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Training Course in Sexual and Reproductive Health Research 2010

Questions and answers

  • Presentations
  • Research ethics
    • What happens if you submit a proposal to one local IRB and they reject the proposal, but you as the PI are not agree with this decision because the reasons that the IRB use are just scientifically without a solid base (are not an ethics issue). Would I submit my proposal to another local IRB or what can I do?

      Cristian Jesam, Chile

      The most preferred, and one that I recommend, is that you appeal to the same IRB with your rationale and resubmit the application. Although the core of an IRB is to look at the ethical issues, it can raise questions regarding the design and methodology to the extent that they compromise on the study subjects safety and other ethics-related matters. In such a case, an IRB could ask the PI to elaborate or suggest an alternative approach. As you are aware, an IRB's job is not to assess and evaluate the design, this should be done by a scientific committee, if there exits one. It not, the researcher can engage her/his colleagues and other professionals to comment on and suggest alternative or best or second best approaches.
      Although you could submit the protocol to a new IRB, and if you decided to do, I suggest that you furnish all the information as to what had happened before, and attached the comments from the previous IRB. The new IRB may wish not to consider the application.
      As I said, the second option is not the one I recommend. I think the first option is your best option.

      Shyam Thapa, WHO Reproductive Health & Research (RHR) Department

      Should health workers (doctors, clinical officers, nurses, etc.) working for a research based organization be given the chance to give their informed consent when information about their individual clinical practices is collected in a research project within their organization but for which they are not contracted to work?

      Ronnie Odiwuor Asino, Kenya

      If the interview, as part of data collection, is for a research study, then the investigator must make sure that consent is obtained from each potential subject (study respondent). This principle applies to all categories, including care providers or lay people. The study subjects are those from whom the data are collected and will be used to make inferences. The process of obtaining consent will be the same.
      That said, it is probably also the case more research activities take place without proper procedure than those with proper procedure in place. However, we all must strive to make corrections, where needed, and do the right thing. This goes back to the essence of my talk: even if good results are obtained, if the means of doing so has not been proper, the study results will not have the same weight as if it were done in the right way. The bottom line is that patient's rights to confidentiality, privacy and participate or not should not be compromised.

      Shyam Thapa, WHO Reproductive Health & Research (RHR) Department
  • Research protocol
    • Are there specific times for submitting research proposals to WHO within the period of the year?

      Mengistu Asnake Kibret, Ethiopia

      Different programs/departments at WHO may have their respective time frames for submission of the proposals. Some of the examples of this are: Call for proposal on medical abortion (RHR Department); Injectable contraception (RHR Department); Patient safety (Patient Safety Department); Implementation Research (RHR Department and Tropical Diseases Institute). Whereas the first three are more specific, the one on ImpRes is much broader in scope and substantive areas. For this reason, it is important to do a "scan" of the website periodically unless you are enlisted to receive such announcements, as and when they are out.

      Shyam Thapa, WHO Reproductive Health & Research (RHR) Department

      In starting new proposals will there be specific interest program areas from WHO where the participant can work on a research proposal?

      Mengistu Asnake Kibret, Ethiopia

      I think comment above addresses this question as well. Briefly, it very much depends on how a particular initiative has evolved and is framed. The Call for proposals on ImpRes is but one example of substantive area of research being fairly wide.

      Shyam Thapa, WHO Reproductive Health & Research (RHR) Department

      Which of the references will be helpful in advising page limits for each of the component areas in the research proposal?

      Mengistu Asnake Kibret, Ethiopia

      Although some organizations may place a limit on the length of a proposal (or even font size), many are not that restrictive. The main point I was trying to emphasize in my talk is that what is essential is to make one'e own proposal a balanced one. That is, if one has too much information on some sections (say, introduction) and too little on other sections, that proposal would not be assessed as being highly meritioius. Hence, it is important that each sections/sub-sections (components) are addressed.
      As well, I might say that one way to have a good sense about this is to review articles on your subject of interest published in peer-reviewed journals. For example journals such as Studies in Family Planning, Perspective on Sexual and Reproductive Health, or Social Science and Medicine include many articles on a wide variety of topics. The American J of Public Health is another good journal to look up to. Again, find an article that is in your area of interest and see how the materials are presented and how some sort of proportionality for different sections is maintained. Also, It could be helpful to review a proposal that has gone through the process and been successful.
      Remember, preparing a study protocol/proposal is both a science and an art. As such, there is some room for one's one judgment and creativity. That said, preparing a study protocol on a clinical trial may be more standardized than one on social science. Finally, remember practice makes one more confident and helps sharpen skills. The process is no different than what might apply to a carpenter. The more s/he does, the better the person gets at it. The first piece of product would most likely not as good as the 10th product, But one has to start from 1, and then go on to 2, 3 and all the way to get to the 10th one. Also note that most of these skills are acquired through hard work and discipline and not handed down.

      Shyam Thapa, WHO Reproductive Health & Research (RHR) Department
  • WHO guidelines
  • Clinical algorithms for STI case management
    • Sometimes the patient dislike to be examined specially females , so can I just depend on history to prescribe medicines?

      Abdallah Mohammed Alhafiz, Sudan

      Role of syndromic STI case diagnosis and management:
      The use of syndromic approach for managing sexually transmitted infections (STIs) is based on simple clinical algorithms founded on patient signs and symptoms to determine antimicrobial treatment. It is recommended to enable patients to be managed in a single visit, mainly at primary health-care level or in any setting where laboratory facilities for etiological testing are either unavailable or not practical.

      Experience with syndromic management so far:
      A number of field evaluations have shown that syndromic case management is of real value in urethral infection and scrotal swelling in men, genital ulcer disease in men and women, neonatal eye infection and, perhaps, in lower abdominal pain in women. In fact, several countries in the industrialized world use syndromic management for most of these conditions, and back up their management with laboratory testing. The laboratory test itself is not prerequisite to treatment decisions.
      However, the syndromic approach is not an excuse for poor delivery of clinical services. Not examining any patient for any clinical condition is bad medical practice, and the syndromic management cannot be used like that. For this approach to work and deliver quality care for patients, a full sexual history must be taken and a full examination of the patient must be done. The purpose of a physical examination is to confirm any STI symptoms the patient has described by checking for signs of STIs. Patients may be embarrassed or uncomfortable with being examined in some settings, either for cultural reasons or being examined by a provider of the opposite sex. In this case it is suggested that the patient be educated and counselled to help the patient understand the importance of the examination and overcome his or her embarrassment, as well as to reassure the patient to gain his/her confidence and co-operation to conduct an efficient examination.
      STIs must be considered to be just like any other infection, such as tonsillitis or a condition affecting the gastro-intestinal or genito-urinary tract, such as rectal bleeding or vaginal bleeding. A diagnosis can never be made accurately unless an examination is done. Similarly, just like in a child who does not what their throat inspected with a tongue spatula, one cannot accurately diagnose tonsillitis without persuading the child of the importance of viewing the tonsils to determine whether an antibiotic is warranted or it is simply a viral infection for which there is no need for an antibiotic.
      Admittedly, examining the most private parts of a person’s body is not quite the same, but it must be done and it requires tact, sensitivity and respect on the part of the service provider. If training is needed for this, there are training modules that have been created to enable health-care providers to acquire the information and skills they need to accomplish this. These are also available on the GFMER website.

      Francis J. Ndowa, Coordinator, Controlling Sexually Transmitted and Reproductive Tract Infections (STI) Team, WHO Department of Reproductive Health & Research

      Some males never bring their partners. Is it possible to give the partner medicines for 2 patients?

      Abdallah Mohammed Alhafiz, Sudan

      Patient-Delivered (partner) Therapy (PDT or PDPT), also called Expedited Partner Therapy (EPT), is the clinical practice of treating the sex partners of patients diagnosed with STIs by providing prescriptions or medications to the patient to take to his/her partner without the health-care provider first examining the partner.
      PDPT works as an addition to the usual patient referral. PDPT may reduce the risk of persistent or recurrent infection compared with patient referral alone, but the success of this approach is very context specific. It has been tried successfully in some States in the USA, but not so successful in others. In some settings it was observed that the medication did not reach the intended sex partner for a number of reasons, including the medication being sold or lost, or indeed thrown away for fear of repercussions from the sex partner.
      One main drawback of this approach is that EPT may compromise the quality of care provided to partners, especially when used as a first-line approach for partners who would otherwise seek clinical services. For instance, the medication could cause serious adverse reactions, including allergy, which could have been detected through history taking during a visit to a health-care provider.
      This option allowing providers to use PDPT is not intended as the first and optimal choice of treatment for partners of individuals diagnosed with STIs. However, the strategy can serve as a useful alternative when the partner is unable or unlikely to seek care. Providers should use their best judgment to determine whether partners will or will not come in for treatment, and to decide whether or not to dispense or prescribe additional medication to the index patient.

      Francis J. Ndowa, Coordinator, Controlling Sexually Transmitted and Reproductive Tract Infections (STI) Team, WHO Department of Reproductive Health & Research