Consent in Research Investigations Whenever

¶ … Consent

In research investigations whenever there is an experimental condition there must always be included a consent form that has either been read by the participant or the participant's legal guardian or verbally presented to the participant and/or guardian and then signed. It is not necessary for the participant's copy to be signed but the study's copy must be signed and dated. Further, all consent forms must be pre-empted by a presentation as to the nature of the study and all consent documents must meet the requirements of 21 CFR 50.20 and include all necessary information with respect to the 14 basic elements of 21 CFR 50.25(a) and 21 CFR 50.25(b). In emergencies situations consent forms may not be able to be acquired. The physician has the right in this instance to treat the individual without consent, verbal or oral, but only to the extent to save the patient's life. However, any advanced knowledge about refusal for treatment abrogates any further treatment.

Question #2: No. Any change in research protocol must be fully documented and agreed upon by the research study participant. The FDA does not permit changes unless they are documented which usually means adding a written addendum to the original consent form and being signed and dated by the parent(s) or legal guardian. In fact, parents are to be fully informed of the full range of options available to them and this information must be contained in the initial consent form release paper. However, whoever is qualified to obtain the consent form can, and should, be able to discuss with the parent or guardian available alternatives as well as to answer any questions that might arise. At all times the consent form should include sufficient information for the person to make an informed decision.

Question #3: Yes and No. The best option would have been to call the study a "randomized trail-based experiment." The word experiment by itself often conjures up negative thoughts and the word trial oftentimes reflects upon "hit and miss' situations. However, together the two words represent the act of conducting a controlled investigation or test. Further, the word randomized should be omitted from the investigative phrase unless denoting sample selection. In this situation randomized infers that either the trial or experiment is random and not the selection of participants nor their placement in the experimental or control group. Probably the better way in which to have labeled the research investigation would have been to call it simply a "clinical trial."

Question #4: The more apt manner in which to explain the concept of randomization to the parents would have been to inform the parents that their child was not to "be assigned" to a particular treatment situation, rather that the children would be impartially selected to participate in one or the other treatment paradigms. Impartially would be further defined as a process of making sure that the assignment of children to either treatment group was made independent of any possible placement foregone conclusions, bias, or pre-conceived notion as to which treatment group favored one participant over another.

Question #5: The Zelen Approach to randomization is not felt to be acceptable for the following reasons: information is withheld from parents; potential bias exists in decision-making; certain data is withheld from parents without knowledge; and the long-term impact on parents is not known.

Question #6: Questionnaires are an excellent pre-emptive move on the part of the research investigator to be able to standardize the information dissemination process. Further an informational questionnaire provides the investigator a measurement tool with which to gage the parent's understanding of the experimental situation and correct any information and procedural errors, confusion, or fears on the part of the parent. More importantly the questionnaire is a means whereby the research investigator is expressing an interest in the parent as well.

Question #7: No. When any research initiative is being conducted recording the proceedings during the trial often occurs for educational purposes similar to those used in competitive sport situations wherein mistakes are recorded, the need for improvement recognized, and alternative methods expressed. Medical trail situations are no different. However, sharing professional and highly technical information with parents in trial medical situations, without proper education and training on the part of the parent, can likely add the element of fear, apprehension, and anxiety for having had their child participate in a research study. Therefore, the recording should only be used for medical education purposes.

Question #8: Yes and No. If I were the parent and informed that the experimental treatment presented no guarantees that a child would survive I would not be angry. In addition, if the ECMO treatment had produced previous evidence that a child can survive and live past one year of age and my child was assigned to the CM sample I would expect to have an opportunity to cross over to the ECMO treatment program as soon as positive results were recorded with the other participants. If I never had an opportunity to place my child in the ECMO group, provided positive recovery results were recorded, I would be extremely angry. Within the present research situation it is not clear if "parents were informed of the trial" means informed of two treatment groups or simply that trial encompassed both and parents were not informed as to the differentiation. If trial is a general term the, as a parent, I would be upset not knowing the difference between the two. However, if both treatments were explained in advance and I, as a parent, did not like placement in the CM group then I would have the opportunity not to participate. The best the physicians can do in this case is to advise parents in the beginning that no promises are made with respect to either treatment but participation will great advance medical science.

Question #9: The answer to this question is, unfortunately, based on a great deal of supposition as the brief did not come straight out and acknowledge the withholding of information. Further there was no mention of possible side effects or treatment efficacy with respect to ECMO being anything more that a medically appropriate experimental treatment. When new treatments are being administered to individual it is a federal regulation by FDA that all participants be given information as to possible side effects as well as benefits. The present study suggested neither.

Case #52

Question #1: Partially. Although "at risk" for any medical disease is an important variable to consider when conducting research, the best-fit model of this research project would have been to follow the treatment and control groups over an extended period of time to determine the long lasting effects of the group treatment method. A pre/post test is an excellent way in which to collect baseline data for longitudinal and cross sectional studies. As bulimia is not a short-term dysfunction it would be extremely important to know the long tern effects of the group treatment format in order to determine risk reduction. Also, on very serious error committed by the research investigator was in the very beginning wherein the statement was made that the investigation sought to determine "cause and effect relationships." Under no circumstance can a treatment variable produce a relationship or correlation between and/or amongst variables. Further, causes and effects are entirely different than relationships and are the result of a treatment variable.

Question #2: Random sampling is important to all research investigation whether they be experimental or descriptive in design. Random sampling reduces selection bias and limits extraneous variable error. When random sampling in its pure form cannot be achieved the research investigator must make necessary changes to the statistical analysis process to accommodate the non-randomization of the sample unit. Random sampling also permits the investigator to make inferences about the overall population with more accuracy and is, therefore, more representative of the population.

Question #3: Yes. Knowing that each moderator had the same manual from which to guide each group adds to standardization and replication. Further, the evaluative material was in written form which also adds to replication. The only hesitation with respect to replicating the study is the lack of information defining "cognitive intervention." To be better able to repeat the study under the same conditions there should be a complete delineation of all concepts and tools employed.

Question #4: The research investigation being reported upon can be classified as pre-experimental design as it is a one shot assessment situation on a pre and post test basis wherein test results are compared to a sample group that has not received treatment. Pre-experimental designs are set up to permit the investigator to make comparisons between the treatment and control group. However, one problem exists with this particular type of research and that is the extent to which internal validity can be controlled visa via testing effects. Once issue that has not been mentioned in the research brief is that of participant communication when not in treatment. Should control and treatment group participants have an opportunity to discuss each other's situation then contamination of the results can readily occur and internal validity greatly reduced.

Question #5: Yes. Small samples are totally justifiable however, the statistical tool selected to analyze the data must be able to accommodate small sample size. The statistical techniques employed for small sample size is what applied statisticians call "robust statistics" or certain parametric types such as the t Test. Although the parametric tool is more robust that the non-parametric counterpart, parametric statistical tools with real small samples may produce misleading information because there is no way to determine if the data came from the Guassian population. That is to say, increasing the number of participants from 15 and 14 respectively to at least 30 and 30 might possibly produce result changes. However, there is no real way of knowing unless the study were replicated with a larger group. The advice to any research investigator is to have a sample size of each group of 25 to 30 at least. When this is not achievable always test the statistical significance of the main statistical value received; i.e., test the statistical significance to the t test or F test value received if that was the statistical test used by the research investigator.

Question #6: Yes and No. Any time there is a gender specific research situation the investigators must be sensitive to their audience. As bulimia is generally thought of to be a female disease, which it is not, it is important to study the disease of at risk people from a very neutral position. Therefore moderator gender is important and only female moderators should be used. Using male moderators with a female at risk audience may possibly bias the results or at least influence the verbal informational dissemination process. As race has no bearing on bulimia the issue is moot. However, without appearing to be stigmatic this reviewer would highly suggest that the moderators not only be female but average in weight and without observable weight issues in order to reduce participant frustration and anxiety which can influence test results for which there is no accounting.