12.Other Ethics Committees:  

If the study will require review of other ethics committees, provide the name and contact information.

a.      Research Involving Nutritional Studies

Any study involving intervention, contact, diet testing, nutrient testing, use of tracers, anthropometric tests, psychological testing or organic sampling shall observe the following rules:

• • Participation must be essentially voluntary.
  • The participant subject must be informed of the benefit which means their contribution to the study and the risks that this entails.
  • Participation of individuals or groups should allow withdrawing from the study to discretion when it is considered necessary for any personal reasons.
  • Intervention must not threaten the modesty, cultural values, moral values, ethical values, social security, or emotional stability of the subjects.
  • Any intervention involving the intake of nutrients, drugs, tracers or organic sampling should respect the physical, emotional and mental health of the subject.
  • Interventions involving clinical evaluations, including measurements, physical examinations, assessment of physical, psychosocial tests, etc., shall be performed by personnel with demonstrated ability and balance, maturity and experience to conduct such evaluation.
  • Evaluations involving obstetric observations (evaluation of pregnancy, gynecological exams, breast exams or any other intervention concerning the State of adolescent and adult women) may be carried out only by trained and experienced professionals, and when demanded by population, preferably should be performed by female sex workers.
  • Interventions related to pediatric population, from the newborn to adolescence, involving any type of procedure (such as blood sampling, organic sampling for culture, analysis, etc.), should be performed by experienced professionals in such procedures, and it should be observed that preferably the mother or responsible for the child shall be present during the procedure.

Any case not included in the above items should be discussed by the Institutional Ethics Committee.

b.  Research involving social, economic and anthropological studies

Social and economic research at the individual, family and community level must also take into account ethical considerations for protection of participating individuals:   

• • Participation in any socio-economic study of an individual or a family must be voluntary.
  • The individual or family must know clearly the objective of the study.
  • The individual or family should not be subject to any criticism or retaliation when refusing to give information.
  • Social and economic information obtained from the family should be collected by suitable and experienced personnel.
  • Personnel who collect such information must handle it with confidentiality.
  • Research involving household direct observations or conditions in which the individual or family lives (inspection or observation of sanitation, toilets, bedrooms, kitchen, etc.) should be made with consent of the head of the family. Comments of any kind should not be made regarding the conditions detected by the observer on any physical environment of the household. Intradomiciliary visits, depending on the objective pursued, should avoid affecting harmonious life and privacy of the household (avoid visits during meal times, nights and weekends, religious ceremonies, mortuary, etc.
  • When dietary information and observation of dietary behavior patterns is required, it must be specified and clarified precisely to the family and conducted in such a way that it does not affect the behavior of any member of the family (malaise, discomfort, embarrassment, loss of appetite, etc.).
  • Any data or information concerning the social or economic status of individuals or families, such as illiteracy, very low income, deplorable housing conditions, etc. should not be discussed with any other member or family in the community.

c.  Responsibilities of the Principal Researcher:

• • Provide a detailed description of the procedures to be followed in order to protect human subjects participating in the study.
  • Transmit to the subject participating in the investigation all the information needed to give a consent duly informed, offering extensive opportunities to ask questions.  
  • Clarify: 

¨       Known benefits and risks or inconveniences for the subjects involved in the study.

¨       Description of information to be given to the subjects:

¨       The objectives and purposes of the study

¨       Duration of study  

¨       Anticipated benefits of the applied procedures 

¨       Known risk to short-term or long-term

¨       Possible discomfort

¨       Alternative methods for treatment if the study is testing a treatment

¨       The suspension of the trial when negative effects or sufficient evidence of positive effects which do not justify continuing with the study are

¨       Suspension of the study when negative effects or sufficient evidence of positive effects which do not justify continuing with the study are found

¨       Freedom of the subject of the study to withdraw from the research at any time if desired

¨       When appropriate, indicate what incentives or treatments subjects will receive for participating in the study. In case there is some kind of remuneration, specify the amount, method of delivery, time and reason for payment.

¨       List drugs, any vaccines, diagnostics, procedures, or instruments to be used, regardless if they registered, unregistered, new or current use in the country.

                 The researcher also has to respond to other ethical aspects such as:

• • In studies where personal information is obtained from the subjects, indicate how the confidentiality of information of participants involved in the study will be kept.
  • For studies that consider the participation of subjects in an experiment (experimental trials, quasi-experimental studies of interventions, etc.), information about the free and informed consent of the participants and the strategy used to obtain it must be provided.
  • Brief description of how the research findings will be reported and delivered to subjects participating in the study or other stakeholders.
  • Indicate and justify the inclusion as appropriate, of children, elderly, physically challenged and pregnant women.  Justify the non-inclusion of women (of any age) or ethnic minority, racial group, in the study group, if any, etc.

When applicable, indicate how the study will ensure the right balance of both sexes in the study groups.  Also when it applies, indicate how inequities of gender and status discrimination and disadvantage of the situation of women, can affect the control over their involvement in the investigation.