Practical elements for oral communications

Conferences or oral communications are usual methods for the transmission of scientific knowledge in biomedical congresses, scientific meetings or academic work presentations (i.e. research works, Master or PhD thesis). There are some key elements for an excellent scientific presentation:

1. Appropriate presentation and order of the data

Before starting your scientific presentation, you need to study the most recent information on the issue that you are going to expose in order to select and prioritize the key points of the exposition. Nowadays, we have very potent bibliographic search tools that can help you to achieve this aim.

You have to keep in mind that the main goal of your presentation is to transmit a clear message.

2. Audiovisual material

Please, remember when preparing the slides of your presentation that "less is more" in order to get across a clear message to the audience:

3.Speaker's attitude

Public speaking is not always a question of talent. You can be a good speaker if you learn some skills for a successful presentation. A speaker must show confidence, clarity and conviction, since if you are not convinced of your words, the audience will conclude that your results are not convincing.  If the presentation is long, you should introduce stories, relaxing slides or some humour to entertain your audience. Speaking manners should always be polite and respectful.

The voice is also important: use a powerful voice, clearly pronounce the words and do not use "filler words" (i.e. um, ah, eh). Maintain the eye contact with your audience.

The body language conveys confidence: balance your body and use gestures supporting the key moments of the speech.

And never forget the courtesy: be grateful with the people that have invited you at the beginning of the presentation, and acknowledge the people that have contributed to your work at the end of the presentation.


A great presentation does not just happen. The excellence at public speaking just takes a lot of practice, determination and willingness to adopt helpful habits.

 

 

Some tips for preparing and delivering a good presentation:

• Do not give a speech about issues that you are not aware of.
• Adapt the complexity of the information regarding your objectives and the audience.
• Do not read the slides and avoid preparing too many slides.
• Explore the room and the audiovisual media before starting. 
• Use graphics of good quality. If you are using the images of a publication, please cite the corresponding reference.
• Avoid exaggerated animation.
• Do not use more than 10 words/line (big font size).
• Prepare readable tables: no more than 6 rows and 6 columns. If a complex table is required, the key information should be highlighted in bold colours.
• Use contrasting colours: this is OK, but this is not OK.
• Expose the slide at least 20 seconds.
• Highlight the important features of the slide.
• "Take home message": What is the main information of your presentation?  

Do you know what type of cells are and what type of staining has been used in the image of the HEAD of the BLOG? And do you know what type of mouse is the one of the PROFILE of the BLOG?

ANSWER FOR THE PICTURE OF THE HEAD OF THE BLOG: The image corresponds to differentiated adipocytes obtained from stromal cells of the murine subcutaneous adipose tissue and stained with Oil Red O, a lysochrome dye used for staining lipids in red. This image was captured by Beatriz Ramírez, Technician of the Metabolic Research Laboratory, key member of our group involved in obesity research. Beatriz entitled her photography "Frutos rojos" and this work was presented at the National Science Photography Competition FOTCIENCIA07.

ANSWER FOR THE PICTURE OF THE PROFILE OF THE BLOG: this photography entitled "Super ratón" was captured by Dr. Sara Becerril, another member of the Metabolic Research Laboratory. The image illustrates a mouse simultaneously lacking the genes encoding leptin and inducible nitric oxide synthase obtained during her PhD in order to study the effects of the absence of both genes on body weight, food intake and metabolism. This picture was selected in the category "MACRO" of FOTCIENCIA07 for the itinerary exhibition and inclusion in the catalogue of the competition.

During the competition of FOTCIENCIA07, a picture captured by Dr. Amaia Rodríguez, entitled "El planeta Adipocito", was also selected for the exhibition and inclusion in the catalogue of the competition in the category MICRO of FOTCIENCIA07. This image captured with an optical microscope shows the adipocytes obtained from an obese patient. The round morphology as well as the varying adipocyte size ranging from 10 to 300 micras that depends on the triglycerides accumulated in the unilocular lipid droplet of the fat cells, can be clearly observed.

Another photography obtained by Dr. Sara Becerril and Beatriz Ramírez, entitled "Cambio climático" was selected in the "MACRO" category of FOTCIENCIA10. This special picture was captured with a termographic camera, a device that forms a thermal image using infrared radiation. In this photography you  can observed five recipients containing elements with very different temperatures: dry ice (-80 ºC), ice (0 ºC), air (20 ºC), water (25 ºC) and boiling water (100 ºC).

As you can see, researchers can also be great artists!!!

The Fundación Española para la Ciencia y la Tecnología (FECYT) and the Consejo Superior de Investigaciones Científicas (CSIC) have recently opened the National Science Photography Competition FOTCIENCIA12. We encourage you to send your macroscopic or microscopic pictures!!

Scientific Rigor

Any scientific study should follow the steps of the scientific method. Experimental data should be collected methodically, systematically, randomly, ethically and with minimum bias. The scientific community does research following a series of principles including integrity, objectivity and honesty, which constitute what is known as scientific rigor. Nowadays, a scientific finding is published after being evaluated by other researchers, in what is known as peer review. However, due to work and academic pressure researchers sometimes proceed inappropriately in what is known as scientific misconduct. There are several actions that can be considered scientific misconduct, among which are the falsification or fabrication of data, lack of ethics or plagiarism. The latter is described in the video shown below.

There are different methods to detect this kind of behaviour. To this end, the scientific community has created entities like the Office of Research Integrity, which ensures the integrity of the scientific production in the United States, trying to detect cases of scientific misconduct.

Practical session 2 - Group 2

BODY COMPOSITION WORKSHOP

Obesity is a public health problem due to its impact on morbidity and mortality, the reduction of quality of life and the health care costs. Data from the ENRICA study published in 2012 indicate that the prevalence of obesity in the adult population in Spain is 22.9% (24.4% in men and 21.4% in women). According to the World Health Organization (WHO), in 2008 approximately 1.5 billion of adults (ages 20 or +) worldwide were overweight with 500 million of them being obese:

An accurate and precise classification of overweight and obesity is required, since the consequences of overweight and obesity are more than mere aesthetic problems due to their high impact on health. Normal weight, overweight and obesity can be defined by the body mass index (BMI) and by the percentage of body fat.

Body mass index

Obesity is defined as an excess of adiposity that presents a risk to health. BMI is used in the clinical practice to evaluate the ponderal categories of the patients. The BMI (kg/m2) is calculated as a person's weight (kg) divided by the square of his/her height in metres (m). The WHO Expert Committee proposed the following BMI cutoff values for the classification of adult ponderal categories:

BMI is the most frequently used diagnostic tool for the classification of obesity, because it is an easy and reproducible measurement. In spite of its wide use for the assessment of overweight and obesity, BMI is not an accurate measurement of body fat; for example, individuals of high muscle mass will exhibit higher BMI and older adults will tend to have more body fat than younger adults for a same BMI due to skeletal muscle mass loss.

Body fat percentage

Overweight and obesity can be also assessed by using the percentage of body fat (i.e. total fat mass divided by total body mass). There is a sexual dimorphism in the percentage of body fat, with women generally having a higher percentage of body fat than men because of gender-specific fat depots in mammary glands and the gluteo-femoral region. A healthy range of body fat for women is 20-30%, whereas for men it is 10-20%. Gender-specific cutoff points for the classification of ponderal categories according to the percentage of body fat are shown below:

Practical exercise

Mary is a 25-year-old woman that practices sport daily with a BMI=26 kg/m2 and a percentage of body fat of 21%, and John is a 31-year-old man that works in an office, with a sedentary life and a BMI=26 kg/m2 and a percentage of body fat of 26%. What is their ponderal category?












Response: According to their BMI, Mary and John should be classified as overweight; however, according to their percentage of body fat (a better surrogate measurement of adiposity), Mary would be classified as normal weight, whereas John would be classified as obese. 

1. You will need to know the cutoff values for the classification of an individual as normal weight, overweight or obese according to the BMI and the percentage of body fat. There are gender-specific differences for the percentage of body fat due to the higher accumulation of fat in the mammary glands and gluteo-femoral region in women.
2. Several methods for the evaluation of body composition can be used, such as plicometry, electric bioimpedance, hydrodensitometry, air displacement plethysmography (Bod-Pod), dual energy X-ray absorptiometry (DEXA), magnetic resonance imaging and echography, among others.
3. Visceral or android obesity is associated with higher cardiovascular risk, metabolic alterations and an increase in morbi-mortality compared with subcutaneous or gynoid obesity. An easy way for the evaluation of visceral obesity in the clinical practice is the measurement of the waist circumference (cm) or the waist-to-hip ratio (WHR). You will need to know the gender-specific cutoff points of waist circumference and WHR associated with increased and substantially increased cardiometabolic risk.

PHYSICAL ACTIVITY WORKSHOP

Physical activity is defined as any body movement produced by skeletal muscles that requires energy expenditure. Although physical inactivity has been identified as the fourth risk factor for global mortality, increasing levels of physical inactivity are seen worldwide. Furthermore, sedentarism is estimated to be an important cause for the development of different types of cancers, diabetes and cardiovascular diseases. In this sense, regular and adequate levels of physical activity help to maintain a healthy body as well as to be more likely to maintain its weight.

The term physical activity should not be mistaken with exercise. Exercise is a subcategory of physical activity that is planned, structured and repetitive. Physical activity includes sports, exercise and other activities such as playing, walking, gardening, briskly pushing a baby stroller, climbing the stairs, and dancing.

 

There are some types of physical activity especially beneficial: 

1. Aerobic activities make your heart beat faster. Aerobic activities can be moderate or vigorous in their intensity.
2. Muscle-strengthening activities make your muscles stronger. These include activities like push-ups and lifting weights.
3. Bone-strengthening activities promotes bone growth and strength. These activities, like jumping, are especially important for children.
4. Balance and stretching activities enhance physical stability and flexibility. Examples are dancing, yoga or martial arts.

1. Total energy expenditure is the energy required by the organism daily and it is determined by the sum of several components: basal metabolism rate, diet-induced thermogenesis and physical activity, among others.

 

2. Physical activity represents the thermic effect of any body movement produced by skeletal muscles that requires energy expenditure. A great variability inter- and intra-individual is shown. In active individuals, the energy required for physical activity corresponds to one to two times that of the basal energy expenditure while in sedentary individuals it can represent less than half.

3. Sedentarism or physical inactivity comes up as the disease of the modern society, being identified as the fourth leading risk factor for global mortality. Sedentarism substantially increases the probability of developing obesity, cardiovascular diseases, diabetes or certain cancers.

4. Sedentarism has been positively correlated with chronic low-grade inflammation associated with obesity.

5. Different dimensions are used to describe physical activity:

• Frequency: sessions or days per week.
• Intensity: amount of effort required for the activity: low, moderate or vigorous.
• Duration: length of session or accumulated length of physical activity during a week.
• Type: other info about the nature of the activity.

6. American Heart Association recommendations for healthy adults aged 18 to 65 years:

• At least 30 minutes of moderate-intensity aerobic activity at least 5 days per week for a total of 150 minutes

      OR

• At least 25 minutes of vigorous aerobic activity at least 3 days per week for a total of 75 minutes; or a combination of the two

      AND

• Moderate to high intensity muscle-strengthening activity at least 2 or more days per week for additional health benefits.

7. The Metabolic Equivalent of Task (MET) corresponds to a physiological measure expressing the energy cost of physical activities. MET is defined as the amount of oxygen consumed while sitting at rest and is equal to 3,5 ml O2 per kg body weight per minute.

8. Two principal methods of assessing physical activity levels are described:

• Subjective methods, depending on our own perception. They are predominantly used for measurements in populations, e.g., questionnaires of physical activity, diaries, logs or recall surveys.

• The objective methods often rely on solid data or observations. These methods are predominantly used for measurements in individuals, e.g., pedometers, heart-rate telemeters, accelerometers, electronic motion sensors, calorimetry, doubly labelled water as well as direct observation.

What do the sedentarism and hibernation have in common?

Basal metabolic rate consists in the amount of energy expended daily by humans and other animals at rest. It corresponds to the minimal quantity of energy required to maintain vital physiological functions such as corporal temperature, respiration, circulation or the functioning of different organs such as liver, kidneys or brain.

Basal metabolic rate is lower in sedentary lifestyle people compared to that of active individuals. In the same way, under hibernation conditions metabolic activity declines precipitously to roughly 5% of the non-hibernating basal metabolic rate.

Bibliographic search strategies

Users of bibliography databases retrieve articles, books and documents that are scientifically relevant to the investigation project or health problem they are trying to solve. In this sense, before you search for any information, you should first develop a search strategy and think about the concepts that form the basic issues of your topic and about the keywords you will use. Precision, specificity, efficacy and accuracy are key in a search strategy. 

The National Library of Medicine (NLM) and Web of Science are important research platforms that collect scientific publication references from different knowledge areas. Free worldwide internet access to the National Library of Medicine’s Medline in early 1997 was followed by a 300-fold increase in searches (from 163,000 searches per month in 1997 to 51.5 million searches per month in 2004) being directly used by clinicians, students, and the general public.

It is important to take into consideration the differences between references and bibliography:
- References allude to articles cited; they only include the specific citations you have listed in your article.
- Bibliography is the articles, books or reviews consulted. The whole material you have read to prepare your article.

What’s a Boolean?
Boolean logic takes its name from the British mathematician George Boole (1815-1864). The principle of Boolean logic lets you organize concepts together in sets. When searching databases, keywords are controlled by the use of operators OR, AND, and NOT, linking words or phrases for more precise searches.
AND: Narrows a search because all terms must be present in each hit.
OR: Widens a search because each hit will contain either term.
NOT: Narrows a search by excluding records containing specified words.

Find below a brief tutorial for using NCBI databases.
 

1. Steps in a bibliographic search strategy:

• Formulate the appropriate question
•  Select the suitable database to answer the question
•  Guarantee the efficacy and accuracy.

2. Efficacy: skill to find all the relevant items in a database. Accuracy: skill to find the main relevant documents.

3. To know the content of specific databases in order to search the adequate information:

• PubMed: scientific papers.
• OMIM: compendium of human genes and genetic phenotypes. 
• Gene: nomenclature, reference sequences, maps, pathways, symbols, variations about genes.
• KEGG Pathways: pathway maps representing the molecular interaction and reaction networks
• Gene Ontology: description of genes in relation to biological process, cellular component and molecular function.
• Google Scholar: scientific papers. 
•  Web of Science: scientific papers - impact factor. 
•  Biocompare: products and new technology.
• TESEO: PhD.
•  Clinical Trials: identification and information about clinical trials.

1. Which journal has the highest impact factor in 2013?
2. How many papers has Calle EE published in 2004?
3. What is the actual address of Spiegelman BM?
4. Which experimental techniques have been used in Figure 1 of the article: Gómez-Ambrosi J et al. Clin Endocrinol 2008; 69:208-215?
5. How many papers have Hoeks J and Schrauwen P published together?






1. CA-A Cancer Journal for Clinicians (IF: 162.500)
2. 15 papers
3. Department of Cancer Biology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts 02215, USA.
4. ELISA and Western blot
5. 35 papers

Animal research ethics

Experimental animals are key elements for biomedical research, since they are used to develop strategies for the prevention and treatment of several transmissible and non-transmissible diseases, such as the vaccines for rabies, smallpox, tetanus, diphtheria, pertussis or poliomyelitis, as well as the antibiotics or insulin treatment for diabetics.

Nowadays, there are also alternatives to the use of experimental animals. However, some type of experiments (i.e. research of certain pathologies and drugs) do not have alternative to animal testing, and submission and approval of the Ethical Committee for Animal Experimentation of the University or the Research Centre were the research project is going to be developed is required. The use of experimental animals must conform to the European Guidelines for the Care and Use of Laboratory Animals (Directive 2010/63/EU) as well as to the national (Real Decreto 53/2013) and regional (Orden Foral del 5 de Agosto de 1991 in Navarra) legal framework.

What are the 3 R's?

In 1959, the zoologist William Moy Stratton Russell (1925-2006) and the microbiologist Rex Leonard Burch (1926-1996) wrote that scientific excellence and humane use of laboratory animals are inextricably linked. In the book “The Principles of Humane Experimental Technique”, they described “The 3 R’s” (Reduction, Refinement and Replacement), which are the ethical guidelines for animal use in life sciences. 

Russell and Burch were honoured guests in several major meetings regarding alternatives for the use of experimental animals. The brilliant Russell with a generous and cheerful disposition and the propensity to break out in a song, explained the benefits of the 3 R's in the 2nd World Congress on Alternatives and Animal Use in the Life Sciences (Utrecht, The Netherlands, 1996) with a song, as you can observe in this video.

The 3 R's principle of Russell and Burch includes:

• Reduction: the number of animals should be the minimum necessary to test the experimental hypothesis and give statistically reliable results. In order to calculate an appropriate sample size, a priori statistic criteria should be used. The validation of alternative methods to the use of animals is also key to reduce the number of animals.
• Refinement: the procedures should be selected to eliminate or minimize the pain and distress or enhance the animal welfare. Much pain and distress can be reduced or eliminated by using analgesia, anaesthesia and non-invasive methods. Researchers can enhance the well-being of the experimental animals by using environmental enrichment techniques, such as proper handling, appropriately sized cages, or group housing of social species.
• Replacement alternatives include methods using less sensitive species (i.e. microorganisms, plants or invertebrates) or completely avoid the use of experimental animals, such as: i) mathematical and computer models; ii) in vitro studies with organs, tissues or cells in culture; and iii) human studies by using volunteers, surveys and epidemiology.       

CROSSWORD: complete the following crossword using one letter in each cell.

ACROSS:

1. The use of non-invasive procedures belongs to this "R" of the 3 R's principle.
2. A physician needs this academic degree and, at least, 10 years of experience in the use of experimental animals to obtain the C category for animal research (from right to left).
3. Ethically unacceptable end-point.
4. A method of refinement to achieve the absence of sense of pain while remaining conscious.
5. The "R" corresponding to the use of the minimum number of animals to achieve statistically reliable results.
6. Point at which the experiment is complete (from right to left).
7. Russell and _______ defined the 3 R's principle (from right to left).
8. Sheeps are _______ animals that require to be housed in social groups.
9. Term that refers to repetitive behaviours in captive animals, particularly those given an inadequate mental stimulation.

DOWN:

1. The use of less sensitive species belongs to this "R" of the 3 R's principle.
2. A period of isolation of the experimental animals arriving from abroad to prevent the spread of diseases and allow the animals to adapt to their new environment (from bottom to top).
3. _____ studies are preliminary studies used to evaluate the feasibility, time, cost or adverse effects in an attempt to predict an appropriate sample size and improve the methodology upon the final study.
4. The ________ mouse is an animal model of immune deficiency due to a genetic mutation that causes a deteriorated or absent thymus and requires aseptic housing conditions (i.e. positive air pressure cages).  
5. The use of ___________ is required to calculate an appropriate sample size.
6. Two words: building where the experimental animals are housed.
7. As researchers, if we must conform the Directive 2010/63/EU for the care and use of laboratory animals, we live in ________.
8. Experimental animals usually show identical _________ with the same phenotype to ensure reproducibility under the same experimental conditions.
9. The ethical guidelines for the use of experimental animals are resumed in the _____ principle (from bottom to top).

 



ANSWERS TO THE CROSSWORD:

Practical Session 1 - Group 1

We have used the first part of the session to explain in great detail what we expect from you in the team work (which is mandatory) as well in the individual essay (which is optional) of our subject. Subsequently, we have shown a film ideally suited to discuss topics related to research ranging from the relevance of the scientific method to the intricacies of ethics.

“Something the Lord Made”

The movie “Something the Lord Made” is based on the verifiable facts of the clinical and experimental work that led to the first-ever surgical intervention with therapeutical purposes on a child suffering from Tetralogy of Fallot (to see the main features of Fallot's tetralogy, please, refer to the Keys of the Practical Session in the post corresponding to Group 2).
The following video outlines in a schematic way the main alterations of this pathology and how they are being surgically repaired nowadays. 

For those of you interested in learning more about how the operation is performed at present go to the explanations and video provided in the link corresponding to Practical Session 1 - Group 3 under the subheading surgical treatment of Tetralogy of Fallot).

Blalock and Taussig published in 1945 the positive results of their first 3 interventions on children with Tetralogy of Fallot in JAMA, one of the most prestigious medical journals.

In spite of the key contributions of Vivien Thomas in the research leading to the development of the surgical technique (subsequently termed the “Blalock-Taussig shunt”), his name does not appear among the authors of the original article. This fact was emphasized some years ago in a comment published in the same journal referring to the Blalock, Taussig & Thomas collaboration as an excellent example of translational research and the impact it exerted on the development of medicine. 

What do the human heart and a super tanker have in common?

Facts:

Your heart beats about 100,000 times in one day and about 35 million times in a year. During an average lifetime, the human heart will beat more than 2.5 billion times.

Your body has about 5.6 liters of blood, which circulates through the body 3 times every minute. In one day, the blood travels a total of 19,000 km (12,000 miles) — that's around 4 times the distance across the US from coast to coast.

The heart pumps about 1 million barrels of blood during an average lifetime—that's enough to fill more than a couple of modern super tankers. 
 

Biomedical research ethics

Biomedical research is needed for the development of medicine. It provides the scientific evidence to improve health care by providing knowledge and information on the usefulness and effectiveness of diagnostic, therapeutic and preventive procedures. Moreover, biomedical research contributes to increase our understanding of the etiology, pathophysiology and risk factors of diseases.

In other words, biomedical research is the careful, meticulous, systematic, diligent inquiry or examination of current knowledge, undertaken to establish facts or principles. Researchers strive to better understand the causes of disease, expand knowledge to discover better ways to prevent ill health, and to develop beneficial medications, and procedures to treat and cure diseases and conditions that cause illness and death. For all these reasons biomedical research should be considered a moral obligation for all physicians and health professionals (37% of you answered correctly via the clickers).

Ethical biomedical research encompasses not only the attainment of moral aims or purposes but also the application of morally acceptable means to obtain them. Therefore, scientific rigor is a necessary condition but not a sufficient one; not all what is scientifically feasible may be acceptable from an ethical standpoint.

Ethics is a set of moral obligations that define what is right and wrong in our practices and decisions. Scientists have long maintained an informal system of ethics and guidelines for conducting research, but documented ethical guidelines did not develop until the mid-twentieth century, after a series of well-publicized ethical breaches and war crimes.

 

During World War II, Nazi scientists launched, among others, a series of studies designed to test the limits of human exposure to the elements with the final aim of better preparing German soldiers. For instance, some experiments addressed the effects of hypothermia in humans. During these experiments, concentration camp prisoners were forced to sit in ice water or were left naked outdoors in freezing temperatures for hours. Numerous victims were left to freeze to death while others were eventually re-warmed with blankets or warm water, or underwent experimental rewarming attempts that left them with permanent injuries. War crimes during World War II led to the Nüremberg Code (1947).

In 1932 the U.S. Public Health Service started the “Tuskegee Study”, an experiment on black men in the late stages of syphilis. These men, for the most part illiterate sharecroppers from one of the poorest counties in Alabama, were never told what disease they were suffering from or of its seriousness. They were only informed to be treated for “bad blood”, and their doctors had no intention of curing them of syphilis at all. The experiment was aimed to collect data from autopsies of the participating men, and they were thus deliberately left to degenerate under the ravages of tertiary syphilis, which can include tumours, heart disease, paralysis, blindness, insanity, and death.

The following video summarizes the atrocities of the “Tuskegee Syphilis Study” and has served us to reflect on the ethical implications and consequences.

Infamous cases of fraud and misconduct highlight the need for a system of ethics to ensure proper behaviour and reliable research in science. As a result of the Tuskegee Syphilis Study (1932-1972), the U.S. Congress passed the National Research Act in 1974. The Act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to oversee and regulate the use of human experimentation and defined the requirements for Institutional Review Boards. To assure that research is conducted in accordance with basic ethical principles, the Commission considered:

1. the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine,
2. the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects,
3. the establishment of appropriate guidelines for the selection of human subjects for participation in such research, and
4. the nature and definition of informed consent in various research settings.

The Belmont Report

The work of the National Commission led to The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research which was presented in 1978 and published in 1979 that states that “persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being”. The Belmont Report summarized and defined the basic ethical principles of respect, justice and beneficence, thereby representing the origins of modern research ethics.

 
Basic Ethical Principles

1. Principle of autonomy: recognizes the rights of individuals to self-determination. The respect for persons incorporates at least 2 ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection.
This principle of respect for persons thus translates into two separate moral requirements:
(i) to acknowledge autonomy and
(ii) to protect those with diminished autonomy.
To respect autonomy is to give weight to the person’s autonomous considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. Withholding information necessary to make a considered judgment, when there are no compelling reasons to do so represents a lack of respect.

However, it has to be highlighted that not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, while some individuals lose this capacity wholly or in part as a consequence of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated requires protecting them as they mature or while they are incapacitated. Respect for persons demands that subjects enter into the research voluntarily and with an adequate information (informed consent).

2) Principle of justice: refers to the ethical obligation of fairness and equality in health resources and treatment. The conception of justice is especially relevant to protect vulnerable groups. In this regard, the selection of research subjects needs to be scrutinized in order not to be discriminatory. It should be determined whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the research condition being studied. Furthermore, justice demands that when research leads to the development of therapeutic devices and procedures, these not provide advantages only to those who can afford them as well as that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

3) Principle of beneficence: means the obligation to act in the best interest of patients maximizing possible benefits and minimizing possible harms. Individuals are treated in an ethical manner not only by respecting their decisions, but also by making efforts to secure their well-being. This principle establishes the need to carefully evaluate the risk-benefit relation; learning what will in fact be beneficial may require exposing persons to risk. The imperative posed by this principle is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks. Moreover, this principle implies the professional competence of the researchers involved to warrant maximization of benefits and the reduction of risk that might occur from the investigation.

The concept of non-maleficence considers that it is more important not to harm your patient, than to do them good; this is embodied by the Latin expression “primum non nocere”, "first, do no harm".

The Declaration of Helsinki

The Declaration of Helsinki represents one of the most relevant documents in the history of research ethics as the first significant effort of the medical community to regulate research itself. With the primary purpose to set international ethical principles for research involving human participants the World Medical Association (WMA), the Declaration of Helsinki was originally enacted in 1964 and forms the basis of most subsequent documents. It has undergone various revisions (the most recent at the General Assembly in October 2013) since its first promulgation. Given that 2014 marked the 50th anniversary of the Declaration of Helsinki, the WMA developed its eighth version of the Declaration updating and revising the 2008 version with the core aim of the working party to preserve the unique character and status of the document. The first draft was out for public consultation until June 15th, 2013 while the final revised and updated version was published in JAMA in November 2013. Major changes with respect to the 2008 version were carried out regarding both its structure and content. Noteworthy, the duty of physicians expands not only to promote and safeguard health but also well-being. The articles pertaining to vulnerable populations have also been changed to better capture several important ethical principles. Although the WMA has been congratulated for the work performed and the transparency of the process, it was agreed that the declaration has not undergone radical change representing “an evolution rather than a revolution”. Additional distinctive aspects contemplated in the 2013 version include appropriate access of underrepresented groups to participation in medical research, the need for compensation for study participants who are inadvertently harmed, and attempts to further clarify the role of placebos, the need to register every study involving human subjects in a publicly accesible database before recruitment of the first subject, provision for post-trial arrangements in advance of study start, and the ethical obligation to publish and disseminate the study results, even if they are negative or inconclusive.

• Understand and remember the basic ethical principles of respect, justice and beneficence derived from the Belmont Report.
• Study in detail the 2013 revision of the Declaration of Helsinki together with the changes introduced as compared to the 2008  version (pdfs available at ADI).
• Learn the characteristics and content of the written informed consent.

Types of research

Clinical trials

Clinical trials are sets of tests in medical research that generate information on health interventions (e.g., drugs, diets, diagnostics, devices, therapy protocols).

Clinical trials often involve patients with specific health conditions. In early phases, participants are healthy volunteers who receive financial incentives for their inconvenience. In coordination with a panel of expert investigators, the sponsor decides what to compare the new agent with (one or more existing treatments or a placebo), and what kind of patients might benefit from the medication or device.
During the clinical trial, the investigators: recruit patients with the predetermined characteristics, administer the treatment(s), and collect data on the patients' health for a defined time period. These patients are volunteers and they are not paid for participating in clinical trials. 

Classification of clinical trials can be done by the way the researchers behave:
- In an observational study, the investigators observe the subjects and measure their outcomes.
- In an interventional study, the investigators give the research subjects a particular treatment (pharmacological, dietary or surgical). Usually, they compare the treated subjects to subjects who receive no treatment or standard treatment. Then the researchers measure how the subjects' health changes.

Taking into account their purpose five different types of trials can be organized:
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Screening trials test the best way to detect certain diseases or health conditions.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Quality of life trials (supportive care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
- Compassionate use trials provide partially tested, unapproved therapeutics to a small number of patients who have no other realistic options. Usually, this involves a disease for which no effective therapy exists, or a patient who has already attempted and failed all other standard treatments and whose health is so poor, he does not qualify for participation in randomized clinical trials.

The following videos show the importance of randomization and blinding.

The classification algorithm shown below can help you to identify the main types of clinical trials being carried out by researchers.

Translational research

The traditional categorization of research identifies two main categories: basic research (also termed fundamental or pure research) and applied research. While basic research often leads to breakthroughs or paradigm-shifts in practice, it usually takes a long time to be applied in any practical context. On the contrary, applied biomedical investigation often represents an incremental improvement to current knowledge rather than a radical breakthrough, however, it has the advantage of exerting a potential direct impact on clinical practice in a relatively short time period. As mentioned by Albani & Prakken in their very comprehensive article published in the 2009 September issue of Nature Medicine, translational medicine encompasses the continuum of activities that extend from the conception of an idea to advanced clinical testing and, ultimately, to the development of a new medical technology or drug. Translational research refers to making findings from basic science useful for practical applications that improve human health and well-being. With a focus on multidisciplinary collaboration, translational research aims to move “from bench to bedside” or from laboratory experiments through clinical trials to point-of-care patient applications. However, translational research is bidirectional and also encompasses “from bedside to bench” approaches.

Compartmentalization within science together with the cultural separation between different scientific fields makes it difficult to establish the multidisciplinary teams that are necessary to be successful in translational research. Additional challenges for translational research arise in the traditional roadblocks encountered in academia, industry and government to successfully move an idea from its conceptual stage to early clinical development and final application. To flourish, translational research requires a knowledge-driven system that establishes a feedback loop to accelerate the translation of data into knowledge whereby the complex and underlying causes and outcomes of disease can be unravelled, to design either effective prevention processes or early detection and personalized treatment strategies. Thus, translational research entails two distinct domains, namely the enterprise of translating knowledge from the basic sciences into the development of new treatments at the same time as translating the findings from clinical trials into everyday practice.

• Study the different classification possibilities of research studies together with their main characteristics, advantages and disadvantages.

• This information will enable you to decide which is the most appropriate type of research in each case.
• You need to know and understand what "translational research" means. 

Go to ADI to see the assignment of topics for the team work!