Which of the following should not be part of the informed consent form?

23.7.3.2 Informed consent form

The informed consent form, an important part of your IRB application and an important part of your empirical UX evaluation, is a requirement; it is not optional. The informed consent form, which is to be read and signed by each participant, should state in clear understandable language:

That the participant is volunteering to participate in your evaluation.

The expected length of time for the evaluation session (the evaluator should have some idea of how long a session will take after performing pilot testing).

That the participant can withdraw anytime, for any reason, or for no reason at all.

That you are taking data that the participant helps generate.

That the data are taken anonymously (neither the name of the participant nor any other kind of identification will be associated with data after it has been collected).

That the participant understands any foreseeable risks or discomforts, which should be minimal to zero for UX evaluation.

That the participant understands any benefits (e.g., educational benefit or just the satisfaction of helping make a good design) and/or compensation to participants (if there is payment, state exactly how much; if not, say so explicitly).

All project/evaluator contact information.

That they can ask the evaluator questions at any time.

Whether any kind of recording (e.g., video, audio, photographic, or holodeck) involving the participant will be made and how you intend to use it, who will view it (and not), and by what date it will be erased or otherwise destroyed.

A statement that, if you want to use a video clip (for example) from the recording for any other purpose, you will get their additional approval in writing.

The consent form may also include nondisclosure requirements. This form must spell out participant rights and what you expect the participants to do, even if there is overlap with the general instruction sheet. The form they sign must be self-standing and must tell the whole story.

Although informed consent may not be required in the case where your participants are also organization employees, this is an area where you should err on the side of caution. In any case, you should have two copies of the consent form ready for reading and signing by participants when they arrive. One copy is for the participant to keep.

Example: Simple Informed Consent Form

Informed Consent for Participant of Development Project

< Name of your development organization > < Date or version number of form > Title of Project: < Project title >

Project team member(s) directly involved: < Team member names > Project manager: < Project manager name >

I. THE PURPOSE OF YOUR PARTICIPATION IN THIS PROJECT As part of the < project title > project, you are invited to participate in evaluating and improving various designs of < name of system or product >, < description of system or product >.

II. PROCEDURES You will be asked to perform a set of tasks using the < name of system or product >. These tasks consist of < description of range of tasks >. Your role in these tests is to help us evaluate the designs. We are not evaluating you or your performance in any way. As you perform various tasks with the system, your actions and comments will be noted and you will be asked to describe verbally your learning process. You may be asked questions during and after the evaluation in order to clarify our understanding of your evaluation. You may also be asked to fill out a questionnaire relating to your usage of the system.

The evaluation session will last no more than four hours, with the typical session being about two hours. The tasks are not very tiring, but you are welcome to take rest breaks as needed. If you prefer, the session may be divided into two shorter sessions.

III. RISKS There are no known risks to the participants of this study.

IV. BENEFITS OF THIS PROJECT Your participation in this project will provide information that may be used to improve our designs for < name of system or product >. No guarantee of further benefits has been made to encourage you to participate (Change this if a benefit such as a payment or a gift is offered). You are requested to refrain from discussing the evaluation with other people who might be in the candidate pool from which other participants might be drawn.

V. EXTENT OF ANONYMITY AND CONFIDENTIALITY The results of this study will be kept strictly confidential. Your written consent is required for the researchers to release any data identified with you as an individual to anyone other than personnel working on the project. The information you provide will have your name removed and only a subject number will identify you during analyses and any written reports of the research.

The session may be recorded. If it is recorded, the recordings will be stored securely, viewed only by the project team members and erased after three months. If the project team members wish to use a portion of your recording for any other purpose, they will get your written permission before using it. Your signature on this form does not give them permission to show your recording to anyone else.

VI. COMPENSATION Your participation is voluntary and unpaid (Change this if a benefit such as a payment or a gift is offered).

VII. FREEDOM TO WITHDRAW You are free to withdraw from this study at any time for any reason.

VIII. APPROVAL OF RESEARCH This research has been approved, as required, by the Institutional Review Board < or the name of your review committee > for projects involving human subjects at < your organization >.

IX. PARTICIPANT RESPONSIBILITIES AND PERMISSION I voluntarily agree to participate in this study, and I know of no reason I cannot participate. I have read and understand the informed consent and conditions of this project. I have had all my questions answered. I hereby acknowledge the above and give my voluntary consent for participation in this project. If I participate, I may withdraw at any time without penalty. I agree to abide by the rules of this project.

Signature Date

Name (please print) Contact: phone or email

Informed consent form

The informed consent form, an important part of your IRB application and an important part of your lab-based UX evaluation, is a requirement; it is not optional. The informed consent form is to be read and signed by each participant and states that the participant is volunteering to participate in your evaluation, that you are taking data that the participant helped generate, and that the participant gives permission to use data—usually with the provision that the participant's name or identity will not be associated with data, that the participant understands the evaluation is in no way harmful, and that the participant may discontinue the session at any time. The consent form may also include non-disclosure requirements.

This form must spell out participant rights and what you expect the participants to do, even if there is overlap with the general instructions sheet. The form they sign must be self-standing and must tell the whole story.

Be sure that your informed consent form contains:

a statement that the participant can withdraw anytime, for any reason, or for no reason at all

a statement of any foreseeable risks or discomforts

a statement of any benefits (e.g., educational benefit or just the satisfaction of helping make a good design) or compensation to participants (if there is payment, state exactly how much; if not, say so explicitly)

a statement of confidentiality of data (that neither the name of the participant nor any other kind of identification will be associated with data after it has been collected)

all project/evaluator contact information

a statement about any kind of recording (e.g., video, audio, photographic, or holodeck) involving the participant you plan to make and how you intend to use it, who will view it (and not), and by what date it will be erased or otherwise destroyed

a statement that, if you want to use a video clip (for example) from the recording for any other purpose, you will get their additional approval in writing

clear writing in understandable language

An example of a simple informed consent form is shown in Figure 14-2.

Informed consent may or may not also be required in the case where your participants are also organization employees. In any case you should have two copies of the consent form ready for reading and signing by participants when they arrive. One copy is for the participant to keep.

Privacy and identification

A part of good research ethics, most informed consent forms for usability testing say that the information from each participant will be aggregated so that no individual can be identified. Concerns about privacy are especially serious in a government context where these data could be made public either in the normal course of government transparency or though a legal request for government information. A usability test that includes sensitive information such as medical or financial details carries an even greater need to handle test data carefully.

Challenges for working with the general public include the risk of accidentally revealing private personal details. In some health contexts, for example, it is common to avoid making recordings that include the participant's face.

When the participants are experts or work in advocacy organizations, there is a risk that the statements and activities of the individual could be associated with their organization. In small communities, government staff often knows many of the people in their field, adding to this risk.

For participants from government staff, there is a risk that personal details may be made known to their colleagues.

17.1.3 Participant Anonymity

We remind you, before we get into the details, that regardless of the kind of evaluation or reporting you are doing, you must preserve participant anonymity. You should have promised this on your informed consent form, and you have an ethical, and perhaps a legal, obligation to protect it religiously thereafter. The necessity for preserving participant anonymity extends especially to evaluation reporting.

There is simply no need for anyone in your reporting audience to know the identity of any participant. This means not including any names in the report and not showing faces in video clips. This latter requirement can be met with some simple video blurring.

Participant anonymity does not mean that you, as the evaluator or facilitator, do not know the names of participants. Somewhere along the line someone must have recruited and signed up and possibly even paid the participants. You should keep participant identification information in just one place—on a sheet of paper or in a database mapping the names to identification codes. Codes, never names, are used everywhere else in the evaluation process—on data collection forms, during data analysis, and in all reports.

4 Institutions, Uniformity, and Innovation

Institutionalist arguments tend to focus on the production of uniformity. As institutionalized practices are more widely adopted in a field, it becomes deviant to do things differently: not to have an affirmative action officer, not to have an informed consent form, not to include a statement about diversity in advertisements for jobs, not to have rules about hate crimes. But these observations about legitimacy and uniformity raise questions about whether institutionalization produces stagnation and how innovation is possible.

Institutionalist arguments about decoupling of ceremony from day-to-day practices provide a partial answer. If legitimacy can be secured by superficial conformity, organizational handbooks may be brought into conformity with law while instrumental practices remain as before. Institutionalization may produce organization handbooks that portray organizations as rigid, and in particular as scrupulously conforming to the law, when they are in fact quite supple and quite innovative in devising ways to redefine the law. Resistance in decoupling ceremony from practice and in devising policies that satisfy the letter if not the spirit of the law, then, is one form of innovation. Edelman et al. (1993), for instance, discovered that in the hands of human resources officers responsible for processing discrimination complaints, civil rights law moved into the managerial realm. As a result, a right to complaint resolution replaced a more political right to a nondiscriminatory workplace.

We should also remember, though, that the standard practices of one field can be significant innovations when imported into another. Thus, increasing uniformity of some sorts may bring with it increasing diversity of other sorts. For instance, uniformity in strategies for solving a category of problems may bring with it diversity in the problems to which an institutionalized solution is applied. Thus Grattet et al. (1998) found that, in the United States, the variety of legal solutions used to combat hate crimes (e.g., criminalizing interference with civil rights, creating new categories of crime, increasing penalties for pre-existing categories of crime) has decreased over time. At the same time, the number of ‘protected statuses’ (e.g., race, religion, ethnicity, sexual orientation) has increased.

These arguments that innovation occurs when actors invent ways to signal compliance without altering mundane organizational practice, transform unpalatable laws into more circumscribed routines, or transport institutionalized practices to new settings, all refocus attention on the innovators. In a variety of settings—employment law, corporate bankruptcy law, medical regulation, to name a few—scholars have found that professionals have played important roles. Rather than being identified solely with the organization, professionals retain commitments associated with their professions. They may dampen or amplify the impact of the law depending on whether legal tools are useful in advancing professional interests and achieving professionally valued goals (Edelman 1992, Heimer 1999). In their investigation of corporate bankruptcy law in the USA and the UK, Carruthers and Halliday (1998) argue that the role of professionals in legal innovation varies with their status and autonomy. Members of strong professions are not limited to devising ways of decoupling ceremony from practice or molding the routines that implement the law. Instead, high status professionals shape more directly the laws that govern an organizational field and frame their own work. They originate the practices that will eventually become the institutions that others adopt. Similar arguments have been made about the creation of international legal regimes (Dezalay and Garth 1996).

Documents and Materials

Documents and materials for structured interviews include the following:

An interview project plan.

A letter of introduction that you can send or e-mail to prospective participants and their management (unless you are planning cold calls).

Informed consent forms that explain the purpose of the study, any risks associated with the interview sessions, an explanation of how the data will be used, and permission for data recordings.

An easy-to-administer questionnaire. You don’t want a questionnaire that the interviewers have trouble reading because the text is too small or the formatting too dense.

Nondisclosure agreement (NDA) forms if the participants have not already signed a form.

Some type of database or software for storing and analyzing qualitative data (if you have large amounts of data). You may want to examine data over a period of time or compare it to other sources of data, so some way to store it can be beneficial in the long run. One emerging theme with survey results is that of privacy of personal information. There are laws about how user/customer data are tracked, stored, and distributed. Check with your corporate security office about privacy laws related to “personally identifiable information (PII).” The key point about PII is that you should not store open information that would allow you to identify a single person in a particular context or present results from interviews that might allow someone to identify a particular participant. For example, if you did interviews at a client site and in your report of the interviews, you noted comments from the “lone disabled engineer” you might be providing enough information for someone to figure out who that disabled engineer was.

Interview agendas or guides with the general areas that you will cover and potential probing questions.

Maps and good directions.

Small gifts or incentives for your hosts and those who you interviewed. See Chapter 6 for more details on intrinsic and extrinsic incentives.

8.8.3.2 The Introduction

Most interviews or focus groups follow the same general outline. You should start with an introduction, telling the interviewees about the research and your goals. If appropriate, this would also be a good time to complete any paperwork, including (when necessary) the informed consent form required to document the interviewee's agreement to participate (Chapter 15). You should also tell participants if you are recording the session and how. For focus groups, you might use the introduction as an opportunity to encourage differing viewpoints (Krueger, 1994).

You might want to keep the introduction to your research brief. You should not go into too much detail regarding your goals and aims (Kvale, 2007), as a detailed description of your aims and goals might encourage your participants to provide answers that they think you would want to hear. This is particularly a concern if you're asking about reactions to a syste that you have built. You can provide more context after the session is over (see Section 8.8.3.5).

The Right to Be Informed

It is only when the participants fully understand the risks and what is going to happen in the study that they can be willing (not deceived) participants. For example, since it is not uncommon for participants to worry that many people are going to see the video of their study and possibly laugh at their mistakes, you should inform all participants (not just the ones who ask) how you will control access to the video and data.

Participants have the right to know the purpose of the activity they are involved in, the expected duration, procedures, use of information collected (e.g., to design a new product), incentives for participation, and their rights as a participant of the study (e.g., freedom to withdraw without penalty). You should also inform participants that the purpose of the study is to evaluate the product, not them, and any difficulty they encounter is a reflection on the product, not them. This information should be conveyed during the recruitment process (refer to Chapter 6, Preparing for Your User Requirements Activity, “Recruitment Methods” section, page 139) and then reiterated at the beginning of the activity when the informed consent form is distributed and signed by the participants. The participants sign this form to acknowledge being informed of these things and agreeing to participate. If you are working with participants under the age of 18, a parent or guardian must sign the informed consent form; however, the minor must still be verbally informed of the same information “in terms they can understand” and provide their consent. If the minor does not consent, it does not matter that the parent has already agreed.

Deception should be avoided unless the benefits greatly outweigh any potential harm. You may not want to reveal every aspect of your study up front to avoid biasing the participant’s response, but the participant should not be tricked into participating if you believe he or she never would have agreed to sign up had he or she known the details of the study. For example, if you want to conduct a brand-blind study (i.e., the creator of the product is not identified) or sponsor-blind study (i.e., you do not wish to reveal that you are conducting an analysis of your competition’s product), a third-party recruiting for your study could provide participants with a list of possible companies (including yours and your competitors) that are conducting the study. The participants should then be asked if they have any concerns or issues with participating in studies by any of those companies. At the end of the study, the evaluator should reveal the true sponsor.

If participants have a misperception about the purpose of the activity (e.g., believing that it is a job interview), the participant must be corrected immediately and given the opportunity to withdraw. Participants should also have the opportunity to ask questions and to know whom to contact with further questions about the study or their rights.

Documents and Materials

Documents and materials for semi-structured interviews include the following:

An interview project plan that describes the goals of the study, the recruiting plan, background on the companies and people you are going to visit, the general topics that are of interest, guidelines for interviewers, and the data collection and analysis plan. The level of detail depends on the magnitude of the study, but even small studies can benefit from a project plan.

A letter of introduction that you can send or email to perspective participants and their management.

Informed consent forms that explain the purpose of the study, any risks associated with the interview sessions, how the data will be used, and permission for data recordings.

NDAs are required if the participants have not already signed a form. Check with your legal office on your company’s NDA policies. For example, some people may not have the authority to sign an NDA (you might need someone at the director or higher level to do so).

Some types of database or software are required for storing and analyzing qualitative data (if you have large amounts of data). You may want to examine data over a period of time or compare it to other sources of data, so some way to store it can be beneficial in the long run.

Interview agendas or guides with the general areas that you will cover and potential probing questions.

Maps and good directions.

Small gifts or incentives for your hosts and those you will interview.

6 Blindability

Extensive reviews of blindability indicated that studies took its validity for granted. It was suspect in the few double-blind trials that tried to carry out such tests of validity. Basoghu, in review of the literature found that only three of 23 double-blind psychopharmacology studies maintained blindability in patients, physicians, and assessors. Side effects, explanations in informed consent forms, past experience with similar drugs, and improvement with the active drug but not placebo sabotaged blindability. In his own comparison study of blindability of alprazolam, an anti-anxiety agent, with behavior therapy for panic disorder, Basoghu found that patients, treating therapists, and assessors were able to guess correctly, to a statistically significant extent, the patient's category. Patients treated with the active drug were more accurate than those on placebo, and active drug accuracy was highest at late stage of therapy, when optimal dosing and maximal efficacy had presumably been achieved.

Morin et al. (1995), recognizing that judgments carried out at the end of a study as to what was drug, what placebo could be influenced by treatment response to active drug, compared Temazepam, a hypnotic, and an inactive placebo. They carried out three assessments over 8 weeks. All patients received cognitive or behavioral therapy. Both patient and physician groups showed a statistically significant high degree of accuracy in guessing at 1 and 8 weeks with no better than chance guessing at week 4.

From these and other studies, it appeared that certainty ratings increased with time, that experienced patients showed greater accuracy in penetrating blinding, and that patients on active drugs guessed better than those on placebo. In summary, neither the patients nor the administering physicians were blinded to any significant degree.