Frequently Asked Questions

Should I submit anything with my application form?

Depending on the nature of your project, you may also need to submit: Consent form(s) Participant Information Sheet(s) (PIS) Risk assessment(s) Organisational agreements/letters Copy of questionnaire or survey or the types of questions Research Data Management (RDM) Plan Copy of lead institution ethics approval (if UoS is not the lead institution for the project)

What level of detail should be on my consent form(s) and participant information sheet(s)?

Any prospective participant needs to have enough information to make an informed decision as to whether to participate in the research project or not. Consider your audience, e.g. if participants will be young children, producing a pictorial participant information sheet as well as a written sheet for their consenting adult might be appropriate. As well as explaining (in layman's terms) what the research is about, you need to include details such as: what they will be asked to do how long their involvement will last who the research is for who are researchers involved any financial considerations (e.g. out of pocket expenses) any potential harm/distress any other pertinent information You should put yourself in the participants' shoes, or imagine they are a friend or family member: what would you want to know if you were being asked to be involved in this project? You also need to ensure that you include details on withdrawal from the research, clearly specifying whether withdrawal can happen at any point, or should have happened by a certain point beyond which it is not possibly or permissible. Clarity is the key.

Is written consent always needed?

Written consent (wet signature or electronic) is good practice. However there are instances where written consent may not be possible and/or appropriate (e.g. public observation, ethnographic research). If this applies to your project please provide full details explaining what the circumstances are that do not allow written consent or where the research will be compromised if written consent is requested. Consent must be sought but other options might be more appropriate for your research project.

Why, and when, would I need to give participants a debrief sheet?

Some projects require that the participants are not told at the start what the actual research aim is for the activity that the participant is asked to do, as to do so would compromise and distort the results (e.g. certain observational studies). In these circumstances, a debrief sheet is required and should be given to participants at the end of their involvement to ensure that they are aware of the real reasons for the research, and are still happy to have their data considered. This sheet must include clear information about how the participant can follow up on the research outcomes, who they can speak to with follow-up questions

Why has my application form been returned?

An ethics application form may be returned for revisions because one of the common errors below has occurred: Lack of detail – as a researcher you will know your project in minute detail – an ethics committee can only work with the information you provide, they cannot make assumptions, so always provide exact details. Try to outline your project in layman's terms. Missing supporting documentation – if a document is referred to in your ethics form (e.g. information sheet, poster/advert, etc.) please make sure that this is also submitted. On participant information sheets or recruitment communications, using phrases that presume participation, i.e. Dear Participant When communicating with proposed participants restrict the use of technical jargon or professional acronym. Where these are necessary, provide an explanation and always use lay terms – get someone from outside your discipline to read and check that they understand everything. Don’t make claims regarding the benefits of the work that cannot be demonstrated, far better to state that there are no direct benefits to participants. If the activity or subject matter is likely to be distressing – provide more detail on specifically what will be distressing, so that a participant can make a fully informed decision. Remember also to include details of help and support information (web links, contacts, etc.) and where possible make sure expert help is on hand (don’t offer to provide support yourself if you are not qualified – and, even if you are, you will have conflict of interest so ensure that your participants are referred elsewhere). Typographical and grammatical errors on externally-facing documents. Omitting a Risk Assessment form – there are different types for different activities and it doesn't just apply to lab-based or science research. If there is any risk to researcher, participants, or the research team, risk assessments should be completed and submitted with the application.

What do the different review outcomes/panel decisions mean?

The Ethics Approval Panel can make three kinds of decisions on an application: 1. Favourable Opinion - project may commence 2. Revisions Required - changes needed and application returned to applicant 3. Resubmission These decisions mean: 1. This application has been carefully and fully considered, and all the correct supporting documentation has been provided. No changes to the application are required and no additional information is requested by the panel. The project may commence on receipt of a favourable opinion, provided that any/all other (non-ethics) requirements have been undertaken. 2. This application is pending a favourable opinion. The panel has provided specific conditions to which the ethics application must adhere, and these considerations must be satisfactorily addressed before a favourable opinion will be granted. This decision may include recommendations that the panel requires the applicant to consider (not necessarily make) before a favourable opinion will be granted. Some applications may receive more than one “Revisions Required" (changes needed and returned to applicant) outcome if the panel’s conditions are not satisfactorily met upon further review. 3. This application falls short of the University/discipline/policy/legal ethics requirements and a new application must be submitted. In preparing the new submission, the applicant must take into consideration all feedback received from the previous application.

Guidance for question: select the nature of your project

Some definitions and guidance on what is needed to respond to the question "select the nature of your project". Many of these definitions are provided verbatim from reputable sources and references can be provided on request (ethics@salford.ac.uk) A clinical trial - A clinical trial compares the effects of 1 treatment with another. It may involve patients, healthy people, or both Archaeological excavation - A controlled examination of buried deposits and features Artificial Intelligence development - Development of artificial intelligence tools or machinery Autoethnography - A research method that uses personal experience to describe and interpret cultural texts, experiences, beliefs, and practices Behavioural observation - Typically in psychology studies but can occur in other disciplines (e.g. observation of audience reactions to a stimulus). A focus on the observable ways a research participant interacts to their environment or a stimulus Biomedical device(s) - A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose Broadcast media - Any information or content distributed through radio or television Epidemiological studies - Studies on human populations, which attempt to link human health effects (e.g. cancer) to a cause (e.g. exposure to a specific chemical) Fieldwork - Study that consists of practical activities done away from a place of work. Fieldwork involves going into a natural setting to understand the environment within that context i.e. understanding people in their everyday natural setting Film Production - The process or activity of making films Human genetic analysis - The study of a sample of DNA to look for mutations that may increase disease or affect the way a person responds to treatment Human physiological investigations - Study of human mechanical, physical or biomechanical functions. May include testing and diagnosis Human remains analysis - Investigation of human materials to determine a biological profile. May be used in forensic anthropology, law enforcement or archeological study. Collection and analysis of human retains may be subject to external legislation and compliance must be ensured before research commences Human tissue(s) - Analysis or extraction of human tissues. Research involving human tissue is subject to the Human Tissue Act (exemptions apply). Compliance must be ensured before research commences. The University of Salford does not hold an HTA licence, as such human tissue storage on site is extremely limited Interview(s) - Conversations (face to face or online) with participants. This constitutes research 'involving human participants' Lab-based experiment - Any experiment undertaken in a space designated as a "laboratory" Lone working or travel to unfamiliar places (e.g. interviews in participants’ homes) - This type of research required a risk assessment and mitigating actions. Lone working in certain locations or with certain equipment may not be appropriate or may require additional indemnity or enhanced risk assessments Psychiatric or clinical psychology studies - Psychiatry is a medical field concerned with the diagnosis, treatment and prevention of mental health conditions Psychological experiments - A series of observations conducted under controlled conditions to study a relationship with the purpose of drawing causal inferences about that relationship. An experiment involves the manipulation of an independent variable, the measurement of a dependent variable, and the exposure of various participants to one or more of the conditions being studied Qualitative methodologies (e.g. focus groups) - Social scientists often want to understand how individuals think, feel or behave in particular situations, or in relations with others that develop over time. They use in-depth interviews, participant observation and other qualitative methods to gather data. Qualitative methods are scientific but are focused more on the meaning of different aspects of people's lives and on their accounts of how they understand their own and others' behaviour and beliefs. Questionnaires - A research instrument consisting of a series of questions for the purpose of gathering information from respondents. Using a questionnaire constitutes gathering data from human participants Software design/development - Software development refers to a set of computer science activities that are dedicated to the process of creating, designing, deploying, and supporting software