POINTS TO CONSIDER WHEN PLANNING RESEARCH
INFORMATION REQUIRED FOR REC TO MAKE AN INFORMED DECISION
Risk/anticipated benefit analysis
Safety of Researchers: SRA Code of Practice
Informed Consent and the Sharing of Data
Waivers of Informed Consent
Selection of Participants
Research involving University Staff and Students
Safeguards: Confidentiality and Anonymity
Limits to Confidentiality
Research Plan for Collection, Storage and Analysis of Data
Data Protection Act (1998)
ABS REC recommendations
DATA COLLECTION NOT NORMALLY COSIDERED AS 'RESEARCH'
In order to facilitate the process of considering ethics around social science research the ESRC have produced a list of points to consider and are examples of likely areas you will need to have explored if submitting a full ethics review.
Have you considered risks to:
The research team?
The participants? Eg harm, deception, impact of outcomes
The data collected? Eg storage, considerations of privacy, quality
The research organisations, project partners and funders involved?
Might anyone else be put at risk as a consequence of this research?
What might these risks be?
How will you protect your data at the research site and away from the research site?
How can these risks be addressed?
- Details and recruitment of participants:
- What types of people will be recruited? Eg students, children, people with learning disabilities, elderly?
- How will the competence of participants to give informed consent be determined?
- How, where, and by whom participants will be identified, approached, and recruited?
- Will any unequal relationships exist between anyone involved in the recruitment and the potential participants?
- Are there any benefits to participants?
- Is there a need for participants to be de-briefed? By whom?
- What information will participants be given about the research?
- Who will benefit from this research?
- Have you considered anonymity and confidentiality?
- How will you store your collected data?
- How will data be disposed of and after how long?
- Are there any conflicts of interest in undertaking this research? Eg financial reward for outcomes etc.
- Will you be collecting information through a third party?
- Have you considered consent?
- If using secondary data, does the consent from the primary data cover further analysis?
- Can participants opt out?
- Does your information sheet (or equivalent) contain all the information participants need?
- If your research changes, how will consent be renegotiated?
- Have you considered ethics within your plans for dissemination/impact?
- Are you conducting research outside the UK? Are there any additional issues that need to be considered as a result? eg local customs, local ‘gatekeepers’, political sensitivities
- Which Ethics Committee is most appropriate for your research?
- Have you considered the time you need to gain ethics approval?
- Have you considered what legislation your project will need to abide by? eg Data Protection Act, Freedom of Information Act, Human Rights Act
- How will the ethics aspects of the project be monitored throughout its course?
- Is there an approved research ethics protocol that would be appropriate to use?
- How will unforeseen or adverse events in the course of research be managed? eg do you have procedures to deal with any disclosures from vulnerable participants?
(SOURCE: ESRC FRE 2010)
Applications put through our ethical review process need to provide, as a minimum, information that allows the SREC members to assess:
If you have any queries please contact Debbie Evans: email@example.com
- Identification and assessment of risks and anticipated benefits
- Determination that risks are minimized
- Determination that risks are reasonable in relation to the potential benefits.
- A clear description of the risks or discomforts to the subject:
- Be accurate and reasonable
- Review any risks related to the procedures and tests relating solely to research and any tests that carry a high risk of harm
- Inform the subject of previously reported adverse events.
- For research involving more than minimum risk, an explanation should describe:
- Whether there will be compensation
- Where the subject may obtain further information.
Ethical issues for consideration would include highlighting sensitivities including risk to researchers and participants, ethical guidelines from other funders or project partners, the ethics of researching particularly sensitive areas, and the need for a clear risk awareness in these scenarios. Research undertaken outside of the UK where there may be issues of local practice and political sensitivities. In some cases partnership with a research organisation in the area involved may prove helpful. It is also necessary to check the requirements for ethics review in the countries included in the research.
CODE OF PRACTICE FOR THE SAFETY OF SOCIAL SCIENCE RESEARCHERS:
The Social Research Association (SRA) has a Code of Practice for the safety of social researchers, particularly those conducting research in the field on their own.
The code focuses on safety in interviewing or observation in private settings but is of relevance to working in unfamiliar environments in general. A copy of the code can be downloaded here.
There are a number of dimensions to the risk that social researchers may face when involved in close social interaction:
- Risk of physical threat or abuse
- Risk of psychological trauma, as a result of actual or threatened violence or the nature of what is disclosed during the interaction
- Risk of being in a comprising situation, in which there might be accusations of improper behaviour
- Increased exposure to risks of everyday life and social interaction, such as road accidents and infectious illness
- Risk of causing psychological or physical harm to others.
The code is designed for research funders, employers, research managers and researchers carrying out fieldwork. The aims are to point out safety issues which need to be considered in the design and conduct of social research in the field and to encourage procedures to reduce the risk. The intention is not to be alarmist about potential dangers but to minimise anxieties or insecurities which might affect the quality of the research, (SOURCE: SOCIAL RESEARCH ASSOCIATION).
‘Informed consent entails giving sufficient information about the research and ensuring that there is no explicit or implicit coercion so that prospective participants can make an informed and free decision on their possible involvement’.
(Definition: ESRC FRE 2010)
- Information that the study involves research (see definition earlier in these guidelines)
- An explanation of the purposes of the research
- The expected duration of the subject’s participation
- A description of the procedures to be followed
- Identification of any procedures that are experimental
- Risks involved: See ‘risk/anticipated benefit analysis’ section above
- A description of the benefits to the subject or others
- A statement that the participation is voluntary, that refusal to participate involves no penalty of loss of benefits to which the person is otherwise entitled, and that the subject may discontinue at any time.
- Consent is understood as an ongoing process and if appropriate should be renegotiated at each stage of the study.
UK Data Archive (UKDA) are becoming increasingly concerned over the issue of informed consent as there are a growing number of research projects stating that they are unable to share data due to a lack of agreed consent. Researchers should be obtaining consent from participants for data sharing, as distinct from consent for the primary use of the information.
While the need to protect personal data and preserve confidentiality (where explicitly required) cannot be overestimated, SREC would query the reasoning of applications where the consent for participation precludes any sharing of research data beyond the Principal Investigator and the associated research team (eg consent forms saying that the research data will only be seen by the PI, to clauses instructing that the data will be destroyed upon project completion). Documentation outlining consent has to differentiate between consent to participate and consent to allow findings to be shared or published.
It is the requirement of many funding organisations to ensure that the resulting data is shared and made available for secondary research, for instance, the ESRC contractually requires all award holders to make any research outputs resulting from the award accessible to others, and that any resulting data (eg survey datasets, interview and audio recordings, diaries, observations, etc) are offered for archiving and sharing.
Guidelines have been produced by the UKDA in response to this issue:
- The agreement of a minor or decisionally impaired individual to participate in research as captured by the assent process and documentation
It is foreseeable that certain conditions may exist where waivers of informed consent may be requested of the SREC (eg covert research). In general, the following conditions may apply to these requests:
- The research involves no more than minimal risk to subjects
- The waiver will not adversely affect the rights and welfare of the subjects
- The research could not practicably be carried out with the waiver.
In this circumstance of waiver, whenever appropriate, the subjects will be provided with additional pertinent information after participation.
As social science research frequently investigates issues that may result in significant benefit to participants (e.g. reduction of stress, increase in productivity, development of leadership potential), researchers should be aware that excluding certain sub-groups within a population may disadvantage those not selected. Thus, researchers should consider the following when selecting participants:
- Equitable selection in terms of gender, race, ethnicity
- Benefits are distributed fairly among the community’s populations
- Additional safeguards are provided for vulnerable populations susceptible to pressure to participate: to demonstrate identification, recruitment and safeguards for these populations.
Guidance Principles from Aston University Ethics Committee
The University offers the same protection to its staff and students as to all other volunteers. Staff and students may be invited to participate in research carried out in the University or by University staff but their participation is voluntary, they may withdraw at any time, and their participation or decision not to participate will not affect their employment or academic assessment in any way. There are risks of perceived/or actual coercion if a researcher seeks to involve as research subjects staff an/or students with whom they have a hierarchical relationship and it is normally desirable to avoid the use of such groups in research - if such groups are necessary for the research, the Ethics Committee would expect to see a robust rationale for their inclusion together with a statement as to how the risk of coercion would be minimised.
It is acceptable and even desirable for students to be invited to take part in research as subjects (eg in psychology) as this can provide them with valuable experience, not just with methodology but also with the ethical problems that can arise when carrying out experiments or other forms of research. Students undertaking research may use each other as research subjects, as well as recruiting participants other than students for their research. However, no coercion should be used in the recruitment of student participants in research. In cases where students do not wish to take part in particular forms of research which form a part of the curriculum and/or learning process, it is recommended that they should be given alternatives activities of equivalent credit in order that there is no coercion to participate in any particular study. Researchers need to consider whether students' participation in research might give them academic advantages and to take steps to ensure fairness between participating and non-participating students. Where research participation is a course requirement, this must be clearly stated in course handbooks or other advertising material, enabling prospective students to make an informed choice and where they do not wish to take part in research to opt for a different course.
Investigators should realise that they are often in a position of authority or influence over participants who may be their students, employees or clients. This relationship must not be allowed to pressurise the participants to take part in, or remain in, an investigation. The Ethics Committee recommends that researchers should consult the University's Guidelines on the Use of Children, Young People, and other Vulnerable Groups in Research (see Appendix 1 below).
Guidelines on the use of Children, Young People, and other Potentially Vulnerable Groups in Research
The University expects researchers to comply with Articles 3 and 12 of the United Nations Convention on the Rights of the Child. Article 3 requires that in all actions concerning children, the best interests of the child must be the primary consideration. Article 12 requires that children who are capable of forming their own views should be granted the right to express their views freely in all matters affecting them, commensurate with their age and maturity. Children should therefore be facilitated to give fully informed consent.
The University considers that the spirit of Articles 3 and 12 above should also apply in research contexts involving students, young people and vulnerable adults (eg those with learning disability, mental illness, arrested or incomplete development of mind, psychopathic disorder, dementia and any other disorder or disability of mind).
In the case of participants whose age, intellectual capability or other vulnerable circumstance may limit the extent to which they can be expected to understand or agree voluntarily to undertake their role, researchers must fully explore alternative ways in which they can be enabled to make authentic responses. In such circumstances, researchers must also seek the collaboration and approval of those who act in guardianship (e.g. parents) or as `responsible others' (i.e. those who have responsibility for the welfare and well-being of the participants e.g. social workers).
Researchers must ensure that they themselves, and any collaborators or research assistants and students under their supervision, comply with legal requirements in relation to working with school children, students or vulnerable young people and adults, (SOURCE: ASTON UNIVERSITY (Extracted from REG/04/623(4)).
Internet research and other research using new technologies can take place in a range of settings, eg email, chatrooms, webpages, various forms of ‘instant messaging’. These can pose new ethics dilemmas. For example:
- What constitutes ‘privacy’ in an online environment?
- How easy is to get informed consent from participants in the community being researched?
- What does informed consent entail in that context?
- How certain can the researcher be sure that they can establish the ‘real’ identity of the participants?
There is a growing literature on ethics in online research:
Association of Internet Researchers:
AoIR has an ongoing commitment to ensuring that research on and about the Internet is conducted in an ethical and professional manner. Their Ethics Working Group has produced a major report (2002), to assist researchers in making ethical decisions in their research:
The BPS report, ‘Conducting Research on the Internet: Guidelines for ethics practice in psychological research online’ (2007):
A report, ‘Conducting Research on the Internet’ (2003) by Clare Hewson, may be useful:
Confidentiality: spoken or written in confidence; entrusted with secrets.
Anonymity: of unknown name, undeclared source or authorship, nameless, featureless, impersonal.
- A description explaining how the institution/investigator will maintain confidentiality of records.
- Statement should include full disclosure and description of approved agencies and /or other designated parties that may access the records.
- Details the procedures that would be in place to assure the confidentiality of the information, collected during the research.
- Ensure that subject recruitment does not invade individuals’ privacy
Researchers working with vulnerable populations will need to make clear the limits to confidentiality when eliciting consent from the vulnerable person (and parent/carer). eg If the vulnerable person reveals that they are in significant and immediate danger, the researcher will be obliged to ensure that the vulnerable person is protected. Before starting a project, the PI should establish a procedure and the name of the person who will take the responsibility for protecting the vulnerable person in the event of a disclosure. If the researcher feels it is necessary to break confidentiality, the vulnerable person will normally be informed what action has been taken by the researcher.
- Data safety monitoring plans adequate to protect human subjects
Secondary data falls into three categories:
i) The first includes data which is not sensitive and where there is a minimum of risk of disclosure of the identity of individuals;
ii) Second is data that is protected by legislation, such as census data. Here the data producer has a strong interest in how researchers will access the data, and may control access to it. This category of data may only be available via ‘safe settings’.
iii) The third category includes data where the inclusion of information, such as birth date or post code, which makes disclosure possible, perhaps via a link to other datasets. This means that the data is ethics sensitive.
The fact that an original piece of research has gone through ethics review for its collection, does not rule out ethics issues arising over its secondary use.
Social Science research often involves the processing of sensitive personal data. Researchers should be aware that the processing of any information relating to an identifiable living individual constitutes ‘personal data processing’ and is subject to the provisions of the DPA 1998, including the eight data protection principles. The Act also has a separate definition for ‘sensitive personal data’.
Data protection principles:
- must be obtained for a specified and lawful purpose
- shall not be processed in any manner incompatible with that purpose
- shall be adequate, relevant and not excessive for those purposes
- shall be kept up to date
- shall be kept for no longer than is necessary for that purpose
- must be processed in accordance with the data subject’s rights
- must be kept safe from unauthorised access, accidental loss or destruction
- shall not be transferred to a country outside the European Economic Area unless that country has equivalent levels of protection for personal data.
- To keep electronic data for 5 years
- To destroy physical data (tapes/audio/paper) after 2 years, but to keep the open-ended comments from questionnaires (scan and store electronically).
- To keep informed consent agreement letters as a scanned .pdf file and store electronically
- Ensure appropriate, scientifically valid, and therefore can justify exposing subjects to research risks
- Detail information on the research processes/methodology
- The specific office, name and telephone number of whom to contact for further information regarding the research participant rights, the research study, or for research-related information.
Multi-institutional research creates complications for formal ethical review procedures. However, we should not assume that the partner institution(s) have in place a rigorous ethical process and, in order to make an informed judgement as to whether the project should go through our research ethics procedures, the ABS SREC would require transparency about the overall project, the partner(s) ethical process of review, their monitoring of the conduct of research that was taking place and also assurance that mechanisms were in place to promptly report to all institutions involved. All multi-centre research should therefore be brought to the attention of the ABS SREC. The full multi-centre application should therefore be submitted to the ABS SREC for oversight.
If research (defined as any form of disciplined inquiry that aims to contribute to a body of knowledge or theory) is carried out as part of consultancy work by an academic member of Aston Business School staff, then it is an expectation that any of that work which falls within the ABS definition of research would require ethical approval, with the following caveats (taken from the ESRC Research Ethical Framework):
All data collection involving human participants normally requires prior ethical approval with the exception of the following, which are NOT normally considered ‘research’:
- Routine audit;
- Performance reviews;
- Quality assurance studies;
- Testing within normal education requirements;
- Service evaluations;
- Polling on current public policy issues; and
- Literary or artistic criticism.
- While data collected and stored as a record at an individual level is considered ‘human data’, material already in the public domain is not.