Protection of Research Participants

MedEdPublish – Policy on protection of research participants
Version 01: June 2019
Last update: June 2019

This policy is intended to complement our 'guidelines for authors' and 'editorial policy' and should be read in conjunction with these documents.


Contents

1. Scope of this policy
2. Variations in local and national requirements
3. Formal ethical approval
4. Research conducted without ethics approval
5. Informed consent
6. Privacy of research subjects
7. Author requirements
8. Exemplar author declarations 9. Research involving animals

1. Scope of this Policy

We follow guidelines on publication ethics and protection of research participants from COPE, ICJME and WAME. It is our policy that all manuscripts submitted to MedEdPublish, including non-research articles, include:
  1. A statement on ethical approval; AND
  2. A statement on informed consent.
If a study involves animals, these should be replaced with statements on care and use of animals and animal welfare.

2. Variations in local and national requirements

We appreciate that laws and regulations governing what constitutes research and what types of research requires formal ethical approval varies between countries, regions and institutions. Editors will consider the local and national requirements and legislation for formal approval in the country where the research was conducted, however authors will need to provide enough detail for the situation to be understood by an international readership who might not be familiar with regulations in that location.

Regardless of local regulations, research involving human participants will only be published in MedEdPublish if authors can demonstrate that it was conducted in accordance with the 2013 Declaration of Helsinki. This includes requirements for authors to seek informed consent from participants and to respect their privacy by publishing only anonymised findings.

3. Formal ethical approval

Where such bodies exist, we expect that all authors will seek approval to conduct research from an independent local, regional or national review body (e.g., Ethics Committee, Institutional Review Board). The author declaration should include the institution, review board name, and permit number(s). If the study is judged exempt from review, the reason for exemption should be noted in the author declaration. Ethics approval must be obtained before the research is conducted. Most Review Boards will not consider retrospective applications and this may mean the study cannot be published.

Where formal ethical approval was not sought, either because authors did not have access to a formal ethics review committee or because local regulations specifically excludes projects from requiring ethical approval, authors will be asked to make a declaration that the principles outlined in the Declaration of Helsinki were followed.

4. Research conducted without ethics approval

Where formal ethical approval was not sought, editors will follow COPE guidelines, and use the following criteria to determine whether a manuscript can be considered for publication:

  1. Is the study scientifically valid and clearly presented; for example is the sample size adequate, are the results adequately and clearly presented and explained, and have the investigators excluded or considered the possible confounding factors and/or biases? Second, does the study contribute sufficiently to knowledge to make acceptance and publication a possibility?
  2. Have the ethical harms been minimised; for example has due care been taken to avoid coercion or exploitation, to protect confidentiality, to minimise the risk of physical and psychological harm and to respect autonomy where possible? (For example, information sheets and consent forms can still be used for certain audits and service evaluations as a demonstration that appropriate ethical standards are being met, even if a research ethics committee has not asked for it). It may be necessary to seek further information from the investigators to establish how they have addressed these issues.
  3. Do the benefits outweigh the harms in this particular study’s case?
  4. If there is doubt about local law or regulations, editors will clarify this with the authors and ask them to provide a letter from the individual research ethics committee or the research ethics authority in that country about the research.

Extract from: https://publicationethics.org/files/Guidance_for_Editors_Research_Audit_and_Service_Evaluations_v2_0.pdf [accessed 03-06-2019]

Regardless of whether formal approval was granted, the editors reserve the right to form their own judgment as to whether the conduct of the research was appropriate, and to reject manuscripts on ethical grounds.

5. Informed consent

Where a study involves human participants and has been explicitly conducted as research, written, informed consent should always be sought prospectively from participants.  When informed consent has been obtained, it should be indicated in the published article. If informed consent was not obtained, for example if the article is an audit or evaluation of an educational activity using routinely collected data, the reasons for this should be clearly stated.

6. Privacy

Submissions that include identifiable participant data, including images, will not be considered for publication unless it is absolutely necessary to the study and the authors can demonstrate that informed consent was obtained. Any use of identifiable images must be accompanied by a statement to confirm that informed consent was obtained from the participant. Signed consent forms must be made available to the MedEdPublish editorial office if requested. If identifying information is discovered after publication, articles will be temporarily withdrawn until the required corrections can be made.

7. Author requirements

When submitting their manuscripts, authors must:
  • Complete the declarations section to indicate that the research was conducted in accordance with ethical principles and guidelines;
  • Include a statement to indicate whether informed consent was sought.
Upon request from the editorial team, authors must additionally:
  • Provide a copy of their research ethics approval letter or exemption statement;
  • Where this is not available, provide documentation or a link to any local or national guidance that was followed;
  • Provide a blank copy of any form that was used to obtain informed consent and any participant information sheets that were provided;
  • Where identifiable participant data has been used, signed consent forms may requested.

8. Exemplar statements for authors

These are examples of the minimum declarations we expect authors to make. You may wish to include more detail about how you addressed ethical issues in your study.

8.1 Ethics Board approval

Ethical approval for this study was obtained from [Institutional review Board / Ethics committee] at [Institution name] on [date] (Approval / ID number).

This research was considered by [Institutional review Board / Ethics committee] at [Institution name] on [date] and deemed exempt because [reason for exemption]. The research was conducted in accordance with the Declaration of Helsinki.

This research was not submitted for Ethics Board approval because [reason]. The research was conducted in accordance with the Declaration of Helsinki.

This research did not require Ethics Board approval because it does not involve human or animal subjects.

Ethical approval was not required for this [article type] because it is not reporting research findings.

If authors are unable to make one of these declarations, they may wish to make an informal enquiry to the editors prior to submitting a manuscript about whether the research is likely to be considered for inclusion in the journal.

8.2 Informed consent

Written informed consent was obtained from all subjects before the study.

Verbal informed consent was obtained from all subjects before the study. This entailed [description of how consent was sought and documented].

Informed consent was not sought for this study because [reason for not seeking consent].

Informed consent was not required as this study/ [article type] does not involve human participants.

Where identifiable participant data is included in an article:
I/we confirm that I/we have obtained written permission to use [images/data] from the individuals included in this article.

If authors are unable to make one of these declarations, and the research involved human participants, it is highly unlikely we will be able to consider it for publication. If informed consent was not sought, authors may wish to make an informal enquiry to the editors prior to submitting a manuscript about whether the research is likely to be considered for inclusion in the journal.
 

9. Research involving animals

When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. Further guidance on animal research ethics is available from the International Association of Veterinary Editors’ Consensus Author Guidelines on Animal Ethics and Welfare.