Hi Meg, I do not know whether there is an Institutional Review Board for the Protection of Human Subjects at the institution. If you so, they should be able to provide guidance after hearing specifics of the proposed study procedures. In general, it is ethical to offer one group "standard care" and to offer a randomly determined intervention group additional care. The "standard care" group cannot be restricted from accessing additional services (equipment or counseling) from another source. That is, if mothers have a way to obtain care or equipment from an alternate source, that option cannot be ethically denied to them. However, control mothers would still have to access additional care on their own initiative and using their own resources just as they do currently. In reality, the study tests the impact of the institution OFFERING ACCESS to additional care. It does not test the impact of the mother UTILIZING said care. This is a good thing - because the institution can only control what it offers to mothers - not what the mothers do. Analysis of the results would be done by "intent to treat". If the investigators record which mothers in each group do obtained pumps and actually do follow the milk expression protocols, then it might be possible to evaluate the impact of the treatment received -- BUT this is more complicated. Because of potential confounding variables, it would be very easy to misinterpret the results if the later analysis is done incorrectly. Wishing you good luck and good science, Judy Hopkinson, Ph.D. Assistant Professor Children's Nutrition Research Center at Baylor College of Medicine 1100 Bates St. Houston, Texas 77030 Date: Tue, 13 Jan 2004 19:34:42 +0400 From: Pascoes in Dubai <[log in to unmask]> Subject: Research proposal My friend works in a hospital with a NICU that cares for about 30 new patients every month. She is writing a research proposal for funding to assess the impact on breastfeeding success and milk volumes, by incorporating a milk expression program into early post partum care of mothers with babies in the NICU-by the provision of hospital grade breast pumps to take home for as long as necessary, support and information. This is opposed to leaving mothers to manage with the standard NICU lactation care, which is minimal and not highly skilled, and offers breast pump availability on the ward only, for mothers visiting their baby/ies. Is it possible for this question to be addressed in a randomized trial? If randomization is not an option can anyone suggest another study design? We are concerned that there are serious ethical implications in denying pumps to mothers in the control group when there are in fact pumps available. Any suggestions greatly appreciated. Meg Kingsley IBCLC Dubai UAE -- Outgoing mail is certified Virus Free. Checked by AVG Anti-Virus (http://www.grisoft.com). Version: 7.0.211 / Virus Database: 261.6.2 - Release Date: 13.01.2004 *********************************************** To temporarily stop your subscription: set lactnet nomail To start it again: set lactnet mail (or digest) To unsubscribe: unsubscribe lactnet All commands go to [log in to unmask] The LACTNET mailing list is powered by L-Soft's renowned LISTSERV(R) list management software together with L-Soft's LSMTP(R) mailer for lightning fast mail delivery. For more information, go to: http://www.lsoft.com/LISTSERV-powered.html ------------------------------ End of LACTNET Digest - 13 Jan 2004 - Special issue (#2004-70) ************************************************************** *********************************************** To temporarily stop your subscription: set lactnet nomail To start it again: set lactnet mail (or digest) To unsubscribe: unsubscribe lactnet All commands go to [log in to unmask] The LACTNET mailing list is powered by L-Soft's renowned LISTSERV(R) list management software together with L-Soft's LSMTP(R) mailer for lightning fast mail delivery. For more information, go to: http://www.lsoft.com/LISTSERV-powered.html