Human Participants

JPNS's policy is to ensure that all articles published by JPNS report on work that is morally acceptable, and expects authors to follow the World Medical Association’s Declaration of Helsinki. To achieve this, we aim to appraise the ethical aspects of any submitted work that involves human participants, whatever descriptive label is given to that work including research, audit, and sometimes debate.

Statement of Ethics Approval

We require every research article submitted to include a statement that the study obtained ethics approval (or a statement that it was not required and why), including the name of the ethics committee(s) or institutional review board(s), the number/ID of the approval(s), and a statement that participants gave informed consent before taking part.

In addition we welcome detailed explanations of how investigators and authors have considered and justified the ethical and moral basis of their work. If such detail does not easily fit into the manuscript please provide it in the covering letter or upload it as a supplemental file when submitting the article. We will also be pleased to see copies of explanatory information given to participants. Even if we do not include such detailed information in a final published version, we may make it available to peer reviewers and editorial committees. We already ask peer reviewers to consider and comment on the ethics of submitted work.

Appraisal of Ethical Issues

Editorial appraisal of ethical issues goes beyond simply deciding whether participants in a study gave informed consent although this is, of course, one very important issue to consider. Editors should judge whether the overall design and conduct of each piece of work is morally justifiable, as summed up by the following questions:

• How much does this deviate from current normal (accepted, local) clinical practice?
• What is the (additional) burden imposed on the patients (or others)?
• What (additional) risks are posed to the patients (or others)?
• What benefit might accrue to the patients (or others)?
• What are the potential benefits to society (future patients)?

Even when a study has been approved by a research ethics committee or institutional review board, editors may be worried about the ethics of the work. Editors may then ask authors for more detailed information such as:

• how they justified the ethical and moral basis of the work
• to provide the contact details of the research ethics committee that reviewed the work, so that the journal can request further information and justification from that committee
• to explain what ethical issues they considered and how they justified their work, for studies that have not been reviewed by research ethics committees or institutional review boards

Editors may ask other editorial colleagues to evaluate the ethical aspects of an article, the authors’ comments, and the response of the relevant research ethics committee to the journal’s queries about ethics approval. This consultation may be informal, between the journal’s editors, or more formal, through seeking the advice of the Committee on Publication Ethics (COPE). Problems referred to COPE will be considered as anonymised summaries of the relevant articles, written by the editors concerned.

What happens when the journal considers a study to be unethical?

We believe that editors have a duty to take on issues of unethical audit or research, not to seek punishment for the authors, but to prevent unethical practice and to protect patients.

If the Editor, with or without the advice of its ethics committee and/or COPE, considers the work in a submitted article to be ethically unsound the editor may seek further advice or recommend investigation or action. The fact that the article would have been rejected anyway for other scientific or editorial reasons would not prevent the editor from taking such further action on serious ethics problems.

In the first instance the editor would usually contact the head of the department where the work was done to explain their concerns and recommend a local investigation. Secondly, the editor might write to the professional registration body of the paper’s guarantor or principal investigator.

Exceptional circumstances

In rare instances the journal might publish an article despite ethics problems in the work it reported. The usual reason would be that work done in one setting might not reach the ethical standard of work done in another setting, because of differing local resources and standards for health care and research. In deciding to publish such an article, we would consider carefully the context of the study and aim to balance the overall benefit to society against the possible harm to the research participants.

Animal Participants

All material published in JPNS which reports experiments performed using animals must adhere to high ethical standards concerning animal welfare.

Manuscripts will be considered for publication only if the work described:

• follows international, national and institutional guidelines for the humane treatment of animals and complies with relevant legislation;
• has been approved by the ethics review committee at the institution or practice at which the studies were conducted (where such a committee exists);
• for studies involving non-human primates, demonstrates that the standards meet those of the NC3Rs primates guidelines;
• for studies using client-owned animals, demonstrates a high standard (best practice) of veterinary care and involves informed client consent.

Before a manuscript can be accepted, authors must:

• confirm that legal and ethical requirements have been met with regards to the humane treatment of animals described in the study;
• specify in the Materials or Methods section the ethical review committee approval process and the international, national, and/or institutional guidelines followed.

Editors retain the right to reject manuscripts on the basis of ethical or animal welfare concerns. Papers may be rejected on ethical grounds if the study involves unnecessary pain, distress, suffering or lasting harm to animals, or if the severity of the experimental procedure does not appear to be justified by the value of the work presented. We ask that the work would be likely to gain approval in Europe under the European Directive 2010/63/EU (on the protection of animals used for scientific purposes).

See ‘What happens when the journal considers a study to be unethical?’ above for an outline of how ethical concerns will be dealt with. Manuscripts describing animal research must include a justification for the use of animals, and for the particular species used. They should also provide details of animal welfare, including information about housing, feeding and environmental enrichment, a description of steps taken to minimise suffering, humane endpoints and method of euthanasia. If the study has any implication for the 3Rs (replacement, reduction and refinement), these should be discussed in enough detail so that readers can implement the 3Rs in similar experiments.

VulnerableParticipants

JPNS places a particular emphasis on research involving vulnerable participants. In the Declaration of Helsinki, the World Medical Association defines vulnerable groups and individuals as those who may have an increased likelihood of experiencing harm or injustice. Specifically, the Declaration identifies vulnerability as arising from a reduced ability to provide informed consent. It states, "Some research populations are particularly vulnerable and require special protection. These include individuals who cannot provide or refuse consent for themselves...," as well as those "who may be susceptible to coercion or undue influence."

According to the guidelines provided by the US Department of Health and Human Services regarding the Protection of Human Subjects, vulnerable groups specifically encompass children, prisoners, pregnant women, fetuses, individuals with mental disabilities, and economically and educationally disadvantaged individuals. Consequently, authors submitting manuscripts to JPNS that involve vulnerable groups must provide a detailed explanation of the ethical process, informed consent procedures, and the legal guardian authorized to grant consent.

Categories of Vulnerability

The categoies of vulnerability based on National Bioethics Advisory Committee:

Cognitive or communicative vulnerability

Cognitive or communicative vulnerability occurs when any participant is unable to process, understand, appreciate, and reason through the consent documentation and/or explanations either by mental limitation or language limitation. There are various degrees as to how this may occur. For example, a participant may not be able to read a consent form because of illiteracy, low reading comprehension skills, and/or not speaking the language in which the form is written. If you are targeting a population where this is likely to occur, you need to provide a consent procedure that will accommodate the needs of your participants either by translating the document, writing it in lay language, or discussing the consent. In some cases, you may not be targeting this population, but the issue may arise during a consent session. Do your best to make sure that the participant understands what he or she is consenting to before enrolling them in the study. If you are likely to work with participants where capacity to consent is an issue, it may be necessary for you to include a procedure to assess the participant's capacity to consent. In the case where a participant may not be able to process the full meaning of consent (such as a young child) or is limited by mental defect or disorder, it will be necessary that you obtain consent from a surrogate who is legally responsible for the individual. Although the person may not be able to give full consent, it is still important to involve the person in the consent procedure as to their capability. 

Institutional vulnerability

Institutional vulnerability occurs when individuals are subject to a formal authority and whose consent may be coerced either directly or indirectly. Examples include prisoners, student/professor relationships, and/or employee/employer relationships. The role of the formal authority in the study will determine the level of perceived or real coercion in the study (i.e. professor studying his students). The solution to this issue is often in the manner in which data are collected and consent is obtained. Using a third party to do so often eliminates any conflicts of interest. However, in the case of prisoners, specific rules are in place regarding their use.

Deferential vulnerability

Deferential vulnerability occurs when individuals informally subordinate to an authority figure. For example, abuse victims, doctor/patient relationships, and/or husband/wife relationships are all situations where one party may feel obligated to follow the advice of another. These situations require a sensitive recruitment and consent plan where participants have the opportunity to consent voluntarily.

Medical vulnerability

Medical vulnerability occurs when individuals' medical state may cloud their ability to make a decision regarding study participation. The patient may see the research study as a miracle cure to their disease instead of a procedure that has no guarantee for results. Often presenting the study in an environment where the participant is able to understand the full meaning of the study will help to alleviate any misunderstanding.

Economic vulnerability

Economic vulnerability occurs when individuals' economic situation may make them vulnerable to the prospect of free medical care and/or the payments issued for participating in the study. It is important that the payment offered will not encourage an individual to put themselves at a greater risk than they would otherwise.

Social vulnerability

Social vulnerability occurs when participants are at risk for discrimination based on race, gender, ethnicity, and age. Researchers may not offer the full explanation in the consent because they feel a participant is not able to comprehend it because of that person’s race, etc. The participant may also be prone to feel discriminated against as well and may not participate as a result of this predisposition. 

Legal vulnerability

Legal vulnerability occurs when participants do not have the legal right to consent or who may be concerned that their consent could put them at risk for legal repercussions. For those who are unable to legally consent, it is important that you obtain consent from a legal representative and in most cases obtain assent from the individual. For those that are concerned about having their legal status compromised by the study, you should take steps to legally protect participants. For example, obtaining a Certificate of Confidentiality for U.S. citizens can protect confidentiality. For some, alternative consent methods may appropriate, such as oral consent.

Study vulnerability

Study vulnerability occurs when participants are made vulnerable by the study’s design. Generally this category refers to participants who are deceived during the study and/or the nature of the study is not revealed to the participant. This can be alleviated by providing full consent and disclosure after the study is completed or whenever a participant withdraws from the study.