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Research Ethics in SBER

Board Training

December 2019

Objectives

Objectives

1. Enhance understanding of risks and benefits in SBER, especially those particular to SBER.

2. Assess strategies for IRBs to encourage SBER data transparency while attending to issues of confidentiality and consent

3. Examine issues in informed consent as related to peculiarities of SBER research design, data laundering, and deception.

Risk Benefit Ratios in SBER

Risks & Benefits

When considering risks and benefits in SBER, a common assumption is that benefits to subjects are negligible, but so are the risks of research. Here, we’re taking a closer look at this assumption…

Benefits

Are there really any direct benefits in SBER?

“It could be argued that the benefits of most social science research, no matter how altruistically packaged, are for the career of the researcher, and that relatively few direct benefits accrue to research participants or society at large” (Wassenaar and Mamotte 2012, 13).

This is a fair point, but it ignores how subjects themselves define benefits and trivializes intangible benefits that could result from well-designed SBER.

Certainly, there are clear cases of SBER that have the prospect of direct benefit...

A behavior study on grief coping strategies might improve the well-being of subjects.

An educational study on the effectiveness ADHD focusing techniques might improve subject learning.

These are reasonable possibilities of direct benefit for a researcher to claim. However, in SBER, determining whether these benefits are actually being realized is a bit trickier than in biomedical research, and the IRB should pay close attention to how and in what time frame these outcomes are being evaluated.

For example, consider the following case:

“Colleen’s study sought to explore how direct feedback to teachers on their performance in the classroom by sixth grade students might be used for professional development. All the teachers were volunteers, and the entire process was guided by Colleen, who was an assistant principal in the school, though not the evaluating supervisor of any of the teachers in the study. Oxford County School District (traditionally a very conservative institution regarding risk in research) recognized the great potential benefit of the study and, after carefully reviewing it, gave the study its approval” (Lincoln and Tierney 2004, 225).

What might determine whether the IRB should view feedback that might lead to greater professional development as a direct benefit? Are there strategies that could increase the possibility of benefit? How might we want the researcher to measure or report the realization of this benefit at continuing review?

Moving toward even less concrete benefits…

Opsal et al. (2015) suggest “that IRBs treat as real the evidence for benefits in qualitative research,” that we pay attention to how subjects express their understanding of benefits, and that we not take for granted that there are “no known benefits” in interview research (11).

To support this claim, their study draws on an analysis of 198 subject experiences in qualitative interview research and finds that subjects recognize the following as real benefits to participation:

Moving toward even less concrete benefits…

Of course, subjects differ in their values.

Research claiming that their project will “relieve a sense of isolation” (for example) should be, at a minimum, pressed to demonstrate how they will evaluate realization of this prospective benefit.

Risks

Are the risks in SBER always ‘no more than minimal’?

In the same study, Opsal et al. 2015 find that the risks perceived by subjects in interview studies align closely with those traditionally associated with SBER.

Are the risks in SBER always ‘no more than minimal’?

Wassenaar and Mamotte (2012) highlight similar risks:

“While social science research is unlikely to cause direct physical harm to participants, the risks of invasion of privacy, loss of confidentiality, psychological trauma, embarrassment, deception, stigma, and stereotyping exist and need to be monitored and prevented” (5).

However, this view of SBER as “unlikely to cause direct physical harm to participants” should not be taken for granted.

Consider this example:

Harms can also be physical. Research assistants can be subject to arrest, detention, or imprisonment (du Toit 1980, 277–78; Paluck 2009) and study participants can be subject to government reprisals. In one notable case of physical harm, anthropologist Georges Condominas (1973, 4) found, to his horror, that the United States Department of Commerce, without his authorization and hence in direct violation of international copyright law, had translated Condominas’s book on Vietnam from French to English and distributed copies to Green Beret soldiers fighting in Vietnam. Condominas learned of this from one of his study participants whom US Special Forces had tracked down and tortured (Fujii 2012, 717).

Moreover, indirect or non-physical harms can also be more than minimal.

Click the link to read the following example:

https://thewpsa.wordpress.com/2014/10/25/messing-with-montana-get-out-the-vote-experiment-raises-ethics-questions/

Beyond the issues of consent, deception, and illegal use of materials, this IRB-approved study also raises the question of serious harms to society – in this case, to the democratic electoral process itself.

Thus, any default judgement of SBER as minimal risk should be carefully reconsidered.

Some parting advice:

"IRBs should also ask researchers how they will monitor their participants’ experiences and well-being […] Part of the point we are trying to make is that an ethical research process is not, for example, providing suicide hotline numbers to every participant at the end of an interview, regardless of their needs. Instead, an ethical research process is one where the researcher is tuned into the needs of the participants, potential strengths and vulnerabilities that the population of focus brings to the table, and ways they can respond appropriately and effectively to each individual" (Opsal et al. 2015, 11).

Risk and Benefits in SBER

Case Study

Case Study

Source: https://tinyurl.com/tvan6lu

A sociologist has teamed up with a psychologist to conduct a long-term study of mental health and social group formation among Latin American refugees to the US. The research cohort will be comprised of adults who have fled violent conflicts in countries where known terror groups are believed to be actively recruiting. A specific aim of this project is to determine what factors influence whether or not refugees are likely to accept, engage, or align themselves with terrorist groups in their post-conflict lives. The researchers will look at the impact of social, personal, experiential, and psychological factors, at both the group and individual level. The study involves taking personal histories from subjects, asking them to recount traumatic encounters, and tell their refugee story. Subjects will be asked to complete standardized psychological evaluations at specific time points throughout the study and will be followed as they settle in new homes and communities. Subjects will also be invited to focus groups in convenient clusters post-resettlement and their social networks will be mapped through periodic in-person interviews. An important aspect of the follow-up interviews will be to gauge changes in opinion regarding certain negative social groups (terrorists or terror-related groups). The research team will also assess personal anecdotes regarding interactions with agents of negative groups within their community as well as with the authorities. Subjects will not be told the specific aims of the research, only that the purpose of the study is to learn the long-term social and psychological outcomes of refugee resettlement on post-conflict groups. The researchers will recruit through flyers at refugee/immigration service agencies, local community centers, churches, grocery stores, etc. This research is funded through a grant from the United Nations. Participants will receive a $25 gift card to a local supermarket chain at 12-month intervals for the duration of the research (based on continued engagement in the study).

Case Study Scenario

  • What are the risks to the subject population as a group?

  • What are the risks to individual subjects within family/community groups?

  • Is there an obligation to provide psychological counseling or other treatment/services to this research population?

  • How can potentially coercive aspects of the study design/compensation be addressed?

  • What benefits are there, if any to participants?

  • Can a benefit be built in to the study somehow?

Risk/Benefit Analysis:

  • Engage a community member in the planning and/or conduct of the research.

  • Utilize a bi-directional consent procedure or other method to help ensure participants understand that their participation in the research is voluntary, and that they clearly understand any risks and benefits before agreeing to participate.

  • Ensure that data is coded such that accidental disclosure will not place participants at risk of harm, embarrassment, threat to social standing, liberty, employability, etc.

  • Obtain a Certificate of Confidentiality to protect the data from compelled disclosure.

  • Ensure that interviewers and focus group leaders are trained to detect anxiety or depression reaching levels requiring evaluation and/or treatment, and have a plan in place (counseling, referral, etc.) to address such situations if they arise.

  • For example: The study adds an intervention designed to aid resettlement and engages participants in psychologically advantageous activities, such as gainful employment at a local charity

Ideas to Improve the Risk Benefit Ratio

What is a Certificate of Confidentiality?

Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being compelled to disclose information that would identify research subjects, Certificates of Confidentiality help achieve the research objectives and promote participation in studies by helping assure confidentiality and privacy to participants.

Confidentiality and Data Transparency

Data Transparency

The Need for Transparency

Transparency in SBER

An issue that requires special attention in SBER is the (perceived or actual) malleability of SBER data – particularly qualitative data—and the need for greater data transparency that simultaneously protects subject confidentiality.

Consider the following sentiment:

An important step in countering any freewheeling interpretations of SBER data and increasing trust in the research process is to make the data itself more transparent.

“Researchers have complete freedom in the interpretive process and can impose on the collected data any theoretical perspective over which RECs and participants have no or little control” (Wassenaar and Mamotte 2012, 5).

Per the NSF:

"Investigators are expected to share with other researchers, at no more than incremental cost and within a reasonable time, the primary data, samples, physical collections and other supporting materials created or gathered in the course of work under NSF grants. Grantees are expected to encourage and facilitate such sharing.

Proposals submitted or due on or after January 18, 2011, must include a supplementary document of no more than two pages labeled "Data Management Plan". This supplementary document should describe how the proposal will conform to NSF policy on the dissemination and sharing of research results."

NSF Data Sharing Policy

With the new(ish) NSF data management plan (DMP) mandate, there is an increasing expectation of data sharing and transparency in SBER.

However, for all SBER research, problems arise when:

  • There is no DMP in the initial protocol (and authors later want to publish in journals that require one, for example).

  • The promises in the DMP don’t align with the permission sought for data sharing in the ICF.

  • Confidentiality, particularly in qualitative studies, is threatened as source data is shared.

Issues in Data Sharing

At the time of IRB approval, IRBs can help PIs to think about the need for a DMP and its uses in the long run.

For example, if an application or consent form promises that no primary source data will be shared with individuals outside of the research team, this may be an opportune time to ask how the PI will respond if journals require it for publication (as many do) or if a potential funder requires it.

PIs should also be aware that if the ICF informs subjects that their data will not be shared, this decision may not be revisited without reconsenting subjects.

In addition, when reviewing a DMP, IRBs should consider social and legal restrictions built into whatever sharing solution the PI provides and be sure it is adequate for the research proposed.

IRB Solutions

Confidentiality

Also note that sharing SBER data requires special attention to maintaining confidentiality, as removing identifiers may not be enough to protect against de-identification.

It would be much easier for subjects (and those who know them) to recognize identities in an anonymized interview transcript than in a de-identified medical record, for example.

As such, many researchers will go to great lengths to obscure recognizable details about their subjects…but this also comes at a cost.

Consider the following example:

“Some of the issues with the children we interviewed, we had to go through all sorts of contortions which ultimately we weren’t always happy with, like for example, we felt we’d better change the gender of this child, we’d better change the age and you start to think: is this an ethical thing to do? But you actually felt that the imperatives of the moment were such that you would do that rather than the child be identified” (R. Wiles et al. 2008, 424).

Paying attention to these issues at the time of review can help to improve the research process, afford greater protection to subjects, and reduce frustration down the line.

Plan Ahead

Informed Consent in SBER

Here, we’ll first touch on 2 issues at the opposite end of the spectrum. On the one side, we have researchers who very much want to obtain meaningful consent from their subjects, but who feel that the biomedical model for obtaining consent does not fit their research model. On the other, we’ll look at researchers who are avoiding the consent process by utilizing industry-generated pre-existing data. Finally, we’ll turn our attention to deception in SBER.

Informed Consent

We understand that consent is a process – one that includes but that is far from limited to signing a consent form.

However, the importance biomedically-oriented IRBs may place on the document itself poses a challenge for some (particularly qualitative) SBER.

It also gives us the opportunity to think a bit more creatively about how we can shape those documents so that they do offer meaningful and complete information to subjects in SBER.

A Flexible Consent Process

Path Forward

A Problem:

“In some forms of qualitative social science research, the research activities are negotiated by all participants at each stage in the research process, and participants can only decide whether to participate or not as the process develops (Boser, 2006). The dynamic and flexible nature of these types of qualitative research makes the possibility of obtaining informed consent problematic, and often requires participants to give consent to the unknown (Löfman et al., 2004)” ( Wassenaar and Mamotte 2012, 5).

Even in quantitative SBER, it maybe be difficult to convey to subjects exactly what they will experience.

One possible solution to this would be to develop a multi-phased consent process, could “require consent to be obtained as each new research activity is negotiated” (Wassenaar and Mamotte 2012, 5).

Another solution is to be clear about the flexible nature of the study in the ICF. Consider this excerpt from an ICF for a qualitative interview project:

In this study, you and an interviewer will talk at length several times about your experience of illness and caring.

This will not be a simple matter of the interviewer asking questions and you answering. You will also shape the conversation and will have opportunities to tell the interviewers what you think they need to know. We know from previous studies that most people will get upset sometimes in these interviews. However, on balance the experience is a good one for most people (Opsal et al. 2015, 11).

Another possibility is to give the subject more control over which elements of the process to which they are consenting. For example:

“To ensure maximal protection, [the researcher] gave her interviewees a menu of options. Participants could decide what they wanted to tell Wood, specify whether it was for publication or her knowledge only, and state whether she could write down what they told her” (Fujii 2012, 717).

This allows the subjects to specify the scope of their consent regardless of how the interview process may develop.

Takeaway

Researchers may need to think about creative ways to design meaningful and comprehensive ICFs, and IRBs that are sensitive to this need can be a useful resource for improving the SBER consent process.

Data Laundering & Research without Consent

1. READ: https://tinyurl.com/v2hubxr

Data Laundering & Research without Consent

In a world where online research and industry partnerships are becoming increasingly prevalent, there is growing concern about consent in this area of research.

2. Consider: IRB Review

Where does the IRB fit into this equation?

Regarding this particular study:

“According to a Cornell University press statement on Monday, the experiment was conducted before an IRB was consulted. Cornell professor Jeffrey Hancock—an author of the study—began working on the results after Facebook had conducted the experiment. Hancock only had access to results, says the release, so “Cornell University’s Institutional Review Board concluded that he was not directly engaged in human research and that no review by the Cornell Human Research Protection Program was required.”

(Source: https://tinyurl.com/zu5msyf)

Hence, there is no regulatory breach here. But where does that leave us?

On one hand, Flick (2016) argues:

“If companies are acting ethically from the outset (and performing their research and innovation responsibly), then the ‘Facebook loophole’ would not exist. Until that day, however, it would be prudent to maintain the ethical requirements and quality of human research science to reject research studies from any organizations, whether research or industry, where the data collection is not performed with ethical oversight (and if not independent ethical oversight, then at least procedures that would satisfy such oversight should it exist)” (25).

On the other hand, she notes:

"There has been a response from a group of bioethicists stating that there was not any ‘egregious breach of ethics or law’ in the study (Meyer, 2014a) and that turning to regulation could drive such research ‘underground’" (23).

Is there a role for the IRB in closing the Facebook Loophole?

3. Discuss

Step 1: Share your thoughts here:

https://pollev.com/gillianbeach179?_ga=2.147709502.865394591.1576687108-1712170592.1576079033

Step 2: View real-time responses here:

https://www.polleverywhere.com/free_text_polls/7D6B61fXXJPnN0nnxRgA6?preview=true&controls=none

DECEPTION

Unlike the previous topic, the use of deception in SBER is the subject of longstanding ethical debates – and it is likely the key issue that comes to mind when thinking about issues of consent in experimental SBER.

Deception

&

Debriefing

What is deception?

According to Anderson’s study, deception consists of the following forms [5]:

1. Lies: to make up information or give information that is false or very different from the truth.

2. Equivocations: to make an ambiguous or contradictory statement.

3. Concealment: to omit important or relevant information in order to mislead the participant or public.

4. Exaggerations: to overstate or extend the truth to a further degree; for instance, telling the participant that participation in the experiment will benefit their health.

5. Understatements: to minimize or scale down facts or the truth. Some of these forms overlap, but they always have one thing in common: they purposely mislead the participants. (Tai 2012, 219)

Why use deception in research?

1. Using deception is the only way to obtain certain kinds of information. Prohibiting all deception in research will “have the egregious consequence of preventing researchers from carrying out a wide range of important studies” [6].

2. Those who do not object to the use of deception note that there is always a constant struggle to balance the study findings so that deception is not harmful to the participants. Christensen, who understands the struggle to balance findings, stated “the need for conducting research that may solve social problems and the necessity for preserving the dignity and rights of the research participant have been found throughout the review of the literature” and that the research participants do not perceive that they are harmed and do not seem to mind being misled [7].

3. In order to acquire reliable and unbiased research results, especially in psychological experiments, the less that the subject knows, the better. (Tai 2012, 220)

Why is it used?

A real but modified case presented by Rucola proposes a study to measure the salad-eating habits of the general public. She will ask members of the public to fill out a questionnaire on their general eating habits over a period of time, and from this material she will gather information on salad consumption. Her consent form explains that she is carrying out research on eating habits but will not mention that she is only interested in salad consumption because she is worried that revealing this fact will distort the results if people know that she is measuring salad-eating habits. Given the assumptions about healthy eating and the benefits of eating salad, her subjects will either change their eating habits or inaccurately report their eating habits. (Tai 2012)

Example

Clearly, it is reasonable to assume that if subjects are aware of the true nature of research, their behavior will change. For that reason, deception in research is often permitted in certain scenarios...

Arguments against the use of deception in research

Why is it a problem?

1. Any deception in research is inappropriate and takes advantage of the implicit trust and obedience given by the participants to the researcher. When the participant volunteers to participate, their dignity must be preserved and should not be taken for granted. Deception can strongly affect the reputation of the individual laboratories and the scientific profession, thus contaminating the pool of participants[8].

2. If the subjects in the experiment are suspicious of the researcher, they are unlikely to behave as they normally would and the researcher’s control of the experiment is then compromised.

3. The values that research ethics rely on include integrity, accuracy, efficiency, and objectivity [9]. (Tai 2012, 220)

4. A deceptive research study cannot possibly receive full informed consent because the researcher is hiding its true purpose from the subject, either to prevent rejection by the participants or to allow the designed deceptive research protocol to be carried out smoothly (Tai 2012).

Given this, can deception be employed ethically?

Can we use deception ethically?

Psychology – given its frequent use of experimental designs, which may sometime rely on deception – has codified an understanding that deception is only to be used in a narrow set of circumstances.

In general, we might expect the use of deception to be permitted only if:

1) no other nondeceptive method exists to study the phenomenon of interest;

2) the study makes significant contributions to scientific knowledge;

3) the deception is not expected to cause significant harm or severe emotional distress to research participants; and

4) the deception is explained to participants as soon as the study protocol permits. (Boynton et al. 2015, np)

What should we do?

What does debriefing entail?

Debriefing

"The principal investigator can gather the participants together to do a group debriefing or choose to gradually reveal the deceptive nature of the study to each individual. The explanation of why the experiment had to proceed this way should be given and the results of the experiment should be shared with them. There should be an explanation as to why it was necessary in order to prevent any shock. The most important aspect of the debriefing is that the participants do not leave with negative feelings about the research. The goal of debriefing is to correct the unethical nature of deception by being honest about what the study is really about and correct any problems. However, the act of debriefing can cause problems in and of itself. Some participants may be angered and embarrassed when the truth is revealed. Some will harbor negative feelings and a mistrust of researchers caused by a scientific study that is different from what they thought. Thus, some debriefings can foster more negative feelings" (Tai 2012, 221).

To Debrief or Not to Debrief

The fact that negative feelings may be caused not by the deception but by the debriefing itself has led researchers to question whether debriefing is always the most ethical choice.

Consider the following case:

"Researchers seeking to examine moral behavior presented students in an introductory psychology course with an opportunity to cheat on one of their exams. Students who took an in-class exam were given an answer key and asked to self-grade their exams at home. Unbeknownst to the students, who did not know they were participants in research, photocopies had been made of their original answer sheets, allowing researchers to compare their initial answers to those they reported after taking the exams home. When the study was over, the researchers decided not to tell participants about their involvement in research or the use of deception. They were concerned that “the benefits from debriefing would be outweighed by the potential stress and embarrassment that might be experienced by students who learned that their cheating behavior had been assessed'” (Smith, Wheeler, & Diener, 1975, p. 325).

In this example, the debriefing, rather than the experiment itself, causes the discomfort.

Is there a regulatory requirement to debrief?

CFR 46.104(d)(3)(iii) Exemption 3 - If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Prospective agreement to deception rather than debriefing is the only protective measure.

Debrief, or no?

Arguments For

Arguments Against

“Debriefing is not merely a tool for making participants feel better; it is also a chance for them to learn they have been deceived and an opportunity to withdraw their data.”

“Forgoing debriefing is necessary to preserve a naïve subject pool”

“When a debriefing procedure is expected to be seriously upsetting, it is usually because the study itself is problematic.”

“Researchers should not impose harmful self-knowledge on participants without their consent”

“Researchers should only be permitted to forgo debriefing…[when it] poses considerable practical barriers but researchers would have no qualms about debriefing if they could.”

“Logistical barriers make debriefing difficult, onerous, or impossible, as is often the case in field experiments for which no consent is obtained”

“Forgoing debriefing is not an acceptable way to minimize risk. Although minimizing risk is a general ethical requirement, it does not warrant jettisoning other important ethical safeguards.”

"Debriefing will make it harder to conduct unbiased deceptive research" in the future.

Source: Sommers and Miller 2013

Based on these considerations, most IRBs will develop their own policies regarding the circumstances in which debriefing is required.

For example:

A debriefing statement that informs the subjects of the true nature of the study is required for most studies that involve deception. However, there are some instances in which debriefing may cause more harm than good, and is therefore not recommended (e.g., if the study results would provide subjects with information that is disturbing about themselves). Debriefing is appropriate if it contributes to the subject’s welfare, e.g., by reducing stress or correcting misconceptions about themselves that resulted from participation in the study. (Rutgers IRB)

Deception and Debriefing in SBER

A Case Study

Case Study

Source: https://tinyurl.com/ttldfxb

An area fitness club has developed a new tai-chi/yoga hybrid in partnership with a local psychiatry practice with the aim of treating a specific kind of anxiety disorder that can result in hospitalizations of acute patients. A research team led by a senior psychiatrist and comprised of an additional two psychiatrists and two certified instructors from the fitness club will collaborate to evaluate the effectiveness of the regimen. A trial of the program requires subjects attend a daylong introductory workshop to learn the basic steps. Subjects will then participate in two one-hour sessions per week (for 16 weeks) during which they will learn new moves, discuss their progress with a support group (composed of other subjects), and undergo psychiatric and biofeedback evaluations to measure their progress. These sessions will be co-led by a fitness instructor and psychiatrist. Subjects are also instructed to complete two 30-minute workouts per day, one in the morning and one just before bed. The researchers worry that some subjects will not truthfully comply with the prescribed regimen of selfdirected workouts. Because of this, they also want to measure compliance. They will give each subject a special yoga mat fitted with a hidden chip that can detect temperature changes as well as motion and sunlight. The chip will record when the mat is unrolled, moved, opened in a lit space, or stood upon. The entrance to the room where the biweekly sessions are held is equipped with Wi-Fi receivers that will download the data from each mat’s chip as the mat enters the room. In this way the researchers can know who is compliant with the regimen and account for lapses when they analyze their data. Patients will not be told about the chip or tracking of usage because the researchers don’t want to influence their behavior or cause them to try and “trick” the device into recording a fake workout. Subjects must be age 19 or older and physically able to perform the necessary regimen. Participants will be recruited from the psychiatry practice; clinicians will identify patients who qualify for participation and will provide these patients with information about the study and procedures. Hoping to curb medical expenses, the patients’ health insurance company has agreed to subsidize each subject’s membership in the fitness club as a way to help sponsor the research. Fitness club membership (valid for six months) will not be canceled should a subject withdraw from the study.

Case Study Scenario

Debriefing Risk/Benefit Analysis

  • If participants will be debriefed, might a participant feel he/she has been coerced and might not have chosen to participate if fully informed?

  • Might a subject feel his/her privacy has been invaded? Could this cause increased anxiety in the population?

  • Could debriefing result in damage to a subject’s self-esteem; could it result in a subject feeling ashamed, guilty, stressed, embarrassed, distrustful or suspicious, or a loss of control/autonomy?

  • Does the cohort suffer from paranoia? If so, might debriefing cause subjects to be more paranoid and experience increase anxiety?

  • Will debriefing empower subjects?

  • Are there reasons beyond "not upsetting subjects" to forgo debriefing?

  • Do the benefits of debriefing (for example, the ability to withdraw data) outweigh the risks?

Consider these questions. Then CLICK BELOW to share your responses and view survey results: https://www.surveymonkey.com/r/IRBdebriefing

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