DMEM Ethics Checklist

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Departmental Ethics Committee (DEC) Ethics Checklists

Code of Practice on Investigations on Human Beings

When implementing a staff or student project which involves investigation on human beings it is important to
note that the university has a code of practice governing the implementation and conduct of such investigations.
This code of practice was developed by the Ethics Advisory Committee and approved by the university court on
5th May 2000. The code governs all investigations on human beings including class teaching experiments and
demonstrations, student projects and research investigations which fall within the scope of the code. The
Departmental Research Committee will act as the Departmental Ethics Committee, and can approve most
routine, non-invasive investigations.
It is the responsibility of the supervisor to make the student aware of relevant guidelines and ensure that
they are observed. The supervisor is also responsible for submitting details of proposed investigations
for approval where necessary.

The following contains 2 checklists to aid the implementation of this practice:


i

The first is to identify cases which require to be approved by the University Ethics Advisory Committee. If any
of the boxes are marked in checklist (i) the investigation must be submitted to the university committee for
approval.

(i) The second is to ensure correct procedure is adhered to in any routine or non-invasive investigation i.e.
those which are readily approved by the Department Ethics Committee (in essence the checklist represents a
summary of Section 6 of the Code of Practice on Investigations on Human Beings.)
These checklists should not be viewed as a substitute for the original document and thus all supervisors should
be familiar with the code before utilising these in staff/student research projects. The checklists are designed to
ensure that the staff/students are immediately aware of the implications of the guidelines to their investigation.
Furthermore, they act as departmental records of staff/student conduct in investigations on humans.
As Ethics Advisory Committee approval of a protocol can take up to 4 weeks (longer for very specific requests),
where research is likely to include an element of investigations on humans, an analysis of expected procedures
should be carried out at as early a stage as possible.
In addition to the university regulations, investigations of a Physiological, Sociological and Biological nature must
conform to additional codes of practice set out by relevant professional bodies - in such cases the secretary of
the ethics advisory board can supply copies of these statements.

The place of useful learning


The University of Strathclyde is a charitable body, registered in Scotland, number SC015263

(i) Supervisor and Student Ethics Checklist


Project Title:

Participants (staff/students carrying out investigation):

Investigation Content:

Does the investigation involve, any of the following (mark as appropriate):


1)

Harm, discomfort, physical or psychological risk (esp. pregnant women,


elderly, the young).

yes no

2)

Participants whose ability to give voluntary consent is limited (cognitively


impaired, prisoners, persons with chronic physical or mental conditions).

yes no

3)

Invasive techniques (DNA testing, collection of body fluids/tissue).

yes no

4)

Extensive degree or duration of exercise or physical exertion.

yes no

5)

Manipulation of human responses (cognitive or affective) which may


involve stress or anxiety.

yes no

6)

Administration of drugs, liquid/food additives.

yes no

7)

Deception of the participants which might cause distress or effect their


willingness to participate in the research.

yes no

8)

The collection of highly personal, intimate, private or confidential


information.

yes no

9)

Payment to the participants (other than travel/time costs).

yes no

If the answer to any of the above questions is yes you must submit a protocol to the Ethics Advisory
Committee unless previous consent has been granted for practising the generic procedure involved.
The protocol for such submissions to the Ethics Advisory Committee can be found in Appendix A of the
Code of Practice on Investigations of Humans Beings.
Supervisors Signature(s)
.

Date

Date

Students/Researchers Signature(s)
.

Date

Date

(ii) Checklist for Department Approved Investigations


Mark all boxes when you have read, understand and, where appropriate, will adhere to the guidelines - also note
the documentation required relative to your investigation:
N.B Investigators must acknowledge, understand and adhere to all of the points on this checklist.

Project Title:

Participants (staff/students carrying out investigation):

Investigation Content:

It is the supervisors responsibility to make students aware of these guidelines and the students to
provide the supervisor with the required documentation from affected investigation components. Signed
copies should be maintained by the supervisor and student(s) for departmental records.
Consent. Obtain informed consent of all volunteers. A consent form must be signed by all volunteers.
Protection. Protect all volunteers from possible harm and preserve their rights. No investigation should
involve significant risks to mental or physical well-being of its participants.
Inducement. Provide no financial inducement nor other coercion (actual or implied) to persuade people to
take part in the investigation.
Withdrawal. Volunteers must be free to withdraw at any stage, without giving reason.
Termination. The investigation should stop immediately if volunteers report any problems (physical, mental or
otherwise) during it. The problems must be reported to the appropriate ethics committee.
Recruitment. Volunteer recruitment should wherever possible be via letter, notice (or orally - if through a
group approach). However, random street or doorstep surveys are acceptable.
Staff Participation. The motives for staff/students to participate as a volunteer in an investigation should be
taken into special consideration i.e. neither declining nor agreeing to participate in an investigation should affect
academic assessment in anyway.
Special Consideration. Special consideration should be given to the young, adults with any cognitive
disabilities or learning difficulties and to all persons who live in or are connected to an institutional environment (in
such cases the investigator should refer to Appendix C of the code of practice on investigations on human
beings).
Pregnancy. Women of child bearing age must not be recruited for any investigation which could be harmful to
fertility/pregnancy (in such cases the investigator should refer to Appendix C of the code of practice on
investigations on human beings).

Selection. Submissions based on the investigation should include details of the basis for volunteer selection
i.e. questionnaires and/or other measures in the selection process.
Justification. Investigators must justify the number/type of subjects chosen for each study.
Confidentiality. Confidentiality and privacy must be maintained. Any waiver of confidentiality should be
justified and consent must be given, in writing, by the volunteer(s). In addition, the investigator must comply with
Data Protection Legislation.
Informing Volunteers. Each volunteer must be provided with an information sheet providing full relevant
details of the nature, object and duration of the proposed investigation and a contact for further queries (whom is
independent of the investigation normally the secretary of the ethics advisory committee).
Deception. There shall be no deception that might affect a persons willingness to participate in an
investigation nor about the risks involved.
Unusual Symptoms. Volunteers will be encouraged to note any unusual or unexpected symptoms arising
during the investigation. These should be reported to the appropriate ethics committee
Location. Places where investigations take place should be appropriate to the type and risk factor of study
undertaken. Further, the ethics committee are entitled to carry out spot checks.
Records. Full records of all procedures carried out should be maintained in an appropriate form. A register of
all volunteers should be taken and a note of the population/sample from which they were drawn.
Queries. Post investigation queries from a participant should be directed to an appropriate professional
(supervisor, head of department etc.).
Insurance. It is the responsibility for the applicant to seek extended insurance if the investigation scope falls
out-with the Universitys Public Liability Policy (in such cases the investigator should refer to Appendix B of the
original code of practice document).
Additional general guidelines exist for biological, psychological and sociological investigations - in such cases
refer to Sections 6.2 and 6.3 of the original code of practice document.

Supervisors Signature(s)
.

Date

Date

Students/Researchers Signature(s)
.

Date

Date

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