Good - more research is indeed needed. It is important that you run to a very high standard, both scientifically and ethically and it sounds as though this is your aim. The usual suspects are:

good research practice - double-blind, environmental and lifestyle controls, standardised or controlled measurements, good statistics;

safety: do as much as you can - safety bloods, vital signs monitoring; medical confirmation of suitability and medical monitoring throughout the dosing periods;

alignment with local laws - ethics and any other approvals; run to a standard of ethics for the study you cite and you should be fine - it will be strange to complain if you had more checks and balances than were required;

Measurements: choose your measures wisely and do your best to run power calculations before hand, mainly to avoid testing too few subjects.

Be nice: be nice to your volunteers and collaborators and put safety above the scientific needs. Pay your volunteers if you can for their time and travel

Apologies if this is all familiar territory and good luck!

Mitul

First, consider the sponsor. They may have ethical guidelines. Next, consider whether your base (university, company, or whoever) has ethical guidelines. Third, if you are not driven by either, you need to consider what harm may come to your subjects. In a developing country, I guess this would be your primary concern anyway. The cost does not come into consideration until you have ruled out any problems from those primary considerations.

My gut says that the government of the Philippines may also have guidelines too, have you contacted them?

I agree with the above suggestions. Also, you need to work closely with the local population and local IRB or research ethics committee (hopefully there is one). They can help you with recruitment strategies and consent issues. It is also important that you research be in some way beneficial to the community: is this a drug they might use? Would it be available to them if the trials are sucessful? Will you be doing anything to enhance the health care infrastructure or provide other community benefits?

Already there are very important suggestions related to both the scientific and ethical aspects. I will only add a bit to the ethical considerations highlighted above. There are of course many considerations to be cognizant of and I am sure you are (and you want input from others).

1. The patient population to be enrolled. Are the trial participants mostly literate or non-literate? I ask this because of the necessity of explaining in detail the use of placebo and the trail intervention. I do not mean to suggest that non-literate will not understand but that the trial may have to be explained differently or in greater detail what placebo means and whether some will get the drug and others will not (and why). After all the idea is not get a signature (or a thumb impression) on a paper but that the enrolled patient is aware of what they have consented to.

2. Patients should not be excluded from research because of social reasons – as non-literate patients (or women).

3. An important principle in research ethics is that of responsiveness. This, responsive research, requires that, first, the research is relevant to the health needs of the patient population and patients are chosen for their appropriateness to answer the research question (and not because they were easy to enrol). Second the proven drug (in this case Mofadinil) will be available to the enrolled patients and (as David Resnik writes, above) to the community. Not only available but at a price that is affordable by the patients – this is even more important if the health care expenditure is borne by patients privately. If the proven drug cannot be afforded by the patients who helped develop it – then that raises an ethical issue of being used as a means to others’ ends. It may also be that the local patient community prefer other form of benefits. This is something that the local IRB will be able to work out and help you with.

4. Once the drug has proven effective then before it is available in the market (or through the hospital) there is a lag time – during that time patients who have benefitted may need the drug (if an alternative is not available) - this needs to be kept ion mind too (and I am sure it is – this is also something the local ethics board will have in mind too).

5. When collaborating with a sponsor- my advice is to make base this collaboration on an equal footing – you (and researchers on the ground) are at the interface with patients and hence aware and cognizant of the ethical issues that arise when conducting research. The collaborations should pay attention to the suggestions (ethically and scientifically valid suggestions) made by researchers in the field.

6. It is advisable to have a look at the National ethical guidelines developed by the Philippine health research ethics board.

You may have already thought of these – hence I apologise for this “long” answer.

Sorry, I'm not able to answer this question since I do not know the context within which such a study will be placed...

Thanks for all the valuable procedural and methodological advice. To give you some context regarding my question, my research on creativity is actually pointing me towards the hypothesis that there might be a functional trade-off to the cognitive enhancements delivered by drugs like Modafinil. Please see my attached mini-proposal for just a bit more background.