Improving Trend of Adhering to Ethical Measures in Iranian Research in Human Genetics: A Survey from 2005 to 2009; and the Road Ahead.

BACKGROUND: The overwhelming rate of progress in biotechnological research especially in human genetics, as well as the high levels of power these researches provide us to intervene in human lives, brings serious concerns on the ethical problems that may rise from these research endeavors. To address this critical issue in Iran, we conducted a study issuing publishing authors of studies in human genetics from Iran, between years 2005 to 2011. METHODS: We contacted 116 corresponding authors of articles issuing genetics research on human subjects, asking them that whether they have gotten either informed consent from their study subjects or ethical approval from their institutional ethics committee. RESULTS: Only 13% of the authors presented both documents; 52% had not gotten any of the documents; 19% of authors felt no need for getting the mentioned documents; 13% declared that they only gotten oral consent and 3% of authors did not remember whether they have gotten any documentation or not. CONCLUSION: The trend for informed consent taking was improving over time, from 5% in year 2006 to 24% in 2009. The result was not satisfactory but showed good trend towards improvement, recommending more serious follow up concerning ethical aspects of articles published in human genetics.

Informed consent for inclusion into clinical trials: a serious subject to note in the developing world.

INTRODUCTION: Informed consent is a critical issue especially in conducting clinical trials that expose human life to medical or surgical interventions. It necessitates a long and complex process through which the participant is presented with all potential favorable and non-favorable consequences upon getting enrolled in the study. REVIEW: The process of taking informed consent is well-understood in developed countries, with every effort taken to enhance and maintain the autonomy of patients and their right to make an informed choice of whether to participate or not. This may not be the case in the developing world.The information given to patients before the trial might not be properly developed and presented, an issue that can result in serious threat to the decision-making process. On the other hand, investigators should remember that enrolling people into a trial with no potential benefit for themselves cannot be considered ethical. In the current debate, we aim to address the issue of how respectfully and ethically clinical research trials can be done on human subjects and what we can do to enhance the practice in an ethical context. CONCLUSION: Development of a system through which we could warrant all rights of study participants in all cases around the world seems far from view. However, if we are in doubt about the ethics of a clinical trial, we can ask ourselves: "what would we do, if we were in the same position our patients are in now?"

Bone marrow involvement by lymphoproliferative disorders after renal transplantation: PTLD. Int. Survey.

CONTEXT: Renal graft recipients who develop post-transplant lymphoproliferative disorders (PTLD) that complicate bone marrow (BM). AIMS: To investigate features, predictors and prognosis of BM involvement by PTLD in renal transplant patients. SETTINGS AND DESIGN: A comprehensive search for the available data though PubMed and Google Scholar for reports of PTLD localization in BM in renal allograft recipients. MATERIALS AND METHODS: Data of 168 PTLD cases in renal transplant context who have developed bone marrow PTLD gathered from 18 studies and were pooled and analyzed. STATISTICAL ANALYSIS USED: Chi-square test, Student's t test and fissure's exact test were employed. RESULTS: Chi-square test showed that renal recipients with BM PTLD were significantly more likely to represent multi-organ disease (P<0.001), and disseminated PTLD (P<0.001). BM PTLD was also more frequently seen among pediatric renal recipients who had developed PTLD (P=0.016). PTLD, in BM PTLD renal recipients more significantly complicated liver (P=0.008), but less commonly affected skin (P=0.045). BM PTLD lesions were relatively more likely to be of monomorph phenomenon (P=0.06). CONCLUSIONS: Renal recipients with BM PTLD represent worse outcome and more unfavorable histopathological phenomenon than in other organ involvements. Moreover, a concomitant PTLD involvement site in liver was found which necessitates full hepatic evaluation for a potential complication by the disease in renal recipients whose BM is involved.

Hepatic involvement by lymphoproliferative disorders post liver transplantation: PTLD.Int. Survey.

BACKGROUND: It is speculated that different localizations of lymphoproliferative disorder after solid organ transplantation (PTLD) have different features and represent specific behavior as well as prognostic individualities. OBJECTIVES: To compare characteristics of hepatic PTLD (H-PTLD) with non-hepatic PTLD (NH-PTLD) in liver transplant recipients. MATERIALS AND METHODS: We searched PubMed and Google Scholar for all published reports of PTLD in liver recipients within their liver. Reported characteristics of H-PTLD and NH-PTLD were compared. RESULTS: A total of 21 studies from various countries were found. Overall, 169 liver recipients with PTLD were included in the analysis, of whom 83 (49%) had H-PTLD. Patients with H-PTLD were more likely to test positive for Epstein-Barr virus (EBV) (p < 0.0001), be older at the time of transplantation (p = 0.009), have a shorter time to PTLD development (80 vs. 41% early-onset PTLD; p < 0.001), and have bone marrow involvement (p = 0.03). Multivariate linear regression showed that H-PTLD and EBV positivity, but not age at transplant, were independently associated with time to PTLD development (p = 0.003, p < 0.0001, and p = 1.0, respectively). CONCLUSIONS: Liver transplant patients exhibiting early deterioration of graft function or other hepatic symptoms should, in addition to assessment for rejection, be evaluated for H-PTLD. In addition, all H-PTLD patients should be evaluated for bone marrow involvement, especially if they are EBV positive. Prospective studies with large patient populations are needed to confirm our results.

Radiotherapy is the best treatment method in post transplant lymphoproliferative disorders localizing in brain: a review of the literature.

BACKGROUND: Localization of post transplant lymphoproliferative disorders (PTLD) in the central nervous system (CNS) is a rare but life-threatening complication of transplantation. In the current study, we sought to aggregate data of PTLD in the series existing in the literatures on brain localization of PTLD and to concentrate on the management methods of the disease to compare and find the best treatment strategies in these patients. MATERIAL/METHODS: We conducted a thorough search of the literature to find treatment strategies employed to manage CNS involvement by PTLD. Data were pooled and standardized and reanalyzed. RESULTS: Overall 79 patients with CNS PTLD were entered into analysis. Patients undergone radiotherapy represented a significant superior outcome compared to that of patients who had not received radiotherapy (p<0.05). other treatment strategies had no significant impact on the survival (p>0.2 for all). One and five years survival rates for CNS involved PTLD patients who underwent radiotherapy were 71% and 37%, respectively; compared to 41% and 28%, respectively, for the control group. CONCLUSIONS: In the current study, we found that radiotherapy is an effective method of treatment for organ recipients who develop PTLD within central nervous system during their post transplant period. No beneficial effect for chemotherapy, interferon alfa, or a combination of them with radiotherapy was detected. We recommend using radiotherapy in all transplant patients developing CNS PTLD.