Considerations for Informed Consent

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Informed Consent is crucial in all aspects of social research and particular attention will be given, when disabled people are involved, that rights are protected and compliance is always freely entered into. Information that will affect the respondent’s willingness to participate will always be provided in appropriate accessible formats and never be deliberately withheld. Potential participants will also not be overwhelmed with unnecessary information.

The following notes should be taken into account by the supervisors/investigators of the Prosperity4All trials. They refer to special issues that need to be known beforehand for testing with persons with several types of impairments. The notes below refer to the consent form itself and/or the treatment of the overall testing.

It has to be remembered that participants with cognitive impairments/ learning difficulties that are unable to understand the informed consent will not participate in the tests. Only participants with who can give informed consent will be offered to participate.

Considerations for speech and hearing impaired persons

  1. If necessary, hire a sign language interpreter for deaf people who use Sign Language.
  2. Remember that some deaf people will not be able to read the consent form since signs and words may not be their main means of communication. In such cases the sign language interpreter will need to interpret the form in sign language so that the person can understand it.
  3. Make sure that a deaf communicator guide is reserved for people who are deaf.
  4. Hire a lip speaker or note taker if necessary.
  5. Provide written notes for hard of hearing people if they require it.
  6. Make sure hearing aid users have hearing aids switched on with working batteries and have a neck loop if necessary. Provide loop induction output from computer sound output.
  7. Make sure that people who are hard of hearing but do not use a hearing aid are provided with a head set if it helps them to hear better.
  8. Follow the guidance on good practice in communicating with people who are hard of hearing and check that the person understands the procedure(s).

Considerations for partly sighted and blind persons

  1. Provide a consent form transcribed into Braille for blind people who need it.
  2. Produce a large print version of the consent form for partially sighted people who need it.
  3. If people are unable to read the form, read it to them and talk through the questions ensuring that the person understands what is being asked of him/her.
  4. Give them the opportunity to make clarifications and ask questions. Record in the notes that you have done so.
  5. Make sure that a blind communicator guide is reserved for people who are blind.
  6. Check that the person fully understands the procedure(s) and possible outcomes

Considerations for illiterate participants

  1. Verbal consent is a valid form of consent provided that the principles of voluntarism, information and capacity are met. This should be witnessed and recorded in the researcher notes.
  2. Make sure that the consent form is fully explained to the person and check that they understand the procedure(s).
  3. The verbal consent should be recorded in the person’s notes.
  4. Some people may wish to make their mark on the form. This should be witnessed and recorded in the researcher notes.
  5. A proxy is necessary in this case. The proxy will sign the initial form on behalf of the participant, whereas in addition the participant will sign the following short form (with a mark). The proxy will verify to the participant that the undersigned is in line with what they have orally consented to.
  6. Another practice that could be followed is to audio record the consent process and give the participant a CD recording of the consent.

Considerations for persons with language impairments (i.e. dyslexic, print-disabled, etc.)

  1. Some people with learning disabilities will be able to consent to participation especially if you take extra time is taken to help them to understand.
  2. Family members or formal care-takers (if any) may express a view about what they think is best. However, they are not able to consent on behalf of an adult with learning disabilities and sign the consent form for them except as a witness.
  3. Follow the good practice guidance on communicating with people with learning disabilities.

It is advised to seek oral consent as capacity to consent may be variable due to specificity of the learning disability. Thus, the initial participant consent form of Annex 1 should be used and consent should be recorded. However, in this case, the participant does not need to sign the additional short form of Annex 1; the original one is enough.

Considerations for persons with motor impairments (only persons with upper limb impairments will participate in Prosperity4All)

Prosperity4All participants include persons with limitations in motion or strength or coordination or anthropometric limitations of upper limbs. This includes people with tetraplegia, hemiplegia, one-handed users, co-ordination and balance disorders, and varying degrees of neuromuscular impediment.

These people are expected to completely understand the test procedures and therefore the same forms as for healthy and able bodied participants can be used. However, it may be the case that people with upper limb impairments may not be able to sign themselves the consent form, and as such, they will have to be witnessed or if applicable provided with the respective aid to do so themselves.

Example Wording for Informed Consent Form

The following consent form is to be pre-filled in by the investigator/supervisor of the Prosperity4All trials and then by each participant of the tests. Signatures are required from both sides. This form will be signed twice. The investigator/supervisor will keep one copy and the other copy will be given to the participant (or, if applicable, to the person representing the volunteer). The following form encompasses all cases (i.e. cases that do not require any special treatment, or cases that do so, like a verbal consent that is required by persons with cognitive impairments or illiterate participants). The supervisor of the trials should pre-review the following form (and its additional part) and remove all those parts that are not applicable in each participant.

The Informed Consent has two parts:

  • Information Sheet (to share information about the study with volunteer)
  • Certificate of Consent (for signatures if volunteer choose to participate)

Prosperity4All Informed Consent Form (General Template)

Information Sheet

This part will be pre-filled by the investigator for each user to participate in one or more trials and as follows it should contain all this information:

Introduction

Briefly state who you are and that you are inviting them to participate in research which you are doing. Inform them that they may talk to anyone they feel comfortable talking with about the research and that they can take time to reflect on whether they want to participate or not. Assure the participant that if they do not understand some of the words or concepts, that you will take time to explain them as you go along and that they can ask questions at any time.

(Example:  I am X, working for the Y organization. I am doing research on accessibility through electronic devices. I am going to give you information and invite you to be part of this research. You do not have to decide today whether or not you will participate in the research. Before you decide, you can talk to anyone you feel comfortable with about the research.

This consent form may contain words that you do not understand. Please ask me to stop as we go through the information and I will take time to explain. If you have questions later, you can ask them of me or of another researcher.)

Purpose of the research

Explain the research question in lay terms that will clarify rather than confuse. Use local and simplified words rather than scientific terms and professional jargon. In your explanation, consider local beliefs and knowledge when deciding how best to provide the information. Investigators however need to be careful not to mislead participants, by suggesting research interests that they do not have. For example, if the study wants to find out about treatments provided by local practitioners, wording should not suggest that they want to find out about how the practitioners are advertising themselves. Misleading participants may be essential and justified in certain circumstances, but that needs to be carefully argued, and approved by an ethics committee.

(Example: We want to find ways to make devices easy to access for people with disabilities through their preferences and needs. We believe that you can help us by telling us what you like and what are your needs when using digital devices. We want to learn about the way you use interactive technologies and the way you would like to use these technologies. We also want to know more about your experiences using technology because this knowledge might help us to learn how to improve auto configuration methods.)

Type of Research Intervention

Briefly state the type of intervention that will be undertaken. This will be expanded upon in the procedures section but it may be helpful and less confusing to the participant if they know from the very beginning whether, for example, the research involves a vaccine, an interview, a questionnaire, or a series of finger pricks.

(Example: This research will involve your participation in a group discussion that will take about one and a half hour, and a one hour interview).

Participant Selection

Indicate why you have chosen this person to participate in this research. People wonder why they have been chosen and may be fearful, confused or concerned.

(Example: You are being invited to take part in this research because we feel that your experience as a disabled person (or as an expert, or as carer) can contribute much to our understanding and knowledge of users’ interaction with digital devices.)

Example of question to elucidate understanding:Do you know why we are asking you to take part in this study? Do you know what the study is about?

Voluntary Participation

Indicate clearly that they can choose to participate or not. State, only if it is applicable, that they will still receive all the services they usually do if they choose not to participate. Explanation: It may be more applicable to assure them that their choosing to participate or not will not have any bearing on their job or job-related evaluations. This can be repeated and expanded upon later in the form as well. It is important to state clearly at the beginning of the form that participation is voluntary so that the other information can be heard in this context. Although, if the interview or group discussion has already taken place, the person cannot 'stop participation' but request that the information provided by them not be used in the research study.

(Example: Your participation in this research is entirely voluntary. It is your choice whether to participate or not.

Examples of question to elucidate understanding:If you decide not to take part in this research study, do you know what your options are? Do you know that you do not have to take part in this research study, if you do not wish to? Do you have any questions?

Procedures

A. Provide a brief introduction to the format of the research study.

(Example: We are asking you to help us learn more about assistive technologies and their use among beneficiaries)

B. Explain the type of questions that the participants are likely to be asked in the focus group, the interviews, or the survey. If the research involves questions or discussion that may be sensitive or potentially cause embarrassment, inform the participant of this.

Example 1 (for focus group discussions)

Take part in a discussion with 7-8 other persons with similar experiences. This discussion will be guided by [name of moderator/guider] or myself.

The group discussion will start with me, or the focus group guide or moderator (use the local word for group discussion leader), making sure that you are comfortable. We can also answer questions about the research that you might have. Then we will ask you questions about the assistive technologies and give you time to share your knowledge. The questions will be about assistive technology, how is it used, what people used, and what happens when used it.

We will not ask you to share personal beliefs, practices or stories and you do not have to share any knowledge that you are not comfortable sharing.

The discussion will take place in [location], and no one else but the people who take part in the discussion and guide or myself will be present during this discussion. The entire discussion will be tape-recorded, but no-one will be identified by name on the tape. The tape will be kept [explain how the tape will be stored]. The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes. The tapes will be destroyed after ______number of days/weeks.

Example 2 (for interviews)

Participation in an interview with [name of interviewer] or myself.

During the interview, I or another interviewer will sit down with you in a comfortable place at XXXX. If it is better for you, the interview can take place in your home or a friend's home. If you do not wish to answer any of the questions during the interview, you may say so and the interviewer will move on to the next question. No one else but the interviewer will be present unless you would like someone else to be there. The information recorded is confidential, and no one else except [name of person(s)] will access to the information documented during your interview. The entire interview will be tape-recorded, but no-one will be identified by name on the tape. The tape will be kept [explain how the tape will be stored]. The information recorded is confidential, and no one else except [name of person(s)] will have access to the tapes. The tapes will be destroyed after ______number of days/weeks.

Example 3 (for questionnaire surveys)

You fill out a survey, which will be provided by [name of distributor of blank surveys] and collected by [name of collector of completed surveys]. Or you may answer the questionnaire yourself, or it can be read to you and you can say out loud the answer you want me to write down.

If you do not wish to answer any of the questions included in the survey, you may skip them and move on to the next question. [Describe how the survey will be distributed and collected]. The information recorded is confidential, your name is not being included on the forms, only a number will identify you, and no one else except [name of person(s) with access to the information] will have access to your survey.)

Duration

Include a statement about the time commitments of the research for the participant including both the duration of the research and follow-up, if relevant.

(Example: The research takes place over ___ (number of) days/ or ___ (number of) months in total. During that time, we will visit you three times for interviewing you at one month interval and each interview will last for about one hour each. The group discussion will be held once and will take about one and a half hour.)

Examples of question to elucidate understanding:If you decide to take part in the study, do you know how much time will the interview take? Where will it take place? Do you know that we will be sending you transport to pick you up from your home? Do you know how much time will the discussion with other people take? If you agree to take part, do you know if you can stop participating? Do you know that you may not respond to the questions that you do not wish to respond to? Etc. Do you have any more questions?

Risks

Although there is no foreseen risk in Prosperity4All research researchers should explain and describe any risks that you anticipate or that are possible. The risks depend upon the nature and type of qualitative intervention, and should be, as usual, tailored to the specific issue and situation.

Or if for example, the discussion is on opinions on government policies and community practices, and in general no personal information is sought, then the text under risks could read something like "There is a risk that you may share some personal or confidential information by chance, or that you may feel uncomfortable talking about some of the topics. However, we do not wish for this to happen. You do not have to answer any question or take part in the discussion/interview/survey if you feel the question(s) are too personal or if talking about them makes you uncomfortable.)

Benefits

Benefits may be divided into benefits to the individual, benefits to the community in which the individual resides, and benefits to society as a whole as a result of finding an answer to the research question. Mention only those activities that will be actual benefits and not those to which they are entitled regardless of participation.

(Example: There will be no direct benefit to you, but your participation is likely to help us find out more about how to provide an easy way to personalize electronic devices and services).

Reimbursements

State clearly what you will provide the participants with as a result of their participation. These may include, for example, travel costs and reimbursement for time lost. The amount should be determined within the host country context.

Example: You will not be provided any incentive to take part in the research. However, we will give you [provide a figure, if money is involved] for your time, and travel expense (if applicable).

Examples of question to elucidate understanding:Can you tell me if you have understood correctly the benefits that you will have if you take part in the study? Do you know if the study will pay for your travel costs and time lost, and do you know how much you will be reimbursed? Do you have any other questions?

Confidentiality

Explain how the research team will maintain the confidentiality of data with respect to both information about the participant and information that the participant shares. Outline any limits to confidentiality. Inform the participant that because something out of the ordinary is being done through research, any individual taking part in the research is likely to be more easily identified by members of the community and therefore more likely to be stigmatized. If the research is sensitive and/or involves participants who are highly vulnerable - research concerning violence against women for example - explain to the participant any extra precautions you will take to ensure safety and anonymity.

(Example: The research being done in the community may draw attention and if you participate you may be asked questions by other people in the community. We will not be sharing information about you to anyone outside of the research team. The information that we collect from this research project will be kept private. Any information about you will have a number on it instead of your name. Only the researchers will know what your number is and we will lock that information up with a lock and key. It will not be shared with or given to anyone except [name who will have access to the information, such as research sponsors, DSMB board, your clinician, etc.])

CERTIFICATE OF CONSENT

This section must be written in the first person. It should include a few brief statements about the research and be followed by a statement similar the one in bold below. If the participant is illiterate but gives oral consent, a witness must sign (The witness has to be accepted by the Local Ethics Research Committee). A researcher or the person going over the informed consent must sign each consent. Because the certificate is an integral part of the informed consent and not a stand-alone document, the layout or design of the form should reflect this. The certificate of consent should avoid statements that have "I understand…." phrases. The understanding should perhaps be better tested through targeted questions during the reading of the information sheet (some examples of questions are given above), or through the questions being asked at the end of the reading of the information sheet, if the potential participant is reading the information sheet him/herself. 

Example: I have been invited to participate in research about audiphones and hearing aids.

(This section is mandatory)

I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions I have been asked have been answered to my satisfaction. I consent voluntarily to be a participant in this study

Print Name of Participant__________________                                     

Signature of Participant ___________________

Date ___________________________

            Day/month/year                 

Special Conditions

If the volunteer is illiterate then the consent certificate will present the following format:

I have witnessed the accurate reading of the consent form to the potential participant, and the individual has had the opportunity to ask questions. I confirm that the individual has given consent freely.

Print name of witness____________                      

Signature of witness    _____________

Date ________________________

                Day/month/year

Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and to the best of my ability made sure that the participant understands that the following will be done:

1.

2.

3.

I confirm that the participant was given an opportunity to ask questions about the study, and all the questions asked by the participant have been answered correctly and to the best of my ability. I confirm that the individual has not been coerced into giving consent, and the consent has been given freely and voluntarily.

 

 A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________                                     

Signature of Researcher /person taking the consent__________________________

Date ___________________________                              

                 Day/month/year

Following the previous guidelines the Informed consent form used during the first users involvement was:

Consent Form for Participants in Prosperity4All Research and Evaluation Studies

Please complete this form after you have read the Information Sheet and/or listened to an explanation about the research.

Thank you for considering taking part in this research. The person organizing the research has explained the project to me and I agree to take part.

I understand that if I have any questions arising from the Information Sheet or explanation already given to me I can ask the researcher before I decide whether to join in. I will be given a copy of this Consent Form to keep and refer to at any time.

I understand that if I decide at any time during the research that I no longer wish to participate in this project, I can notify the researchers involved and withdraw from it immediately without giving any reason. Furthermore, I understand that I will be able to withdraw my data.

I consent to the processing of my personal information for the purposes explained to me. I understand that such information will be treated in accordance with the terms of Data Protection Laws.

Contact details of the participant:
[the following to be filled in by the participant or his/her proxy]:

·         Name (in capitals):

·         Gender:

·         Age:

·         Nationality:

·         E-mail:

·         Telephone:

·         Type of impairment (if applicable; for users with impairments participating):

·         Type and years of expertise (if applicable; for experts participating):

·         Any medication taken or health condition that would be needed to be known by a medical emergency centre:

·         Participant’s reference number: [this is to be given and filled in by the supervisor]

·         Contact details of the proxy (may be witness, carer, etc.): [the following to be filled in by the proxy of the participant, if any/applicable]:

·         Name (in capitals):

·         Relationship to participant:

·         Expertise (if any; i.e. carer, ...):

Participant’s Statement:

I ____________________________________  (Print Name) agree that the research project has been explained to me to my satisfaction and I agree to take part in the study. I have read both the notes written above and the Information Sheet about the project, and understand what the research study involves.

Signed:                                                                       Date:

Venue (address):

Proxies/Witnesses Statement [only if applicable]:

I witness that the participant is unable to sign the consent form but has consented to participate in the project.  They have read/been read both the notes written above and the Information Sheet about the project, and they understand what the research study involves.

Signed:                                                                       Date: 

Venue (address):

Relationship to participant: _____________________

Investigator’s Statement:

I, _________________, confirm that I have given this research participant information on the study, which in my opinion is accurate and sufficient for the participant to understand fully the nature, risks and benefits of the study, and the rights of a research participant. There has been no coercion or undue influence. I have witnessed the signing of this document by the participant (and/or the proxy).

Signed                                                            Date:

Venue (address):

Additional form to be signed in addition to the above by the participant, the investigator and the proxy in cases of persons with cognitive impairments and illiterate persons

In these cases, the consent form should be verbally explained in a language that the participant can understand. His/her proxy should sign the above form on his/her behalf, whereas the participant needs to give oral consent that will be recorded and sign (with a mark if not possible in other way) the following short form (the proxy will verify that what the participant signs below is in compliance with what s/he has agreed orally).

Documentation of verbal presentation of English-language consent form

By signing below, I voluntarily agree to participate in this research study. The study and consent form have been verbally explained to me in a language I understand. I have had the opportunity to ask all my questions about this study. I have received answers to all my questions.

Date:

Venue (address):

Participant name (in capitals):

Participant signature:

Proxy name (in capitals):

Proxy signature:

Investigator/supervisor name (in capitals):

Investigator/supervisor signature