infants; it coats and dries mucus membranes, causes hemorrhage, edema, desquamation of bronchial epithelium, and clogs and compromises mucociliary clearance; larger quantities completely obstruct airways. Progressive diffuse pulmonary fibrosis is a recognized sequel to massive aspiration of baby powder. IARC has classified perineal use of talcum powder as a possible ovarian carcinogen, while a recent study has found that perineal talcum powder increases the risk of endometrial cancer among postmenopausal women. There is a need to raise public awareness of the serious risks associated with the use of talcum powder and for legislation to protect the health of the uninformed who represent the poorer segment of the community, and infants and young children. The dangers associated with cosmetic use of talc outweigh any possible benefits.

Keywords: Endometrial, ovarian cancer, pulmonary fibrosis, granuloma, pulmonary hypertension, talc inhalation.

Citation: IeJSME 2011: 5 (1): 10-16

DOI: https://doi.org/10.56026/imu.5.1.10

Why Metabonomics?

Author: Ivan K S Yap

ABSTRACT

Metabonomics can be used to quantitatively measure dynamic biochemical responses of living organisms to physiological or pathological stimuli. A range of analytical tools such as high-resolution nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry (MS) combined with multivariate statistical analysis can be employed to create comprehensive metabolic signatures of biological samples including urine, plasma, faecal water and tissue extracts. These metabolic signatures can reflect the physiological or pathological condition of the organism and indicate imbalances in the homeostatic regulation of tissues and extracellular fluids. This technology has been employed in a diverse range of application areas including investigation of disease mechanisms, diagnosis/prognosis of pathologies, nutritional interventions and drug toxicity. Metabolic profiling is becoming increasingly important in identifying biomarkers of disease progression and drug intervention, and can provide additional information to support or aid the interpretation of genomic and proteomic data. With the new generation of postgenomic technologies, the paradigm in many biological fields has shifted to either top down systems biology approaches, aiming to achieve a general understanding of the global and integrated response of an organism or to bottom up modelling of specific pathways and networks using a priori knowledge based on mining large bodies of literature. Whilst metabolic profiling lends itself to either approach, using it in an exploratory and hypothesis generating capacity clearly allows new mechanisms to be uncovered.

Keywords: Metabonomics; Metabolomics; gut microbiota; nuclear magnetic resonance spectroscopy; superorganism.

Citation: IeJSME 2011: 5(1): 17-26

DOI: https://doi.org/10.56026/imu.5.1.17

Mentoring in the clinical setting: Process, issues and challenges

Author: Sivalingam Nalliah

ABSTRACT

Mentoring in academic medicine requires the trained mentor to commit time, purpose and dedication for the personal and professional development of three categories of protégés or mentees i.e. medical students, the clinician-trainee and the clinical-educator. Conventionally, assigned mentors monitor the progress of the first two categories of personnel as their career pathway is clearly defined. On the other hand the clinician–educator in academic medicine could be a scientist or a career clinician expected to contribute to medical education activities and research. The clinician-educator has grown in complexity as he multitasks in providing clinical care, assists in delivering the medical curriculum and is expected to do research and publish. Although there is dearth of research in mentoring the clinician-educator, it is clear that mentored clinical-educators are more productive by way of scientific publications. Trained mentors are expected to identify the needs of the mentee with regards to the level of his career development and his aptitude to move up the academic ladder, successfully nurturing the maturation process. Processes of mentoring in the clinical setting, attributes of the successful mentor and facilitating the mentee in overcoming challenges in academic medicine are discussed.

Keywords: Mentor, clinician-educator, clinical setting.

Citation: IeJSME 2012 : 6(1) 4-10

DOI: https://doi.org/10.56026/imu.6.1.4

Mentorship in the research setting

Author: Joon-Wah Mak

ABSTRACT

The research mentorship programme is unique in that it is a planned journey undertaken by the mentor and mentee, preferably with well-defined milestones along the journey. During the journey, familiar landmarks will be pointed out by the mentor. In path-finding situations the experience and wisdom of the mentor and the critical appraisal of both mentor and mentee will contribute to learning from the encounter. In most mentor-mentee partnerships, a formal acceptance to the relationship, well-defined landmarks measuring progress in the journey, regular appraisal of the skills developed and acquired, and phased, judicious modification in the individual roles of that relationship will be required. Although there is no consensus on the elements of mentorship, there are some strategies which can contribute to the success of the relationship. Critical success factors include convergence of the research area within the broad expertise of the research mentor. The research mentor should have a proven research track record and is committed to serve in that official capacity. The research mentoring process is dynamic and characteristics of both mentor and mentee contribute to the robustness of that relationship. The mentee would have identified some attributes of the mentor that are desirable and is willing to work hard to achieve, build on, and improve upon. In the research setting endpoint measurements of success will be based on recognition of the research standing of the mentee, measurable outcomes such as number of papers in top tier journals, citation indices, etc. consultancies attracted as well as invitations to deliver plenaries in scientific conferences, patents filed and research findings translated and applied, and other measures of research productivity. In the pursuit of research excellence the mentee would have imbibed values of professionalism and ethics in research and would have constantly kept in mind that to be successful, the mentee would be able to excel beyond his mentor and that the next generation of researchers will seek mentorship from him.

Keywords: Research mentors, endpoint measurements, successful mentorship.

Citation: IeJSME 2012 : 6(1) 11-14

DOI: https://doi.org/10.56026/imu.6.1.11

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