training in research ethics and standardsinterwork.sdsu.edu/capri/docs/tres_self-studyguide.pdf3...

PROJECT

TRES

JUSTICE

RESPECT

BENEFICENCE

Training in Research Ethics and Standards:A Self-study Guide for Promotores

Dear Promotor:

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It is with great pleasure that we acknowledge your hard work and dedication to the community! Your commitment to the community is one reason your involvement in research is so important. Conducting research with an understanding of ethical and responsible research practices demonstrates your respect for those you serve. The knowledge gained through research will ultimately improve the health and wellbeing of members of your community.

Project TRES: Training in Reseach Ethics and Standards: A Self-study Guide for Promotores was created for promotores who carry out research within the Latino community. You, as a promotor, are an important member of the research team and serve as a bridge of communication between the research investigators and members of the community who participate in research studies. This Self-study Guide was written for you with sensitivity to language differences and unique aspects of the Latino culture. We hope it will help you to better understand the importance of your role in conducting ethical and responsible research within your community.

Our sincerest thanks for making Project TRES a part of your professional training.

Camille Nebeker


SESSION 1: LAYING THE FOUNDATION 1

Defining research 2

Differences between research studies and service projects 2

Government protections for research participants 3

The Belmont Report 4

Groups involved in the protection of research participants 5

Applying E.T.I.C.A. as a promotor 6

Applying the three principles of the Belmont Report 8

What you learned 9

SESSION 2: PROTECTING THE PARTICIPANT 14

Research benefits to the participant and the community 15

Risks to the participant 15

Protecting confidentiality in research 17



What you learned 24

SESSION 3: PRESENTING THE INFORMATION 29

The informed consent process 30



What you learned 39

TERMS TO REMEMBER 43

Table of Contents

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Description of Symbols

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Training in Research Ethics and Standards: A Self-study Guide for Promotores

Key pointThis symbol represents an important training concept of each section that directly relates to a learning objective.

ExampleThis symbol represents an example related to the theme of the section. The example represents the work of a promotor. Each example is followed by one or more questions.

Your answerThis symbol represents an opportunity for the promotor to provide a written answer to the questions from the example.

Answer in more detailThis symbol represents a more detailed explanation (the “correct” answer) to the questions from the example.

SituationThis symbol represents a situation relating to the session objective(s). It allows the promotor to “stop and think” about what has been learned.

!The following symbols are used throughout the Self-study Guide.

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Session

1Laying the foundation

Session 1 offers an introduction to research and provides a foundation for ethical research practices. Further, this session provides a description of the responsibilities of those involved in research including your role as a promotor and

member of the research team. Background information about the history of government regulations designed to protect research participants is included. A description of the groups involved in making sure that research is carried out according to these regulations and accepted ethical practices is also provided. We hope this information helps you to better understand your responsibilities as a promotor when conducting research.

At the end of the session, you will be able to:

• Define research and explain why it is important.

• Know the difference between research studies and service projects.

• Explain why government protections for research participants were established.

• Name the four groups involved in the protection of research participants.

• Define five key areas of responsibility for a promotor when conducting ethical research practices.

Apply one of the three principles of the Belmont Report.


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Session 1

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Defining research

Research is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood. To conduct research, a detailed plan is developed to gather the information needed to answer a research question or learn more about a problem. Research results offer important information about how to improve the overall health of individuals. A specific community may be involved in research to learn more about practices that influence health or to answer questions about existing health problems in the community.

Individuals in research studies are called research participants or human subjects. For the purpose of this training, individuals who take part in research are referred to as research participants. If a research study is designed to obtain knowledge about individuals within a community, members of that community are recruited as participants. As members of their community, participants provide information needed to answer the research questions on behalf of the community. It is important that these individuals understand what is involved when participating and are able to ask questions before and during their voluntary participation in the research study.

Research is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood.

Differences between research studies and service projects

In addition to research studies, service projects are also carried out within a community. The primary goal of a service project is to benefit a community or an individual with services that are known to be helpful. However, the primary goal of research is to contribute to scientific knowledge. The difference between a research study and a service project is that a service project provides a service that is already known to be helpful to a community or an individual. A research study is conducted to gain new knowledge and may not directly benefit the participant. A promotor involved in a service project knows that most people who receive the service will benefit. A promotor involved in a research study cannot offer any guarantee that the participant will benefit from participation.

A service project provides a service that is already known to be helpful to a community or an individual. A research study is conducted to gain new knowledge and may not directly benefit the participant.

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Session 1

The following example illustrates the difference between a research study and a service project.

Mrs. Ramos, a promotor, works in a community health clinic. As part of her job, she talks to women about a free screening test offered by the clinic that is proven to detect a specific disease. She encourages women to get the screening test.

Mrs. Gutiérrez, another promotor, recruits women to participate in a research study that is designed to find out the best way to teach women about a health problem that may occur during pregnancy. One group of women completes a survey before and after attending a class about the health problem. Another group completes the same survey, but does not attend the class. The responses to the survey are compared for both groups to see if the class helps to improve women’s knowledge about the health problem.

Which promotor is involved in a service project? Which promotor is involved in a research study?

Mrs. Ramos is involved in a

Mrs. Gutiérrez is involved in a

Mrs. Ramos is involved in a service project. The free screening test has been proven to detect a specific disease. Women who receive the screening test obtain accurate results. Therefore, Mrs. Ramos encourages women to take the test.

Mrs. Gutiérrez is involved in a research study. This study is considered research because it is not known if the class will improve knowledge about the health problem during pregnancy. To see if the class is effective, all participants complete the survey and only one group attends the class. At the end of the study, both groups are compared to see if there are differences in knowledge.

Government protections for research participantsOver the past century, there have been problems with some research studies that resulted in severe harm and even death of participants. These harmful research studies brought the mistreatment of research participants to the public’s attention prompting the government to create a set of regulations for conducting research with human participants. The following example illustrates a research study that caused harm to research participants:

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Session 1

In 1932, the United States Public Health Service enrolled several hundred African-American males infected with syphilis in a research study known as the Tuskegee Syphilis Study. At the time, there was no cure for syphilis. The purpose of the research study was to study the effects of syphilis on infected individuals over the course of their lives. In 1943, penicillin was discovered as a cure for syphilis. However, participants were not offered this treatment so that the effect of untreated syphilis could continue to be studied. This study was not stopped until 1973.

Participants were never told that a treatment for syphilis was available. When syphilis is left untreated, it can result in death. Not offering an available treatment was unethical and violated the rights and welfare of the participants and their families.

This study, as well as other harmful research studies, prompted the development of regulations to protect human participants in research. In July 1974, the National Research Act was passed and federal regulations to protect participants were established. Now, all human research conducted with federal funds must follow these regulations.

Due to problems with past research studies, the government created regulations to protect human research participants.

The Belmont Report The National Research Act also resulted in the formation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission was responsible for creating a report that identified and summarized the basic ethical principles that guide the conduct of human research. This report is called the Belmont Report. The three principles identified in this report are Respect for Persons, Beneficence and Justice. A brief description of each principle follows:

Respect for PersonsThe principle of Respect for Persons acknowledges an individual’s right to make an independent decision and protects those who are not able to make decisions on their own. Respect for persons occurs throughout an individual’s involvement in the research study. For an individual to make a decision to participate he/she should have adequate information about the study, should comprehend that information and should not feel pressured to participate.

BeneficenceThe principle of Beneficence requires that possible harm to the participant be evaluated against potential benefits of the study. The research team follows the protocol to minimize harm to the participant and increase possible benefits that may occur to the individual and to the greater community.

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Session 1

JusticeThe principle of Justice is about fairness. In research, it is important that the study results provide meaningful information to all that can possibly benefit from the new knowledge gained. Individuals selected to participate in research should represent those who are most likely to benefit from the study results.

Each of these ethical principles must be carried out during a research study so that the rights and well being of participants are protected. Several groups are responsible for ensuring that these principles are applied before potential participants become involved in a study.

Groups involved in the protection of research participants

There are many people and groups involved in the conduct of research, each with a specific interest in seeing that the research study is carried out correctly and that participants in research are protected. These groups include the federal government, the institution, the Institutional Review Board, and the principal investigator.

Federal GovernmentThe federal government provides leadership and support to institutions involved in human research.

InstitutionsInstitutions conducting federally funded research, such as universities or hospitals, have a formal agreement stating that federally funded research will comply with federal regulations.

Institutional Review Board The Institutional Review Board (IRB) is responsible for ensuring that research conducted by the institution complies with federal regulations to protect the rights and welfare of research participants. The IRB members are investigators and members of the community. The IRB is guided by the ethical principles as set forth in the Belmont Report. All research studies involving human participants must be approved by the IRB before the research can begin.

Principal Investigator The principal investigator is the person in charge of the research study and develops the research plan. The research plan, also called a protocol, must meet federal and institutional standards for conducting research. The protocol includes a complete description of the proposed research and discusses procedures for protecting the rights and welfare of participants in the study. The IRB can provide guidance to the principal investigator about how to develop the protocol. In addition to developing the protocol, the principal investigator is responsible for forming the research team. The research team may include a project manager, research assistants, and promotores.

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Session 1

The research team is responsible for carrying out the research study within the target community according to the protocol. The promotor, as a member of the research team, must communicate with the principal investigator or any supervising member of the research team when there are problems or concerns about how the study is conducted.

The four groups involved in protecting the participant are the federal government, the institution, the Institutional Review Board (IRB), and the principal investigator.

Applying E.T.I.C.A. as a promotor

All members of the research team are responsible for carrying out the research study according to the protocol to ensure that ethical research practices are conducted. As a promotor, you are responsible for knowing the purpose of the study and the activities that you may be asked to do as a member of the research team. To help you better understand these responsibilities and your role within the research study, the Spanish acronym E.T.I.C.A. was created. There are five key areas of responsibility in E.T.I.C.A. which are defined as follows:

E is “Enlace,” T is “Tres Principios,” I is “Integridad,” C is “Cultura” and A is “Atención”

ENLACE [LINK]: It is your responsibility to serve as a link, or a bridge, between the research participants and the research team. TRES PRINCIPIOS [THREE PRINCIPLES]: It is your responsibility to keep in mind the three principles of Respect for Persons, Beneficence, and Justice as described in the Belmont Report.

INTEGRIDAD [INTEGRITY]: It is your responsibility to understand and follow the research protocol to ensure the study is conducted correctly.

CULTURA [CULTURE]: It is your responsibility to know the language, traditions, and customs of the community.

ATENCIÓN [ATTENTION]: It is your responsibility to pay attention to the details outlined in the research protocol and take the steps necessary to carry out your responsibilities.

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Session 1

Ms. Romero, a promotor, works on a research study to see whether participation in a class affects individual health choices. One of her responsibilities in the study is to teach a class about health choices. Prior to teaching the class, Ms. Romero reviews the materials so that she is prepared. Ms. Romero notices that the materials are poorly translated from English into Spanish. The translation

changes the meaning of the content making the materials difficult to understand and not culturally appropriate. Ms. Romero, shares this information with a supervising member of the research team so that the materials can be revised to reflect the traditions, language, and customs of the community.

In another study, Mr. Velázquez, a promotor, explains to Mr. Torrado, a potential participant, the eligibility requirements to participate in a research study. Mr. Torrado shows interest in participating. In the conversation to determine if Mr. Torrado is eligible, Mr. Velázquez asks several questions and realizes that he does not meet the necessary eligibility requirements. Mr. Velázquez does not enroll Mr. Torrado in the research study and explains that he does not meet the eligibility requirements.

Ms. Romero demonstrates Link between the participant and the research team by informing a supervising member of the research team that the materials are poorly translated. In addition to Link, what other key areas of responsibility of E.T.I.C.A. are demonstrated by Ms. Romero and Mr. Velázquez?

Ms. Romero demonstrates Attention by

Mr. Velásquez demonstrates both Respect (one of the Three Principles) and Integrity by

Ms. Romero demonstrates Attention by reviewing the study materials prior to teaching the class. When she notices that the materials are poorly translated from English into Spanish, Ms. Romero demonstrates her knowledge of Culture. Ms. Romero also demonstrates Link between the participant and the research team by communicating her observation to the supervising member of the research team.

Mr. Velázquez demonstrates both Respect (one of the Three Principles) and Integrity by explaining the eligibility requirements to the potential participant. In the process of determining if Mr. Torrado is eligible, Mr. Velázquez realizes that Mr. Torrado does not meet the necessary requirements to participate. Mr. Velázquez also demonstrates Integrity and stays true to the protocol by not enrolling Mr. Torrado in the study and explaining why he cannot participate.

The following example illustrates the application of E.T.I.C.A.

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Session 1

! The five key areas of responsibility for a promotor in conducting ethical research practices are defined in the Spanish acronym E.T.I.C.A.: Link, Three Principles, Integrity, Culture, and Attention.

Applying the three principles of the Belmont Report

When applied, the three principles of the Belmont Report –Respect for Persons, Beneficence and Justice– protect the rights and welfare of participants. It is important that everyone involved in research become familiar with these principles and understand how they are applied.

The following example illustrates how to apply the three principles of the Belmont Report in a research study.

Dr. Gómez, a principal investigator at a local hospital, develops a research study to compare two medicines, A and B. Medicine A is known to be effective. If the new medicine B works, it is possible that the health problem can be treated more effectively than it is now. Individuals with this health problem are invited to participate.

All participants are informed about the details of the study. Some of the participants receive medicine A, while others receive medicine B. The participants cannot choose which medicine they will receive. If the new medicine B does not help the participant, he/she will be treated with medicine A, which is known to be effective in treating the health problem.

Describe how the three principles of the Belmont Report are demonstrated.

Dr. Gómez demonstrates the principle of Respect by

The principle of Beneficence is demonstrated if

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Session 1

Dr. Gómez helps carry out the principle of Justice by

Dr. Gómez demonstrates the principle of Respect by providing details about the study to every potential participant. The individual can decide whether to volunteer to participate by having the necessary information.

The principle of Beneficence is demonstrated if the results of the study show that medicine B is more effective allowing others with the same health problem to benefit from this medicine. If medicine B does not help the participant, he/she will be treated with medicine A, which is known to be effective in treating the health problem.

Dr. Gómez helps carry out the principle of Justice by following the protocol. The protocol specifies the study eligibility requirements. The principle of justice helps to make sure that those who might benefit from the study results are fairly represented.

What you learnedCongratulations! You have reached the end of this session. A summary of main points of the session follows:

• Research is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood.

• A service project provides a service that is already known to be helpful to a community or an individual. A research study is conducted to gain new knowledge and may not directly benefit a participant.

• Due to problems with past research studies, the government created regulations to protect human research participants.

• The four groups involved in protecting the participant are the federal government, the institution, the Institutional Review Board (IRB), and the principal investigator.

• The five key areas of responsibility for a promotor, in conducting ethical research practices are defined in the Spanish acronym E.T.I.C.A.: Link, Three Principles, Integrity, Culture, and Attention.

Use the following three situations to review what you learned and to see how well you know the main points covered.

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Session 1

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2

You, a promotor, are at a health fair recruiting individuals to participate in a research study. The research study is investigating a recent increase of a health problem in Latina women. At the health fair, you approach Mrs. Álvarez to invite her to participate in the study. You mention that the research study is only recruiting Latina women. After informing Mrs. Álvarez about the purpose of the study, she asks, “why are you only recruiting Latina women?”

How would you answer Mrs. Álvarez?

“Mrs. Álvarez, we are conducting this research study because there are signs that this health problem is increasing in Latina women. We would like to know more about what is causing this health problem. We are recruiting Latina women from this community because they are similar to women from other communities being studied.”

When you answer Mrs. Álvarez’ question, you should make sure to cover the following points:

• A specific community may be involved in research to learn more about practices that influence health or to answer questions about existing health problems in the community.

• As members of their community, participants provide information needed to answer the research questions on behalf of the community.

You are working as a promotor in a community health clinic asking participants to join a research study to examine the role that stress has in the health of Latinos. At the same time, Mrs. Gómez, a nurse, is offering health screening services to women in the clinic. Mrs. Gómez asks you, “What is the difference between the two projects?”

How would you answer her question?

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Session 1

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“Mrs. Gómez, your project is a service project while ours is a research study. The difference between the two is that a service project is known to be helpful to the community or an individual while a research study is conducted to obtain new knowledge. The information gathered from research studies is often used to develop health services like the ones you are offering. A research study does not

always benefit the participants directly. On the other hand, a service project, like yours, usually provides a direct benefit to individuals by improving their health.”

When you answer Mrs. Gómez’ question, you should make sure to cover the following points:

• Research is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood.

• A participant may not receive a direct benefit from the research study.

• A service project provides a service that is already known to be helpful to a community or an individual.

• A service project directly benefits an individual or a community.

At a health clinic, a group of investigators gathered to study the effects of a new medicine in treating a health problem. A research protocol is developed to carry out the research study. The Institutional Review Board (IRB) reviews the protocol and approves the research study. As part of the research protocol, you, a promotor, recruit participants that meet the eligibility requirements to participate in the study. At the health clinic you approach Mr. Romero, a

potential participant. You explain the purpose of the study and the eligibility requirements for becoming a participant. Mr. Romero asks, “Why do you have so many eligibility requirements for people to participate in your study?”

How would you answer Mr. Romero?

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Session 1

“Mr. Romero, in the past, participants have experienced great risk in research studies. Because of these problems, the protocol provides guidelines to protect research participants. In this research study, we want to learn about the effects of a new medicine. Because the effects of the new medicine are not known, participants could be exposed to severe risks. Our protocol has been developed

to minimize risks to individuals when they participate in our research study. Our protocol must follow the guidelines created by the federal government and the Institutional Review Board that oversee research with participants.”

When you answer Mr. Romero’s question, you should make sure to cover the following points:

• The principal investigator is the person in charge of the research study and develops the research plan.

• The research plan, also called a protocol, must meet federal and institutional standards for conducting research.

• The protocol includes a complete description of the proposed research and discusses procedures for protecting the rights and welfare of participants in the study.

• The IRB provides guidance to the principal investigator.

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Session

2Protecting the participant

Session 2 provides an overview of the risks and benefits of participating in research. In addition, information about confidentiality of research materials is included. We hope this information helps you to better understand your

responsibilities as a promotor.

At the end of the session, you will be able to:

• Explain how research may benefit the participant and community represented.

• Identify the four elements of risk associated with a research study.

• Define confidentiality.

• Explain why practices to protect confidentiality are important to the ethical conduct of research.

• Describe two ways in which a promotor can protect confidentiality.

• Apply one of the three principles of the Belmont Report.


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Session 2

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Research benefits to the participant and the community

As discussed in Session 1, research is carried out to gain new knowledge or answer questions about something that is currently unknown or not well understood. A research study may provide answers about a disease that is commonly found in a specific community. The information gathered from representatives of this community can then be used to help to improve the health of individuals within the community.

The primary benefit of conducting research is to obtain information that helps find answers to important questions about health problems or untested treatments. New information that comes from research can then be used to create effective programs or improve medical treatments for use by the community.

To gather information to answer a research question, individuals are asked to volunteer as study participants. A participant may not receive any direct benefit from the research study; however, the community at large may benefit from the study results. In some cases, participants in the research may learn how to improve their health, receive access to services, or gain new knowledge as a result of research participation, though this is not always the case.

A participant may not receive any direct benefit from participating in the research study; however, the community at large may benefit from new information about health problems.

Risks to the participant

Participating in a research study may have both benefits and risks. These risks to the participants are evaluated by the principal investigator and the IRB. The IRB determines if the study benefits outweigh the risks associated with participation and if the risks are well managed. The four elements of risk associated with participation in research are: type, probability, severity, and duration. Before joining a study, the potential participant must be given information about the risks associated with the study and the opportunity to think about these risks.

TypeWhile in a research study, a participant may be exposed to different types of risks. The risks that the participant may face depend on what the study is about and the procedures or activities required. Studies might involve physical activity, personal or private information, medical procedures, new and untested medicines, or topics that may be culturally sensitive. Types of risks may include: physical, psychological, social, legal, and/or economic.

ProbabilityThe likelihood that a participant will experience risks when participating in a research study is usually known in advance. Risks can vary from very likely to very unlikely. As with other choices

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Session 2

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in life, it is important for a potential participant to know if the risk will definitely occur, will occur about half of the time, or will occur only once in a million times.

Severity

Knowing the type of risk is not enough for a potential participant to decide whether the risk is acceptable. The potential participant also needs to know how severe that risk can be. For example, pain or suffering could be tolerable in some cases and unbearable in others.

Duration

The potential risk of participating in a research study is also evaluated in terms of time. For example, risk could be brief, extended, or permanent in duration. It is likely to make a difference, when deciding to participate, whether pain might last for only a brief moment, for hours or, possibly, be irreversible.

The four elements of risk associated with participation in research are: type, probability, severity, and duration.

The following example illustrates the risks and benefits to a participant in a research study.

Juan Hernández, a promotor, from La Lucha Community Clinic works on a research study to find out whether an untested medicine can help prevent a certain disease in Latino children. Families in the Latino community are asked to participate in the study because the number of Latino children who may develop this disease is increasing. If a family is enrolled in the study, their child

may receive the untested medicine that may help to prevent this disease.

Some children enrolled in the study will receive the untested medicine while others will not. The effectiveness of the medicine can be evaluated by comparing the two groups. The benefit of the study is that the results may help identify how to prevent this disease. The child may not directly benefit from participating. It is unknown if this medicine will work until the study is over, which may take 18 months or longer.

The risks that the child may experience depend on whether or not he/she receives the untested medicine. Those receiving the medicine may have physical risks as a result of taking the untested medicine. These risks to the participants have been evaluated by the principal investigator and the IRB. The IRB has determined that the study benefits outweigh the risks associated with the child’s participation and that the risks are well managed.

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Session 2

The risks to participants in the study are managed by:

• keeping all personal information about the participant in a locked file,

• not discussing information about participants with anyone outside the research team,

• hiring qualified staff that is well trained to conduct the study, and

• removing children from the study if the untested medicine causes problems.

What is a possible benefit for the community? How are risks to participants managed?

A possible benefit for the community is

The risks to participants in the study are managed by

A possible benefit for the community is if the untested medicine is successful in preventing this disease among Latino children in the study, it may help prevent this disease among other Latino children in the community. It is important to understand that it is not known if the medicine works and it may be harmful to some children.

The risks to participants are managed by protecting personal information that is documented in the research study and by training the research team to respond to any problems that may occur from the medicine. There may also be unknown side effects from the untested medicine, which must be considered when the parent is deciding whether or not their child may participate.

Protecting confidentiality in research

Confidentiality in research means protecting the information that the participant provides during the study. Participants are often asked to reveal personal and, sometimes, sensitive information. This may occur during an interview or when completing a survey. Personal information about a participant may also be obtained through a review of his/her medical record. This information may include, age, income, or years of education. It may also include psychiatric or medical history, health behaviors, or illegal activities. The principal investigator uses this information to better understand the research outcomes.

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Session 2

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Confidentiality in research means protecting the information that the participant provides during the study.

Confidentiality practices are implemented because the participant could suffer lasting personal, legal, economic, or social damage from disclosure of this information to others. The consequences to the participant of revealing their information depends on the sensitivity of the information. Participants might be upset by having their information released to others who are not part of the research team.

Confidentiality practices are important because the participant could suffer lasting personal, legal, economic, or social damage from disclosure of this information to others.

Due to the risks involved with a breach of confidentiality, it is very important for the principal investigator and research team to implement appropriate confidentiality procedures to protect information collected from participants in research studies.

The research protocol addresses several ways to protect the confidentiality of information provided by participants during a research study. These may include:

• Carefully store research materials in locked filing cabinets and do not leave them unattended on desktops or in unlocked filing cabinets.

• Use password protection, log off, and shut down your computer if you leave your workstation for any length of time.

• When referring to participants, use their code number or “pseudonym” (false name) instead of their real name.

• If you are responsible for transporting study materials (samples, completed surveys, etc.), remove the materials from your car as soon as possible to avoid loss, theft or damage.

• If you are working with participants from your community, do not discuss their participation in the study with your family and friends or other members of your community.

• A participant may not want family or friends to know of his/her involvement in a study. If the study involves home contact, ask the participant how to respect their wishes.

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Session 2

• When appropriate, obtain written permission to video or audio tape study participation and explicitly state how the individual’s image or voice will be used.

• Remove any information that will identify the participant when study materials are stored for future analysis.

Two ways for protecting confidentiality are: to carefully store the research materials in locked filing cabinets, and to refer to participants by their “pseudonym” (false name) when discussing study details with members of the research team.

The following example illustrates how to protect participant confidentiality in research.

Ms. López, a potential participant, is interested in participating in a research study about health risk behaviors. Ms. Muñoz, a promotor, schedules time to talk with Ms. López about the study and explain what it involves, its potential risks and benefits and how her information will be protected if she chooses to enroll in the study.

Ms. López agrees to participate and Ms. Muñoz begins the interview to see if Ms. López is eligible to participate. During the interview, Ms. López informs the promotor she has a serious, but treatable disease. Ms. López does not want her family to find out about this problem. The promotor assures Ms. López that her information is kept confidential and explains that all information collected from her is labeled with a code instead of her name. In addition, Ms. Munoz assures Ms. López that none of her information will be discussed outside of those directly involved with the study. She also encourages Ms. López to seek treatment at the local clinic.

What are two ways to maintain confidentiality?

One way to maintain confidentiality is

Another way to maintain confidentiality is

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Session 2

One way to maintain confidentiality is to avoid disclosing information about Ms. López to others unless permission has been given to do so. A breach in confidentiality presents different types of risk to Ms. López depending on how serious the disease is to her health. Since the disease is serious, Ms. López may suffer social risk if the disease is not socially acceptable and she may suffer

economic risk if the disease will affect her employment or insurance status. The research protocol should include a plan to manage these risks with specific information about how confidentiality of the information collected in the study will be protected. Following the confidentiality procedures outlined in the research protocol will help to ensure that the information provided by the participant is protected. Another way to maintain confidentiality is to have the information about Ms. López’ health status stored in a secure location, such as in a locked file cabinet within a locked office. When discussing information about Ms. López with members of the research team, she should not be referred to by name. Instead, she should be referred to using a “pseudonym” (false name) or a code number. Study materials including samples, surveys, and other materials should be transported to the research office and carefully stored in a locked cabinet.


All members of the research team are responsible for carrying out the study according to the protocol so that the study risks are minimized and confidentiality is maintained. Specifically as a promotor, you are responsible for knowing the study risks and benefits, and for communicating information about risks and benefits to the participants. You are also responsible for protecting the participant’s privacy and keeping information about the participant confidential. Knowing the five key areas of E.T.I.C.A. will help you better your responsibilities as a member of the research team in protecting participants in research. The Spanish acronym E.T.I.C.A. is defined as follows:


ENLACE [LINK]: It is your responsibility to serve as a link, or a bridge, between the research participants and the research team. TRES PRINCIPIOS [THREE PRINCIPLES]: It is your responsibility to keep in mind the three principles of Respect for Persons, Beneficence, and Justice as described in the Belmont Report.

INTEGRIDAD [INTEGRITY]: It is your responsibility to understand and follow the research protocol to ensure the study is conducted correctly.

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Session 2

CULTURA [CULTURE]: It is your responsibility to know the language, traditions, and customs of the community.

ATENCIÓN [ATTENTION]: It is your responsibility to pay attention to the details outlined in the research protocol and take the steps necessary to carry out your responsibilities.

The following example illustrates the application of E.T.I.C.A. to protect the participant in a research study.

Mrs. Álvarez, a promotor, is recruiting women to participate in a study that will evaluate ways to improve the health of Latina women in a local community. Mrs. Rolando, a community member, shows interest in participating after receiving information about the study. She shares with the promotor that she does not want her family to know about her participation because it can cause

conflict within the family. Therefore, she asks Mrs. Álvarez that the research team not call or send mail to her home. Mrs. Álvarez discusses this situation with a supervising member of the research team. The principal investigator decides to modify the protocol so that an alternative method of communication can be used to contact Mrs. Rolando. Mrs. Álvarez is then able to respect Mrs. Rolando request to not call or send mail to her home and uses an alternative way of communicating. Another potential participant, Mrs. Gutiérrez, expresses interest in participating as well, but explains that she wishes to first speak with her family before making a decision to participate. Mrs. Álvarez asks Mrs. Gutierrez to call her after she speaks with her family to let her know if she would like to participate. Lastly, Mrs. Álvarez contacts her friend, Ms. Catalano, whom she feels could benefit from participating in the study. Without checking to see if Ms. Catalano meets the eligibility requirements or asking for her medical history, Mrs. Álvarez enrolls her friend to participate in the study.

Mrs. Álvarez demonstrates Respect (one of the Three Principles) by providing information about the study to Mrs. Rolando and listening to her concern about being contacted at her home. She also demonstrates Attention by asking the supervising member of the research team for direction when an alternative method of communication with Mrs. Rolando is needed. In addition to Respect and Attention, how does Mrs. Álvarez demonstrate Link and Culture, key areas of responsibility of E.T.I.C.A.?

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Mrs. Álvarez demonstrates Link by

Mrs. Álvarez demonstrates Culture by

Mrs. Álvarez demonstrates Link by informing the research team of Mrs. Rolando’s request to use an alternative method of communication so that her family does not learn of her participation. To protect Mrs. Rolando’s confidentiality, an alternative method of communication is used to reduce her risks.

Mrs. Álvarez demonstrates Culture by asking Mrs. Gutiérrez to contact her once she has spoken to her family. Mrs. Álvarez acknowledges that at times, within the Latino culture, important decisions are made by the entire family. Mrs. Álvarez does not demonstrate Integrity when she fails to follow the eligibility requirements for study enrollment when she recruited her friend, Ms. Catalano. Ignoring the eligibility requirements places Mrs. Catalano at risk, since she may have a medical condition that could be made worse by her participation in the study. Maintaining the Integrity of the research study involves following the study procedures, which includes screening for eligibility requirements. It is important that Mrs. Álvarez pays Attention to the details of the study protocol and not make any changes without discussing the situation with the supervising member of the research team. In order for the research to produce results that are meaningful and that will eventually help the community, it is necessary to apply all the key areas of E.T.I.C.A.


When applied, the three principles of the Belmont Report –Respect for Persons, Beneficence and Justice– protect the rights and welfare of participants. It is important that everyone involved in research become familiar with these principles and understand how they are applied. A brief description of each principle follows:


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Session 2

BeneficenceThe principle of Beneficence requires that possible harm to the participant be evaluated against potential benefits of the study. The research team follows the protocol to minimize harm to the participant and increase possible benefits that may occur to the individual and to the greater community.

JusticeThe principle of Justice is fairness in the distribution of research benefits and burdens. In research, it is important that the study results provide meaningful information to all that can possibly benefit from the new knowledge gained. Individuals selected to participate in research should represent those who are most likely to benefit from the study results.

The following example illustrates how to apply the three principles of the Belmont Report when protecting the participant in a research study.

Mrs. Peña, a promotor, is working for a local community health clinic where she is recruiting potential participants for a research study who have a specific disease. The research study focuses on the beliefs, opinions, and myths that the Latino community has towards the treatment of the disease. The IRB has determined the study risks are reasonable when compared to the study benefits

and has approved the protocol. With the information collected, the study can help to identify factors that influence the decision to continue medical treatment and eventually create programs that can help this local community and other similar communities. Mrs. Peña approaches a potential participant, Mrs. Galván, to inform her about the details of the study, including the risks and benefits of participating. When Mrs. Galván expresses her interest in participating, Mrs. Peña takes Mrs. Galván to a private area where she can discuss the study in more detail. Mrs. Peña also chooses this private area so that no one outside the research team, other potential participants, or other individuals may overhear the conversation. Mrs. Galván agrees to participate in the study. Mrs. Peña asks Mrs. Galván for her phone number, address, monthly income, and questions from the survey about her beliefs, opinions, and myths towards the disease.


Mrs. Peña demonstrates the principle of Respect when

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The principle of Beneficence is demonstrated when

Mrs. Peña helps to carry out the principle of Justice by

Mrs. Peña demonstrates the principle of Respect when she informs Mrs. Galván about the details of the study so that Mrs. Galvan can decide if she is interested in participating. Respect is also demonstrated when Mrs. Peña asks questions from the survey in a private location so that Mrs. Galván, can talk about her beliefs and opinions. The principle of Respect is also demonstrated when Mrs.

Peña invites Mrs. Galván to a private area where she can consider her decision to participate. The IRB has approved this procedure to ensure that Mrs. Peña’s rights are protected. The principle of Beneficence is demonstrated when the IRB determined that the study risks are reasonable when compared to the study benefits. Mrs. Peña follows the protocol to help make sure that it is carried out correctly. Mrs. Peña helps to carry out the principle of Justice by making sure that only those who are eligible to participate are included in the study. The principle of Justice is more directly applied when the principal investigator defines the types of people who are appropriate for enrollment in the study. The IRB confirms that those who will participate are representative of those likely to benefit from the study results.

What you learned

Congratulations! You have reached the end of this session. A summary of the main points of the session follows:

• A participant may not receive any direct benefit from participating in the research study; however, the community at large may benefit from new information about health problems.

• The four elements of risk associated with participation in research are: type, probability,

severity, and duration. • Confidentiality in research means protecting the information that the participant

provides during the study.

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• Confidentiality practices are important because the participant could suffer lasting personal, legal, economic, or social damage from disclosure of this information to others.

• Two ways for protecting confidentiality are: to carefully store the research materials in

locked filing cabinets, and to refer to participants by their “pseudonym” (false name) when discussing study details with members of the research team.

Use the following three situations, you can review what you have learned and see how well you know the main points covered.

You are recruiting potential participants for a research study that is evaluating an untested medicine. Mrs. Rodriquez thinks she may be eligible to be part of this study since she has many of the symptoms that this new medication may relieve. Mrs. Rodríguez asks, “How will I benefit from participating in the study?”

How would you answer Mrs. Rodríguez’ question?

“Mrs. Rodríguez, we are doing this research study because we want to know if this new medication will help relieve your symptoms. We would like to know more about the effects of this new medication. This medication has shown some positive results in other small studies. Because we are not completely familiar with this medication, we do not know if you will feel better or worse. If

the study shows that this new medication works for most participants, then it can be used to help others with these symptoms.

When you answer Mrs. Rodríguez’ question, you should make sure to cover the following points:

• Research is conducted to gain new knowledge or answer questions about something that is currently unknown or not well understood.

• The principle of Beneficence requires the research team to minimize harm to the

participant and increase possible benefits that may occur both to the individual and to the greater community.

• A participant may not receive any direct benefit from participating in the research study;

however, the community at large may benefit from new information about health problems.

1

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2

You are at a parent meeting recruiting potential participants for a research study. Mrs. Martínez asks, “If I choose to participate in this study, who will see the information you collect from me and how will my information be kept private?”

How would you answer Mrs. Martínez’ questions?

“Mrs. Martínez, only the person who interviews you, the principal investigator, and authorized members of the research team will see your information. All members of the research team are trained to protect the confidentiality of your information from anyone outside the research team. We only use a code number or false name when discussing your information with the research team. Your

name is not associated with any of the information we collect from you. Your information is kept in locked filing cabinets. We take your privacy very seriously.”

When you answer Mrs. Martínez’ questions, you should make sure to cover the following points:

• All personal information should be protected. Participants are often asked to reveal personal and, sometimes, sensitive information such as age, income, years of education, medical history, health behaviors, or illegal activities.

• Confidentiality in research means protecting the information that the participant

provides during the study. • Participants could suffer lasting personal, legal, economic, or social damage from

disclosure of their information to others.

A new study has been introduced nationally to increase physical activity in migrant farm workers. You, as a promotor, are responsible for informing individuals about the study using language and terminology easily understood by those who may become involved. You are also responsible for enrolling those who meet the eligibility criteria and want to participate. In order to participate,

the individual cannot have a health problem that prevents him/her from being physically active. A potential participant, Mr. Salazar, tells you that he has a health problem and sometimes has weakness in his legs. Due to this problem, Mr. Salazar is not eligible to participate. You explain this to him and offer a referral for care of his health problems.

3

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How are the three principles of the Belmont Report – Respect for Persons, Beneficence, and Justice - demonstrated, in this example?

Respect: One of the elements of this principle is the need to provide special protection to those who are vulnerable. It is important to inform potential participants about all the activities involved in the research study and the potential risks to their health, so that they understand what is involved in participation and can make an informed decision. To do this, the information

presented must be in terms easily understood by the migrant farm worker. Beneficence: The study is designed to develop a physical activity intervention. If effective, this study could prevent other health problems in migrant farm workers. Any time an individual is physically active, there is a risk of injury. The IRB evaluates potential risks to participants and determines if the potential benefits that may result from the study are greater than the risks that a participant may encounter. If the risks are well managed and reduce the chance of harm, the IRB will approve the study. In this example, Mr. Salazar’s health problem may put him at greater risk, since he may be more likely to experience harm from participating in physical activity. Excluding him from the study is one way to manage and reduce the overall risk. Justice: The principle of Justice focuses on selecting individuals to participate who are representative of those who may benefit from the knowledge gained from the study. In this example, all migrant farm workers were invited to participate. Those whose health would be placed at risk by participating were not enrolled. It is fair to involve groups of people in the research, if the research will benefit others who are like them and to exclude those who might be harmed.

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Session

3Presenting the information

Session 3 provides a description of the components of the informed consent process. The informed consent process is a very important aspect of research. Informed consent occurs when individuals from the community are asked to

volunteer as participants in the research study. We hope the information helps you carry out your responsibilities as a promotor and member of the research team when conducting the informed consent process.

At the end of this session, you will be able to:

• Define the purpose of the informed consent process.

• Name the three components of the informed consent process.

• Describe what information is presented to the potential participant during the consent discussion.

• Define voluntary participation.

• Describe what factors may influence the decision to participate.

• Apply one of the three principles of the Belmont Report.


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Session 3

!

!

The informed consent process

As discussed in Session 1, research is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood. To obtain this new knowledge or to answer these questions, individuals from the community are asked to volunteer as participants in the research study. Informed consent is an important process in which information is provided to the potential participant so that an informed decision can be made about whether to volunteer to participate in the research study.

The purpose of the informed consent process is to ensure that an individual is able to make an informed decision about whether to volunteer to participate in research.

The informed consent process directly involves both the research team and the potential participant. The informed consent process includes the following three components: recruitment, enrollment, and participation. Information is provided and questions are answered from the moment of recruitment to the completion of the individual’s participation in the study. As a promotor, you may be a part of the informed consent process. Understanding the informed consent process helps you make sure that the rights and welfare of research participants are protected.

The three components of the informed consent process are: recruitment, enrollment, and participation.

Recruitment

The first component of the informed consent process is recruitment. Individuals are invited to consider participation in the research study according to the protocol. The type of recruitment method depends on the specific research study. Recruitment methods may include direct contact with a potential participant, or announcing the study using flyers, newspaper and/or radio advertisements. During recruitment, a brief description about the research study is provided which includes the study purpose, who may participate, and whom to contact for additional information. The information presented during recruitment should be neutral and accurate without overstating study benefits or incentives. This will help to avoid pressuring or coercing individuals to participate.

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Enrollment

If during recruitment an individual expresses interest in participating in the research study, a qualified member of the research team, such as a promotor, will discuss the study in more detail with the individual. Enrollment is considered the second component of the informed consent process. The purpose of enrollment is to provide the potential participant with more details about the study in order for the individual to make an informed decision about whether to participate. Enrollment involves a consent discussion with the potential participant and is generally followed by signing the consent form. The individual’s signature documents that information about the study was presented, questions have been answered and the potential participant has agreed to participate.

Consent discussion

During the consent discussion, a qualified member of the research team presents the following information to the potential participant: • name of the investigator and their university or hospital affiliation, • purpose of the study, • details of what participants will be asked to do, • amount of time involved, • risks associated with participation, • benefits to the participant and/or to the community, • type of information that will be collected about the participant, • explanation of who will have access to personal information, how it will be used, and where

and for how long it will be stored, • description of any incentive or compensation offered, • statement that participation is voluntary, and • contact information.

It is important that information about the research study is presented to the potential participant in an appropriate setting in which the individual is able to understand the information and ask questions before making a decision to participate. Attention should be paid to the language and terms used, so that the information is easily understood by the potential participant.

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!During the consent discussion, the following information is presented: details of the study, risks and benefits, a statement that participation is voluntary, and whom to contact should the individual have questions.

Consent documentation

During or following the consent discussion, a written consent form is usually presented. The consent form includes all the information presented during the consent discussion. This form should be written using language and terms that are easily understood by the potential participant.

Consent documentation involves the potential participant reading the consent form, asking questions, and signing and dating the consent form to indicate agreement to participate. The promotor or other member of the research team responsible for obtaining consent also signs and dates the form. The participant is generally given a copy of the consent form.

The signed consent form is used to document the consent discussion. The signature indicates that the individual has received information about the research study, has had an opportunity to ask questions, and has agreed to participate. The participant can stop involvement in the research study at any time.

Factors that may influence the decision to participate

Several factors may influence a potential participant’s decision to participate in a research study. These factors include: the information received, the terms used, and the setting where informed consent is discussed.

During the informed consent process, the potential participant must receive accurate and complete information about the study and what is involved in participation. This allows the potential participant to make a voluntary and informed decision about participation.

During the consent discussion and documentation, it is important to present information about the study using terms that are familiar and culturally appropriate. By doing so, the potential participant is able to understand the activities involved in participation.

An individual may feel obligated to participate and may have difficulty declining participation. To make sure that the potential participant is able to make an informed decision about whether to participate, it is important that the consent discussion take place in an appropriate setting. The setting should allow for information about the study to be presented, questions to be asked and adequate time given for an individual to make a decision. When the setting is appropriate for an informed decision to be made, the individual may feel less pressure to participate. It is important to keep in mind that while some individuals may make the decision to participate at that moment, others may want to take more time or discuss study participation with family members before making a decision.

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!

!

Factors that may influence a potential participant’s decision to participate include: the information received, the terms used, and the setting where informed consent is discussed.

Special considerations for research with children

There are times when research studies may include children as participants. In most cases, the parents or legal guardian must first give permission for the child to participate in the study. When a child agrees to participate in a study it is called “assent,” since legal consent can be provided only by a parent or legal guardian. If you are working as a promotor on a research study that includes children, discuss the assent process in more detail with a supervising member of the research team.

Participation

After the consent discussion and documentation have taken place according to the protocol, the participant is officially enrolled in the study and participation may begin. This is the third component of the informed consent process. Participation includes attempting or completing the tasks involved in the study. Depending on the study, participation may last only a few minutes, many days, months, or even years. For example, in a research study about nutrition, a participant may complete a one-time survey about eating habits. In another nutrition study, a participant may complete several surveys over the course of one year about eating habits. No matter how long a study lasts, the informed consent process does not end when the consent form is signed. The informed consent process ends upon completion of study participation or when the individual voluntarily ends participation.

Research participants are always volunteers in a study. Voluntary participation means an individual may discontinue participation at any time and for any reason. The informed consent process takes place to ensure voluntary participation. The participant must be encouraged to ask questions about his/her involvement over the course of the study. If the participant has concerns or questions at any time during the study, a member of the research team should address these concerns and questions immediately.

Once participation ends for an individual, the study will continue until the necessary information is collected from all participants. Eventually, a report summarizing the results of the study is shared with other investigators. It is not always possible to share the research results with the community initially involved in the research. In general, it is hoped that the results will contribute to policy and improvements of health programs designed to help the community at large.

Voluntary participation means an individual may discontinue participation at any time and for any reason.

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The following example illustrates the informed consent process.

Mr. Valenzuela is a promotor at La Vida Community Clinic. He is responsible for posting flyers around the clinic to advertise a new research study. While waiting for an appointment at the clinic, Mr. Ríos reads about the study and is interested in knowing more about it. He contacts Mr. Valenzuela for more information of what is involved in the study. Mr. Valenzuela schedules an appointment with Mr.

Ríos to further discuss possible participation in the study.

During the appointment, Mr. Valenzuela presents details about the study including what is involved in participation, risks and benefits to participation, a statement that participation is voluntary and contact information should Mr. Ríos have questions about the study. Mr. Valenzuela asks Mr. Ríos if he understands what he will be asked to do in the study and if he has any questions. Mr. Ríos signs the consent form to formally indicate his willingness to participate. He is now enrolled in the study. Mr. Valenzuela schedules Mr. Ríos’ appointment so that he may begin the tasks involved in the study. As the study progresses, Mr. Valenzuela provides Mr. Ríos with information about changes that may affect his participation.

What does Mr. Valenzuela do during each of the three components of the informed consent process?

During recruitment, Mr. Valenzuela is responsible for

During enrollment, Mr. Valenzuela presents the following information

During participation, Mr. Valenzuela assists

During recruitment, Mr. Valenzuela is responsible for posting flyers with information about the research study. Mr. Ríos shows interest in learning more about the study, and contacts Mr. Valenzuela.

During enrollment, Mr. Valenzuela presents the following information to Mr. Ríos: details about the study, what is involved in participation, risks and benefits to participation, a statement that participation is voluntary and contact information should Mr. Ríos have questions about the study. Mr. Valenzuela asks Mr. Ríos if he has any questions and if he understands what he will be asked to do in the study. Mr. Ríos agrees to participate and signs the consent form to document his willingness to participate.

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During participation, Mr. Valenzuela assists Mr. Ríos with the tasks involved in the study. He also provides Mr. Ríos with information about changes that may affect his participation. Throughout his involvement, Mr. Ríos can ask questions so that any concerns that arise about participation can be addressed. Mr. Ríos should know that while his participation is highly valued, he can discontinue his participation either temporarily or permanently for any reason and at any time.


Some members of the research team are responsible for carrying out the informed consent process. As a promotor, you are responsible for understanding the informed consent process and your role within the process. You should also be able to answer questions asked by the participant and, when in doubt, seek clarification from a supervising member of the research team.

Knowing the five key areas in E.T.I.C.A. will help you better understand your responsibilities as a member of the research team in the informed consent process. The Spanish acronym E.T.I.C.A. is defined as follows:


ENLACE [Link]: It is your responsibility to serve as a link, or a bridge, between the research participants and the research team.

TRES PRINCIPIOS [Three Principles]: It is your responsibility to keep in mind the three principles of Respect for Persons, Beneficence, and Justice as described in the Belmont Report. INTEGRIDAD [Integrity]: It is your responsibility to understand and follow the research protocol to ensure the study is conducted correctly.

CULTURA [Culture]: It is your responsibility to know the language, traditions, and customs of the community.

ATENCIÓN [Attention]: It is your responsibility to pay attention to the details outlined in the research protocol and take the steps necessary to carry out your responsibilities.

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The following example illustrates the application of E.T.I.C.A. during the informed consent process.

Ms. Vásquez, a promotor, is recruiting individuals for a research study. The study hopes to increase participation in a screening test for a disease that is common in the Latino community. In this study, participants receive information about the screening test in one of three ways:

• Some participants receive a brochure about the importance and purpose of the screening test.

• Some receive a one-on-one counseling session about the advantages and disadvantages of the screening test, with a trained promotor.

• Others receive information about healthy nutrition.

Ms. Vásquez approaches Mr. Téllez, a potential participant, at a community event to see if he is interested in knowing about the study. Mr. Téllez shows interest in knowing more about the study. Ms. Vásquez invites him to an appropriate setting where they can discuss the study in more detail. Ms. Vásquez presents information about the study in Spanish, Mr. Téllez’ primary language.

Ms. Vásquez asks Mr. Téllez if he has any further questions. Once Mr. Téllez agrees to participate, he signs the consent form. Ms. Vásquez provides Mr. Téllez with a copy of the consent form so he can refer back to it at any time.

Mr. Téllez is enrolled in the one-on-one counseling session. Ms. Vásquez looks at the available dates for Mr. Téllez’s counseling session and selects one that does not interfere with an upcoming cultural event. Ms. Vásquez informs the research team about the upcoming cultural event.

Three months later, Ms. Vásquez reviews Mr. Téllez’s medical record to see if he received the screening test. This information is carefully recorded on a form that is returned to the research team. This information allows the researchers to assess which group worked the best in increasing the number of participants who took the screening test.

Ms. Vásquez demonstrates Integrity by assigning Mr. Téllez to the one-on-one counseling session according to the study protocol. In addition to Integrity, how are Respect (one of the Three Principles) and Culture, key areas of responsibility of E.T.I.C.A., demonstrated by Ms. Vásquez?

Ms. Vásquez demonstrates Respect (one of the Three Principles) by

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Ms. Vásquez demonstrates Culture by

Ms. Vásquez demonstrates Respect (one of the Three Principles) by presenting the details of the study in an appropriate setting and by speaking Spanish, Mr. Téllez’s primary language. These factors will help Mr. Téllez make an informed and voluntary decision about participating.

Ms. Vásquez demonstrates Culture by knowing that there is an upcoming cultural event, therefore, not scheduling Mr. Téllez’s one-on-one counseling session on that particular day.

In addition to demonstrating Respect (one of the Three Principles), Integrity, and Culture, Ms. Vásquez also demonstrates Attention and Link. Ms. Vásquez demonstrates Attention by ensuring Mr. Téllez signs the consent form and providing him with a copy. Ms. Vásquez demonstrates Link by informing the research team of the upcoming cultural event.


When applied, the three principles of the Belmont Report –Respect for Persons, Beneficence and Justice– protect the rights and welfare of participants. It is important that everyone involved in research become familiar with these principles and know how they are applied. A brief description of each principle follows:


BeneficenceThe principle of Beneficence requires that possible harm to the participant be evaluated against potential benefits of the study. The research team follows the protocol to minimize harm to the participant and increase possible benefits that may occur - both to the individual and to the greater community.

JusticeThe principle of Justice is fairness in the distribution of research benefits and burdens. In research, it is important that the study results provide meaningful information to all that can possibly benefit from the new knowledge gained. Individuals selected to participate in research should represent those who are most likely to benefit from the study results.

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The following example illustrates how to apply the three principles of the Belmont Report to the informed consent process.

Mrs. Ramírez has a disease that is particularly dangerous for women because they can pass it on to their babies during childbirth. From a flier posted in the local community clinic, Mrs. Ramírez learns about a study which tests a new medicine for this disease. She is interested in participating and contacts Ms. Gutiérrez, a promotor working on the research study, to receive more information.

During the consent discussion, the promotor explains the study to Mrs. Ramírez. She also explains the possible side effects of this new medicine. The IRB has determined the study risks are reasonable when compared to the study benefits and has approved the protocol. After Mrs. Ramírez asks questions and understands the risks and benefits of this new medicine, she agrees to participate.

Mrs. Ramírez is hopeful that the new medicine will help her. However, during participation, Mrs. Ramírez experiences side effects. These side effects were explained to Mrs. Ramírez during the informed consent process. She was told that if she experienced any side effects, or for any other reason, she could withdraw from the study. Mrs. Ramírez informs Ms. Gutiérrez that she is experiencing side effects and that she wants to stop her participation in the study. The promotor informs the research team about Mrs. Ramírez’ side effects and she is removed from the study.


Ms. Gutierrez demonstrates the principle of Respect by

The principle of Beneficence is demonstrated when

The principle of Justice is carried out when

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1

Ms. Gutiérrez demonstrates the principle of Respect by reviewing the details of the study with Mrs. Ramírez during the consent discussion. Respect is also shown by accepting Mrs. Ramírez decision to stop participation.

The principle of Beneficence is demonstrated when the IRB determined that the study risks are reasonable when compared to the study benefits. Ms. Gutiérrez follows the protocol to help make sure that it is carried out correctly.

The principle of Justice is carried out when the principal investigator defines the types of people who are appropriate for enrollment in the study. The IRB confirms that those who will participate are representative of those likely to benefit from the study results. Ms. Gutiérrez carries out the principle of Justice by following the eligibility requirements that are defined in the protocol. Mrs. Ramírez is eligible to participate because she has the disease and she might benefit from this new medicine. In addition, Mrs. Ramírez is eligible because she represents the community affected by this disease. The new medicine that is being tested with Mrs. Ramírez may help members of this community in the future.

What you learnedCongratulations! You have reached the end of this session. A summary of the main points of the session follows:

• The purpose of the informed consent process is to ensure that an individual is able to make an informed decision about whether to volunteer to participate in research.

• The three components of the informed consent process are: recruitment, enrollment, and participation.

• During the consent discussion, the following information is presented: details of the study, risks and benefits, a statement that participation is voluntary, and whom to contact should the individual have questions.

• Factors that may influence a potential participant’s decision to participate include: the information received, the terms used, and the setting where informed consent is discussed.

• Voluntary participation means an individual may discontinue participation at any time and for any reason.

Use the following three situations to review what you learned and to see how well you know the main points covered.

You are working on a research study where new promotores are trained to help in the recruitment of potential participants. At the end of the training, the principal investigator, Dr. Reyes asks you to help the new promotores working in the community for the first time.

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2

You introduce yourself to the new promotores, “Hello, my name is Carina Gómez, I am a promotor. I have been working with this project for two years. Welcome! I am here to assist in case you have questions about what you are asked to do as members of the research team.”

A new promotor, Mrs. Bilbao, asks you, “Carina, I do not understand all the information about the informed consent process. Why do I have to provide so much information about the study to the potential participant? It takes too much time explaining every detail about the study! The only thing we need is for the individual to agree to participate and sign the consent form. Why do I have to do all of this?”

How would you explain to Mrs. Bilbao the purpose of the informed consent process?

“Mrs. Bilbao, the informed consent process helps an individual to make an informed decision about whether to participate. This is one way we can show respect to those who may contribute their time to participate in research. The research results can benefit others within our community. It is very important to take the time to make sure the individual understands what the study involves

and has a chance to ask questions before deciding to participate. This discussion must happen before the individual signs the consent form. ”

When talking to Mrs. Bilbao, you should make sure to keep the following in mind:

• The information presented should be detailed and explained to the individual using terms that are familiar and culturally appropriate.

• The purpose of the informed consent process is to ensure that an individual is able to make an informed decision about whether to volunteer to participate in research.

Dr. Pérez, a principal investigator and physician, wants to study the effectiveness of a new medication in treating a disease. He assigns promotores to recruit potential participants for the study.

Mr. Inzunza, a patient of the clinic, sees Dr. Pérez for a routine visit. Dr. Pérez tells Mr. Inzunza about a research study that he may be eligible for and suggests

that he speak to you, the promotor, if he wants additional information.

When you meet with Mr. Inzunza you say, “Hello, my name is Guadalupe Espinoza. I am a promotor working on a research study. The purpose of the study is to find out if a new medicine

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is effective in treating a disease. I am recruiting individuals, like you, to participate in the study. Would you like to know more about the research study?”

Mr. Inzunza replies, “Yes, it sounds very interesting.”

You take Mr. Inzunza to an appropriate setting where you can talk about the study. You present to Mr. Inzunza details about the study and explain what he will be asked to do as a participant.

What information would you present to Mr. Inzunza, so that he is able to make an informed decision about whether to participate?

“Mr. Inzunza, I would like to talk to you about the research study in more detail. I will provide you with information about the principal investigator, the purpose of the study, what you’ll be asked to do and how much time it will take.

Mr. Inzunza, I will also inform you about the potential risks and benefits. All of the information you provide will be kept confidential and will only be used for the research study. Your participation is completely voluntary. Do you have any questions?”

When talking to Mr. Inzunza, you should make sure to keep the following in mind:

• During the consent discussion, the following information is presented: details of the study, risks and benefits, a statement that participation is voluntary, and whom to contact should the individual have questions.

• The consent discussion should take place in an appropriate setting to make sure that the potential participant is able to make an informed decision about whether to participate.

Dr. Guzmán, a principal investigator, plans to conduct a study on weight loss among cancer survivors. You, as a promotor, are hired by Dr. Guzmán to recruit participants at a health fair.

While working, you see Mrs. Villarreal, a fellow promotor, conduct the consent discussion and documentation while an individual is waiting in line to get a refreshment from the concession stand.

You hear Mrs. Arroyo, a potential participant, say, “It is rather noisy and crowded here, isn’t it?” Mrs. Villarreal replies, “Yes, this year the health fair attracted a lot of people. Well, to continue, you will receive ten dollars as compensation for filling out the survey. Would you like to participate?”

3

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Session 3

Before Mrs. Arroyo decides whether to participate, you take Mrs. Villarreal aside to remind her that the consent discussion is taking place in an inappropriate setting.

Mrs. Villarreal asks you, “How does this inappropriate setting influence Mrs. Arroyo’s decision to participate in the study?”

How would you answer Mrs. Villarreal’s question?

“The potential participant, Mrs. Arroyo, may not be able to consider the information you are presenting to her while she stands in line at the concession stand. The place where you and Mrs. Arroyo are having the consent discussion is noisy and crowded. She is most likely thinking about what refreshment to buy at the concession stand rather than the information you are presenting. She may

also be concerned about her friends and neighbors overhearing the discussion.

Instead, you should take Mrs. Arroyo, to a quiet and less crowded place. It is important that the consent discussion and documentation take place in an appropriate setting for Mrs. Arroyo to make an informed decision.”

When answering Mrs. Villareal, you should also keep in mind the additional factors that may influence the decision to participate, such as:

• Information. The potential participant must receive accurate and complete information about the study and what is involved in participation.

• Terms. Information about the study should be presented using terms that are familiar and culturally appropriate.

• Setting. The setting should allow for information about the study to be presented, questions to be asked, and adequate time given for an individual to make a decision.

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ACRONYM: A word formed from the initial letters of a name or by combining initial letters or parts of a series of words.

ASSENT: A child’s agreement to participate in a research study. In most cases, the child’s parent or guardian must also give permission for the child to be involved in the research study.

ATTENTION: One of the five key areas of responsibility in the Project TRES acronym E.T.I.C.A. which refers to the responsibility of a promotor to pay attention to the details outlined in the research protocol and take the steps necessary to carry out his/her responsibilities.

BELMONT REPORT: A report written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research that summarizes the basic ethical principles that guide the conduct of human research. The three ethical principles identified in this report are Respect for Persons, Beneficence and Justice.

BENEFICENCE: One of the three ethical principles identified in the Belmont Report which means to “do no harm.” The application of beneficence requires evaluating possible harm and potential benefits of a research study. The benefits should be greater than the risks involved.

BENEFIT: For the purpose of this curriculum, “benefit” means finding answers to important questions about health problems or untested treatments. A participant may not receive any direct benefit from participation in the research study; however, the community at large may benefit from the study results. CONFIDENTIALITY: In research, this means protecting the information that the participant provides during the study.

CULTURALLY APPROPRIATE: Taking into account the language, traditions and customs of an individual or community.

CULTURE: One of the five key areas of responsibility in the Project TRES acronym E.T.I.C.A which refers to the responsibility of a promotor to know the language, traditions, and customs of the community.

DISCLOSURE: When information is revealed to others.

DURATION OF RISK: The amount of time that a person involved in a research study may experience pain or suffering.

ELIGIBILITY REQUIREMENTS: The criteria used to determine if an individual will be allowed to participate in a research study.

ENROLLMENT: The second component of the informed consent process which involves a discussion of the study with the potential participant and is generally followed by signing the consent form.

ETHICS: For the purpose of this curriculum “ethics” refers to what is widely accepted as “right” or “wrong.” In this curriculum, this applies to practices and standards of conducting research that protects the rights and welfare of research participants.

Terms to Remember

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E.T.I.C.A.: Created for the Project TRES curriculum, an acronym that describes the responsibilities of a promotor during a research study. The “E” represents Link (Enlace); “T” represents Three Principles of the Belmont Report; “I” represents Integrity; “C” represents Culture and “A” represents Attention.

HUMAN SUBJECT: An individual who volunteers to participate in a research study. In this curriculum, human subjects are called “participants.”

INCENTIVE: A reward that is provided to participants to encourage involvement in a research study.

INFORMED CONSENT PROCESS: A process in which information is provided to the potential participant so that an informed decision can be made about whether to volunteer to participate in the research study. This process includes the three components of: recruitment, enrollment and participation.

INSTITUTION: Universities or hospitals that host research studies and that have a formal agreement to conduct all research in compliance with federal regulations. INSTITUTIONAL REVIEW BOARD (IRB): A committee formed by investigators and members of the community responsible for ensuring that research conducted by the institution complies with the federal regulations that protect the rights and welfare of research participants.

INTEGRITY: One of the five key areas of responsibility in the Project TRES acronym E.T.I.C.A. which refers to the responsibility of a promotor to understand and follow the research protocol to ensure that the study is conducted correctly.

JUSTICE: One of the three ethical principles identified in the Belmont Report that relates to fairness. In research, it is important that the study results provide meaningful information to all that can possibly benefit from any new knowledge gained. Individuals selected to participate in research should represent those who are more likely to benefit from the study results.

LINK (ENLACE): One of the five key areas of responsibility noted in the Project TRES acronym E.T.I.C.A which refers to the responsibility of a promotor to serve as a link or a bridge, between the research participants and the research team.

MEDICAL RECORD: Medical and treatment history about a patient that may include sensitive information about a disease status and treatment history. A medical record is considered a legal document.

PARTICIPANT: An individual who enrolls in a research study. Participants provide information needed to answer the research questions on behalf of the community they represent.

PARTICIPATION: Attempting or completing the activities involved in a research study.

PERSONAL INFORMATION: The information that an individual may be asked to reveal about themselves during a research study such as age, income, years of education, medical history, health behaviors, or illegal activities.

PRINCIPAL INVESTIGATOR: The person responsible for all parts of the research study and who develops the research plan.

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PROBABILITY OF RISK: The chance that a participant will experience harm while participating in a research study.

PROMOTOR: A person who is a liaison between the research team and the target community they represent.

PROTOCOL: A complete description of the proposed research that includes procedures that protect the rights and welfare of participants in the research study.

PSEUDONYM: A false name used to protect an individual’s identity.

RESEARCH STUDY: Defined for the purpose of this training: A study that is carried out to gain new knowledge or to answer questions about something that is currently unknown or not well understood.

RESEARCH PARTICIPANT: See Participant.

RESEARCH TEAM: A group of individuals in research who are responsible for carrying out the research study within the target community according to the protocol.

RESPECT FOR PERSONS: One of the three ethical principles identified in the Belmont Report which acknowledges an individual’s right to make an independent decision and protect those who are not able to make decisions on their own.

RISK: The possibility of experiencing harm during a research study. Types of risks may include: physical, psychological, social, legal, and/or economic harm.

SERVICE PROJECT: A program that is already known to be helpful to a community or an individual.

SETTING: For the purpose of this curriculum, “setting” refers to the location where the informed consent process (recruitment, enrollment, participation) takes place.

SEVERITY OF RISK: The degree of serious pain or suffering that a participant involved in research may experience.

SURVEY: A set of questions for research participants to answer.

THREE PRINCIPLES: Basic ethical principles that guide the conduct of human research. As described in the Belmont Report these three principles are Respect for Persons, Beneficence and Justice. Also, one of the five key areas of responsibility in the Project TRES acronym E.T.I.C.A.

TYPE OF RISK: The kind of pain or suffering that a research participant may experience. Risks may include physical, psychological, social, legal, and/or economic harm.

VOLUNTEER: An individual who freely decides to participate in a research study and understands that participation may be discontinued at any time and for any reason.

training in research ethics and standardsinterwork.sdsu.edu/capri/docs/tres_self-studyguide.pdf3...

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