Informed Consent

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Informed consent for carers - Better Health Channel

If adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent. The informed consent process makes sure that your health care provider has given you information about your condition along with testing and treatment options before you decide what to do. The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider. It implies that your health care provider has given you information about your condition and treatment options and that you have used this information to choose the option that you feel is right for you.

The way in which your treatment options must be given to you for example, verbally or in writing may be listed in your state's laws. Your health care provider works with you to figure out the best way to give you the information you need.

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  • The provider may choose to use methods other than a verbal discussion or a written document, such as videos, interactive computer modules, audio files or other methods to help you understand the information better. Be sure you understand all the information given, even if it means going over it many times or asking your provider to explain it in different ways.

    Yes, you can change your mind at any time, even if you have already started treatment. While some assessment methods were validated for their respective study populations through pilot methods, validation for the population under study was not a consistent feature for all methods. Meta-analysis of multimedia-based consent approaches showed a non-significant increase in understanding scores compared with control consent approaches SMD 0.

    Due to this heterogeneity, the meta-analysis results should be tempered with contextual data from the component studies. Several contextual details of the control procedures and intervention design of the studies included in the meta-analysis are of note. Three of the included trials had non-standard controls. Mittal et al. They specified no control, but the data allowed us to assign the enhanced form as a non-standard control. Hack et al.

    Agre and Rapkin compared several interventions to a consent form that was modified to read at the 8th grade level [ 33 ].

    Why do I have to sign a consent form?

    Relatedly, Bickmore et al. We included the data comparing the computer-based proctor intervention to the human proctor control , which showed no significant difference. Finally, as noted elsewhere [ 34 ], the multimedia intervention tested by Llewellyn-Thomas et al. Six additional studies were reviewed but not included in the meta-analysis due to the absence of requisite data in their published results. Fureman et al. While the intervention of Kass et al. Campbell et al.

    We averaged the results for both, which were similar and non-significant. Finally, Wirshing et al. The team compared a specialized video to a general IRB video with university students, Veterans Affairs VA patients, and patients with schizophrenia. While all showed significant improvement in understanding post-intervention, the students benefited the most.

    Results from other studies included data for populations with mental illnesses [ 31 , 38 , 39 ], history of injecting drug use IDU [ 36 ], and varying stress levels [ 33 ]. Meta-analysis showed that the enhanced consent form category was associated with significant increase in understanding scores compared with control consent approach SMD 1.

    These subgroup interactions simulated and human proctor partially explain the observed heterogeneity. In addition to the impact of simulation and presence of a proctor, other factors may have impacted study heterogeneity in the meta-analysis. Three other studies included populations that had mental illness [ 41 ], low literacy levels [ 27 ], or low-income levels [ 42 ].

    Another source of heterogeneity is the way in which researchers assessed participant understanding.

    Why is Informed Consent essential? - Dr. Ritu Rawat

    Unlike the paper-based testing formats used by most studies, Rogers et al. Of the studies not included in the meta-analysis, only one had significant results. Bjorn et al. For the scenario involving a theoretical hypertension study, the results were significant, but for a sterilization scenario, results were non-significant [ 44 ]. However, Agre and Rapkin, as with their trial of a multimedia intervention, used a control form with improved readability potentially decreasing the perceived effectiveness of the intervention [ 33 ].

    Murphy et al. The approach of using extended discussion was associated with significant increase in understanding scores compared with control consent approach SMD 1. These subgroup interactions partially explain the minimally observed heterogeneity. Studies not included in the meta-analysis for this category of intervention showed varied results. Sarkar et al. Aaronson et al. Both studies assessed outcomes with an interview-style format. Simes et al. However, an intervention reassessed in this review as part of a randomized control trial did show a significantly positive effect [ 24 ].

    CPMS informed consent forms

    None of the other interventions from the review were randomized, thus they were not included in this analysis. Two of the five new miscellaneous interventions showed significant improvement in understanding [ 47 , 48 ]. Four studies in the meta-analysis had multiple intervention arms [ 32 , 49 — 51 ]. The choice of intervention arm did not affect the overall conclusions of this meta-analysis. There is little to no indication that the interventions tested in these trials negatively impact participant satisfaction or study accrual.

    Data regarding rates of participant satisfaction were tracked for eleven interventions. Preferences between interventions and controls were either insignificant or showed that participants significantly preferred the interventions [ 19 , 27 , 29 , 32 , 35 , 43 , 47 , 52 — 54 ]. Accrual rates, tracked for trials with real parent studies, were also reported as improved or unchanged by interventions in all categories [ 13 , 23 , 29 , 43 , 52 , 55 , 56 ], with one exception [ 46 ].

    These findings are consistent with those discussed in the review [ 14 ]. The seven interventions in the multimedia and enhanced form categories significantly improved knowledge retention rates [ 25 , 36 , 37 , 50 ]. Three interventions in the other categories had insignificant results for retention [ 24 , 46 , 48 ]. Of these studies, all found significantly positive impacts from their interventions. Different types of intervention to improve research consent across a variety of settings show mixed impact on improving participant knowledge.

    In addition, this first of its kind meta-analysis, notwithstanding the stated limitations, demonstrates that enhanced consent forms, extended discussion, and multimedia interventions favor improved knowledge outcomes.


    Our findings confirm those from other previously performed systematic reviews. However, they may not be applicable to illiterate or socially disadvantage groups, given the limits of our search, indicating an important domain for more research. Our data highlight several key points.