Retracted: Evaluation by an Aeronautic Dentist on the Adverse Effects of a Six-Week Period of Microgravity on the Oral Cavity

[This retracts the article DOI: 10.1155/2011/548068.].


Redundant Publication and Experimental Details
A 2009 article by the same group [2] should have been cited and discussed. e baseline results in Table 2 are identical, and the results in Table 1 are highly similar and some are identical: the baseline amylase means and the Cl and malonaldehyde means for during simulated microgravity vs. last day of HDT. e ranges/variances are the same at baseline for flow rate, Na, K, calcium, phosphate, protein, Cl, protein output, amylase, vitamin E, vitamin C, lactate dehydrogenase, MIP 1 alpha, malonaldehyde, 8-hydroxydeoxyguanosine, and thiocynate, and the ranges/variances are the same during simulated microgravity vs. last day of HDT for flow rate, Na, K, calcium, phosphate, protein, Cl, protein output, amylase, vitamin E, vitamin C, lactate dehydrogenase, MIP 1 alpha, malonaldehyde, 8-hydroxydeoxyguanosine, and thiocynate.
Dr. Rai said the studies had many of the same participants, i.e., volunteers who were members of the Joint Board of Research (JBR Institute of Health Education Research & Technology, India, the first affiliation of Dr. Rai), who were given the same diet and supplements. However, the age ranges do not overlap: 20 participants aged 18-22 in 2009 (though the abstract says 40 participants) versus 10 participants aged 22-30 in 2011. No information about a standard diet and supplements was included in the article or in the consent form and study protocol provided by Dr. Rai. e exact protocol used in the study is unclear; the study protocol provided by Dr. Rai is brief and lacks additional detail compared to the article. e article implied that participants stayed in the head-down-tilt position for 8 hours, but Dr. Rai clarified that the participants were allowed to leave the position to go to the toilet. However, Dr. Bik noted that, in another study by the same group also published in 2011 [5], it was stated that participants stayed in the head-down-tilt position for 60 days, even during meals, showers, and toilet visits, and compliance was monitored by video. ese protocols are therefore inconsistent.
ere are further inconsistencies and missing information: (i) Details of the protocol are missing from the 2011 article [1] compared to the 2009 article [2]. For example, the earlier article says the participants had eight hours head-down-tilt and then four hours recovery in a chair.
(ii) e consent form says "about 20 people" would be recruited, whereas the study protocol says "ten to thirty healthy controls." (iii) e protocol mentions "controls" rather than "participants." (iv) e protocol discusses measuring heart rate variability during sleep, but sleep studies are not mentioned in the consent form or article.
(v) It is not stated when the study began and ended, what the roles of the authors were in the research, and whether anyone other than the authors contributed to the study. (vi) It is not clear whether the differences reported in Tables 1 and 2 were statistically significant nor whether the numbers in brackets in Table 1 are ranges or variances (e.g., 95% confidence intervals, standard error, or standard deviation).
Dr. Rai did not provide anonymised individual data points at all timepoints for all outcomes and measurements when this was requested.

Ethics
Dr. Rai provided a blank copy of the written informed consent document, which only briefly refers to what could be serious adverse effects (e.g., infection) without describing the likelihood or medical monitoring procedures. e consent form only refers to "the influence of isolated environment on human physiology and psychology," not that participants would be subject to six weeks of head-down-tilt bed rest. e number is "IRB #2013," which appears to correspond to a study done in 2013, not 2011. e ethical approval document is signed by Prof. Suresh C. Anand, who has been a collaborator of Dr. Rai since 2006, when they were affiliated to the Government Dental College, and they were collaborators at the time of the study: this is not evidence of independent ethical approval. Because Prof. Anand was actively collaborating with Drs. Rai  Dr. Rai said the participants were members of the Joint Board of Research, which was not disclosed in the article. Because Dr. Rai found and is president of this organisation, the use of these participants created a risk of coercion because they may have felt obliged to volunteer for this research.
e 2006 Indian Council of Medical Research (ICMR) guidelines that applied to this research state "adequate justification is required for the involvement of participants such as prisoners, students, subordinates, employees, service personnel etc. who have reduced autonomy as research participants, since the consent provided may be under duress or various other compelling reasons" [6]. No such justification was provided. is is particularly relevant in the absence of independent ethics oversight. e consent form says that no compensation would be paid in the event of injury. However, the ICMR guidelines [6] state "Research participants who suffer physical injury as a result of their participation are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability."