Deliverable 6 2 Professional and Ethical Issues Report (1.1)

This project has been funded with support from the European Commission. This publication (communication) reflects the views only of the author, and the Commission cannot be held

responsible for any use which may be made of the information contained therein.

CMAster Project Deliverable 6.2:

Professional and ethical issues

report

1 Version History

Version Date Change Author(s)

1.0 24 April 2013 Initial draft Richard Baker

1.1 25 Sept 2014 Revision after comments Richard Baker

2 Content

1 Version History ................................................................................................................................ 1

2 Content ........................................................................................................................................... 1

3 Purpose and Background ................................................................................................................ 2

4 Professional and ethical issues ....................................................................................................... 2

4.1 Identification of professional issues ....................................................................................... 2

4.2 Ethics of human participation in research .............................................................................. 3

4.3 Ethics of human involvement in educational and training ..................................................... 5

4.4 Special provision for distance learning ................................................................................... 6

5 Guidelines for professional and ethical issues within the CMAster programme ........................... 7

5.1 Professional competency of graduates ................................................................................... 7

5.2 General ethical issues ............................................................................................................. 7

5.3 Risks of clinical movement analysis ........................................................................................ 8

5.4 Learning activities involving human participants ................................................................... 9

5.4.1 Practising on peers .......................................................................................................... 9

5.4.2 Clinical placements ......................................................................................................... 9

5.4.3 Clinical case material ..................................................................................................... 10

5.5 Research activities involving human volunteers ................................................................... 11

2 | D6.2 Professional and ethical issues report

3 Purpose and Background

As specified in the original proposal this document:

this document will outline the various professional and ethical issues related to the course with a specific focus on work based study, mentored practice and clinical placements. A particular issue will relate to Clinical Gait Analysts having with a range of different professional qualifications some of which may not be recognised in states in which some students might prefer to have their clinical placements.

This document will try to identify the issues and provide guideline as to how they should be addressed within the CMAster programme.

4 Professional and ethical issues

4.1 Identification of professional issues

Clinical movement analysis is inherently multi-disciplinary. Health professionals involved in clinical gait analysis alone include doctors (including neurologists, orthopaedic surgeons, rehabilitation specialists and others), physiotherapists, orthotists, prosthetists, podiatrists, kinesiologists, human movement scientists, sports scientists, engineers and physicists. Different clinical gait analysis services choose to employ individuals from a diverse range of backgrounds to fulfil on specific responsibilities and there is also considerable variability in how staff are managed both for clinical and professional responsibilities.

Most of the professions are regulated at a national level. The 2005 European Union Directive on Recognition of Professional Qualifications has established a framework for moving towards better integration of professional qualifications within Europe but the extent to which this has been implemented varies quite widely across Europe and across the professions. The Regulated Professions Database is part of this process and illustrates the bewildering range of regulatory frameworks. There are, for example, 1,368 different regulated professions within medicine across Europe. By contrast only 17 or the 28 EU states have prosthetist/orthotists recorded in the database as a regulated profession with this being a primarily vocational training in some states and an academic one in others. There is no listing within the database for sports scientists, kinesiologists or human movement scientist as a regulated profession in any of the EU states.

There is also wide variability in how staff from different professional backgrounds are employed and managed within clinical gait analysis services across Europe (and even wider variation outside Europe) and of what tasks they are assumed to be competent. In some countries professionals allied to medicine are perceived as professional practitioners applying independent clinical judgement whereas in others they are perceived as essentially technical working under medical supervision.

The mechanisms used to manage such disparate professional teams also vary widely. Line management will generally be structured to map onto service delivery. In some services professional accountability will be separate to this within a profession, in others it will be assumed to be part of line management responsibility regardless of whether the manager is of the same profession. In many cases issues of professional accountability will never have received explicit consideration.

There is also widespread variation across Europe in governance arrangement for hospitals and other clinical services. In some countries restricting employment in specific areas to staff with specific qualifications or regulated by specific professional bodies is a core component of clinical governance.


In others there is much less regulation at this level. There can even be variation within countries depending on factors such as whether a hospital or other clinical service is publicly or privately run.

The initial assumption for the CMAster programme was that there would be specific guidance as to how students from different professional backgrounds would be accommodated within the programme. The sheer complexity of the European context as outlined above however renders this impossible. As an alternative a set of broad guidelines has been developed to address this issue.

4.2 Ethics of human participation in research

Taught masters degree programmes within Europe have a taught component and a research component. Both components give rise to a number of ethical issues.

The ethical basis for medical research involving human subjects is well established. All such research should now be conducted in accordance with the Helsinki Declaration. A broad summary of the responsibilities which this places upon medical researchers is given in clause 9 of its General Principles:

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects1. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Further key issues are then outlined:

Risks, Burdens and Benefits:

Physicians may not be involved in a research study involving human subjects unless they are confident that the risks have been adequately assessed and can be satisfactorily managed. When the risks are found to outweigh the potential benefits or when there is conclusive proof of definitive outcomes, physicians must assess whether to continue, modify or immediately stop the study. (Clause 18)

Vulnerable groups and individuals

Some groups and individuals are particularly vulnerable and may have an increased likelihood of being wronged or of incurring additional harm. All vulnerable groups and individuals should receive specifically considered protection. (Clause 19)

Scientific requirements and research protocols

The design and performance of each research study involving human subjects must be clearly described and justified in a research protocol.

The protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed. The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study. (Clause 22)

1 Note the participants is now generally preferred to subjects.


Research Ethics Committees

The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration. (Clause 23)

Privacy and confidentiality

Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information (Clause 24)

Informed consent

Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary. (Clause 25)

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subjects freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed. (Clause 26)

When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress. In such situations the informed consent must be sought by an appropriately qualified individual who is completely independent of this relationship. (Clause 27)

Publication and dissemination of results

Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available.

There is no reason for ethical issues arising out of clinical movement analysis research to be different to those of any other form of research. Some clinical movement analysis requires collection of normative reference data from healthy individuals but from the perspective of research ethics these should be considered in exactly the same way as individuals with a known medical condition.


4.3 Ethics of human involvement in educational and training

There is no equivalent to the Helsinki declaration for clinical education and training and surprisingly little formal guidance has been found. There is a general assumption that the issues that are relevant to involving human subjects in research are also applicable to involvement of human subjects in education and training. There are a number of specific additional issues:

Competence and supervision

The Health and Care Professions Council (UK) Standards of conduct, performance and ethics includes the responsibility:

You must act within the limits of your knowledge, skills and experience and, if necessary, refer the matter to another practitioner.

By definition a student does not possess the full range of competencies required of an fully qualified health professional and thus they always act under the supervision of an appropriately accredited health professional who has overall clinical responsibility for the patient. It should always be clear to both the student and the patient that this is the case and who the supervisor is.

As a student progresses they will attain competencies in specific roles and may be expected to undertake these with some degree of independence. There should be explicit agreement between supervisor and student as to what roles these are and what degree of independence is appropriate. The supervisor, however, retains ultimate responsibility for delivery of clinical services.

Professional education is now regarded as lifelong and thus continues after qualification and registration. After qualification the same principles apply except that it becomes the Health Professionals responsibility to understand what clinical competencies they do and dont possess and the level of independence with which it is appropriate for them to offer services.

Education and training through routine and non-routine service provision

Many health professionals train through the provision of routine clinical services. In other words the service provision is unaffected by the training (other than through the individual that is delivering it). There is no particular requirement for specific patient consent for this (beyond that required for any other routine treatment).

In other cases the service provision might be altered specifically to ensure a training or education requirement. A student may, for example be required to make a repeat clinical measurement to demonstrate that this is in agreement that made by another staff member. In such cases the patient should be asked explicitly for informed consent.

Practising on peers

Particularly early in clinical training basic skills can be practiced on fellow students. Thus physical examination skills might be first introduced by requiring students to examine each other. Such exercises are generally low risk but importantly include an element of reciprocity. It is generally assumed that such exercises need has been assumed in the past that such exercises raise minimal ethical issues but there is a growing awareness that educators should be aware of cultural issues in assigning such tasks.

Patient information

Data interpretation exercises are clearly not possible without clinical data to analyse. Such exercises will be most relevant to the student in work-based learning if it they reflect the patient groups they work with most often and will be optimal if students are able to use data collected during their


professional practice. This is confidential patient data, however, and appropriate consent needs to be obtained to use data in this way. In some jurisdictions the patients have some ownership of their own clinical data which further reinforces the need for explicit permission to use it.

Generally it is assumed that a health professional reflecting on a case they have been involved in does not require explicit consent as long as the case is de-identified and a minimum of clinical data is included whereas if a case study is being presented then consent should be obtained. There will, of course, be a grey area as to which category many cases fall.

Consent may also be required from the institution in which the data is collected as well as from the patient. Indeed many hospitals now have procedural, physical and electronic mechanisms in place to prevent clinical data being accessed and removed or copied. Clearly any use of data should be consistent with the governance provisions of the institution in which it was collected.

All patient data used in teaching exercises should be anonymous. This includes the removal of partial identifiers such as date of birth (refer to age instead) as well as absolute identifiers. Many hospitals have a policy of printing identifiers on all outputs. Both patient and hospital identifiers should be removed. Video records of patients in various states of undress are often part of a gait analysis. Best practice requires that such recordings should be taken in such a way as to maximally maintain the dignity of the patient and that such recordings are made anonymous either by excluding identifying features from the original recordings or masking them later. The same applies to clinical photography.

4.4 Special provision for distance learning

The programme to be delivered by the University of Salford from 2014 and elements of the joint programme to be delivered by the University of Salford and VU Amsterdam from 2017 will be delivered by distance learning. This raises particular issues because the framework for ethical and professional issues within the country in which the student is studying may be different from that from which education is being offered.

The general requirement here is that any learning activity fulfils the ethical and professional requirements for both the University involved and the institution in which that activity is taking place. This will, of course, require that activity to fulfil the requirements of the more stringent legislation or governance provisions of the two respective institutions.


5 Guidelines for professional and ethical issues within the CMAster programme

5.1 Professional competency of graduates

The aim of the CMAster programme is to offer education and training to allow an individual from whatever professional background to acquire the competencies to take responsibility for all aspects of the clinical movement analysis process as defined in the Key Competencies Report. Because of the widespread variability in professional regulation across Europe (and beyond), however, it cannot be assumed that successful students are necessarily qualified to practice within any particular country. Graduates of the programme should satisfy themselves and their employers that they are working within the scope of their primary professional qualification in the tasks they actually undertake in the location where they are employed. Consultation with the professional body regulating their profession in the country in which they are working is recommended if this is uncertain. If such doubts persist then specific tasks should not be undertaken.

5.2 General ethical issues

All three partner universities have ethics committees with specific responsibilities to ensure the safe and ethical conduct of learning and research activities. These committees have specific procedures to ensure that learning and teaching activities are approved in advance. Teachers should ensure that appropriate approvals have been obtained for all activities that students will be required to participate in.

The notes below are to help guide the planning of learning activities and may be a useful reference for local ethics committees but are not in any way seen as an alternative to the formal processes.

If students are undertaking learning or research activities in another institution (a local hospital for example) then activities may well need to be approved by the ethics committee of that institution as well as the university. The requirement should be discussed by teachers with the manager of the relevant service or department. If formal approval is required then the appropriate processes should be followed to obtain that approval before the student starts the relevant activities. If not then that manager should give written permission for the student to use the facilities for the required activities. Students on distance learning programmes will need to use local facilities to master clinical movement analysis skills and there will be a specific requirement to obtain such written approval.

In some countries there may be legal requirements pertaining to obtaining ethical approval or the use of personal health information. Clearly such students should always work within such legislation.


5.3 Risks of clinical movement analysis

Implicit in the Helsinki Declaration is assumption the medical ethics is essentially about risk assessment do the potential benefits to wider society outweigh the risks and burdens placed upon individuals. Although the Helsinki Declaration focusses on research this assumption clearly extends to teaching and learning activities as well. An understanding of the risks involved in clinical movement analysis is thus required as a precursor to any consideration of ethics issues.

The majority of measurements techniques used in clinical movement analysis impose little more risk than the activity being measured. Tasks are generally assessed under idealised conditions and may thus be less risky than the same activities carried out under the general conditions of daily living. Much of clinical movement analysis focuses on the analysis of ordinary walking in an uncluttered environment and the risks of this are generally less than that of walking in a community environment.

Even where risks can be identified these can generally be reduced by minimal levels by adhering to simple principles of good laboratory practice. Such risks include:

Infection. Many movement analysis techniques require physical contact with the person being assessed which can be minimised by the provisions of basic personal hygiene with appropriate hand washing being the most obvious requirement. Sensors, markers or other measuring equipment may need to be applied to individuals and clearly there is a need for appropriate cleaning of any non-disposable equipment which comes into contact with patients between assessments.

Electrical hazards. With a trend to wireless sensors in EMG and accelerometry there is very little requirement for electrical equipment to come in contact with humans as part of contemporary movement analysis. Even where wired systems exist, all equipment registered as a medical device must have appropriate isolation of the individual from any mains supply.

Invasive procedures. The only invasive procedure in mainstream clinical movement analysis is fine-wire electromyography. This should only ever be conducted by individuals with appropriate professional registration who have had specific training in the techniques. It is thus regarded as a specialist skill and will not be required as part of any of the CMAster programmes.

Manual handling. There are potential risks in transferring individuals with limited mobility within the movement analysis laboratory. These are generally minimal in that in order to perform the required activities (such as walking) individuals generally also have the ability to manage transfers independently.

Exertion. In wider human movement analysis a number of tests set out to measure maximal performance of some type (e.g. VO2 max) and these may be risky for patients with certain pathologies. Such tasks are actually very rare in clinical movement analysis services. Where they are used there should be specific guidelines to ensure safe conduct which may include screening of participants for specific risk factors

In summary, where appropriate facilities and procedures are involved, most clinical movement analysis tests carry very low risks. Participants are often safer within the test environment than they are in the general activities of daily living. Routine testing on healthy mentally competent adult volunteers carries extremely low risks of any adverse events.


5.4 Learning activities involving human participants

Procedures for obtaining ethical approval for learning activities are generally not as clear cut as for research activities and there is often particular ambiguity as to whether formal approval is required for the sort of low measurement processes used in clinical movement analysis. Where formal procedures are available they should be complied with but in some areas some common sense is required in determining whether explicit approval is required.

5.4.1 Practising on peers

Given the extremely low risk of routine clinical movement analysis tests on healthy adults the common practice of students making measurements on each other as part of laboratory practical is viewed as entirely appropriate. By the very nature of what they are being taught students are aware of what is being asked of them and well placed to give informed consent. There is generally an element of reciprocity with students volunteering to be subjects for each other. In this environment consent is clearly implied by the volunteers willingness to cooperate with the tests and written consent may not be required on every occasion.

The only real issue is to ensure that students with particular cultural or religious views are not required to act in opposition to those views. Given the range of such views it may not be practical to try and predict who might be affected and how. A more appropriate strategy is to make students aware that if they are uncomfortable in any role that is being asked of them that they discuss this with the teacher responsible for the exercise. In this circumstance teachers should work to find alternative strategies to allow students to acquire skills.

In most distance learning environments there is still a requirement to practice routine clinical movement analysis skills but students will generally not be in close enough proximity to test each other. Given the low risk of these tests, however, it will generally be appropriate for students to ask colleagues or friends to volunteer to be measured. They should avoid involving children or anyone As stated in Section 2 this should be discussed with the manager of the facility and written approval for such use obtained before any testing starts. (There may be some ambiguity here as to how formal approval can be obtained in that clinical facilities will often have a clear policy on ethical approval for research but may not have any mechanism for granting such approval for learning activities. A pragmatic approach may be for the manger to accept the universitys oversight of the ethical issues when granting approval for us of the facility.)

5.4.2 Clinical placements

Clinical placements within the masters programmes envisaged as part of CMAster will be to observe practice in other centres and should not involve students taking any responsibility for clinical procedures. Local practice and attitudes of supervisors will dictate whether and to what extent students can assist qualified clinicians in conducting tests or making measurements. Such decisions should always involve a consideration of the professional qualifications and registration of the student (if any) and whether these are considered valid in the country in which they are working. All such placements should be approved with a written Partnership Agreement (Deliverable 5.4).

International best practice is for each patient to be informed of the background and role of the student in the students absence and being asked if it they are willing to allow the student to observe. If not then their wishes should be respected without them having to give any particular


reason. The student should only be admitted and introduced only after such approval has been granted.

Local practice varies considerably form location to location however and should generally be used as a guide to how students are introduced to patients.

5.4.3 Clinical case material

Students will be expected to study case material and to write case reports. Wherever possible real case material should be used and students who also have clinical responsibilities (particularly but not only those on the work-based distance learning programme) will often benefit most from using material form their own personal practice. Whether this is possible will depend on the information governance procedures for the institution in which they are working. Students should get written permission from the manager of the service to use patient data for such purpose. (Which may clearly require formal approval to have been obtained for such release, it may also require the consent of which would be best practice anyway).

Such data should only be copied (the original should be retained by the institution in which it was captured). Any identifying features in the data should be removed before the data are copied. Video recordings should only be copied after they have been deidentified. No identifying information should be added to the data afterwards.

If data has been obtained with the approval of the institution in which it was captured (preferably with the consent of the patient) and has been thoroughly deidentified then it will generally be accepted for students to present and share in the form of case reports. Students should keep written copies of the approval letter and where applicable of the patients consent. These should be added as an appendix to any case material submitted for any official part of the programme (as part of an assignment for example).

In some countries it is now extremely difficult to obtain approval to copy and use such case material even after deidentification. Teachers and programme developers should thus ensure that a students progress is not dependent on obtaining such case data. The most obvious way of circumventing this is to have a stock of case material available for any student who is not able to obtain access to their own material.


5.5 Research activities involving human volunteers

In most countries and institutions the ethical regulation of research involving human volunteers is more advance than that of learning activities. All three partner universities have very clear procedures for obtaining ethical approval for the conduct of research.

Where research is conducted outside of one of the three partner universities it will generally require approval of the university ethics committee and that of the institution in which the research is being conducted. Most hospitals and universities have very clear rules for obtaining approval for such research from a local ethics committee. Generally speaking a student should apply for ethical approval from the University first and then from the local institution. This may be time consuming and students will need to be aware of this when planning their research.

As with all other activities research projects must be carried in within the legislative requirements of the country in which the research is being conducted.

Deliverable 6 2 Professional and Ethical Issues Report (1.1)

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