The Submission Process for the Purdue Institutional Review Board

1. The Submission Process for the Purdue Institutional Review Board Purdue University Cooperative Extension Service Spring 2002 The topic for this morning�s training is the Purdue Institutional Review Board and how we in Extension will work with it. You have been hearing a great deal about human subjects and the Institutional Review Board in the last several months, and a number of you have had experience dealing with it. This morning our goal is to acquaint each of you with it so that you will know when and how you will need to work with it. The topic for this morning�s training is the Purdue Institutional Review Board and how we in Extension will work with it. You have been hearing a great deal about human subjects and the Institutional Review Board in the last several months, and a number of you have had experience dealing with it. This morning our goal is to acquaint each of you with it so that you will know when and how you will need to work with it.

2. Introduction IRB History Why Extension is now being asked to comply Deciding if you need IRB Approval The three forms of IRB approval The process you will use Management of your effort once approval is received

3. Historical Perspectives on Human Subjects Research 1946 Nuremberg Doctors� Trial 1960s Thalidomide Tragedy 1932/72 Tuskegee Syphilis Study Historically there are 3 events that have had significant impact on the federal regulations for the protection of human subjects research. The modern era of human subject protection is routinely dated from the promulgation of the Nuremberg Code that resulted from the Nazi doctors� trial where 23 doctors were charged with murder, torture, and other atrocities committed in the name of medical science. A set of standards, called the Nuremberg Code, came out of that trial. It called for informed consent of volunteers, and other issues, such as human experiments based on prior animal research. Another event that played a role in the development of the Federal regulations governing human subject research was the Thalidomide tragedy of the 1960s. Thalidomide was an experimental drug that although not approved by the Food and Drug Administration, doctors often gave samples to patients. Unfortunately, the drug had horrific effects on unborn children. Finally, a study that had been going on since 1932 came to light in 1972. The Tuskegee Syphilis Study was designed to show the need for establishing treatments for the disease, by showing what happens to individuals who go untreated. The study would follow affected individuals for a period of 6-8 months, but instead the study went on for 40 years, denying these subjects treatment, or knowledge of what was going on. Subjects were told that doctors were looking for �bad blood.� Historically there are 3 events that have had significant impact on the federal regulations for the protection of human subjects research. The modern era of human subject protection is routinely dated from the promulgation of the Nuremberg Code that resulted from the Nazi doctors� trial where 23 doctors were charged with murder, torture, and other atrocities committed in the name of medical science. A set of standards, called the Nuremberg Code, came out of that trial. It called for informed consent of volunteers, and other issues, such as human experiments based on prior animal research. Another event that played a role in the development of the Federal regulations governing human subject research was the Thalidomide tragedy of the 1960s. Thalidomide was an experimental drug that although not approved by the Food and Drug Administration, doctors often gave samples to patients. Unfortunately, the drug had horrific effects on unborn children. Finally, a study that had been going on since 1932 came to light in 1972. The Tuskegee Syphilis Study was designed to show the need for establishing treatments for the disease, by showing what happens to individuals who go untreated. The study would follow affected individuals for a period of 6-8 months, but instead the study went on for 40 years, denying these subjects treatment, or knowledge of what was going on. Subjects were told that doctors were looking for �bad blood.�

4. National Research Act Department of Health, Education and Welfare Established the Institutional Review Boards Belmont Report These cases and other similar cases led to federal regulations protecting human subjects in 1974. Under the auspices of the then Department of Health, Education and Welfare, the National Research Act provided for the establishment of the Institutional Review Board as a mechanism through which Human Subjects would be protected. It also established a Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which developed the Belmont Report, which is often considered as one of the cornerstone foundations of Human Subjects research. These cases and other similar cases led to federal regulations protecting human subjects in 1974. Under the auspices of the then Department of Health, Education and Welfare, the National Research Act provided for the establishment of the Institutional Review Board as a mechanism through which Human Subjects would be protected. It also established a Commission for the Protection of Human Subjects of Biomedical and Behavioral Research which developed the Belmont Report, which is often considered as one of the cornerstone foundations of Human Subjects research.

5. Belmont Report Respect for persons Beneficence Justice The Belmont Report set forth the basic ethical principles that should underlie the conduct of research involving human subjects. These principles are: Respect for Persons Beneficence Justice These 3 principles, among those generally accepted in our culture, are now accepted as the three quintessential requirements for the ethical conduct of research involving human subjects. Let�s now turn our attention to the video which will give you a better understanding of these principles. The video was developed by the Office of Human Research Protections in the U.S. Department of Health and Human Services and shows how the principals apply in the resolution of ethical conflicts in research. The Belmont Report set forth the basic ethical principles that should underlie the conduct of research involving human subjects. These principles are: Respect for Persons Beneficence Justice These 3 principles, among those generally accepted in our culture, are now accepted as the three quintessential requirements for the ethical conduct of research involving human subjects. Let�s now turn our attention to the video which will give you a better understanding of these principles. The video was developed by the Office of Human Research Protections in the U.S. Department of Health and Human Services and shows how the principals apply in the resolution of ethical conflicts in research.

6. The Belmont Report: Basic Ethical Principles and Their Application Video VIDEO: The Belmont Report: Basic Ethical Principles and their Application VideoVIDEO: The Belmont Report: Basic Ethical Principles and their Application Video

7. Respect for Persons 2 Ethical convictions Acknowledge autonomy Protect those with diminished autonomy Voluntary participation Possess adequate information Consent forms Let�s take a minute to review the principles, as these are key to our discussion today. Respect for Persons incorporates at least two ethical convictions: 1) Individuals be treated as autonomous agents 2) Persons with diminished autonomy are entitled to protection. Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. In most cases, respect for persons demands that subjects enter into the research voluntarily and with adequate information. Thus the consent forms become a requirement when working with vulnerable audiences. Let�s take a minute to review the principles, as these are key to our discussion today. Respect for Persons incorporates at least two ethical convictions: 1) Individuals be treated as autonomous agents 2) Persons with diminished autonomy are entitled to protection. Respect for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. In most cases, respect for persons demands that subjects enter into the research voluntarily and with adequate information. Thus the consent forms become a requirement when working with vulnerable audiences.

8. Beneficence Keeping individuals from harm Is the person embarrassed? Does the person feel coerced to answer? What are the repercussions if they decline to participate? The second guiding principle is Beneficence which entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Harm may come in very subtle ways that we may not even consider. Such things as: Is the person embarrassed by one of the questions? Does the person feel coerced to answer this survey? What are the repercussions if they decline to participate? The second guiding principle is Beneficence which entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Harm may come in very subtle ways that we may not even consider. Such things as: Is the person embarrassed by one of the questions? Does the person feel coerced to answer this survey? What are the repercussions if they decline to participate?

9. Do Not Harm! Would the answer jeopardize The participant�s job? Financial standing? Ability to get insurance? Would they suffer any stigma if word got out? Maximize benefits and minimize harms Think of your survey questions, your evaluation instrument, or your interview questions, and ask yourself, �Are any of the questions ones that, if something happened, and the responses were made public, would: the answer to any of these questions jeopardize the participant�s financial standing or ability to get insurance? Would the individual suffer any stigmatism if the responses were not kept confidential? Always keep in mind that our goal is to maximize the benefits and minimize the harms. Said another way, the benefits are, in most cases, the information we receive, while the harms are any risks that may come to the respondents from participating. Think of your survey questions, your evaluation instrument, or your interview questions, and ask yourself, �Are any of the questions ones that, if something happened, and the responses were made public, would: the answer to any of these questions jeopardize the participant�s financial standing or ability to get insurance? Would the individual suffer any stigmatism if the responses were not kept confidential? Always keep in mind that our goal is to maximize the benefits and minimize the harms. Said another way, the benefits are, in most cases, the information we receive, while the harms are any risks that may come to the respondents from participating.

10. Justice Fairness in distribution Inclusion Exclusion Are subjects included because of: Ease of availability? A compromised position? Consider issues of: Gender Age Ethnicity Justice requires that the benefits and burdens of research be distributed fairly. To explain the concept of justice further, consider that the selection of research subjects needs to be done in a fair and equitable manner. Are subjects being included because of their: Ease of availability? Their compromised position? Justice requires that when planning a research effort you will consider issues of: Gender Age Ethnicity And plan your effort so these groups will be as fairly represented as possible. Justice requires that the benefits and burdens of research be distributed fairly. To explain the concept of justice further, consider that the selection of research subjects needs to be done in a fair and equitable manner. Are subjects being included because of their: Ease of availability? Their compromised position? Justice requires that when planning a research effort you will consider issues of: Gender Age Ethnicity And plan your effort so these groups will be as fairly represented as possible.

11. Law Changes in 1996 Initially investigator determined need for IRB review New federal regulations for exempt research Now all research must go to IRB even to receive an exempt approval Things were a lot easier for researchers in the early years of the human subjects legislation. Up until 1996, it was the researcher's job to determine if his data-gathering project was considered research, and whether or not it needed to be reviewed by an IRB. However, in 1996, the Federal government agreed on 6 categories of research that would be exempt from federal regulations, and decided the Institutional Review Boards would make the determination if a study was exempt from federal regulations or not. What this means is that the Institutional Review Board must review all data-gathering efforts being conducted for any reason other than educational program improvement, and carried out by anyone employed by the University, or conducting research using university funds. Principal Investigators who believe they are doing exempt research must still fill out a one-page form and send it to the human subjects committee to receive their approval for exemption. Things were a lot easier for researchers in the early years of the human subjects legislation. Up until 1996, it was the researcher's job to determine if his data-gathering project was considered research, and whether or not it needed to be reviewed by an IRB. However, in 1996, the Federal government agreed on 6 categories of research that would be exempt from federal regulations, and decided the Institutional Review Boards would make the determination if a study was exempt from federal regulations or not. What this means is that the Institutional Review Board must review all data-gathering efforts being conducted for any reason other than educational program improvement, and carried out by anyone employed by the University, or conducting research using university funds. Principal Investigators who believe they are doing exempt research must still fill out a one-page form and send it to the human subjects committee to receive their approval for exemption.

12. The Environment has Changed Universities are being audited for compliance Extension systems included At Purdue Compliance is a priority All university staff and resources will comply Many of you are probably still asking yourself what all this has to do with you and your programs. We never did anything like this before, and so much of what they are asking seems irrelevant to our work. Well, times have changed my friends, and we have no choice but to change with them. Since the changes in the laws in 1996, the federal government has gone around the country and audited universities to make sure they are in compliance. Some of you may have heard of the shutdowns in all university research that occurred at John Hopkins university, and at Brown University. Just recently The University of Wisconsin was audited and their Extension system took quite a beating. At Purdue we have a new President. Dr. Jische made it a priority that all interests associated with the university will be in compliance with the Institutional Review Board regulations. There are no options here. We will comply. We have been working diligently with the IRB staff to sort through when and how our Extension programs fit into the requirements, and what we will share with you today are the rules as they apply today. That is not to say that there may be some fine-tuning and changes in the future as we learn more, but these are what we know to be the rules. We�ve developed a set of questions that you should ask yourself when trying to determine if an approval from the IRB is required for your project. Many of you are probably still asking yourself what all this has to do with you and your programs. We never did anything like this before, and so much of what they are asking seems irrelevant to our work. Well, times have changed my friends, and we have no choice but to change with them. Since the changes in the laws in 1996, the federal government has gone around the country and audited universities to make sure they are in compliance. Some of you may have heard of the shutdowns in all university research that occurred at John Hopkins university, and at Brown University. Just recently The University of Wisconsin was audited and their Extension system took quite a beating. At Purdue we have a new President. Dr. Jische made it a priority that all interests associated with the university will be in compliance with the Institutional Review Board regulations. There are no options here. We will comply. We have been working diligently with the IRB staff to sort through when and how our Extension programs fit into the requirements, and what we will share with you today are the rules as they apply today. That is not to say that there may be some fine-tuning and changes in the future as we learn more, but these are what we know to be the rules. We�ve developed a set of questions that you should ask yourself when trying to determine if an approval from the IRB is required for your project.

13. Question 1 �Are You Using Human Subjects? Are you dealing with human subjects? Living individual Obtain data through: Intervention Interaction Private information The first question to ask yourself is, �Does my effort involve human subjects?� Probably in the vast majority of cases your answer to this is going to be YES, so depending on how you answer the next couple of questions, you effort may be subject to review by the IRB. If you won�t be using human subjects, you can stop right here! However, be aware that if you are doing research on animals, there is a university animal review process that you must go through. Just so we are clear on this�. A human subject is defined as a living individual about whom an investigator conducting research obtains data through intervention, interaction, or identifiable private information. Interventions can be: a) invasive or noninvasive procedures b) manipulations of the subject�s environment, or c) voice or image recordings Interactions can be through: a) communications b) interpersonal contact c) interviews, or d) surveys Private identifiable information is any information that may link a person to the data. It can be obtained, received, or possessed directly or indirectly, even when it is coded. The first question to ask yourself is, �Does my effort involve human subjects?� Probably in the vast majority of cases your answer to this is going to be YES, so depending on how you answer the next couple of questions, you effort may be subject to review by the IRB. If you won�t be using human subjects, you can stop right here! However, be aware that if you are doing research on animals, there is a university animal review process that you must go through. Just so we are clear on this�. A human subject is defined as a living individual about whom an investigator conducting research obtains data through intervention, interaction, or identifiable private information. Interventions can be: a) invasive or noninvasive procedures b) manipulations of the subject�s environment, or c) voice or image recordings Interactions can be through: a) communications b) interpersonal contact c) interviews, or d) surveys Private identifiable information is any information that may link a person to the data. It can be obtained, received, or possessed directly or indirectly, even when it is coded.

14. Question 2 � What is the Purpose of the Information? Are you doing research or evaluation? Research is: �Systematic investigation� �Contribute to generalizable knowledge� Published outside of system Impact statements Conference presentations or posters Journal article OK, since you more than likely answered �YES� to the first question, the next one to ask yourself when trying to decide if you need to seek approval for your evaluation efforts is, �Why am I gathering this information?� Are you conducting research? Research is defined (for these purposes) by the Department of Health and Human Services as a �Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.� Now, that�s a pretty lofty definition, and for most of us, we probably would simply dismiss it with a resounding �NO,� and go on with our busy schedules. But, as employees of the University, we aren�t allowed that luxury, so to help you better determine if your effort is research or evaluation, test it by these guidelines. How will you use the information that you receive from the effort? Do you have any plans to use the information outside of our normal Extension system? Do you plan to turn the results of your effort into an Impact Statement? Will this be something that you will develop into a presentation or a poster session for an upcoming national or regional meeting of educators or other professionals? Will you take the results of this effort and write a Journal of Extension, or any other journal article with it? If you answered YES, to any of these questions, then you are conducting research, and you will be required to seek approval from the Purdue IRB. OK, since you more than likely answered �YES� to the first question, the next one to ask yourself when trying to decide if you need to seek approval for your evaluation efforts is, �Why am I gathering this information?� Are you conducting research? Research is defined (for these purposes) by the Department of Health and Human Services as a �Systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.� Now, that�s a pretty lofty definition, and for most of us, we probably would simply dismiss it with a resounding �NO,� and go on with our busy schedules. But, as employees of the University, we aren�t allowed that luxury, so to help you better determine if your effort is research or evaluation, test it by these guidelines. How will you use the information that you receive from the effort? Do you have any plans to use the information outside of our normal Extension system? Do you plan to turn the results of your effort into an Impact Statement? Will this be something that you will develop into a presentation or a poster session for an upcoming national or regional meeting of educators or other professionals? Will you take the results of this effort and write a Journal of Extension, or any other journal article with it? If you answered YES, to any of these questions, then you are conducting research, and you will be required to seek approval from the Purdue IRB.

15. Research or Evaluation? Evaluation is: Used for planning To improve the quality of the program To assess the value of the program Not intended to be replicated Not generalized beyond the program site Much of our work is program evaluation. If we are collecting information to: A) Inform the participants in the study, or B) To improve the quality of the program, or C) To assess the value of the program or services The design of these evaluation efforts are not intended to be replicated in other settings, nor are we planning them to be generalized to larger populations beyond our local site. These kinds of efforts are program evaluation and will not require approval from the IRB. However, if we are collecting data on a local program effort that we plan to broadly circulate to the general public through presentations, newspaper articles, or by publishing a research paper, or impact statement, then you will be required to gain IRB approval. Much of our work is program evaluation. If we are collecting information to: A) Inform the participants in the study, or B) To improve the quality of the program, or C) To assess the value of the program or services The design of these evaluation efforts are not intended to be replicated in other settings, nor are we planning them to be generalized to larger populations beyond our local site. These kinds of efforts are program evaluation and will not require approval from the IRB. However, if we are collecting data on a local program effort that we plan to broadly circulate to the general public through presentations, newspaper articles, or by publishing a research paper, or impact statement, then you will be required to gain IRB approval.

16. Question 3- Who are Your Participants? Will you be working with vulnerable audiences? Pregnant women Prisoners Youth under 18 Elderly or nursing home residents Other institutionalized individuals There is one more question that will quickly help you determine if you need to seek approval from the IRB for your efforts. That question deals with whether or not you will be working with a �vulnerable audience.� The federal government has defined a number of audiences as �vulnerable� for human subjects research because they may not be in a position to understand that their participation is strictly voluntary and/or the implications of their participation or responses. If you are doing any work with: Pregnant Women Prisoners Children under 18 Elderly, or nursing home residents, or Other institutionalized individuals Then your work is required to have IRB approval, and you will need to complete the application process. There is one more question that will quickly help you determine if you need to seek approval from the IRB for your efforts. That question deals with whether or not you will be working with a �vulnerable audience.� The federal government has defined a number of audiences as �vulnerable� for human subjects research because they may not be in a position to understand that their participation is strictly voluntary and/or the implications of their participation or responses. If you are doing any work with: Pregnant Women Prisoners Children under 18 Elderly, or nursing home residents, or Other institutionalized individuals Then your work is required to have IRB approval, and you will need to complete the application process.

17. Children Tests to see what they have learned are exempt Surveys, interviews, or observations of behavior of children are subject to review All efforts in a school will require letters from the school One word of clarification about children is required here. If you are doing an educational program with children, and want to know what they have learned from your presentation, this is considered an educational test, and you are able to carry on this type of program evaluation without IRB approval. However, if you are surveying, interviewing, or observing them about likes or dislikes, especially anything of a sensitive nature, then an expedited or full review is required. If you are doing any work in a school with a class or with a large number of the students, you will be required to furnish the IRB with a letter from the school system stating that your efforts are part of the school curriculum. A good example is the annual Ag Day programs many of you host with 4th and 5th graders. You may, depending on the kind of program you are doing, want to consider just giving any program evaluation forms to the teachers you are working with. Have them distribute them to the students, and tally them, and then share the results with you. If this works for the kinds of programs you do with the schools, you may not have to seek IRB approval, but you will need to weigh this alternative with the way you want to use the information you gain. One word of clarification about children is required here. If you are doing an educational program with children, and want to know what they have learned from your presentation, this is considered an educational test, and you are able to carry on this type of program evaluation without IRB approval. However, if you are surveying, interviewing, or observing them about likes or dislikes, especially anything of a sensitive nature, then an expedited or full review is required. If you are doing any work in a school with a class or with a large number of the students, you will be required to furnish the IRB with a letter from the school system stating that your efforts are part of the school curriculum. A good example is the annual Ag Day programs many of you host with 4th and 5th graders. You may, depending on the kind of program you are doing, want to consider just giving any program evaluation forms to the teachers you are working with. Have them distribute them to the students, and tally them, and then share the results with you. If this works for the kinds of programs you do with the schools, you may not have to seek IRB approval, but you will need to weigh this alternative with the way you want to use the information you gain.

18. Question 4 - Are theParticipants at Risk? Are you collecting sensitive information? Are subjects at risk of: Criminal or civil liability? Damage to financial standing? Employability? Reputation? Next you will want to ask if you are asking any sensitive information. Do any of your questions include information that, if it were to be made public would place any one at risk? Would someone possibly be in danger of criminal or civil liability, or could the information damage their financial standing or their employability? Or, if anything from your effort were leaked would a participant potentially be embarrassed, or could anything cause damage to their reputation? If the answer to any of these questions is �YES�, then you will need to send your effort through to the IRB for approval. Next you will want to ask if you are asking any sensitive information. Do any of your questions include information that, if it were to be made public would place any one at risk? Would someone possibly be in danger of criminal or civil liability, or could the information damage their financial standing or their employability? Or, if anything from your effort were leaked would a participant potentially be embarrassed, or could anything cause damage to their reputation? If the answer to any of these questions is �YES�, then you will need to send your effort through to the IRB for approval.

19. Question 5- Is Your Effort Voluntary and Anonymous? Participation is totally voluntary No identifying information is included Social Security Numbers Names, addresses for follow -ups Data is reported in way to assure anonymity Probably two of the biggest points to consider when evaluating your effort, is whether or not participation is voluntary, and whether the results are anonymous. The federal guidelines are designed to ensure that no one participates in research efforts that they do not want to take part in, and therefore it is vitally important that our participants know that completion of our evaluations are voluntary. This may not be much of an issue in many of our programs, but it does become important in situations where you may be working with students who feel a grade may be based on their participation, or when you are working with court-mandated audiences where they may feel their participation is not voluntary. Or you may be working with audiences that may not understand English well enough to understand instructions or the explanation of the consent form. The other issue of vital importance to the IRB is that there is no tracking information on your evaluation instrument. Such things as social security numbers, names, addresses, and other identifiers send up �red flags� to the IRB. They will want to know that this information will not be used to identify any participant, and that all data will be reported in such a way that a person�s identity is impenetrably disguised in any report that you may make. Probably two of the biggest points to consider when evaluating your effort, is whether or not participation is voluntary, and whether the results are anonymous. The federal guidelines are designed to ensure that no one participates in research efforts that they do not want to take part in, and therefore it is vitally important that our participants know that completion of our evaluations are voluntary. This may not be much of an issue in many of our programs, but it does become important in situations where you may be working with students who feel a grade may be based on their participation, or when you are working with court-mandated audiences where they may feel their participation is not voluntary. Or you may be working with audiences that may not understand English well enough to understand instructions or the explanation of the consent form. The other issue of vital importance to the IRB is that there is no tracking information on your evaluation instrument. Such things as social security numbers, names, addresses, and other identifiers send up �red flags� to the IRB. They will want to know that this information will not be used to identify any participant, and that all data will be reported in such a way that a person�s identity is impenetrably disguised in any report that you may make.

20. Procedures That IRB May Question Pre � post tests Demographic information Names and addresses Social security numbers Follow-up contacts Video or audio taping There are also several indicators you will want to keep in mind when you design an evaluation instrument. Use of any of the following are triggers that may cause the IRB to Question if you are assuring a voluntary and anonymous program effort. If you use: Pre post tests Demographic information Names and addresses Social Security Numbers Follow-up Contacts Video or audio taping Even if it is used with adults and for program evaluation only, you will need to complete the appropriate IRB paperwork. If you have any concerns about the design of your instrument, or just want to ensure that your questions will get you useful information, consider talking it over with the appropriate specialist who works in that area. Hopefully, in the next few months we will have established a good database of questions you can draw from when designing your evaluation instruments, which will also help you with this. There are also several indicators you will want to keep in mind when you design an evaluation instrument. Use of any of the following are triggers that may cause the IRB to Question if you are assuring a voluntary and anonymous program effort. If you use: Pre post tests Demographic information Names and addresses Social Security Numbers Follow-up Contacts Video or audio taping Even if it is used with adults and for program evaluation only, you will need to complete the appropriate IRB paperwork. If you have any concerns about the design of your instrument, or just want to ensure that your questions will get you useful information, consider talking it over with the appropriate specialist who works in that area. Hopefully, in the next few months we will have established a good database of questions you can draw from when designing your evaluation instruments, which will also help you with this.

21. Question 6 � What is the Funding Source? Information collected for work funded by Grants Contracts Collaborative efforts with other agencies Requires proper completion of transmittal slip Copy of grant proposal When you are working with an outside grant, contract, or funds from a collaborative effort with other agencies or organizations, then you are going to need to have your effort approved by the IRB. This will require that you properly complete the Purdue Transmittal slip that asks about Human Subjects protection. You will also be asked to furnish the IRB a copy of your grant proposal in the package of information that you send to them When you are working with an outside grant, contract, or funds from a collaborative effort with other agencies or organizations, then you are going to need to have your effort approved by the IRB. This will require that you properly complete the Purdue Transmittal slip that asks about Human Subjects protection. You will also be asked to furnish the IRB a copy of your grant proposal in the package of information that you send to them

22. Purdue UniversityGrant Transmittal Slip Transmittal Slip Box for Human Subjects This is the question and the information that you need to supply when filling out the Purdue Grants transmittal slip. 27 Will human subjects be used in this project Yes No If �yes�, has approval been obtained from the University Human Subjects Committee? In Review No Yes, Approval #_________ Date Approved:__________ If �yes�, List the title of the Protocol, Note: If the title has changed, please notify the committee. Transmittal Slip Box for Human Subjects This is the question and the information that you need to supply when filling out the Purdue Grants transmittal slip. 27 Will human subjects be used in this project Yes No If �yes�, has approval been obtained from the University Human Subjects Committee? In Review No Yes, Approval #_________ Date Approved:__________ If �yes�, List the title of the Protocol, Note: If the title has changed, please notify the committee.

23. Question 7 � Has This Effort been Previously Approved? Has this effort received approval by specialists? Check it out https://www.extension.purdue.edu/intranet Letter giving permission to use Must follow protocol exactly Notify the PI of any changes, mishaps Report number of participants Finally, you need to ask your self if this program may have received approval earlier from state specialists. If it is a long standing program that is used throughout the state, then chances are good that it already has IRB approval. You can find out if your program has been approved by visiting the Extension Intranet web site at http: If your program is listed there, then you need to contact the person who is listed as the Principal Investigator and ask for permission to use the program. Remember it must be used exactly as the protocol states. You cannot add additional instruments, and you must use them in the manner that was approved. You will need to send the Principal Investigator a letter addressed to you that he/she will sign. The letter will state that you intend to furnish them a complete listing of all the numbers of participants you had in the programs, and that you will follow the protocol exactly as it was approved. You will also notify them of any problems that occur that may cause deviations from the approved protocol. You will keep this letter in a file in your office with all the other information you have about the program effort including the subjects� instruments, your tally sheets, all recruitment information, and all reports that are generated as a result of the effort. Finally, you need to ask your self if this program may have received approval earlier from state specialists. If it is a long standing program that is used throughout the state, then chances are good that it already has IRB approval. You can find out if your program has been approved by visiting the Extension Intranet web site at http: If your program is listed there, then you need to contact the person who is listed as the Principal Investigator and ask for permission to use the program. Remember it must be used exactly as the protocol states. You cannot add additional instruments, and you must use them in the manner that was approved. You will need to send the Principal Investigator a letter addressed to you that he/she will sign. The letter will state that you intend to furnish them a complete listing of all the numbers of participants you had in the programs, and that you will follow the protocol exactly as it was approved. You will also notify them of any problems that occur that may cause deviations from the approved protocol. You will keep this letter in a file in your office with all the other information you have about the program effort including the subjects� instruments, your tally sheets, all recruitment information, and all reports that are generated as a result of the effort.

24. Question 8- How Will You Use the Information? Publish in written or oral forms WWW site News releases Journal article Public Forum Provide program accountability Used solely within Extension system Program improvements The final question you will want to ask your self, and this probably one of the most important. How will you use the information? Will the information be used for presentation on a WWW site, or in news releases designed to show Extension Impact? Will you: write an impact statement of this program that may be distributed by the university to much larger audiences? Will you use the information to publish a journal article, or in a bulletin, or will you propose a presentation or poster session at a professional meeting with this information.? If the answer to any of these questions is YES, then you will need to apply for IRB approval. Keep in mind that if you at first decide that you will not do any of these things, but then through the course of your effort, it seems appropriate to carry through with one of the about programs, then you are required to go back and seek approval after the effort has taken place. If, however, you will only use the information internally within the Extension system, or for improvements to the next year�s programs, or to recruit audiences for the following year, then your program is considered strictly program evaluation and accountability and you will not be required to seek IRB approval. The final question you will want to ask your self, and this probably one of the most important. How will you use the information? Will the information be used for presentation on a WWW site, or in news releases designed to show Extension Impact? Will you: write an impact statement of this program that may be distributed by the university to much larger audiences? Will you use the information to publish a journal article, or in a bulletin, or will you propose a presentation or poster session at a professional meeting with this information.? If the answer to any of these questions is YES, then you will need to apply for IRB approval. Keep in mind that if you at first decide that you will not do any of these things, but then through the course of your effort, it seems appropriate to carry through with one of the about programs, then you are required to go back and seek approval after the effort has taken place. If, however, you will only use the information internally within the Extension system, or for improvements to the next year�s programs, or to recruit audiences for the following year, then your program is considered strictly program evaluation and accountability and you will not be required to seek IRB approval.

25. Types of Reviews Exempt - (Administrative) Expedited Full When applying for approval from the IRB, you will apply in one of three categories. Most all of the kinds of data-gathering activities carried out in Extension will be eligible for an Exempt review. However a number of programs, especially those that are directed at some of the vulnerable population groups will be required to have an expedited or full review. We�ll discuss what�s involved in each of these next. When applying for approval from the IRB, you will apply in one of three categories. Most all of the kinds of data-gathering activities carried out in Extension will be eligible for an Exempt review. However a number of programs, especially those that are directed at some of the vulnerable population groups will be required to have an expedited or full review. We�ll discuss what�s involved in each of these next.

26. Exempt Reviews Research in normal educational settings Research using educational tests Surveys or interviews with adults Taste testing Most all Extension activities will fall into the Exempt review category. We evaluate many of our programs, mostly for program evaluation and improvement, which requires no submission thorough the IRB. But when those activities will be added into state or multi-county efforts, or if the programs will be published outside the system, then these program evaluations become research and are subject to the IRB process. There are 6 categories of research that will receive exempt review status from the IRB. The four that we are most concerned with are: Research in normal educational settings Research using educational tests Surveys or interviews with adults Taste testing Two other categories that Extension does not work with often are: Archived data collected by ethical means, and Observation of public officials The first two categories, research in normal educational settings, and research using educational tests can involve children and still be an exempt review. However, when your effort involves surveys, interviews, or observation of public behavior of children, then it is not covered under the exempt review process and will require either an expedited or full review. DON�T GET CONFUSED BY THE TERMINOLOGY! Just because the IRB uses the term Exempt, that does not mean that you do not have to go through the process of completing the forms and having IRB review them. Remember it this way, you cannot decide if an effort that fits into one of these categories is exempt, you must first send it to the IRB committee, and they will tell you if it is exempt. Most all Extension activities will fall into the Exempt review category. We evaluate many of our programs, mostly for program evaluation and improvement, which requires no submission thorough the IRB. But when those activities will be added into state or multi-county efforts, or if the programs will be published outside the system, then these program evaluations become research and are subject to the IRB process. There are 6 categories of research that will receive exempt review status from the IRB. The four that we are most concerned with are: Research in normal educational settings Research using educational tests Surveys or interviews with adults Taste testing Two other categories that Extension does not work with often are: Archived data collected by ethical means, and Observation of public officials The first two categories, research in normal educational settings, and research using educational tests can involve children and still be an exempt review. However, when your effort involves surveys, interviews, or observation of public behavior of children, then it is not covered under the exempt review process and will require either an expedited or full review. DON�T GET CONFUSED BY THE TERMINOLOGY! Just because the IRB uses the term Exempt, that does not mean that you do not have to go through the process of completing the forms and having IRB review them. Remember it this way, you cannot decide if an effort that fits into one of these categories is exempt, you must first send it to the IRB committee, and they will tell you if it is exempt.

27. Exempt Reviews, cont. Form X-HS-03-1 Director as Principal Investigator Educators and others involved in the effort? What is your project? How will you recruit your subjects? Who are they, and how many are there? Ways you will assure the effort is voluntary? Ways you will assure anonymity? What will you do with the results? An exempt review will require completion of form HS-96/4. It is a one-page form that will ask for: The Director listed as PI Educators involved in the effort what your project is, how you will recruit your subjects, who they are, and how many there are, the ways you will assure that the effort is voluntary, the ways you will assure anonymity What you will do with the results. You will complete this form, attach your instruments, and supporting information and send to the appropriate Program Leader�s office. They will review your evaluation instruments for accuracy and then pass them on to the Director�s office. You will only need the original copy of the form. An exempt review will require completion of form HS-96/4. It is a one-page form that will ask for: The Director listed as PI Educators involved in the effort what your project is, how you will recruit your subjects, who they are, and how many there are, the ways you will assure that the effort is voluntary, the ways you will assure anonymity What you will do with the results. You will complete this form, attach your instruments, and supporting information and send to the appropriate Program Leader�s office. They will review your evaluation instruments for accuracy and then pass them on to the Director�s office. You will only need the original copy of the form.

28. Expedited Reviews Moderate exercise programs Most psychology-like experiments Surveys or interviews with minors Subjects can be identified Voice recordings �Risk that is not above that of daily life� Your application will require an expedited review when you are planning: To use voice recordings or video recordings of your effort, If you may be involved in moderate exercise programs, Your effort involves psychology-types surveys, interviews, or observations When you are working with youth under 18 and using surveys, interviews or observations. Subjects can be identified Basically anytime your effort will present no more than minimal risk to the subjects you can apply for an expedited review. By minimal risk, they mean the probability of harm or discomfort anticipated is no more than that encountered in daily life. Your application will require an expedited review when you are planning: To use voice recordings or video recordings of your effort, If you may be involved in moderate exercise programs, Your effort involves psychology-types surveys, interviews, or observations When you are working with youth under 18 and using surveys, interviews or observations. Subjects can be identified Basically anytime your effort will present no more than minimal risk to the subjects you can apply for an expedited review. By minimal risk, they mean the probability of harm or discomfort anticipated is no more than that encountered in daily life.

29. Expedited Reviews Complete Reviewed Research Form Application narrative Consent forms All supporting materials Evaluation instruments Original copy When seeking an expedited review from the IRB you will want to furnish them with: Completed HS-3 Application Narrative Consent forms All supporting materials Evaluation Instruments Original copy � Although the IRB requires that the original and two copies be furnished for an expedited review, those extra copies will be made by the Director�s office. That will safe you the extra cost of mailing extra copies to the campus. Say thank you to Dave next time you see him. When seeking an expedited review from the IRB you will want to furnish them with: Completed HS-3 Application Narrative Consent forms All supporting materials Evaluation Instruments Original copy � Although the IRB requires that the original and two copies be furnished for an expedited review, those extra copies will be made by the Director�s office. That will safe you the extra cost of mailing extra copies to the campus. Say thank you to Dave next time you see him.

30. Full Reviews Research that involves more than minimal risk Any research that involves vulnerable groups Get application package in early When you are working with one of the vulnerable groups we talked about, or if your effort will involve more than minimal risk to the individuals involved, you will need to submit an application for full review. This means that you will complete form HS 3, write an application narrative, attach all your instruments, consent forms, and supporting materials. Again you will only need to send the original copy of the form and all supporting documents. A full review requires the original and 24 copies, but these will be furnished by the director�s office. The IRB meets on the last Tuesday of the month, and requires that they have applications in hand two weeks prior to that date. This means that you will want to get them in early. They will need to go through all our internal Extension reviews prior to the 2nd Tuesday of the month, so that the Director�s office can sign them, make the copies and get them over in time for the IRB deadline. Realistically, if you want your effort to gain IRB approval at the end of a particular month, then you probably want to get your application package to the campus around the first of the month, so it can be reviewed first by your program leader and then reviewed and signed by the Director. With meetings, and all that our administrators have to do, giving them an extra week up front will be to your advantage. When you are working with one of the vulnerable groups we talked about, or if your effort will involve more than minimal risk to the individuals involved, you will need to submit an application for full review. This means that you will complete form HS 3, write an application narrative, attach all your instruments, consent forms, and supporting materials. Again you will only need to send the original copy of the form and all supporting documents. A full review requires the original and 24 copies, but these will be furnished by the director�s office. The IRB meets on the last Tuesday of the month, and requires that they have applications in hand two weeks prior to that date. This means that you will want to get them in early. They will need to go through all our internal Extension reviews prior to the 2nd Tuesday of the month, so that the Director�s office can sign them, make the copies and get them over in time for the IRB deadline. Realistically, if you want your effort to gain IRB approval at the end of a particular month, then you probably want to get your application package to the campus around the first of the month, so it can be reviewed first by your program leader and then reviewed and signed by the Director. With meetings, and all that our administrators have to do, giving them an extra week up front will be to your advantage.

31. Timelines Exempt Review Approval 10 to 14 Days Expedited Review 7 to 10 Days Full Review To IRB by 2nd Tuesday Committee meets the last Tuesday Plan to attend the IRB meeting Let�s take a minute to review the deadlines for approval of the different reviews, so you can start planning when your forms must be on the campus. In most cases, an IRB approval for an Exempt review takes about 7-10 days. This is the time required for notification of approval from the time the application package is received in the IRB office. You will want to add another 3-5 days to that for your application to be reviewed and approved by your Program Leader and the Director. Much of the time, it won�t take that long, but with as busy as administrators are, it is wisest to allow the extra time. The same time frame is required for an Expedited review. These reviews are done by a subgroup of the full committee, and can usually be handled in the same 7-10 day format once they reach the IRB office. Again, you will want to add additional time for review by your program leader and the director. In the case of a full review, the application must be in the IRB office at least 2 weeks prior to the last Tuesday of the month, so for most months, that is the 2nd Tuesday. Your application will also need to be reviewed by your program leader and the Director�s office, so to be safe, you will probably want to add another 7-10 days to that, making arrival on the campus around the first of the month a good time to shoot for. Be aware, that if your project requires a full IRB review you will want to clear your calendar to attend the IRB meeting on the last Tuesday of the month. Presently these meetings take place at 10:30 in the morning. Let�s take a minute to review the deadlines for approval of the different reviews, so you can start planning when your forms must be on the campus. In most cases, an IRB approval for an Exempt review takes about 7-10 days. This is the time required for notification of approval from the time the application package is received in the IRB office. You will want to add another 3-5 days to that for your application to be reviewed and approved by your Program Leader and the Director. Much of the time, it won�t take that long, but with as busy as administrators are, it is wisest to allow the extra time. The same time frame is required for an Expedited review. These reviews are done by a subgroup of the full committee, and can usually be handled in the same 7-10 day format once they reach the IRB office. Again, you will want to add additional time for review by your program leader and the director. In the case of a full review, the application must be in the IRB office at least 2 weeks prior to the last Tuesday of the month, so for most months, that is the 2nd Tuesday. Your application will also need to be reviewed by your program leader and the Director�s office, so to be safe, you will probably want to add another 7-10 days to that, making arrival on the campus around the first of the month a good time to shoot for. Be aware, that if your project requires a full IRB review you will want to clear your calendar to attend the IRB meeting on the last Tuesday of the month. Presently these meetings take place at 10:30 in the morning.

32. Consent Forms Expedited or Full Reviews Follow Purdue template www.purdue.edu/Research/ORA/humans/ humans-main.shtml What to include: All efforts that will be submitted for an expedited or full review will require that you attach a Consent form to the application. The consent form should follow the Purdue template that is located on the IRB web site, and a copy is included in your handout materials. The consent form is designed to ensure that all participants fully understand what the project is, and that their participation is voluntary. Yow will want to include: Program title Investigators Purpose of study Procedures Confidentiality Compensation for Injury Voluntary Participation Who to contact Signatures All efforts that will be submitted for an expedited or full review will require that you attach a Consent form to the application. The consent form should follow the Purdue template that is located on the IRB web site, and a copy is included in your handout materials. The consent form is designed to ensure that all participants fully understand what the project is, and that their participation is voluntary. Yow will want to include: Program title Investigators Purpose of study Procedures Confidentiality Compensation for Injury Voluntary Participation Who to contact Signatures

33. Extension Process for County Educators Complete appropriate form and attach all supporting documents E-mail to District Director, CED Let� s talk about the process that County Extension Staff will use to receive IRB approval for their data-gathering efforts. Please be aware that this is the process that county staff will use. Extension Specialists will use their departmental system for working with the Institutional Review Board. In planning your evaluation you may wish to contact the appropriate specialist for help in developing Fill out appropriate form and attach all supporting documents E-mail to district directo Let� s talk about the process that County Extension Staff will use to receive IRB approval for their data-gathering efforts. Please be aware that this is the process that county staff will use. Extension Specialists will use their departmental system for working with the Institutional Review Board. In planning your evaluation you may wish to contact the appropriate specialist for help in developing Fill out appropriate form and attach all supporting documents E-mail to district directo

34. Extension Process for County Educators Program Leaders will review data-gathering instruments Help you with needed revisions Forward to Director�s Office Director's Office will review, sign and send to IRB Upon IRB notice, Director will notify educator, Program Leader Extension Process for County Educators, cont. 4. Program Leaders will review data-gathering instruments Help you with needed revisions Forward to Director�s Office Director's Office will review, sign and send to IRB. 6. Upon IRB notice, Director will notify educator, program leader and district director Extension Process for County Educators, cont. 4. Program Leaders will review data-gathering instruments Help you with needed revisions Forward to Director�s Office Director's Office will review, sign and send to IRB. 6. Upon IRB notice, Director will notify educator, program leader and district director

35. Approval Good for 1 year from date of IRB approval Send notification near expiration date, asking for status If effort is ongoing, renewal of effort can be requested Federal regulations require that Human Subjects approval be given for no longer than a 12-month period. Close to the Expiration date of your project, the Director will receive a Surveillance form which seeks information on the status of the effort. The questions range from the number of subjects tested, to changes in the protocol and a report of research findings. It may also request additional materials. It will ask you whether the effort is on-going or has been terminated. Once the completed form is returned to the IRB with supporting information, a renewed approval can by generated. Federal regulations require that Human Subjects approval be given for no longer than a 12-month period. Close to the Expiration date of your project, the Director will receive a Surveillance form which seeks information on the status of the effort. The questions range from the number of subjects tested, to changes in the protocol and a report of research findings. It may also request additional materials. It will ask you whether the effort is on-going or has been terminated. Once the completed form is returned to the IRB with supporting information, a renewed approval can by generated.

36. Record Keeping Keep all materials for 3 years from project Termination date. Store in a locked file. Include: Copies of recruitment pieces Participant surveys Data compilation sheets Results of study Reports generated from results Keep all materials for 3 years from project termination date. Store all these records in a locked file. Include: Copies of recruitment pieces Participant surveys Data compilation sheets Results of study Reports generated from resultsKeep all materials for 3 years from project termination date. Store all these records in a locked file. Include: Copies of recruitment pieces Participant surveys Data compilation sheets Results of study Reports generated from results

37. IRB Audits Possible Audits by: Internal by Purdue Extension 2. The Purdue IRB 3. External by the Federal Office of Human Protections Research (OHRP) Finally , to ensure that the IRB is safeguarding the rights of human subjects, a system of audits has been put into place. Your record keeping is important if your project is selected for such an audit. We will be conducting internal audits within Purdue Extension to ensure that the proper record keeping is in place. We have been assured that the campus IRB will also be conducting audits so they can provide proper documentation to the federal government that they are carrying out their assignments. And the Federal Office of Human Protections Research also conducts it�s own investigations. Finally , to ensure that the IRB is safeguarding the rights of human subjects, a system of audits has been put into place. Your record keeping is important if your project is selected for such an audit. We will be conducting internal audits within Purdue Extension to ensure that the proper record keeping is in place. We have been assured that the campus IRB will also be conducting audits so they can provide proper documentation to the federal government that they are carrying out their assignments. And the Federal Office of Human Protections Research also conducts it�s own investigations.