Research Governance researcher conduct

Research is defined as any activity which is funded either internally or externally, and involves the collection of information from individuals who may be:

• service users.
• their relatives or friends.
• members of the public.
• employees of the department.

It includes any consultations, surveys or audit carried out in connection with best value.

It does not include the routine collection of management information.

Ethics

The respect, dignity, rights, safety and well-being of participants must be of primary importance in the consideration of any proposed research.

All proposed research project plans involving Salford Community, Health and Social Care directorate which involve data concerning:

• service users
• their relatives or friends
• care professionals
• volunteers

must be referred to the Research and Information Services team of the directorate for appraisal, prior to commencing the project.

The arrangements for obtaining informed and written consent from participants must be considered as a matter of prime importance in the project plan. In cases where it is not possible to obtain a written signature directly from the participant, the researcher must take all reasonable steps to identify and obtain consent from a legal guardian or advocate. Approval of the arrangements must be sought from the appropriate reviewing body prior to commencing the research. See details below of how the Mental Capacity Act 2005 affects research.

Every effort should be made to ensure that the design of the research does not discriminate against participants on the basis of:

• age
• disability
• ethnic origin
• gender
• sexual orientation

This may mean that special arrangements need to be made to ensure participation, such as:

• audio cassettes
• payment of travelling expenses
• plain English
• translations in minority languages
• use of braille

Wherever appropriate, participants or their representatives should be given the opportunity to help with the research, including planning, data collection and analysis.

During contact with participants, care must be taken not to raise expectations of services. It should neither be implied that resources will be available to meet their needs.

Researchers have a duty to pass on requests for help or information to the appropriate agency, in any situation which gives rise to serious concern such as child protection issues or domestic abuse.

An appropriate channel for registering any complaints must be identified to participants.

All data is confidential. It should not be put to any use which may conflict with the original purpose for which it is gathered, without the informed and written consent of the participants.

Notes

(i) Informed consent includes:

• giving participants as much information as is appropriate about the purpose of the study
• give information of it's intended outcomes.
• explaining clearly their rights and limits to their participation such as location (if appropriate), time involved, how the data will be used and stored etc.
• raising participant's awareness to any potential harm or risk in taking part.
• ensuring compliance is freely given.
• ensuring participants are made aware of their right to withdraw from, or refuse to take part in, any study. Withdrawal or refusal will not affect their right of access to services.
• giving consideration to obtaining informed consent from vulnerable people such as children or people with learning difficulties.
• ensuring that all reasonable steps will be taken to assure confidentiality and anonymity. However, they should be informed that data which gives postcodes or other geographic data identifiers could lead to identification.
• The issue of informed consent does not apply if data is collected through anonymous questionnaires.

(ii) Method of collection of data 

If data is collected by observing behaviour without the participant's knowledge, such studies should only take place in a location in which people would normally expect to be in public view. If possible, an attempt should be made to obtain consent after the study has taken place.

(iii) Mental Capacity Act 2005

There is a requirement in law, under the Mental Capacity Act 2005, for any research undertaken with "any person who lacks a capacity to consent", to first undergo an ethics approval process.

Loss of capacity during a research project

From 1 October 2007, any person who has given informed consent, including any given before that date for an ongoing research project, is protected under the Act.

This means that if a person who has already given informed consent, but before the conclusion of the research project loses capacity to consent to continue to take part in it, must have safeguards put in place to protect their interests.

These safeguards include a responsibility on the researcher to:

• identify a person who is caring for, or is interested in, the welfare of the person who loses capacity. If not possible, nominating another person, with their agreement, who can advise the researcher about the person who lacks capacity.
• ensure that the person who lacks capacity is withdrawn from the project, if the identified or nominated person advises that they should do so.
• ensure that any prior knowledge of the researcher regarding the wishes of a person, who subsequently loses capacity, are to be complied with.
• ensure that if a person, who now lacks capacity, indicates, in any way, that they wish to withdraw, the research is discontinued without delay.

The interests of the person losing capacity are assumed to outweigh those of science and society.

Science

To avoid replication of existing work, all existing sources relating to the proposed area of study must be considered, before undertaking the project.

All project plans must be submitted to the Research and Information Services team of Salford Community, Health and Social Care directorate for checking. No work can begin on the study until the appropriate level of approval has been granted. If the plan requires ethical approval, it will be reviewed by the Research Review Panel.

All data collected during the course of the research must be stored securely for an appropriate period. This is to allow further analysis by the original researcher or others. It is also for the purposes of monitoring, and the development of good research practice. This may require gaining the consent of the participants involved if there are any consequences for the participant from whom the data was originally collected.

Information

Once appropriate approval has been granted, all information about the research and its findings should be made freely available.

All results of the research need to be presented at an appropriate level e.g. in such a way that it is easily understood, using jargon free language.

All research work should be open to critical review through accepted scientific and professional channels.

Health and safety

The safety of participants and research staff must be given priority at all times. Health and safety regulations must be strictly observed.

Participants

Harm can arise from:

• stress through participation.
• loss of self-esteem.
• psychological injury. 
• other side effects.

All researchers must assess potential risks as part of their project plan, and advise participants accordingly.

Researchers

Employing organisations are responsible for the safety of their staff. All researchers should carry identification. They should ensure that a system is in place, so that their whereabouts are known. Contact should be made before any home visits, and a risk assessment made beforehand.

Finance and intellectual property

You must:

• consult your employing agency or organisation regarding details of arrangements for compensation to yourself, or anyone harmed by the research, should the need arise, prior to submitting you project plan.
• give details about any grants covering the study.
• give details of any estimates of any expenditure.
• state if you, or anyone else, will profit financially from the results of your study.

This page was last updated on 29 March 2011