Moral Issue With Research Protocol

[greekatholic]

I am reviewing a protocol for a clinical research study in which elderly volunteers will be exposed to very low amounts of investigational product. As is typical in developing new drugs much caution is taken that no harm will come to participants or to spouses. An important part of this is that male participants are advised to not expose sexual partners to semen which may either contain the drug or might contain sperm with genetic mutations. The period of risk for this is 3 months (the time to develop new, unaffected sperm). The problem is that the protocol explicitly recommends use of condoms for this purpose. Moreover, it says that if the partner is of childbearing potential then even a second method of contraception should be used (it says: "diaphragm in combination with a spermicide, intrauterine device, contraception implants, “mini pills” (with
gestagens only), injectable gestagens, or combination hormonal contraceptive methods (tablets, patch, or vaginal ring with both ethinylestradiol and gestagen)"). I'm not sure what to do here?!? Realistically whatever I say as a reviewer the section will not be deleted. Perhaps I could achieve that the part of the text saying "should use condom" is saying "should abstain or use condom" but definitely not "should abstain" without mentioning the condoms. This whole section of the protocol is an evil means for a good end and it much bothers me.

[Brother Adam]

I hope someone else will add to what little I can provide.

I believe you would be morally obligated not to recommend any immoral means be used when submitting your review. What method you use to do so is up to you. Perhaps it would be easiest to question the use of sexual activity when a drug is being used that can harm a spouse or unborn child. Maybe you could bring up the legal issue it presents as well as a way of avoiding the moral argument. If condoms are not 100% effective, how is the pharmaceutical company protecting itself from a lawsuit? They are clearly giving patients permission to engage in risky behavior. You could make a medical argument instead of a moral one. You could write up an argument expressing serious concern with any exposure and stress abstinence because of the risk to the spouse. There must be some medical precedent with some medications that require those on the medicine to avoid any sexual contact that you could use.

If you are unable to take one of these routes, it may be best to ask to be transferred from the project.