Health care users’ acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda

Background: Implementation of appropriate informed consent has become a cornerstone for the use of biological materials and data from clinical care to use in research. During 2017–2018, the Ugandan National Biorepository has since sought prior informed consent for long-term storage and use of remnant clinical human biological materials, where a shortened informed consent form (ICF) was incorporated on the laboratory investigation form. This project aimed at determining the acceptability rate of broad consent from health care users (HCUs) for storage of biological materials and data for research purposes in Uganda. Methods: A cross-sectional study was conducted at three Primary Health Care Facilities. 500 HCUs above 18 years of age seeking health care at outpatient departments between March to December 2020 were invited to enrol. A shortened experimental ICF for this study was developed and attached to the Laboratory investigation form. Results: Overall the acceptability of broad consent for storage of biological materials and data was 86.2% [95% CI: 82.9%-88.9%]. Compared to participants who perceived that the informed consent information is understandable (OR=0.10, CI [0.03-0.32], participants who either partly or totally disagreed were significantly less likely to perceive information as understandable (OR=0.27, CI [0.15-0.46]. 226 out of 431 respondents that accepted storage of biological materials and data, majority (61.7%) preferred to receive feedback on results of relevance to their health. Conclusion: Acceptance of broad consent for storage of biological materials and data for future research purposes was high among HCUs. A shortened and simplified ICF may trigger discussions between participants and health care workers hence increase research participant understanding of study related materials in biobanking. This in turn could enrich ethically collected biobank resources for future research of public health relevance.


Background
Uganda adopted a centralized model of testing to scale-up its national Health programmes such as HIV Early Infant Diagnosis (EID) and HIV viral load monitoring (VL) programmes.Human biological materials such as dried blood spots (DBS) and plasma are collected from remote health facilities in Uganda and delivered to HUBS.A HUB is a coordination center of the sub-district network serving approximately 20-40 health facilities where several referral tests are done.Currently, there are 100 functional HUBS bringing together a network of over 2,500 heath facilities.Biological materials are transported from the HUB to the Central Public Health Laboratory for testing 1 .The total national coverage of both EID and VL for over 150,000 HIV exposed infants and 1,200,000 HIV patients on Antiretroviral Therapy (ART) has resulted in the collection of over 1,500,000 remnant biological materials in a Biorepository for future research.
In September 2016, a National Biorepository was proposed and established to enable storage of human biological materials in a retrievable manner for future research purposes and to foster both local and international research collaborations.During 2017-2018, the National Biorepository sought prior informed consent for long-term storage and use of remnant clinical human biological materials mainly from the programmes mentioned above.A shortened informed consent form has been incorporated on the laboratory request form 2 .
Several bottlenecks in governance and regulation of Biobanks in LMICs were highlighted in our previous work 3 .National Research Biobanking Guidelines have since been developed.They state that all biological materials and associated data obtained during research, clinical care, public health interventions and surveillance require evidence of documented informed consent from the sample donor or their representative for storage [4][5][6] .Each biospecimen should have documentation of informed consent status 7 .Consent for Biobanking for specified or unspecified future research raises unique challenges and concerns for informed decision making especially in the context of clinical care.Participants often do not understand much of the information they are provided with and this is attributed to overly complex Informed consent forms 8 In most cases, there are competing clinical demands that limit time for HCUs engagement with the informed consent document 9 .Broad consent provides participants with a choice about whether to allow their stored specimens to be used in future research based on a broad category, e.g., cancer, heart disease, or behavioral research 10 .However, in the genomics era, broad consent should be implemented within health systems that are trust worthy and have measures in place to ensure that open-ended agreements are not used 11 .This is because broad consent may provide participants with insufficient information to make a reasonable choice 12 while others may change their minds in the future 13 .Additionally, several studies show the lack of understanding of consent and preferences about broad consent 14 .Few studies have investigated the African population, so this research conducted is very relevant and needed.
Implementation of appropriate informed consent is fundamental for the collection and use of biological materials and associated data from clinical care 4,15 .This project aimed to understand the acceptance for broad consent and HCUs knowledge, attitudes, and perceptions of broad consent for storage of biological materials and associated data in Uganda.Findings from this study may contribute to current debate regarding understanding the content of informed consent documents, the purpose of biobanks generally, or the scope of the future research and projects to be carried out.Additionally, findings from this study may be used to design evidencebased practices and procedures for obtaining informed consent for biobanking and to inform research ethics committees (RECs) on assessment of biobanking protocols based on the preferences of actual donors 16,17 .

Methods
The Uganda National Health Laboratory Services Research Ethics Committee (UNHLSREC) for ethics reviewed and approved this study (UNHLSREC008032020).The study

Amendments from Version 1
One of the limitations to this study is that we did not adjust for key confounding variables such as level of education.However, Health Care Users' that are illiterate of the English language were excluded from the study since the Experimental informed consent form about biobanking was written in English.
The media of presentation of the information on the informed consent form is conveyed is key as supported by the participants' suggestions that the form should be translated into local language.Other innovative ways of conveying the information on the consent forms to HCUs should be used.For example Health Facilities could develop short video clips on what and how human biological materials are used in research and the role of the National Biorepository as a resource for scientific research.
Any further responses from the reviewers can be found at the end of the article was approved by Uganda National Council for Science and Technology (HS652ES).Permission was sought from the Medical officer in-charge of each health facility.
A cross-sectional study design was conducted at three Primary Health Care Facilities; Kiruddu National Referral Hospital, Mukono Health Center IV and Reach-Out Mbuya Community Health Initiative.Two data collection tools were used in this study; (i) a shortened experimental informed consent form and (ii) a semi-structured questionnaire that contained the predictor variables.It is comprised of both closed-and open-ended questions.Both the shortened experimental informed consent form and the questionnaire can be found in the Extended data.
HCUs above 18 years of age seeking health care at outpatient departments (OPDs) between March to December 2020 from the selected Health Facilities (HFs) in Uganda were invited to enrol.Only HCUs who consented were enrolled in this study.HCUs that are were not fluent in English were excluded since the shortened Experimental informed consent form about biobanking was in English language only.The sample size was estimated using the modified Kish Leslie (1965) formula N= Z 2 *P (1-P)*D/d 2 where: Z= Standard normal value corresponding to the 95% confidence interval= 1.96, P= Meta-analytic results of studies examining comprehension of 'generic' domains of informed consent.The proportion of participants that understood the right of withdrawal 7 = 0.567, D= Design effect = 1.Because sampling will be implemented in same level of Health facilities, d=Error that can be tolerated in the study=0.05,N= [1.96 2 *0.72(1-0.567)*1]/0.05 2 ≈ 479.Thus, a sample size of 500 participants was enrolled in this project.
HCUs at the selected health facilities were approached by trained research assistants and asked whether they were willing to participate.If willing, they were asked to read and sign a study consent form that explained the essential elements of this study to them before they decided whether to participate in this study or not.Once they consented they were asked to study the experimental Informed consent form about biobanking and then complete a closed-ended and open-ended questionnaire on knowledge, perceptions and attitudes towards biobanking.
A shortened experimental informed consent form (ICF) was developed for this study.This was read, understood and "completed" by the participant before the questionnaire was administered.The experimental ICF contained all the essential elements of informed consent such as background to the National Biorepository, purpose of the consent form, examples of possible future research, benefits, risks, costs, refusal to store left-over specimens, return of research findings, inquiry and consent statement.Completion of the experimental ICF was 'hypothetical' and agreement with it did not mean that the participants' samples were actually to be stored in the National Biorepository.It was simply to collect data about the acceptability of HCUs to store human biological material and associated data.A semi-structured questionnaire consisted of both closed-and open-ended questions.
Predictor variables included; Socio-demographic variables (Age, Sex, Level of Education), understanding of informed consent form, attitude towards the informed consent form, motivation of HCUs for storage of biological material and associated data and perceptions of broad consent for storage of biological material and data.Outcome variable was defined as hypothetical acceptability of the HCUs to store biological material and associated data in the National Biorepository.
Outcome variables were computed and presented as percentages with a 95% Confidence Interval.Continuous variables were computed and presented as means and standard deviations while categorical variables were computed and presented as proportions.Independent/ predictor variables were computed and analyzed as percentages with a 95% Confidence Interval.The statistical associations between socio-demographic characteristics, understanding, attitudes, motivation and perception and acceptability to store biological material to the National Biorepository were determined using logistic regression.Odds ratios (OR) and 95% confidence intervals were generatedto measure the strength of the association of each factor.All statistical analysis was performed using STATA 14.2.

Background characteristics of the HCUs enrolled at selected Primary Health Care Facilities
The mean age of the HCUs was 30.18 years.The proportion of female HCUs was higher (53.80%) than males.The highest percentage (49.40%) of HCUs had attained secondary education.The highest proportion (92.40%) of respondents had never participated in health-related research.Most HCUs (91.20%) did not work in a health-related field.
The lowest proportion of respondents (6.45%) understood that remnant biospecimens are sometimes stored for beyond clinical use.Other background characteristics of participating HCUs are summarized in Table 1.
Prevalence of acceptability of storage of biological material and data related to the background characteristics of health care users The overall prevalence of acceptability of storage of biological materials and data among HCUs was high (86.2%,95% CI [82.9%-88.9%]).Acceptability was higher among the young adults aged 18-35 years (76.6%, 95% CI [72.3%-80.3%]).The prevalence of acceptability was higher among respondents that completed at least secondary education (50.1%, 95% CI [45.4%-54.8%]).Acceptability of storage of biological materials and data for research purposes among HCUs stratified by various background characteristics is summarized in Table 2.

Perception of the format of the experimental informed consent form
Informed consent information that is either partly or not understandable was found to be statistically significant (OR=0.27,95% CI [0.15-0.46])and (OR=0.10,95% CI [0.03-0.32])respectively as compared to informed consent information perceived as understandable.Less informed consent form information was found to be statistically significant (OR=4.39,95% CI [2.03-9.53]with acceptability for storage of biological materials and data.Difficult language was found to be statistically significant (OR= 2.65, 95% CI [1.30-5.39]).Length of informed consent form was found not to be statistically significant.HCUs opinion on the format of the informed consent form is summarised in Table 3 and Figure 1.

Understanding of essential elements of the experimental informed consent form
The majority of respondents understood that their specimen and data could also be used for other health research questions (93.The various reasons that motivate HCUs to accept storage of biological materials and data are summarized in Table 5. HCUs' attitudes towards return of research findings from biological materials and associated data used for research purposes Among respondents that accepted storage of biological materials and data, the majority (266 of 431) preferred to receive feedback on results of any relevance to their health.Figure 2 summarizes HUCs opinion on the return of research results from utilized biological materials and data.
Reasons given for why HCUs wanted feedback of results of clinical relevance included:      HCUs who perceived the ICF language as easy to read were 3 times more likely to accept storage of biological materials and data compared to those who found the language quite difficult (OR= 2.65, 95% CI [1.30-5.39]).HCUs opinion on the format of the informed consent form is summarised in Table 3 and Figure 1.
Most respondents understood that their specimen and data could also be used for other health research questions (93.2%, 95% CI [90.6%-95.1%]).A high proportion of respondents understood that they could withdraw consent for storage of specimens and data at any time (84.34%,95% CI [80.9%-87.3%]).Most HCUs incorrectly believed that their specimens and data would only be used by the National Biorepository (46.48%, 95% CI [42.1%-50.9%]),instead of being accessible from there by other researchers on request.Among respondents that accepted storage of biological materials and data, the majority (266 of 431) preferred to receive feedback on results of relevance to their health.A summary of HCUs understanding of the essential elements of the informed consent form is described in Table 4.
The majority of the HCUs accepted storage of biological materials and data to help other future patients with the same disease/health problem (84.35%, 95% CI [80.6%-87.5%]).
A low proportion of respondents worried that they might be somehow disadvantaged if they gave consent to store biological materials and data for research purposes (5.9%, 95% CI [3.9%-8.6%]).
One of the limitations is that the study did not adjust for key confounding variables such as level of education.However, health care users that were illiterate of the English language were excluded from the study since the experimental informed consent form about biobanking was written in English language.

Discussion
Prevalence of acceptability for storage of biological materials and data Acceptance of storage of biological materials and data was found to be high at 86%, suggesting that most participating HCUs hypothetically accepted broad consent for storage and use of biological material and data for unspecified and/or broad research purposes.This acceptance was higher than the 49.5% that indicated that they would want to be contacted each time their sample was re-used, as reported by Moodley  et al. (2014).Additionally, our acceptance rate was higher than the 66.1% that agreed that broad consent was permissible as reported by Mwaka et al. (2019).
This could partially be explained by the fact that the concept of broad consent and alternative approaches to consent for re-use of biological materials and data has increasingly been discussed in LMICs [17][18][19] .As mentioned in our Background section 20,21 , several challenges have been highlighted in obtaining only specific informed consent; e.g., samples obtained from pediatric and autopsy studies regarded as precious resources, considering the circumstances of the consent process and scarcity of such cases.Biological materials obtained during outbreak investigations may not be traceable to the primary source.Consent to re-use biological materials for unspecified future research helps to lessen the cost and time burdens on researchers.
Almost half of the participants (43.8%) believed that remnant biospecimens were destroyed immediately after laboratory tests.Only 6.6 % and 21.3% thought clinical specimens might be stored for a specified period and for research purposes, respectively.This data may guide in the development of Standard Operating Procedures for sample retention times for biological materials used for clinical purposes that have not been consented for storage.This suggests that sample storage and further use possibilities should be more clearly specified at the time of sampling.

Perception of format of experimental informed consent form
A shortened experimental Informed consent form was developed and tested with HCUs in a public health setting.One of the objectives of this study was to determine HCUs' perception of the length and technical content of the informed consent form.Our data suggest that 82.3% of HCUs found that the length of the informed consent form was appropriate.Sixty five percent of HCUs who accepted storage of biological materials and data indicated that they did not understand some technical terms.However, acceptability of storage of biological materials was not a statistically significant preference.Compared to participants who perceived that the informed consent information is understandable, participants who either partly or totally disagreed were significantly less likely to perceive the information as understandable.Lengthy informed consent forms remain common in research settings in LMICs, despite the fact that they negatively affect potential participants' understanding about the proposed research.A shortened informed consent form may prompt better understanding and willingness to consent, as has been shown elsewhere 22,23 .
HCUs responses on how to improve the broad consent form were articulated as follows:

Understanding of the essential elements of experimental draft informed consent form
The current study found that most HCUs understood the essential elements of the informed consent form.This may have been biased by the fact that our questionnaire was administered immediately after the discussion of the informed consent information.Although there are several reports on assessment of understanding in clinical trials in Africa 24 , there are no existing guidelines on assessment of comprehension of informed consent information used in biobanks, clinical trials and/or research studies.
Regulations and National guidelines 5,15 have set forth topics that should be covered in consent forms however, there is lack of guidance on the action that should be done when a prospective participant fails to understand the information.

Conclusions
Our study showed high HCUs acceptance of broad consent for storage of biological materials for future unspecified research uses.This was statistically significant in HCUs with a history of participating in research and those that worked in a healthrelated field.Almost half of the participants believed that their biological materials were destroyed immediately after the laboratory test.A shortened Informed consent form was developed and assessed by HCUs in a public health setting.
A clear majority of HCUs stated that the length of the informed consent form was appropriate.HCUs that found information either not or partly understandable were less likely to support storage of their biological material and data.Therefore, understanding of the essential elements of the informed consent form is critical as a core ethical principle.A shortened and simplified informed consent form may trigger constructive discussions between potential participants and health care workers and potentially increase research participant understanding of study related materials in biobanking.The current National Research Biobanking Guidelines should be reviewed to include validated assessment tools for comprehension of informed consent information used in biobanks.
The media of presentation that information on the informed consent form is conveyed is key as supported by the participants' suggestions that the informed consent forms should be translated into local languages.Other innovative ways of conveying the information on the consent forms to HCUs should be used.

Zisis Kozlakidis
International Agency for Research on Cancer, World Health Organization, Lyon, France This is a well-structured study, and the limitations are clearly indicated.
The introduction is sufficiently detailed.It is unclear how representative the HCUs are to the rest of the Ugandan population -a succinct statement should be made by the authors to that effect.
The discussion presents the results well within the Ugandan context, it would benefit by comparing and contrasting to the few similar, other studies that have taken place in sub-Saharan Africa on the subject of broad consent.Currently it is mentioned in passing.
The authors correctly state: "there is lack of guidance on the action that should be done when a prospective participant fails to understand the information" -however, they provide no potential recommendation on what may be appropriate within the Ugandan context; or as the basis for future research on the topic.

If applicable, is the statistical analysis and its interpretation appropriate? Yes
Are all the source data underlying the results available to ensure full reproducibility?Yes from? Results: Background characteristics of the HCU enrolled at the selected Primary Health Care facilities.Are these characteristics of the universe population or participants?How many HCU participated?How many did not participate?
Pag 5. First para.When saying that most participants incorrectly believed that their specimens and data would only be used by the Biorepository -was this information included in the hypothetical Informed Consent form?Please clarify.
Table 2. Please add the total number of respondents for reference.Are percentages taken from a total of 431 or total respondents?Page 6, last para.Reasons given for why HCU wanted feedback.Were these obtained via open ended questions?Please clarify.
Table 3. Please add the total number of participants.Please add total numbers for each answer, as well as the numbers for "accept" and "decline" and clarify what total number the percentages refer to.
Some statements are somehow confusing as they use double negatives.I.e., "Did not understand the technical terms" Yes 79, does that mean that 79 participants did not understand the technical terms?Please clarify.
Similarly, "not interested in the content".Please clarify.
Not sure about what Figure 1 adds, as it is the same data shown in Table 3. Please clarify/justify.Table 4. Please add the total number of participants.Please mention which is the correct answer for each question.
Table 5. Please add the total number of participants.
Figure 2. Please add the total number of participants.Could participants select more than one answer for this question?Please clarify.
"HCUs with a history of participating in health-related research were statistically different from those that had never participated (p-value = 0.019).And HCUs with a history of professional work in a medical field were statistically different from those that worked in non-medical fields (p-value = 0.005)."Please clarify how were these groups statistically different.
"Compared to participants who perceived that the informed consent information is understandable (OR=0.10,95% CI [0.03-0.32],participants who either partly or totally disagreed were significantly less likely to perceive information as understandable (OR=0.27,95% CI [0.15-0.46]." Partially or totally disagree with?I cannot see any questions that include partially or totally disagreement (like Likert scales?).Please clarify.
Suggest moving the limitations to the discussion section, and explain how the exclusion of non-English fluent HCUs might have affected the results and its generalizability.
Please describe LMICs in full the first time it appears in the text (Discussion section, second para).The discussion could be strengthened by adding references to existing literature and recommendations for further research and practice that can be drawn from this study.
Hope these comments are helpful.I would be happy to review an updated version.

Is the work clearly and accurately presented and does it cite the current literature? Partly
Is the study design appropriate and is the work technically sound?Partly

Are sufficient details of methods and analysis provided to allow replication by others? Partly
If applicable, is the statistical analysis and its interpretation appropriate?I cannot comment.A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?Partly

Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Clinical ethics, research ethics, end of life and palliative care, paediatrics.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Version 1
Reviewer This manuscript reports on an interesting and truly relevant study on information and hypothetical consent procedure for a biorepository in Uganda.Additionally, authors apply an open science approach, which deserves compliments.However, before indexing the manuscript requires major revision.

General issues
Overall, there is a lack of transparency or clarity in the report of this study.It is not possible yet to understand or replicate the study easily.The structure of this manuscript requires improvement.
Results are incorrectly reported which worries the reviewer a bit.Lastly the report is superficial in relating to the literature, description of the methods, and discussing the implications of the results.

Detailed comments
Abstract "short informed consent statement (ICF)" = shortened informed consent form (ICF) or shortened statement of informed consent (IC)."Broad consent provides participants with a choice about whether to allow their stored specimens to be used in future research based on a broad category, e.g., cancer, heart disease, or behavioural research (9).":Better define broad consent and relate to the literature, since there much more literature discussing consent and the complexity of being informed.For example, Manson, 2019 1 .Or Horton R, Lucassen A., 2019 2 .
○ "However, a few researchers argue that broad consent may provide participants with insufficient information to make a reasonable choice (10) while others may change their minds in the future (11).": this is somewhat an understatement of the ongoing debate on consent in literature.Additionally, several studies show the lack of understanding of consent and preferences about broad consent, for example Ballard et al., 2020[re-3].Few studies have investigated the African population, so this research conducted is very relevant and needed.
○ "Implementation of appropriate informed consent has become a cornerstone for the collection and use of biological materials and associated data from clinical care10.": This is a very strange reference for this statement.
○ "Findings from this study may hopefully contribute to current debate regarding understanding the content of informed consent documents, the purpose of biobanks generally, or the scope of the future research and projects to be carried out11.": Why does your hope need a reference?That does not seem right.

○
"aim" = "objective", the current descriptions of aim/objective/research question are rather confusing or not correct and overlap.Keep a revised objective and loose the rest.

Methods
The study design (experimental versus non-experimental) should be written more clearly.
How was the study introduced to potential participants in the study consent form, and how were research assistants trained?This might influence your outcome measure, for example being a hypothetical willingness or closer to a 'real' willingness.

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Lack of description of variables chosen and rationale for the choice.It requires the reader to check the attachments to get some understanding.The authors should help the reader by providing more information in the text.

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The following reads as results, but is mentioned as discussion.Is this correct?
"Almost half of the participants (43.8%) believed that remnant biospecimens were destroyed immediately after laboratory tests.Only 6.6 % and 21.3% thought clinical specimens might be stored for a specified period and for research purposes, respectively.This data may guide in the development of Standard Operating Procedures for sample retention times for biological materials used for clinical purposes that have not been consented for storage.This suggests that sample storage and further use possibilities should be more clearly specified at the time of sampling.

Perception of format of experimental draft informed consent form
A shortened draft experimental Informed consent form was developed and tested with HCUs in a public health setting.One of the objectives of this study was to determine HCUs' perception of the length and technical content of the informed consent form.Our data suggest that 82.3% of HCUs found that the length of the draft informed consent form was appropriate.Sixty five percent of HCUs who accepted storage of biological materials and data indicated that they did not understand some technical terms.However, acceptability of storage of biological materials was not a statistically significant preference.HCUs who could not understand some of the draft ICF were 90% less likely to accept storage of their biological material and data for research purposes.Those who partly understood the draft ICF were 73% less likely to accept storage of their biological material and data for research purposes.Lengthy informed consent forms remain common in research settings in LMICs, despite the fact that they negatively affect potential participants' understanding about the proposed research.A shortened informed consent form may prompt better understanding and willingness to consent, as has been shown elsewhere18,19."I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
How the information on the consent form is conveyed is key as supported by the participants' suggestions that the form should be translated into local languages.The authors could recommend other innovative ways of conveying the information on the consent forms to healthcare users.For example, healthcare facilities could develop short video clips on what and how human biological materials are used in research and the role of the National Bio-repository as a resource for scientific research.
Overall, this is a very good paper and will be of interest to the broader readership.The authors conclude that acceptability of Broad Consent was high among healthcare users and that participants are more likely to accept this model of consent if they understand the purpose of future uses of human biological samples.The recommendations drawn from the study are important and could inform other research initiatives on how understanding of research could be enhanced to support the ethical use of biological samples and associated data.
Under Acknowledgement, with more than one author listed, all the singular pronouns should be changed to plural i.e. 'we would like to thank my participants' should be 'our participants' etc.

Is the work clearly and accurately presented and does it cite the current literature? Yes
Is the study design appropriate and is the work technically sound?Yes

Are sufficient details of methods and analysis provided to allow replication by others? Yes
If applicable, is the statistical analysis and its interpretation appropriate?Partly Are all the source data underlying the results available to ensure full reproducibility?Yes

Are the conclusions drawn adequately supported by the results? Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Public health, bioethics, social science research, research ethics, health policy I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
One of the limitations is that this study did not adjust for key confounding variables such as level of education.However, Health care users' that are illiterate of the English language were excluded from the study since the draft Experimental informed consent form about Biobanking was written in English language 1.
The National Research Biobanking Guidelines should be reviewed to include a validated assessment tool for comprehension of ICFs used in Biobanking 2.
The media of presentation of the information on the ICFs is conveyed is key as supported by the participants' suggestions that the Informed Consent form should be translated into local languages 3.
Other innovative ways of conveying the information on the ICFs to HCUs should be adopted.For example development of short video clips on what and how human biological materials are used in research and the role of the National Biorepository as a resource for scientific research 4.

Objective 1 :Objective 2 : 3 : 4 :
Determine factors associated with the relationship between understanding of essential elements of the informed consent form and acceptability of storage of biological material and data Determine the factors associated with attitudes and acceptability of storage of biological material and data Objective Determine HCUs acceptability rate for storage of biological materials and associated data Objective Determine factors associated with motivation and acceptability for storage of biological materials and data Objective 5: To determine the factors associated between HCUs' perceptions and acceptability of storage of biological materials and data

Figure 1 .
Figure 1.Perception of the format of the experimental informed consent form by HCUs in Uganda, 2020.

Figure 2 .
Figure 2. HCUs' attitudes towards return of research results from biological materials and data in Uganda, 2020.
(a) Simplify the technical terms and language used.(b) The Informed consent form should be translated in various languages.(c) Shorten the informed consent form to make it brief.(d) Offer participants enough time to understand the information.(e) More sensitization of the informed consent process should be done.(f) The examples for possible re-use of biological materials should be written in a simplified language.

Pag 11 ,
second para "HCUs responses on how to improve the broad consent form were articulated as follows: (a) Simplify the technical terms and language used.(b) The Informed consent form should be translated in various languages.(c) Shorten the informed consent form to make it brief.(d) Offer participants enough time to understand the information.(e) More sensitization of the informed consent process should be done.(f) The examples for possible re-use of biological materials should be written in a simplified language."This should go in the results section.
Report 05 May 2022 https://doi.org/10.21956/wellcomeopenres.19505.r48966© 2022 Broekstra R.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Reinder Broekstra 1 Clinical Ethics and Law Southampton (CELS), Faculty of Medicine, University of Southampton, Southampton, UK 2 Health Psychology Research, Health Sciences, Faculty of Medicine, University of Groningen, Groningen, The Netherlands Review Health care users' acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda

○"
"shortened experimental draft ICF" revise to shortened or experimental, since the draft is used eventually.Consent for bio-banking for specified or unspecified future research raises unique challenges and concerns for informed decision making especially in the context of clinical care.":Explain, give some examples, and add references.

○ ( 2 )
: 85-91 PubMed Abstract | Publisher Full Text 3. Ballard LM, Horton RH, Dheensa S, Fenwick A, et al.: Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study.Eur J Hum Genet.28 (6): 732-741 PubMed Abstract | Publisher Full Text Is the work clearly and accurately presented and does it cite the current literature?Partly Is the study design appropriate and is the work technically sound?Partly Are sufficient details of methods and analysis provided to allow replication by others?No If applicable, is the statistical analysis and its interpretation appropriate?Partly Are all the source data underlying the results available to ensure full reproducibility?Yes Are the conclusions drawn adequately supported by the results?Partly Competing Interests: No competing interests were disclosed.Reviewer Expertise: Ethical, Legal, and Social Aspects of innovative (Information) Technology in biomedical sciences and Medicine.

Table 1 . Background characteristics of 500 HCUs at selected health facilities in Uganda, 2020. Characteristics Health Care Users (n=500) Mean Age (SD)
History of participation in health related research n (%)Yes 38 (7.60)No 462 (92.40)History of professional work in a medical field n (%)* Certificate

Knowledge of what happens to remnant biospecimen after laboratory tests
*Certificate

Table 4 . Understanding of essential elements of the experimental informed consent form by HCUs in Uganda, 2020. Characteristics Correct n (%) [95% CI] Not correct n (%) [95% CI] Not sure n (%) [95% CI]
If in the course of the research with my specimen and data something is found out that is relevant to my health, this will be reported to me

Open Peer Review Current Peer Review Status: Version 2
For example Health care facilities could develop short video clips on what and how human materials are used in research and the role of the National Biorepository as a resource for scientific research.This is an open access peer review report distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Table 2 ,
percentages do not correspond to the relevant information in table 1 and table 2. It would help to have a comparison per characteristic of accepted versus declined.
○Prevalence is a strange term to use in this context.○Itwould be good to understand how motivations are associated with other characteristics, ○

Table 4 .
Show the reader what the correct answers were because some do not know or do not have time to check your documents themselves.