International Research Guidelines Research Articles

Arterial blood gas analysis of Inhabitants Healthy Adults at two levels of altitude in La Libertad ‐ Peru

Arterial blood gas is a procedure that allows knowing the internal environment of a person through an arterial puncture; however, its results are different according to altitude and barometric pressure. The objective was to evaluate the differences in arterial blood gas (AGA) values of healthy adult inhabitants in Florencia de Mora (FM) at 115 and in Huamachuco (H) at 3164 meters above sea level. Descriptive, cross-sectional and comparative study. 114 samples were analyzed, made up of two independent groups that met the selection criteria, of 57 inhabitants each, during the months of April and May 2019. A GPS altimeter was used to determine the altitude level. International research guidelines were met. Of the 114, 64 (56%) were women and 50 (44%) were men, with a mean age in FM of 34 and 21 years in H. The pH corrected to the temperature was 7.412 in FM and 7.428 in H (p <0.001). The following means were obtained: PO2 in FM was 110.7 and in H was 69.9 mmHg (p<0.001); pCO2 in FM was 36.0 and in H 32.2 mmHg (p<0.001); HCO3- in FM was 23.12 and in H it was 21.37 mmol/L (p<0.001); BE (B), in FM it was 1.3 and in H it was -2.2 mmol/L (p<0.001); SatO2 in FM was 95.2 and in H 94.2% (p <0.001); A-aDO2 in FM was 35.8 and in H 41.2 mmHg (p<0.001); THbc in FM of 14.6 g/dL and in H of 15.5 g/dL (p<0.001); lactate in FM of 2.1 and in H of 2.4 mmol/L (p<0.001). There are significant differences when comparing AGA values. The 5th and 95th percentiles of the AGA obtained in the total population and according to sex of H.

Assessing the quality of health research from an Indigenous perspective: the Aboriginal and Torres Strait Islander quality appraisal tool

BackgroundThe lack of attention to Indigenous epistemologies and, more broadly, Indigenous values in primary research, is mirrored in the standardised critical appraisal tools used to guide evidence-based practice and systematic reviews and meta-syntheses. These critical appraisal tools offer no guidance on how validity or contextual relevance should be assessed for Indigenous populations and cultural contexts. Failure to tailor the research questions, design, analysis, dissemination and knowledge translation to capture understandings that are specific to Indigenous peoples results in research of limited acceptability and benefit and potentially harms Indigenous peoples. A specific Aboriginal and Torres Strait Islander Quality Appraisal Tool is needed to address this gap.MethodThe Aboriginal and Torres Strait Islander Quality Appraisal Tool (QAT) was developed using a modified Nominal Group and Delphi Techniques and the tool’s validity, reliability, and feasibility were assessed over three stages of independent piloting. National and international research guidelines were used as points of reference. Piloting of the Aboriginal and Torres Strait Islander QAT with Aboriginal and Torres Strait Islander and non-Indigenous experts led to refinement of the tool.ResultsThe Aboriginal and Torres Strait Islander QAT consists of 14 questions that assess the quality of health research from an Aboriginal and Torres Strait Islander perspective. The questions encompass setting appropriate research questions; community engagement and consultation; research leadership and governance; community protocols; intellectual and cultural property rights; the collection and management of research material; Indigenous research paradigms; a strength-based approach to research; the translation of findings into policy and practice; benefits to participants and communities involved; and capacity strengthening and two-way learning. Outcomes from the assessment of the tool’s validity, reliability, and feasibility were overall positive.ConclusionThis is the first tool to appraise research quality from the perspective of Indigenous peoples. Through the uptake of the Aboriginal and Torres Strait Islander QAT we hope to improve the quality and transparency of research with Aboriginal and Torres Strait Islander peoples, with the potential for greater improvements in Aboriginal and Torres Strait Islander health and wellbeing.

REFOCUSING THE RESPONSIVENESS REQUIREMENT

Many guidelines for international research require that studies be responsive to host community health needs or health priorities. Although responsiveness possesses great intuitive and rhetorical appeal, existing conceptions are confusing and difficult to apply. Not only are there few examples of what research the responsiveness requirement permits and what it rejects, but its application can lead to contradictory results. Because of the practical difficulties in applying responsiveness and the danger that misapplying responsiveness could harm the interests of developing countries, we argue that responsiveness should be refocused in three ways: in terms of (1) who enforces it, (2) under what standard, and (3) in what cases. We conclude that responsiveness should be applied by host country officials at the policy level with the exercise of judgment when externally funded research threatens to displace scarce local resources.

The intensive care research coordinator position in Australia and New Zealand: Self-perception of professional development priorities and “best” and “worst” aspects of the position. A cross-sectional web-based study

Many intensive care units (ICU) research coordinators (RCs) work in isolation with limited access to professional development and peer support. (1) To map professional development priorities and "best" and "worst" aspects of the ICU RC role. (2) To compare results of "best" and "worst" aspects to a similar 2004 study. On-line study conducted from July 2009 to October 2009. Respondents scored 26 individual items related to professional development and described in free text "best" and "worst" aspects. 56 RCs participated. Maintaining high ethical standards for the research participant was ranked the highest priority. RCs had considerable interest but less confidence in completing own research. The "best" and "worst" aspects exposed three thematic clusters: work conditions; work environment; work role. Most often recorded notations were Work Conditions for "best" and work environment for "worst" aspects. RCs judge adherence to international research guidelines the most important pre-requisite for the position and wish involvement in research design and dissemination. With little change from 2004, inadequate peer support and unsatisfactory employment conditions constituted most of the "worst" aspects. Autonomy and working in the ICU team are the "best" aspects of the role in addition to the intellectual stimulation of research.

Insiders and outsiders: Levels of collaboration in research partnerships across resource divides.

With increasing recognition of the health and psychosocial challenges in developing countries, more research in these countries is essential. Research collaborations between wealthier and less wealthy countries are, however, complex. A partnership model has been proposed which emphasizes the importance of mutually respectful and beneficial relationships in international research. Using an example of a mother-infant intervention project in South Africa we describe the elements of an equitable partnership model of research. An issue which has been overlooked, however, is the reality of power differentials within the poorer countries themselves. We show that there are many intersecting levels of relationships within intercountry research, and suggest that power dynamics within countries deserves equal attention as international issues. Based on our experiences, we present some tentative guidelines for international research which builds long-term capacity and recognizes the importance of multiple levels of analysis and interaction.

MODULE THREE: VULNERABLE/SPECIAL PARTICIPANT POPULATIONS

ABSTRACT This module is designed to sensitise you to the special needs of participants who belong to populations that are more vulnerable than other participant populations. These populations typically include incompetent persons women who may or may not be pregnant, children, prisoners and refugees, impoverished people, and ethnic minorities. These and similar groups deserve special consideration for a number of important ethical and historical reasons, specifically those that surround the potential for exploitation, problems with informed consent, and concerns about respect for participant autonomy. This module introduces modus operandi that are based on national and international research guidelines for dealing with vulnerable/special participant populations, offering contextually-dependent advice and relevant ethical considerations/arguments for and against their involvement in scientific research endeavours.

Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation?

The maternal-fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki--the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow 'local conditions' to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta-ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects.