___________________________________________________________________________
200 First Street SW
Rochester, MN 55905
Jennifer B McCormick, PhD, MMP
Division of General Internal Medicine
Assistant Professor of Biomedical Ethics
507-293-0185
mccormick.jb@mayo.edu
Adrian Aldcroft, Executive Editor
BMC Medical Ethics
BioMed Central
236 Gray's Inn Road
London WC1X 8HB
United Kingdom
24 May 2013
Dear Dr Aldcroft:
Please find our revised manuscript for re-submission to BMC Medical Ethics. It is titled Improving
Understanding in the Research Informed Consent Process: A Systematic Review of 54 Interventions
tested in Randomized Control Trials, and presents our findings from review of the literature assesing
interventions for research informed consent. Our primary outcome is understanding, and all
interventions in our sample were tested in randomized controlled studies. We have responded to the
thoughtful comments of reviewers, and detail this in the attached pages.
Research informed consent is a key component of biomedical research that seeks to uphold the ethical
value of participant autonomy. To that end, emphasis is often placed on ensuring research participants
understand the study in which they are enrolling. With the changing landscape of biomedical research
it is critical to develop new approaches to informed consent that are effective and efficient. To remind
you, our findings show that enhanced consent forms, extended discussion, and multimedia
interventions favor improved knowledge outcomes, while only enhanced consent forms and extended
discussion interventions were significant in changing the outcome. The consistency of multimedia’s
effectiveness was not clear. Our analysis adds to what has been previously published. Finally, we
have included a meta-analysis, a first of its kind meta-analysis.
This work has not been previously published in any other English or non-English journal. Neither this
manuscript nor any similar form of it is under consideration for publication in any other journal. We
believe the findings in the manuscript are appropriate for, and would be of great interest to, a wide
range of your readership including those engaged in bioethics, biomedical research, translational and
clinical research, and research policy. All the authors listed here are qualified for authorship and all
those individuals qualified have been included as authors. None of the authors have any conflicts of
interest to disclose.
Thank you for your consideration of our revised manuscript, and we look forward to your response.
Sincerely,
Jennifer B McCormick, PhD, MPP (Corresponding Author)
mccormick.jb@mayo.edu, 507-293-0185 (O)
Major Compulsory Revisions
1) We have corrected all figure labels within the text.
2) We have reduced the length of the discussion; please see the version of the revision with track
changes. We believe that the text we removed does not reduce the points we hope to convey in
the discussion.
3) We have included a statement in the discussion that points out that our findings may not be
applicable to illiterate or socially disadvantaged societies and that this is an for additional
research. See the first paragraph of the discussion.
4) In the description of the traits of the studies we point out that validation of the instruments used
in the studies was not apparent in all instances. We feel that this is sufficent in addressing this
comment, given that a full description of which were validated and which were not would require
significant back-tracking through the literature cited by each of the studies in our analysis. Our
original manuscript included a description of the traits of studies, including the instruments used;
adding more detail we believe would lengthen the manuscript without providing significantly
more information to the findings.
5) We included in the sub-section describing primary our outcome more context about what is
meant by understanding.
6) We have corrected the formatting of the scales in our figures. In this revision, we have
consolidated the data presented in the ‘old’ figures 2-4 into one figure that is now the ‘new’
figure 2. We believe the reviewers, editorial staff, and journal readers will find this new figure
easier to follow.
7) We have included specific sections for Competing Interests, Author Contributions, and
Acknowledgements.
Minor Revisions
1) We have unified our use of authors’ initials.
2) The concern about Table 6 in the context of layout and abbreviations havs been addressed.
3) We thank the reviewer for making the literature search update as a discretionary revision. We
currently do not have additional funding to re-do the search. Also, since our research question
does not relate to a treatment or therapy of a particular disease, we don't believe that the
evidence base for our topic has changed in the last few months.
4) We have clarified by what we mean by proctor, with an explaintion under the section Other Key
Variables in the Methods section. We believe this definition will clear up any confusion a reader
might have.
5) We have removed the alternation between grey and white background in the tables, making all
rows white.
6) We did make reference in the discussion section that interventions aimed explicitly at improving
communication skills of those obtaining consent would be an interesting and novel approach to
investigate for improving the consent process.