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Purdue Extension Human Subjects Training

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Purdue Extension Human Subjects Training

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    1. Purdue Extension Human Subjects Training Based on CITI Course in the Protection of Human Subjects Research Fall 2004 Welcome to the Purdue Extension Human Subjects Training to become certified Human subjects investigators. This training will prepare you to take the special online test located at the University of Miami CITI site. Purdue University is requiring that all individuals doing human subjects work become certified, through a training and testing program. We have worked with the Purdue IRB, and have developed this specialized training for Extension Educators. All educators will participate in this training, and will take the test, passing at an 80% or above level. Let’s get started. Welcome to the Purdue Extension Human Subjects Training to become certified Human subjects investigators. This training will prepare you to take the special online test located at the University of Miami CITI site. Purdue University is requiring that all individuals doing human subjects work become certified, through a training and testing program. We have worked with the Purdue IRB, and have developed this specialized training for Extension Educators. All educators will participate in this training, and will take the test, passing at an 80% or above level. Let’s get started.

    2. Topics To Be Covered History and Ethical Principles Defining Research with Human Subjects Regulatory Overview Assessing Risk Informed Consent Privacy and Confidentiality Research with Prisoners Research with Children Research in Public Schools Internet Research In the time we have this morning, we will be sharing with you the information you will need to pass the online test. We recommend that you pay attention, as some of this information will be very new to you. Included in our presentation today will be information on the history and ethics of Human subjects protections. You will learn how the work we do in Extension is defined as research, and why we follow the regulations. We will talk some about the federal regulations that govern human subjects research, and how risk is assessed. You will learn the rules of informed consent, and why the issues of privacy and confidentiality are so important to human subjects research. We will talk about the issues surrounding research with prisoners, with children, and in the public schools. We will talk about internet and email research. In the time we have this morning, we will be sharing with you the information you will need to pass the online test. We recommend that you pay attention, as some of this information will be very new to you. Included in our presentation today will be information on the history and ethics of Human subjects protections. You will learn how the work we do in Extension is defined as research, and why we follow the regulations. We will talk some about the federal regulations that govern human subjects research, and how risk is assessed. You will learn the rules of informed consent, and why the issues of privacy and confidentiality are so important to human subjects research. We will talk about the issues surrounding research with prisoners, with children, and in the public schools. We will talk about internet and email research.

    3. History and Ethical Principles Provides a Structure for Analysis and Decision making Supports – Reminds to Protect Human subjects Aids in Assessing Risks and Benefits Research ethics provides us with a structure for analysis and decision-making. These principles support and remind researchers to protect human subjects, and they provide the definitions of benefits and risks, along with the guidelines for evaluating and balancing the benefits and risks.Research ethics provides us with a structure for analysis and decision-making. These principles support and remind researchers to protect human subjects, and they provide the definitions of benefits and risks, along with the guidelines for evaluating and balancing the benefits and risks.

    4. Historical Influences Nuremberg Code Resulted from Nazi Doctors Atrocities The Code didn’t Impact U.S. Scientists Declaration of Helsinki Broadened Nuremberg Code The development of research ethics has evolved over time. At the end of WWII, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used for research subjects. Included in the legal judgments handed down at the end of the trial were 10 points describing required elements for conducting research with humans. These points became known as the Nuremberg code. This document had little effect on U.S. researchers, who felt they already followed the principles in the code. They felt it was created solely to condemn the Nazi atrocities and to convict the Nazi doctors. In 1964 the World Medical Association developed a code of ethics that became known as the Declaration of Helsinki. It really was an interpretation of the Nuremberg Code. This document set the stage for the Institutional Review Process, and Institutional Review Boards. The development of research ethics has evolved over time. At the end of WWII, 23 Nazi doctors and scientists were put on trial for the murder of concentration camp inmates who were used for research subjects. Included in the legal judgments handed down at the end of the trial were 10 points describing required elements for conducting research with humans. These points became known as the Nuremberg code. This document had little effect on U.S. researchers, who felt they already followed the principles in the code. They felt it was created solely to condemn the Nazi atrocities and to convict the Nazi doctors. In 1964 the World Medical Association developed a code of ethics that became known as the Declaration of Helsinki. It really was an interpretation of the Nuremberg Code. This document set the stage for the Institutional Review Process, and Institutional Review Boards.

    5. Historical Case Studies Obedience to Authority Study Involved Deception of Subjects Caused Some Emotional Problems Public Health Service Syphilis Study 1932-1972 Withheld Available Treatment Led to Establishment of National Research Act Current Protections for Human Subjects There are a number of famous studies conducted that used some of the unethical practices. We will review two here: The Obedience to Authority Study called the Milgram Study The purpose of this study was to determine response to authority in normal humans. The researchers told recruited volunteers that the purpose was to study learning and memory. Each subject was told to teach as “Student” and to punish the students errors by administering increasing levels of electric shocks. The “student” was a confederate of the researcher who pretended to be a poor learner and mimicked pain and even unconsciousness as the subject increased the levels of electric shock. 63% of the students administered lethal shocks; some even after the “student” claimed to have heart disease. Some of the subjects, after being “Debriefed” from the study experienced serious emotional crises. The Public Health Service Study was initiated by the Public Health Service to document the natural history of syphilis in African-American men. Even after penicillin was found to be an effective treatment for syphilis, the men were denied the antibiotics. The study started in 1932, and continued till 1972 when the public found out. The outrage by the public about this study let to the establishment of the National Research Act and the current protections for Human subjects.There are a number of famous studies conducted that used some of the unethical practices. We will review two here: The Obedience to Authority Study called the Milgram Study The purpose of this study was to determine response to authority in normal humans. The researchers told recruited volunteers that the purpose was to study learning and memory. Each subject was told to teach as “Student” and to punish the students errors by administering increasing levels of electric shocks. The “student” was a confederate of the researcher who pretended to be a poor learner and mimicked pain and even unconsciousness as the subject increased the levels of electric shock. 63% of the students administered lethal shocks; some even after the “student” claimed to have heart disease. Some of the subjects, after being “Debriefed” from the study experienced serious emotional crises. The Public Health Service Study was initiated by the Public Health Service to document the natural history of syphilis in African-American men. Even after penicillin was found to be an effective treatment for syphilis, the men were denied the antibiotics. The study started in 1932, and continued till 1972 when the public found out. The outrage by the public about this study let to the establishment of the National Research Act and the current protections for Human subjects.

    6. Ethical Problems Lack of Informed Consent Coercion Use/Exploitation of Vulnerable Populations Withholding information including about risks Failure to Assess Risks vs. Benefits Deception Violation of Rights In 1966, Dr. Henry Beecher wrote an article titled, “Ethics and Clinical Research.” In it he described a number of research studies with controversial ethical procedures. This article played an important role in heightening the awareness of U.S. researcher, the public, and the press. Until the article was published in the U.S., people assumed that unethical research could only occur in a depraved regime like the Nazis. The Beecher article increase public awareness and brought to light problems with ethics in research such as: Lack of informed consent Coercion or undue pressure on volunteers (or on a parent to volunteer their child) Use of a vulnerable population Exploitation of a vulnerable population Withholding information Withholding information about risks Risks to subjects outweigh the benefits Deception Violation of rightsIn 1966, Dr. Henry Beecher wrote an article titled, “Ethics and Clinical Research.” In it he described a number of research studies with controversial ethical procedures. This article played an important role in heightening the awareness of U.S. researcher, the public, and the press. Until the article was published in the U.S., people assumed that unethical research could only occur in a depraved regime like the Nazis. The Beecher article increase public awareness and brought to light problems with ethics in research such as: Lack of informed consent Coercion or undue pressure on volunteers (or on a parent to volunteer their child) Use of a vulnerable population Exploitation of a vulnerable population Withholding information Withholding information about risks Risks to subjects outweigh the benefits Deception Violation of rights

    7. The Belmont Report 1974 National Commission formed to study Human subjects concerns 1979 Belmont Report Respect For Persons Beneficence Justice No One Principle “Trumps” Another All must be weighed equally In 1974 Congress authorized the formation of a National Commission that would study these Human subjects concerns. This commission was charged with developing guidelines to assure that human research is conducted ethically. This group published the Belmont Report in 1979. The Belmont Report identifies three basic ethical principals that underlie all human subject research. These principles are commonly called the Belmont Principles and include Respect for Persons, Beneficence, and Justice. The Belmont Report states that one principle does not always outweigh another. We are required to consider each case separately and on its own merits in light of all three principles.In 1974 Congress authorized the formation of a National Commission that would study these Human subjects concerns. This commission was charged with developing guidelines to assure that human research is conducted ethically. This group published the Belmont Report in 1979. The Belmont Report identifies three basic ethical principals that underlie all human subject research. These principles are commonly called the Belmont Principles and include Respect for Persons, Beneficence, and Justice. The Belmont Report states that one principle does not always outweigh another. We are required to consider each case separately and on its own merits in light of all three principles.

    8. From Principles to Practice Respect Beneficence Justice Informed Consent Voluntariness Risks/Benefits Privacy/Confidentiality = Burdens =Benefits Diversity Respect for Persons requires that we must allow people to choose for themselves and provide extra protection to those with limited autonomy. Included in this principle is the voluntariness component and the freedom from control or influence of others. Rules derived from the principle include the requirements to obtain informed consent, and to respect the privacy of research subjects. From the principle of respect for persons we need to conduct initial and continuing informed consent. We need to evaluate whether the research allows subjects to withdraw from the research and maintains the welfare of each subject. Beneficence reminds us to minimize harms and maximize benefits. Rules derived from this principle include the requirement to use the best possible research design to maximize benefits and minimize harms. The requirements to make sure the researchers are able to perform the procedures and handle the risks. And the prohibition of research that is without a favorable risk-benefit ratio. From the principle of beneficence we need to evaluate the social and scientific value of the research, the scientific validity of the research, and determine whether the research has a favorable risk benefit ratio. Justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. It also includes the requirements to avoid exploitation of vulnerable populations or populations of convenience. From the principle of justice we need to evaluate whether there is fair subject selection. We also need to evaluate the inclusion and exclusion criteria and the methods of recruitment.Respect for Persons requires that we must allow people to choose for themselves and provide extra protection to those with limited autonomy. Included in this principle is the voluntariness component and the freedom from control or influence of others. Rules derived from the principle include the requirements to obtain informed consent, and to respect the privacy of research subjects. From the principle of respect for persons we need to conduct initial and continuing informed consent. We need to evaluate whether the research allows subjects to withdraw from the research and maintains the welfare of each subject. Beneficence reminds us to minimize harms and maximize benefits. Rules derived from this principle include the requirement to use the best possible research design to maximize benefits and minimize harms. The requirements to make sure the researchers are able to perform the procedures and handle the risks. And the prohibition of research that is without a favorable risk-benefit ratio. From the principle of beneficence we need to evaluate the social and scientific value of the research, the scientific validity of the research, and determine whether the research has a favorable risk benefit ratio. Justice requires us to treat people fairly and to design research so that its burdens and benefits are shared equitably. It also includes the requirements to avoid exploitation of vulnerable populations or populations of convenience. From the principle of justice we need to evaluate whether there is fair subject selection. We also need to evaluate the inclusion and exclusion criteria and the methods of recruitment.

    9. Regulatory Overview Common Rule (45 CFR 46) Department of Health and Human Services All Institutions that Receive DHHS Funds Subparts to Common Rule Special Protections for Prisoners- Subpart C Children – Subpart D Pregnant Women (when their pregnancy affects their ability to participate) fetuses, neonates -Subpart B Research with human subjects is governed by federal, state, and local laws, as well as by institutional policy. The federal regulations are often referred to as the Common Rule. The regulations were first written by the Department of Healthy and Human Services (DHHS). THE DHHS regulations are sometimes referred to as 45 CFR 46, Subpart A. Three subparts have need added to the basic provisions of the regulations. These include Subpart B, Pregnant women, fetuses, and neonates; Subpart C, Prisoners; and Subpart D Children. Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the source of funding. This position is based on the premise that the regulations reflect ethical principles common to the entire research enterprise and that all research subjects should be provided the same protections regardless of the source of the financial support for the research. Most institutions also choose to apply the additional subparts to all research.Research with human subjects is governed by federal, state, and local laws, as well as by institutional policy. The federal regulations are often referred to as the Common Rule. The regulations were first written by the Department of Healthy and Human Services (DHHS). THE DHHS regulations are sometimes referred to as 45 CFR 46, Subpart A. Three subparts have need added to the basic provisions of the regulations. These include Subpart B, Pregnant women, fetuses, and neonates; Subpart C, Prisoners; and Subpart D Children. Most institutions decide to apply the Common Rule to all research with human subjects, regardless of the source of funding. This position is based on the premise that the regulations reflect ethical principles common to the entire research enterprise and that all research subjects should be provided the same protections regardless of the source of the financial support for the research. Most institutions also choose to apply the additional subparts to all research.

    10. The Common Rule Dictates What an IRB Should do The basic criteria for IRB review of protocols Description of the types of review Composition of the IRB Primary Purpose Protect the rights and welfare of research subjects The regulations define what must be reviewed, who must review it, and how it should be reviewed. Included in those regulations are such things as the Basic Criteria for IRB review of protocols,. As description of the types of review, and the composition of the IRB The primary purpose is not to make everyone’s job harder, it’s primary purpose is to monitor research to ensure that individuals’ rights are upheld.The regulations define what must be reviewed, who must review it, and how it should be reviewed. Included in those regulations are such things as the Basic Criteria for IRB review of protocols,. As description of the types of review, and the composition of the IRB The primary purpose is not to make everyone’s job harder, it’s primary purpose is to monitor research to ensure that individuals’ rights are upheld.

    11. Institutional Review Board (IRB) Evaluates Research According to Belmont Report Principles Respect for Persons Beneficence Justice Federal Regulations derived from it Common Rule IRB Committee Decision is Final No one can override a decision of the IRB Institutional Review Boards are the committees set up to review application for human subjects research. The evaluate that research according to the Belmont Principles of Respect for people, beneficence, and justice. Ethical principles and Federal regulations provide a framework for IRBs to evaluate research . The IRB Committee decision is Final. No one can override the decision of the IRB. This is true of the campus IRB. For the Extension Human subjects Committee, the Director of Extension can override the Extension Committee’s decision, and send an application on to the Purdue IRB for review, or withdraw an application from the review process.Institutional Review Boards are the committees set up to review application for human subjects research. The evaluate that research according to the Belmont Principles of Respect for people, beneficence, and justice. Ethical principles and Federal regulations provide a framework for IRBs to evaluate research . The IRB Committee decision is Final. No one can override the decision of the IRB. This is true of the campus IRB. For the Extension Human subjects Committee, the Director of Extension can override the Extension Committee’s decision, and send an application on to the Purdue IRB for review, or withdraw an application from the review process.

    12. Defining Research A Systematic Investigation Research Development, Testing, Evaluation Contributes to Generalizable Knowledge Will it be Disseminated? Will it be Read by others outside of Purdue Extension? Poster Sessions Journal Articles Impact Statements Research is defined as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. In the social and behavioral sciences, much research fits within the traditional understanding of scientific methodology. However the application of the term “Systematic” depends largely upon discipline-specific methodology. A systematic inquiry in psychology might involve observing the interaction between dependent and independent variables. On the other hand, when ethnographers study communities, they may not have a hypothesis, but their observations and interviews are informed by constructs, such as the function of communities, and are thus systematic in terms of their discipline. Pilot studies, feasibility studies, and other preliminary studies clearly fall under the definition of research. Both of these constitute research with human subjects A focus group of Latino immigrants helping researchers develop a questionnaire with regard to the transfer of sexually transmitted disease between immigrant receiving and immigrant sending communities. Community pilot testing of the questionnaire prior to the administration of the questionnaire and analyses of the results. To generalize is to give general form, to derive general conclusions from particulars, and is thus the enterprise of most basic research. Even research about the most narrowly defined topic, such as individual case study or the study of an isolated community, may be intended to contribute to some body of knowledge such as the function of culture, the expression of gender, or the political views of marginalized community members. An essential question is whether or not it is the intention of the researcher to contribute to generalizable knowledge. Some activities that involved interactions with humans and data gathering may not fit the definition of research with human subjects, since they are designed to accomplish something else, such as in-house quality improvement. For example, a survey of college students about their university’s counseling services may be designed strictly to improve the service delivery for students on that campus, and thus not involve research. (However, should the surveyors believe that the results may be generalizable, they should request IRB review before they initiate the survey.) Publication of results is sometimes used as a measure of whether or not research is generalizable, but this is too narrow a measure for two reasons. First not every study will produce results worthy of publication. Second there are multiple ways in which results can be made available to others without being published in a peer-reviewed journal. They may be shared with colleagues through the Internet, appear in a dissertation, or provided to Board members in a project report.Research is defined as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. In the social and behavioral sciences, much research fits within the traditional understanding of scientific methodology. However the application of the term “Systematic” depends largely upon discipline-specific methodology. A systematic inquiry in psychology might involve observing the interaction between dependent and independent variables. On the other hand, when ethnographers study communities, they may not have a hypothesis, but their observations and interviews are informed by constructs, such as the function of communities, and are thus systematic in terms of their discipline. Pilot studies, feasibility studies, and other preliminary studies clearly fall under the definition of research. Both of these constitute research with human subjects A focus group of Latino immigrants helping researchers develop a questionnaire with regard to the transfer of sexually transmitted disease between immigrant receiving and immigrant sending communities. Community pilot testing of the questionnaire prior to the administration of the questionnaire and analyses of the results. To generalize is to give general form, to derive general conclusions from particulars, and is thus the enterprise of most basic research. Even research about the most narrowly defined topic, such as individual case study or the study of an isolated community, may be intended to contribute to some body of knowledge such as the function of culture, the expression of gender, or the political views of marginalized community members. An essential question is whether or not it is the intention of the researcher to contribute to generalizable knowledge. Some activities that involved interactions with humans and data gathering may not fit the definition of research with human subjects, since they are designed to accomplish something else, such as in-house quality improvement. For example, a survey of college students about their university’s counseling services may be designed strictly to improve the service delivery for students on that campus, and thus not involve research. (However, should the surveyors believe that the results may be generalizable, they should request IRB review before they initiate the survey.) Publication of results is sometimes used as a measure of whether or not research is generalizable, but this is too narrow a measure for two reasons. First not every study will produce results worthy of publication. Second there are multiple ways in which results can be made available to others without being published in a peer-reviewed journal. They may be shared with colleagues through the Internet, appear in a dissertation, or provided to Board members in a project report.

    13. Human Subjects Definition “A living Individual about whom an investigator conducting research obtains: Data through intervention or interaction with the individual Identifiable private information” Private Information Reasonable Expectation of Privacy Provided for Specific Purpose – not to be made public A Human subjects is a “living individual about whom and investigator conducting research obtains 1. data through intervention or interaction with the individual, or 2. identifiable private information Interventions are physical procedures, but also include the manipulation of subject’s in their environment, i.e. studies investigating the impact of environmental factors on cognition or memory. Interactions include communication or interpersonal contact between the subject and the investigator. Communication does not have to be face to face and may even exist entirely on paper or in electronic format. Participant observation is a form of interaction. Identifiable private information is information that occurs in a context that the individual can reasonably expect that no observation or recording is taking place. OR information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public/ Individuals provide personal information with the expectation that it not be made public, in a variety of settings: at work, at school or college, when receiving health care, or as a member of an organization. If you are looking at historical data when all the individuals would no longer be living, then that effort would not require human subjects review.A Human subjects is a “living individual about whom and investigator conducting research obtains 1. data through intervention or interaction with the individual, or 2. identifiable private information Interventions are physical procedures, but also include the manipulation of subject’s in their environment, i.e. studies investigating the impact of environmental factors on cognition or memory. Interactions include communication or interpersonal contact between the subject and the investigator. Communication does not have to be face to face and may even exist entirely on paper or in electronic format. Participant observation is a form of interaction. Identifiable private information is information that occurs in a context that the individual can reasonably expect that no observation or recording is taking place. OR information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public/ Individuals provide personal information with the expectation that it not be made public, in a variety of settings: at work, at school or college, when receiving health care, or as a member of an organization. If you are looking at historical data when all the individuals would no longer be living, then that effort would not require human subjects review.

    14. Benefit A positive value to the individual of participating in a study Direct Benefits Indirect Benefits Benefits to Science and society Let’s define some of the words you will hear often this morning. A benefit is the positive value or advantage of being part of the research study. The value or advantage might be concrete for individual subjects, or it may be more intangible and general. For example, the results from a study could be crucial to understanding the underlying socioeconomic causes of drug addition.Let’s define some of the words you will hear often this morning. A benefit is the positive value or advantage of being part of the research study. The value or advantage might be concrete for individual subjects, or it may be more intangible and general. For example, the results from a study could be crucial to understanding the underlying socioeconomic causes of drug addition.

    15. Risk Harms that may occur to individual Probability and Magnitude May be: Physical Social Economic Legal Psychological Weigh Risks against Potential Benefits Not all Risks and Benefits may be known Risks generally are evaluated according to the probability and magnitude of any harm that might occur. Will the risk occur in almost all subjects or in only one of 10,000 subjects? We can also quantify risk according to the magnitude of harm. Risks may be physical, as sometimes occurs in medical research. Risk may also be social, legal, economic, or psychological in nature. In addition, risk may apply to the individual subject or may apply to a broader segment of the society. Neither the potential benefits or risks can be known ahead of time. The risks are assumed by individuals, while the benefits may accrue to society at large rather than to individuals.Risks generally are evaluated according to the probability and magnitude of any harm that might occur. Will the risk occur in almost all subjects or in only one of 10,000 subjects? We can also quantify risk according to the magnitude of harm. Risks may be physical, as sometimes occurs in medical research. Risk may also be social, legal, economic, or psychological in nature. In addition, risk may apply to the individual subject or may apply to a broader segment of the society. Neither the potential benefits or risks can be known ahead of time. The risks are assumed by individuals, while the benefits may accrue to society at large rather than to individuals.

    16. Assessing Risk Falls into 3 General Categories Invasion of Privacy Information accessed without knowledge or consent Breach of Confidentiality May be unintentional Information disclosed outside to research setting Study Procedures Just participating can cause stress or issues of privacy Can be culturally determined Risk, for our purposes, generally falls into three categories: Invasion of privacy Breach of Confidentiality 3) Study Procedures Invasion of Privacy can occur if personal information is accessed or collected without the subject’s knowledge or consent. Invasions of privacy can occur if a subject’s participation in a study is revealed without the subject’s knowledge. Confidentiality can occur if information obtained in the process is disclosed outside the research setting. Such incidences could have a negative impact on the subjects’ psychological, social, or economic, status. In some case, simply participating in the research can cause social or psychological harm. For example, research may induce psychological distress in a participant responding to questions regarding a sensitive topic or past traumatic event. We need to remember that risk may differ depending on the area, or ethnic group we are working with. Can anyone think of an example of a risk that would be culturally determined?Risk, for our purposes, generally falls into three categories: Invasion of privacy Breach of Confidentiality 3) Study Procedures Invasion of Privacy can occur if personal information is accessed or collected without the subject’s knowledge or consent. Invasions of privacy can occur if a subject’s participation in a study is revealed without the subject’s knowledge. Confidentiality can occur if information obtained in the process is disclosed outside the research setting. Such incidences could have a negative impact on the subjects’ psychological, social, or economic, status. In some case, simply participating in the research can cause social or psychological harm. For example, research may induce psychological distress in a participant responding to questions regarding a sensitive topic or past traumatic event. We need to remember that risk may differ depending on the area, or ethnic group we are working with. Can anyone think of an example of a risk that would be culturally determined?

    17. Managing Risks Collect Data without Identifiers Remove all Direct Identifiers Code Data Keep code lists and data separately Aggregate Data so as not to identify Secure Technology/computers Minimize risks of exposure from Participation Sensitive to Psychological Risks When a possible disclosure of subjects’ responses is the primary source of potential harm, safeguarding the data from unauthorized access can be accomplished in various standard ways including: Collect data without identifiers 2) Remove all direct identifiers as soon as possible 3) Substitute codes for identifiers 4) Maintain code lists and data files in separate secure locations 5) Use accepted methods to protect against indirect identification, e.g. aggregate reporting or misleading identifiers 6) Utilize and protect computer passwords. 7) Access and store data on computers without internet connections. Common methodologies such as surveys, questionnaires, and interviews are considered, sometimes erroneously, low risk since they do not involve procedures associated with risk of physical harm. However, it is not the procedures per se that engender potential harm, When a possible disclosure of subjects’ responses is the primary source of potential harm, safeguarding the data from unauthorized access can be accomplished in various standard ways including: Collect data without identifiers 2) Remove all direct identifiers as soon as possible 3) Substitute codes for identifiers 4) Maintain code lists and data files in separate secure locations 5) Use accepted methods to protect against indirect identification, e.g. aggregate reporting or misleading identifiers 6) Utilize and protect computer passwords. 7) Access and store data on computers without internet connections. Common methodologies such as surveys, questionnaires, and interviews are considered, sometimes erroneously, low risk since they do not involve procedures associated with risk of physical harm. However, it is not the procedures per se that engender potential harm,

    18. Privacy in Research Privacy/of participant About the person Identifying and Recruiting subjects Covert observation Privacy of Third parties Sensitive Questions Limits to Confidentiality Child/Elder Abuse Reporting Focus Groups Methods used to identify subjects can constitute violations of privacy. For example, a recruitment technique referred to as “Snowball sampling” involves asking an identified subject to provide the researcher with names of other individuals who have characteristics or experiences of interest to the researcher. The research topic might be innocuous, in which case the possibility of an invasion of privacy is minimal – for instance the names of local retirees from a particular company for an oral history project. However, some people might find it a violation of privacy to be contacted by a researcher who knows something about them they regard as private. Concealed devices to record information for later analysis, i.e. tape recording conversations or videotaping personal interactions Concealment of the researcher or concealment of the researcher’s identity are all situations that may have some ethical concerns. Here are some questions to ask yourself: Would reasonable people be offended by such an intrusion? Can the research be redesigned to avoid the intrusion? Would information gathered through covert observation place the subjects at risk if disclosed? Is any invasion of privacy justified by the benefits of the study? Is the knowledge to be gained important enough to involve subjects without their consent? If a researcher plans to ask for private information about individuals other than the research subjects, they must determine if that practice would constitute an invasion of privacy. Studies about sexual behavior, childhood abuse, use of psychotropic medications, and so on should include a disclosure in the consent form about the nature of the questions. Privacy refers to our right to control access to ourselves and to our personal information. IT means that we have the right to control the degree, the timing, and the conditions for sharing our bodies, thoughts, and experiences with others. Privacy is about the person, and or the individual There are some limits to Confidentiality. Laws require that you disclose information you learn about suspicion of child abuse, or elder abuse. It’s important to tell people in focus groups that the information they provide may be repeated by others in the group, so confidentiality cannot be maintained. Methods used to identify subjects can constitute violations of privacy. For example, a recruitment technique referred to as “Snowball sampling” involves asking an identified subject to provide the researcher with names of other individuals who have characteristics or experiences of interest to the researcher. The research topic might be innocuous, in which case the possibility of an invasion of privacy is minimal – for instance the names of local retirees from a particular company for an oral history project. However, some people might find it a violation of privacy to be contacted by a researcher who knows something about them they regard as private. Concealed devices to record information for later analysis, i.e. tape recording conversations or videotaping personal interactions Concealment of the researcher or concealment of the researcher’s identity are all situations that may have some ethical concerns. Here are some questions to ask yourself: Would reasonable people be offended by such an intrusion? Can the research be redesigned to avoid the intrusion? Would information gathered through covert observation place the subjects at risk if disclosed? Is any invasion of privacy justified by the benefits of the study? Is the knowledge to be gained important enough to involve subjects without their consent? If a researcher plans to ask for private information about individuals other than the research subjects, they must determine if that practice would constitute an invasion of privacy. Studies about sexual behavior, childhood abuse, use of psychotropic medications, and so on should include a disclosure in the consent form about the nature of the questions. Privacy refers to our right to control access to ourselves and to our personal information. IT means that we have the right to control the degree, the timing, and the conditions for sharing our bodies, thoughts, and experiences with others. Privacy is about the person, and or the individual There are some limits to Confidentiality. Laws require that you disclose information you learn about suspicion of child abuse, or elder abuse. It’s important to tell people in focus groups that the information they provide may be repeated by others in the group, so confidentiality cannot be maintained.

    19. Research with Prisoners Definition: Some one in the legal system Consent Issues with Prisoner Free Choice Undue Inducements Breach of Confidentiality Sensitive Questions when there is no support IRB must include an Prisoner Advocate when reviewing The Purdue definition of prisoner is “anyone in the legal system.” This is a broader than the federal regulations, but it is what we will be working with. The most important thing to remember about working with prisoners is the issue of Consent. The autonomy of prisoners is limited, and thus their ability to exercise free choice. One of the key rules of designing a consent form is that there be no undue inducements to participation. Prison cultures and structures are such that even the most trivial outside will carry great significance. Breach of confidentiality and asking sensitive question when there is no support. At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity. Suitable individuals could include former prisoners, prison chaplains, The Purdue definition of prisoner is “anyone in the legal system.” This is a broader than the federal regulations, but it is what we will be working with. The most important thing to remember about working with prisoners is the issue of Consent. The autonomy of prisoners is limited, and thus their ability to exercise free choice. One of the key rules of designing a consent form is that there be no undue inducements to participation. Prison cultures and structures are such that even the most trivial outside will carry great significance. Breach of confidentiality and asking sensitive question when there is no support. At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity. Suitable individuals could include former prisoners, prison chaplains,

    20. Research with Children Definition: Persons who have not yet attained the legal age of consent. In IN it is 18 In Commonly Accepted Educational Settings Research about educational Tests “Is your survey to find out what they learned, or what behavior changed?” The federal regulations define children as one of the vulnerable populations and as such, they require special protections. Indiana defines a child as someone who has not yet attained the legal age of consent, 18 years of age. As a vulnerable population, most efforts with children would require an expedited or full review because consent forms would be required. Children themselves cannot legally provide consent, so what is normally required is that you would have to have parental consent as well as having the teen or young adult sign the consent. If the children you are working with you young, then you will want to have assent. This is a form written at a level the child can understand that describes the effort they will be involved in, and tells them it is voluntary, and they can stop participating any time they want. There are times when efforts with children are exempt, and most of the work we do with youth falls into two of these categories. As we mentioned earlier, when we are doing educational programming, it can be considered exempt. Can you make the case that everything Cooperative Extension does is educational? If so, then when you work with youth, it will fall into the first category above, efforts in commonly accepted educational settings. The question you need to ask your self is: “Am I asking these questions because I want to know what these young people learned, or what behavior they changed as a result of participating in some program?” If the answer to that question is YES, then the effort will be exempt. The federal regulations define children as one of the vulnerable populations and as such, they require special protections. Indiana defines a child as someone who has not yet attained the legal age of consent, 18 years of age. As a vulnerable population, most efforts with children would require an expedited or full review because consent forms would be required. Children themselves cannot legally provide consent, so what is normally required is that you would have to have parental consent as well as having the teen or young adult sign the consent. If the children you are working with you young, then you will want to have assent. This is a form written at a level the child can understand that describes the effort they will be involved in, and tells them it is voluntary, and they can stop participating any time they want. There are times when efforts with children are exempt, and most of the work we do with youth falls into two of these categories. As we mentioned earlier, when we are doing educational programming, it can be considered exempt. Can you make the case that everything Cooperative Extension does is educational? If so, then when you work with youth, it will fall into the first category above, efforts in commonly accepted educational settings. The question you need to ask your self is: “Am I asking these questions because I want to know what these young people learned, or what behavior they changed as a result of participating in some program?” If the answer to that question is YES, then the effort will be exempt.

    21. Not Exempt Studies with Children cannot be Exempt when: Interviews and or surveys outside of an educational experience Observations when the researcher participates in the activities observed Will require an Expedited or Full Review If you are interviewing or surveying youth outside of an educational experience, then the efforts cannot be exempt. The traditional CSR surveys where you want to know the extent of what youth in the community are doing, is an example of an effort that is not exempt. You are not doing any education, although, you may administer the survey in the schools, so the effort will not be exempt. IT will require either a expedited or full review and the consent forms. If you are asking questions that have nothing to do with an educational experience, then the effort will require either an expedited or a full review, and consent forms will be necessary. Expedited and/or full reviews will also be necessary when you are asking young people any kind of questions of a sensitive nature, i.e.,, “Do you drink or smoke cigarettes?” or “have you even been raped?” Another effort with children is when you may be observing the youth, and you are also participating in the experience. Can anyone think of an example of this? How about if you are taking a group of your Junior Leaders to see an x-rated movie, and then observing their reaction to it. This would be an example of an observation that would require an expedited or full review. Can you see the reason why? In such a case there would be some deception because the youth would not assume that their behavior would be reported.If you are interviewing or surveying youth outside of an educational experience, then the efforts cannot be exempt. The traditional CSR surveys where you want to know the extent of what youth in the community are doing, is an example of an effort that is not exempt. You are not doing any education, although, you may administer the survey in the schools, so the effort will not be exempt. IT will require either a expedited or full review and the consent forms. If you are asking questions that have nothing to do with an educational experience, then the effort will require either an expedited or a full review, and consent forms will be necessary. Expedited and/or full reviews will also be necessary when you are asking young people any kind of questions of a sensitive nature, i.e.,, “Do you drink or smoke cigarettes?” or “have you even been raped?” Another effort with children is when you may be observing the youth, and you are also participating in the experience. Can anyone think of an example of this? How about if you are taking a group of your Junior Leaders to see an x-rated movie, and then observing their reaction to it. This would be an example of an observation that would require an expedited or full review. Can you see the reason why? In such a case there would be some deception because the youth would not assume that their behavior would be reported.

    22. Issues with Children Potential Coercion Peer Pressure Child Abuse/Neglect Reporting Age Appropriateness Compensation Here are some human subjects issues that apply to children. Is there any potential coercion that occurs with your effort? Is there peer pressure to participate, or not participate? What about the issues of reporting child abuse or neglect? Is the program designed to be understood by the age group you are targeting? Is is age appropriate? Are there compensation issues? Are you offering reimbursement incentives that are suitable?Here are some human subjects issues that apply to children. Is there any potential coercion that occurs with your effort? Is there peer pressure to participate, or not participate? What about the issues of reporting child abuse or neglect? Is the program designed to be understood by the age group you are targeting? Is is age appropriate? Are there compensation issues? Are you offering reimbursement incentives that are suitable?

    23. Written Informed Consent Required for Expedited and Full Reviews Include: Purpose of the Research Procedures to be Followed Risks or Discomforts Benefits How records will be Maintained Compensation if any Contact Information Voluntary Statement/Ability to Withdraw Informed consent is a process that begins with the recruitment and screening of subjects and continues throughout the subject’s involvement in the research. It is required when you have a project that will require an expedited or full review. Children cannot give consent, and therefore an assent process is used. If you are working with a wide age range of youth, then you may have to have assent forms in two different reading levels. as well as a parental consent form. Special assent forms are needed for youth under 14-16 and must be written at reading level that these younger children can comprehend. Consent forms must include: An explanation of the purposes of the research and the expected duration 2) Any foreseeable risks or discomforts that may occur 3) The benefits to the subjects or others 4) How the records will be maintained to ensure confidentiality 5) The kinds and amount of compensation 6) Contact information for someone with questions 7) The voluntary statement, and the ability to withdraw at any timeInformed consent is a process that begins with the recruitment and screening of subjects and continues throughout the subject’s involvement in the research. It is required when you have a project that will require an expedited or full review. Children cannot give consent, and therefore an assent process is used. If you are working with a wide age range of youth, then you may have to have assent forms in two different reading levels. as well as a parental consent form. Special assent forms are needed for youth under 14-16 and must be written at reading level that these younger children can comprehend. Consent forms must include: An explanation of the purposes of the research and the expected duration 2) Any foreseeable risks or discomforts that may occur 3) The benefits to the subjects or others 4) How the records will be maintained to ensure confidentiality 5) The kinds and amount of compensation 6) Contact information for someone with questions 7) The voluntary statement, and the ability to withdraw at any time

    24. Issues of Informed Consent Recruitment Language/Cultural Appropriateness Reading Levels Rights and Welfare Subjects Potential Coercion Waivers of parental consent may be granted: Parent’s knowledge of situation my cause harm Child is emancipated There are a number of issues that are of concern with informed consent, and the process of informed consent. Recruitment is part of the consent process. This is the reason that we ask to see a piece of your publicity materials when you send in an application. If the consent form in the appropriate language and is it cultural correct for the participants? Consider that the terms- “focus group” and “intervention” are specialized terms. If we aren’t comfortable with the wording, do we think our subjects will be? Rights and welfare of subjects is hard to define because they are not defined in the regulations. People may not always agree about what the rights and welfare are. Free Choice. The principle of respect for persons requires that participation in research be truly voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects must be informed that they do not have to participate, they may choose not to answer particular questions, and they may choose to stop participating at any time. There are times when you will not need to get consent. If the parent’s knowledge of the effort will cause harm to the child, or if the child is emancipated then consent is not required. However, you will be required to file for a waiver of consent. There are a number of issues that are of concern with informed consent, and the process of informed consent. Recruitment is part of the consent process. This is the reason that we ask to see a piece of your publicity materials when you send in an application. If the consent form in the appropriate language and is it cultural correct for the participants? Consider that the terms- “focus group” and “intervention” are specialized terms. If we aren’t comfortable with the wording, do we think our subjects will be? Rights and welfare of subjects is hard to define because they are not defined in the regulations. People may not always agree about what the rights and welfare are. Free Choice. The principle of respect for persons requires that participation in research be truly voluntary, free from coercion or undue influence. Even when a study is innocuous, subjects must be informed that they do not have to participate, they may choose not to answer particular questions, and they may choose to stop participating at any time. There are times when you will not need to get consent. If the parent’s knowledge of the effort will cause harm to the child, or if the child is emancipated then consent is not required. However, you will be required to file for a waiver of consent.

    25. Research in Public Schools Regulations affecting schools Common Rule Common Rule –Subpart D for Children Family Education Rights and Privacy Act FERPA Educational Records Protection of Pupil Rights Amendment PPRA- Written Notification to Parents for Surveys No Child Left Behind Act Surveys containing sensitive Topics There are regulations that cover research in public schools and now there are a number of laws that govern work in schools. Included are the common rule, and common rule-subpart D which governs work with children. Then there are the other laws that affect the schools including, and not limited to, FERPA, the family Education Rights and Privacy Act, and PPRA, the Protection of Pupil Rights Amendment and the No Child Left Behind Act, which is the one that governs surveys containing sensitive issues. PRPA is the law that requires that parents provide written approval before their students take surveys not associated with the curriculum What is important to remember here, is that efforts that you do in the public or private schools in your communities will require that a school curriculum letter is included. The reason for this is that when you work in the schools, there are other regulations that must be followed. If Purdue has a letter from that school stating your effort is part of their curriculum, then the obligations to follow those regulations falls back on the school, and not on Purdue. Approval for any effort you do will be contingent on you furnishing school letters from the teacher, principal, or superintendents of the schools you are working in. Another recent change in the work with youth in the schools is that these efforts can no longer be considered voluntary. It makes sense that if your program is part of the curriculum, then it is not voluntary. We will be watching for that in you applications, and asking you to make that change if you are working with youth in an educational setting. 4-H is included in that definition of an educational setting. There are regulations that cover research in public schools and now there are a number of laws that govern work in schools. Included are the common rule, and common rule-subpart D which governs work with children. Then there are the other laws that affect the schools including, and not limited to, FERPA, the family Education Rights and Privacy Act, and PPRA, the Protection of Pupil Rights Amendment and the No Child Left Behind Act, which is the one that governs surveys containing sensitive issues. PRPA is the law that requires that parents provide written approval before their students take surveys not associated with the curriculum What is important to remember here, is that efforts that you do in the public or private schools in your communities will require that a school curriculum letter is included. The reason for this is that when you work in the schools, there are other regulations that must be followed. If Purdue has a letter from that school stating your effort is part of their curriculum, then the obligations to follow those regulations falls back on the school, and not on Purdue. Approval for any effort you do will be contingent on you furnishing school letters from the teacher, principal, or superintendents of the schools you are working in. Another recent change in the work with youth in the schools is that these efforts can no longer be considered voluntary. It makes sense that if your program is part of the curriculum, then it is not voluntary. We will be watching for that in you applications, and asking you to make that change if you are working with youth in an educational setting. 4-H is included in that definition of an educational setting.

    26. Internet Research Observing On-Line Communications Are they Public or Private? Technical Issues Email is not secure IP Addresses can be used to Identify Subjects Ensure Servers are secure Encrypt Data Storage of data must be protected The internet has much to offer as one plans to gather data. However there are problems and issues unique to the internet environment. When planning to gather data using email or the internet you will need to apply familiar principles and guidelines to a new research medium. Some of the issues that may be of concern to us in Extension is the issue of security with both email and servers, the issues of identity, people being who they say they are, and storage of data. Several counties have applied to use email as a method of sending and receiving surveys. The issue was debated for long time because the identity of the respondent can be identified from the header. The Purdue IRB finally decided that it could be an exempt protocol, because adults had the ability to choose whether they responded or not, and knew, or probably should know, that their header would appear to the receiver. All database storing data must be protected. Encrypting the data is the most secure way to protect it.The internet has much to offer as one plans to gather data. However there are problems and issues unique to the internet environment. When planning to gather data using email or the internet you will need to apply familiar principles and guidelines to a new research medium. Some of the issues that may be of concern to us in Extension is the issue of security with both email and servers, the issues of identity, people being who they say they are, and storage of data. Several counties have applied to use email as a method of sending and receiving surveys. The issue was debated for long time because the identity of the respondent can be identified from the header. The Purdue IRB finally decided that it could be an exempt protocol, because adults had the ability to choose whether they responded or not, and knew, or probably should know, that their header would appear to the receiver. All database storing data must be protected. Encrypting the data is the most secure way to protect it.

    27. Issues with Internet Research Ensuring Comprehension Underage Participants Withdrawal Documenting Consent Privacy Identifiers Breach of Confidentiality Assessing Risks When doing an email or internet survey, how do you ensure that everyone understands and that all your participants are who they say they are. How do you document consent. What about the ability to withdraw from a survey any time the respondent wishes, or the option of not answering some questions. Many on-line surveys won’t allow you to move to the next screen unless you answer all the questions. This is a violation of your rights. And of course the issues of privacy are of utmost importance when using the internet for data collection.When doing an email or internet survey, how do you ensure that everyone understands and that all your participants are who they say they are. How do you document consent. What about the ability to withdraw from a survey any time the respondent wishes, or the option of not answering some questions. Many on-line surveys won’t allow you to move to the next screen unless you answer all the questions. This is a violation of your rights. And of course the issues of privacy are of utmost importance when using the internet for data collection.

    28. Workers Some Argue that Workers are a Vulnerable population Issues of workers as subjects Effects of individual entitlements Impairment of Family Relationships Possible threats to job retention Peer Pressure Constraints to Job Advancement Findings may affect individuals, corporations, unions, government Some argue that workers are a vulnerable population. They are not, at this point, included in the protected classes or vulnerable populations in the law. Workers may experience pressure from supervisors to participate, or not participate, or to respond to a study in a way the employer or union may promote or perceive as advantageous to the organization. Additional vulnerability (job loss, job restriction, health impact) relates to individual or group study findings. The ability to give informed consent may be compromised, diminished, or negated.Some argue that workers are a vulnerable population. They are not, at this point, included in the protected classes or vulnerable populations in the law. Workers may experience pressure from supervisors to participate, or not participate, or to respond to a study in a way the employer or union may promote or perceive as advantageous to the organization. Additional vulnerability (job loss, job restriction, health impact) relates to individual or group study findings. The ability to give informed consent may be compromised, diminished, or negated.

    29. Exempt Research Educational Settings Surveys, Interviews, and Observation of Adults Research on Public Officials Existing Data Federal Govt. Public Benefit Consumer Evaluation/Taste Testing Implied Consent- Voluntary Research may be eligible for exemption if all the activities associated with the research fall into one on six categories. They are: Research conducted in established or commonly accepted educational settings, involving normal educational practices Research involving survey procedures, interview procedures, or observation of public behavior providing that any disclosure or identifiable information outside the research setting would not place the subjects at risk of criminal or court liability or be damaging to the subjects’ financial standing, employability, or reputation. Research on or observation of public officials. Research on existing data Federal government public benefit programs Consumer evaluations and taste testing Let’s talk a minutes about Observations. It’s not something we generally use in Extension, but it could be, and we may use more of it in the future. For IRB purposes, who decides if a setting is public or private? For example, if you were having dinner with your spouse or significant other in a nice restaurant, would you expect someone to eavesdrop on your conversation, or count the number of times you put your fork in your mouth? What if you were at a park, and having a discussion with your teen, would you expect that conversation was private? How about if you are sitting in the stands at your sons’ football game, would you expect your behavior and comments there to be public or private? How about if you are observing the audience at your premier showmanship contest at your fair. Your purpose is to compare the behavior of your fair’s audience to that of a county. Your goal is to show the value of showmanship contests as a family activity. IS this a research project requiring IRB approval? Exempt Research includes the requirement of implied consent. The subjects or participants are aware that they do not have to participate, and may choose to withdraw at any time. Research may be eligible for exemption if all the activities associated with the research fall into one on six categories. They are: Research conducted in established or commonly accepted educational settings, involving normal educational practices Research involving survey procedures, interview procedures, or observation of public behavior providing that any disclosure or identifiable information outside the research setting would not place the subjects at risk of criminal or court liability or be damaging to the subjects’ financial standing, employability, or reputation. Research on or observation of public officials. Research on existing data Federal government public benefit programs Consumer evaluations and taste testing Let’s talk a minutes about Observations. It’s not something we generally use in Extension, but it could be, and we may use more of it in the future. For IRB purposes, who decides if a setting is public or private? For example, if you were having dinner with your spouse or significant other in a nice restaurant, would you expect someone to eavesdrop on your conversation, or count the number of times you put your fork in your mouth? What if you were at a park, and having a discussion with your teen, would you expect that conversation was private? How about if you are sitting in the stands at your sons’ football game, would you expect your behavior and comments there to be public or private? How about if you are observing the audience at your premier showmanship contest at your fair. Your purpose is to compare the behavior of your fair’s audience to that of a county. Your goal is to show the value of showmanship contests as a family activity. IS this a research project requiring IRB approval? Exempt Research includes the requirement of implied consent. The subjects or participants are aware that they do not have to participate, and may choose to withdraw at any time.

    30. Expedited Review No More than Minimal Risk Falls into one of the 9 eligible categories Medical drugs and devices approved by FDA Collection of biological specimens Collection of data from audio, video, or image recording Non-exempt research using surveys, interviews, observations Others Expedited review can be used when there is no more than minimal risk, and the effort falls within the eligible categories of activities. 1) Drugs and devices that have already been approved by the FDA and are not being tested for new uses 2) Blood collection, under clearly regulated conditions 3) Collection of certain biological specimens by noninvasive methods 4) Collection of certain types of medical data by noninvasive means 5) Research on materials that were collected, or will be collected, for non-research purposes 6) Collection of data from voice, video, digital, or image recordings made for the research itself 7) Non-exempt research on individual or group behavior and research using surveys, interviews, observation of public behavior and other types of similar methodologies 8) Certain types of continuing review 9) Minor protocol revisionsExpedited review can be used when there is no more than minimal risk, and the effort falls within the eligible categories of activities. 1) Drugs and devices that have already been approved by the FDA and are not being tested for new uses 2) Blood collection, under clearly regulated conditions 3) Collection of certain biological specimens by noninvasive methods 4) Collection of certain types of medical data by noninvasive means 5) Research on materials that were collected, or will be collected, for non-research purposes 6) Collection of data from voice, video, digital, or image recordings made for the research itself 7) Non-exempt research on individual or group behavior and research using surveys, interviews, observation of public behavior and other types of similar methodologies 8) Certain types of continuing review 9) Minor protocol revisions

    31. Full Review Greater than Minimal Risk Use of a Vulnerable Population Must be present at IRB Committee meeting Continuing Reviews will go back to the full committee for approval Applications requiring Full Committee Review must be received at least ten working days prior to the next scheduled Full Committee meeting. Currently, the Committee meets on the last Tuesday of the month (with the exception of November and December in which case the first Tuesday in December constitutes the November-December meeting). The Committee's practice is to circulate applications requiring Full Review to all Committee members prior to the meeting. Questions, comments or concerns raised by members are transmitted to the principal investigator for response prior to the meeting. To the extent possible, all necessary additional information is made available to the Committee prior to the meeting. To allow for questions raised at the meeting to be promptly addressed, the investigator should plan to attend the Committee meeting. Applications requiring Full Committee Review must be received at least ten working days prior to the next scheduled Full Committee meeting. Currently, the Committee meets on the last Tuesday of the month (with the exception of November and December in which case the first Tuesday in December constitutes the November-December meeting). The Committee's practice is to circulate applications requiring Full Review to all Committee members prior to the meeting. Questions, comments or concerns raised by members are transmitted to the principal investigator for response prior to the meeting. To the extent possible, all necessary additional information is made available to the Committee prior to the meeting. To allow for questions raised at the meeting to be promptly addressed, the investigator should plan to attend the Committee meeting.

    32. Continuing Reviews/Revisions Approval is for 364 Days Continuing Review for Exempt Approval Approximately 10 months after approval Email continuing review form Complete and send back Same process for an Expedited or Full Review Revisions- for all Complete the Revision form for all revisions, Send to IRB who approved

    33. CITI Site for Quiz https://www.citiprogram.org/default.asp Log –in Choose “Purdue Extension Educators” Click on Basic Course Complete Introduction Complete Extension Institutional Page Scroll down to complete the quiz If you pass, download a completion report If not, try again, using the CITI Modules

    37. Extension Exempt Process Complete X-HS-03-1 Attach Instrument and Publicity Send Electronically to DD He/she will Forward to IRB coordinator Reviewed by Extension Human Subjects Comm. Sent to Three Reviewers When all agree, approval is Emailed, with Official notification sent from Director’s office Complete X-HS-03-1 Attach Instrument and Publicity Send Electronically to DD He/she will Forward to IRB coordinator Reviewed by Extension Human Subjects Comm. Sent to Three Reviewers When all agree, approval is Emailed, with Official notification sent from Director’s officeComplete X-HS-03-1 Attach Instrument and Publicity Send Electronically to DD He/she will Forward to IRB coordinator Reviewed by Extension Human Subjects Comm. Sent to Three Reviewers When all agree, approval is Emailed, with Official notification sent from Director’s office

    38. Process for Expedited and Full Reviews Complete Application on IRB website Write a Narrative Describing Research Develop a Consent Form Send to Director’s office to sign as P.I. Will be sent to Purdue IRB for review IRB will review the research component of the project IRB will review and asks for clarification Plan ahead for Questions

    39. Questions???? If you have questions, please contact Janet Bechman, Extension Plan of Work & Accountability Coordinator, jcb@purdue.edu Prepared by Catherine E. Burwell, Ph.D. Extension IRB and Reporting Coordinator ceb@purdue.edu

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