What is the IRB

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What is the IRB? (cont) Purpose. IRBVsTo protect human subjects used in research conducted at the institution To ensure that the research it reviews strictly adheres to the three principles of the Belmont report : Respect for persons, beneficence, justiceTo educate researchers on protectin

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What is the IRB

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1. What is the IRB? Basic components that define an IRB: At least five voting members Sole purpose is to protect the rights of human subjects as it pertains to institutionally based research Federally regulated by the policies of the Department of Health and Human Services (DHHS) Reviews all research protocols involving human subjects Located at the institution Definition The IRB is an administrative body composed of scientists and non-scientists, established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. Although it is the researcher’s primary responsibility to safeguard the rights and welfare of the human research subjects, it has been decided by US law that research using human subjects be reviewed by committees called institutional review boards (IRB’s), whose members are not involved in the research being reviewed. Definition The IRB is an administrative body composed of scientists and non-scientists, established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. Although it is the researcher’s primary responsibility to safeguard the rights and welfare of the human research subjects, it has been decided by US law that research using human subjects be reviewed by committees called institutional review boards (IRB’s), whose members are not involved in the research being reviewed.

2. What is the IRB? (cont) Purpose IRB Vs To protect human subjects used in research conducted at the institution To ensure that the research it reviews strictly adheres to the three principles of the Belmont report : Respect for persons, beneficence, justice To educate researchers on protecting human research subjects and to increase their awareness of human research subjects protection Once the principal investigator has determined that he/she is conducting research using human subjects, then the next step is to determine how that research fits into the human research protections program. Learning more about what the IRB is will help to establish the fit. At CCNY and all other federally funded institutions engaged in research using human subjects, the IRB’s function is to apply the highest ethical standards for the conduct of the institution’s research where human subjects are involved. These ethical standards serve to ensure that the research participants are treated in accordance with the three principles of the Belmont report: Respect for Persons, Beneficence, and Justice. The IRB could not achieve a strong human research protections program without the continual effort to educate researchers on protecting human research subjects. Also, promoting communication among all of the individuals involved in human subjects research—research administrators, department heads, investigators, human subjects, institutional officials—is key in the program, and is a central part of following federal regulations, policies and guidelines related to human subjects research. Case 1: Researcher X submits a protocol that is being reviewed by the IRB. His research proposes to investigate a topic using human subjects which is beyond the scope of any of the research topics in his department but that nevertheless, may have beneficial results for the human subjects involved. One of the IRB members, Mr. Y, is from the same department as X, but of course is in no way connected to the research except in the capacity of an IRB reviewer. Should Mr. Y be concerned about the research deviating from Researcher X’s departmental mission? No. When reviewing protocols, the IRB members should only be concerned with the rights and welfare of the human subjects involved in the research. Since the proposed research is in the interests of the human subjects, the fact that it is not part of the mission of X’s department must have no bearing.Once the principal investigator has determined that he/she is conducting research using human subjects, then the next step is to determine how that research fits into the human research protections program. Learning more about what the IRB is will help to establish the fit. At CCNY and all other federally funded institutions engaged in research using human subjects, the IRB’s function is to apply the highest ethical standards for the conduct of the institution’s research where human subjects are involved. These ethical standards serve to ensure that the research participants are treated in accordance with the three principles of the Belmont report: Respect for Persons, Beneficence, and Justice. The IRB could not achieve a strong human research protections program without the continual effort to educate researchers on protecting human research subjects. Also, promoting communication among all of the individuals involved in human subjects research—research administrators, department heads, investigators, human subjects, institutional officials—is key in the program, and is a central part of following federal regulations, policies and guidelines related to human subjects research. Case 1: Researcher X submits a protocol that is being reviewed by the IRB. His research proposes to investigate a topic using human subjects which is beyond the scope of any of the research topics in his department but that nevertheless, may have beneficial results for the human subjects involved. One of the IRB members, Mr. Y, is from the same department as X, but of course is in no way connected to the research except in the capacity of an IRB reviewer. Should Mr. Y be concerned about the research deviating from Researcher X’s departmental mission? No. When reviewing protocols, the IRB members should only be concerned with the rights and welfare of the human subjects involved in the research. Since the proposed research is in the interests of the human subjects, the fact that it is not part of the mission of X’s department must have no bearing.

3. What is the IRB? (cont) Purpose Federally regulated—Common Rule (45CFR46) In 1974, exposure of Tuskagee syphilis study abuses led to the formation of IRB procedures and practices DHHS establishes special provisions for research involving women, prisoners and children—45CFR46 Subpart B, Subpart C, Subpart D Federal regulations dictate what an IRB can and cannot do. It is important for researchers to know the limitations of their IRB and to be clear about who is responsible for what. As the IRB’s purpose is to protect the rights, safety and welfare of human research participants, it must function with in certain parameters. For example, the IRB has a meeting place, and designated meeting times and appointed voting members. On the other hand, it does not have the capacity to see what is going on in human subjects research at all times and places, which is why your protocol and consent document are the topic of discussion here—they provide the IRB with a bird’s eye view of how you will be conducting your research so that it can protect the rights and welfare of the individual research subjects. In 1974, after the abuses of the human research subjects used in the Tuskagee syphilis study (1932-1972) were exposed, Congress went ahead and established “a permanent board with the authority to regulate at least all federally supported research involving human subjects”. At that point, the DHHS also established the regulations for the protection of human subjects that included the framework for IRB procedures (45 CFR 46). In 1991, the human protections program expanded its regulations to include special provisions for research involving women, prisoners and children (45 CFR 46 Subpart B, Subpart C, and Subpart D respectively). Federal regulations dictate what an IRB can and cannot do. It is important for researchers to know the limitations of their IRB and to be clear about who is responsible for what. As the IRB’s purpose is to protect the rights, safety and welfare of human research participants, it must function with in certain parameters. For example, the IRB has a meeting place, and designated meeting times and appointed voting members. On the other hand, it does not have the capacity to see what is going on in human subjects research at all times and places, which is why your protocol and consent document are the topic of discussion here—they provide the IRB with a bird’s eye view of how you will be conducting your research so that it can protect the rights and welfare of the individual research subjects. In 1974, after the abuses of the human research subjects used in the Tuskagee syphilis study (1932-1972) were exposed, Congress went ahead and established “a permanent board with the authority to regulate at least all federally supported research involving human subjects”. At that point, the DHHS also established the regulations for the protection of human subjects that included the framework for IRB procedures (45 CFR 46). In 1991, the human protections program expanded its regulations to include special provisions for research involving women, prisoners and children (45 CFR 46 Subpart B, Subpart C, and Subpart D respectively).

4. What is the IRB? (cont) Function IRB VS Approve research Disapprove research Modify research Case 2: Researcher X has written a rough draft of his research plan loosely describing his methods, intentions, informed consent procedure. He submits this draft expecting the IRB to revise, correct and redraft it so that later the researcher can submit the final protocol for review. Does X appear to understand the function of the IRB? No, because the function of the IRB is to review protocols, not to edit, draft or revise research proposals. Case 3: Researcher X has submitted a protocol describing a research design modeled on observing college students in a classroom setting and distributing a survey which asks them questions about their parents’ sexual orientation. The IRB disapproves the research on the basis that the survey is invading the privacy of third parties. Despite the IRB’s disapproval, X decides to begin the observations while he revises the survey and the protocol for another IRB review. Has X done anything wrong? Yes. X’s protocol was disapproved, which means that he is not permitted to perform any aspect of the proposed research. He needs to rewrite the survey but also adjust other aspects of the research protocol that have the potential of being equally invasive. Case 2: Researcher X has written a rough draft of his research plan loosely describing his methods, intentions, informed consent procedure. He submits this draft expecting the IRB to revise, correct and redraft it so that later the researcher can submit the final protocol for review. Does X appear to understand the function of the IRB? No, because the function of the IRB is to review protocols, not to edit, draft or revise research proposals. Case 3: Researcher X has submitted a protocol describing a research design modeled on observing college students in a classroom setting and distributing a survey which asks them questions about their parents’ sexual orientation. The IRB disapproves the research on the basis that the survey is invading the privacy of third parties. Despite the IRB’s disapproval, X decides to begin the observations while he revises the survey and the protocol for another IRB review. Has X done anything wrong? Yes. X’s protocol was disapproved, which means that he is not permitted to perform any aspect of the proposed research. He needs to rewrite the survey but also adjust other aspects of the research protocol that have the potential of being equally invasive.

5. What is the IRB? (cont) Function

6. What is the IRB? (cont) Function IRB VS Suspend or terminate approval Observe the informed consent process and the research procedures Researcher Do not conduct the research Share information and be open about research procedures and informed consent process with the IRB

7. IRB Review Criteria Human subjects are exposed to minimum risks Sound research design Human subjects are not exposed to unnecessary risks Use recognized procedures on human subjects that have diagnostic or treatment value The researcher must use procedures which are consistent with sound research design and do not unnecessarily expose subjects to risks. Whenever appropriate, the research design should use procedures already being performed on the subjects for diagnostic or treatment purposes. The researcher must use procedures which are consistent with sound research design and do not unnecessarily expose subjects to risks. Whenever appropriate, the research design should use procedures already being performed on the subjects for diagnostic or treatment purposes.

8. IRB Review Criteria 2. The anticipated risks to the human subjects are considerably lower than the benefits Have the probability, magnitude and duration of the risks been considered in relation to the benefits? Identify physical pain, discomfort as well as the psychological, emotional, or sociological harm, including invasion of privacy, loss of confidentiality, harassment, and lessening of an individual’s dignity The risks to human research subjects must be reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.The risks to human research subjects must be reasonable in relation to anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research.

9. IRB Review Criteria 2. The anticipated risks to the human subjects are considerably lower than the benefits (cont) Consider the subject’s time or pay Consider risk to a community or a group of individuals Consider the magnitude and probability of direct benefit to a subject in order to ensure that the research protocol does not overstate the benefits or potentially raise false expectations in the participants Evaluate the risk/benefit ratio so that it is acceptable

10. IRB Review Criteria 3. The subjects are selected equitably. In doing so, the researcher must consider the following: No individual or group should be over burdened with out receiving potential benefits Researcher should not select research participants because they are convenient to recruit Recruitment procedures should ensure an equitable distribution across the population Inclusion and exclusion criteria should take into account the 1994 NIH Guidelines on the inclusion of women and minorities in researchand any vulnerable populations

11. IRB Review Criteria 4. Informed consent will be sought from prospective subjects and documented appropriately by the investigator PI may waive written consent under special circumstances but not the informed consent process Assent when using children as research subjects and consent from parents or guardians Written consent translated into another language if research participant does not speak English

12. IRB Review Criteria 5. The privacy and confidentiality of the subjects is protected. Special attention should be given to the following: Methods used to identify and recruit subjects Identifiable information of third parties involved in research Nature of questions asked

13. IRB Review Criteria 6. The subject’s well being is monitored during the research The research plan must make adequate provision for monitoring the data collected to ensure the subject’s safety Researcher must be familiar with SAE reporting procedures

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