...Internal Review Board For The Protection Of Human Subjects In Research North Carolina Central University INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH Request for Review of Research Involving Human Subjects COVER SHEET | | (For Staff Use Only) | | |1. School/Department/Unit:NCCU/Psychology |REQUEST #____________ |Today's Date February 3, 2005 | 2. Name of Principal Investigator (PI) ______________________________________________ Name of Faculty Advisor (FA), if PI is a student__Dr. Les Brinson _________________________________ Telephone Number (PI): 919*530*4526_ Mailing Address (PI): PO Box 19408 Durham, NC 27707 Telephone Number (FA):919*530*5166 Mailing Address(FA): Taylor Ed. Rm 217A Durham, NC 27707 3. PROJECT TITLE: ____________Organizational Communication and Its Relationship With Job Performance and Job Satisfaction _________ 4. PROJECT TYPE: __N__ (Select one: N = New; AR = Annual Renewal; PC = Protocol Change) This is a : _SP__ (Select one: SP = SPECIFIC PROJECT or GP = GRANT PROJECT PROPOSAL) If Grant Project Proposal, list agency and address to which project is being submitted: __________________________________________________________________________________________ ...
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...Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary...
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...Obtaining Informed Consent in Emergency Situations Introduction As research advances in finding answers and treatment for diseases, the process of obtaining a patient’s informed consent becomes more detailed required. The informed consent is known as the cornerstone of Good Clinical Practice for ensuring patient safety. In a normal clinical paced environment, time is given to ensure patients are provided all the required information and the time to make a rational and voluntary decision to participate in a study. At times this process is not feasible do to emergency situations, such as when a patient arrives in the emergency room in a compromised mental and physical state that does not permit ample time for this process. Such cases may also be further aggravated when a family member or a Legal Authorized Representative (LAR) is not available to decide if the patient should participate in a clinical trial that offers a treatment may increase the of survival more than the current standard of treatment. We must than think of the patient’s best interest at this point. History of Informed Consent Following World War II, the Nazis who performed medical experiments on prisoners of war without obtaining their consent were convicted of murder, but not for their actions of conducting unethical research. Their actions helped bring to life the Nuremberg Code of 1948; the first legal document to enforce the idea that subjects’ participation in clinical research must be voluntary...
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...Main Menu › VA Human Subjects Protection › Informed Consent Informed Consent Content Author * Diane Paul, M.S., RN National Comprehensive Cancer Network Introduction It is important to understand that informed consent is a process that begins with the recruitment and screening of a subject and the signing of the consent document, continues throughout the subject's involvement in the research, and continues beyond study termination. It includes: * Recruitment efforts encompassing the means of first creating awareness or contact and spanning everything from medical record review to advertisements and other recruitment materials. * Providing specific information and answering questions about the study to subjects in a way that is understandable to them while giving subjects adequate time to consider participation. * Obtaining the voluntary agreement of subjects to take part in the study. While the subject may agree to participate in the study, subjects may withdraw at any time. Part of the ongoing nature of the consent process is verifying the subject's continued interest in participating in the study. * Making plans for the provision of new information to be shared with former subjects, even after the study ends. There is consensus regarding the importance of informed consent. Informed consent is a demonstration of how investigators and those involved in human subjects research show respect to research subjects, and it is...
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...Informed Consent 1 Running Head: HUMAN SUBJECTS Human Subject’s Comprehension of Informed Consent Informed Consent 2 Statement of the Problem A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and research staff. Several papers have addressed problems with the current process. Brady (2003) identifies the following issues: subject’s hesitation to ask detailed questions, variable presentation of the content, and difficulty verifying the subject’s comprehension. Also, a survey performed by Center Watch in 2002 found that 14% of subjects did not read the consent before signing it and a high percentage of volunteers admitted to not fully understanding the risks and not knowing what questions to ask. The concept of “therapeutic misconception” (Joffe, Cook, Cleary, Clark, & Weeks, 2001) in research is another problem that has received much attention in both legal and bioethics literature. It is important that potential subjects are aware that...
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...15. The purpose of this study is to assess the effects of speed on the recall of abstract and concrete words. The hypothesis of this research is that words heard at normal speed will be easier recalled then those heard at a fast speed. 16. The participant population will consist of undergraduate students currently enrolled in psychology courses at Valdosta State University. Approximately 20 participants will perform the experiment. All participants will be at least eighteen years of age. Students will be asked to voluntarily participate in this experiment. If a participant refuses to participate in the experiment then he or she will not be bothered again. 17. Participants will be asked to read and sign a consent form. The consent form will briefly inform the participants about the experiment, but the details of exactly what is being measured will be kept from them. Each participant will be assigned a number for coding of their data to protect their anonymity. Before and after the informed consent process, participants will be reminded that their participation is voluntary and that at any point in time during their involvement in the experiment, they may decline from further involvement in the experiment. They will again be made aware that if they choose not participate further, they will not be penalized in any way and they will not be bothered further. 18. Participants will not receive any compensation for participating in this experiment. 19. There aren’t any...
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...Informed consent is a critical component of sociological research. Discuss the significance of this principle and its relevance for research practice in New Zealand. Informed consent is a critical component of sociological research because of the significance with this principle. Informed consent is about the respect and protection for research subjects. It is not simply signing a form, but entails informing the subject about the purpose of the study, potential risks or benefits and the details of the procedure that they will be participating in. The significance of this procedure within sociological research is that it provides sufficient information so that the participant can make an informed decision about whether or not to begin or continue participation. Gaining informed consent from the individual in the research is an essential element of ethically valid social research, because it will prevent a negative outcome such as the Tuskegee Syphilis Study. The purpose of this study was to monitor these men until death; as a result the autopsy would then disclose how syphilis took over the human body (reference book). The 600 African American men, 399 with Syphilis and a remaining 201 who did not have the disease were not informed on the details of the research or give informed consent to what they unfortunately encountered. Penicillin became available as a cure for this disease however this was withheld from the subjects of this research. If informed consent was a part of...
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...OVERVIEW Qualitative Research Methods: A Data Collector’s Field Guide Module 1 Qualitative Research Methods Overview F A M I L Y H E A L T H I N T E R N A T I O N A L Qualitative Research Methods Overview OVERVIEW T • • • • • • his module introduces the fundamental elements of a qualitative approach to research, to help you understand and become proficient in the qualitative methods discussed in subsequent modules. We recommend that you consult the suggested readings at the end of the module for more in-depth treatment of the foundations of qualitative research. This module covers the following topics: Introduction to Qualitative Research Comparing Qualitative and Quantitative Research Sampling in Qualitative Research Recruitment in Qualitative Research Ethical Guidelines in Qualitative Research Suggested Readings Introduction to Qualitative Research What is qualitative research? Qualitative research is a type of scientific research. In general terms, scientific research consists of an investigation that: • • • • • seeks answers to a question systematically uses a predefined set of procedures to answer the question collects evidence produces findings that were not determined in advance produces findings that are applicable beyond the immediate boundaries of the study Qualitative research shares these characteristics. Additionally, it seeks to understand a given research problem or topic from the perspectives of the local population it involves...
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...she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct? Your answer : The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. Correct Answer : The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. Comment : When a care provider becomes a researcher, both the child clients and their parents may not feel free to choose not to participate in the provider's study. A researcher who is also a care provider needs to be very clear that a decision not to participate in a study, or to allow records to be used, will not affect the care provided in the future. The fact that the therapist has access to her clients' records as a clinician does not entitle her to use information in the records for research purposes without parental permission and child assent. A school authority's permission to conduct the research does not replace the need for permission or assent. Finally, the children's right to choose cannot be overridden in the pursuit of an indeterminate community interest. Points Earned : 1 Question 2 Question : A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language...
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...limited to the Nazi regime The use of prisoners in research is a concern under the Belmont principle of Justice because: Prisoners may be used to conduct research that only benefits the larger society Issued in 1974, 45 CFR 46 raised to regulatory status: US Public Health Service Policy (45 CFR 46 raised to regulatory status the US Public Health Service policy of 1966 "Clinical research and investigation involving human beings".) Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.) Which of the following is included in the Nuremberg Code? Voluntary Consent Informed consent is considered an application of which Belmont principle? **** Respect for Persons (Respect for persons involves respecting individual autonomy in the decision to participate in research. That respect is implemented through the process of informed consent) How should the investigator proceed, with respect to the IRB, after the discovery of the adverse event occurrence? Report the adverse drug experience in a timely manner, in keeping with the IRB's policies and procedures, using the forms or the mechanism provided by the IRB. How long is an investigator required to keep consent documents, IRB correspondence & research records? For a minimum of three years after completion...
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...Introduction The topic requires and to observe and assess five ethical principles to be considered when carrying out educational research .Relevant examples should be cited from educational systems in Zimbabwe .Ethical principles encompass morals or rules for distinguishing between right and wrong .This paper is taking an ethic as a method ,procedure or perspective for deciding how to act ,norm for behavior that suits particular aims and goals for analyzing complex problems and issues when conducting educational research .There are several reasons why it is important to adhere to ethical norms in research .Norms promote the aims of an educational research , such as knowledge , truth and avoidance of error for example prohibitions against fabricating falsifying or avoid error .The five ethical principles are now going to be observed and assessed intern as the essay unfolds Definition of terms Educational system Ethics Ethical principles Educational research An examination of five ethical principles to be considered when carrying out educational research The first ethical principle to be considered in this paper is confidentiality ,privacy or protection of anonymity when carrying out educational research .Sales and Folkman(2000) assets that there is need to protect confidential communications ,such as papers , grants submitted for publication...
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...The informed consent is a written document in which a person, whether client or participants in a research study, agrees with the course of treatment (for counseling) or to participate (in case of study) after having received specific and enough information on the procedures that would be subject to. The area of psychology that I will consider for this discussion is research. Informed consent in research involves many factors. Informed consent should be provided to participants prior the study takes place. This document should provide sufficient and clear information of the study: duration, any possible risks or discomforts participants may suffer, and if participants will be or not compensated (amount must be specified). Additionally, informed...
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...Three rights of subjects that need to be protected in research include the: • Right to self-determination-incorporates the ethical conviction that a person should be treated as an autonomous agent. An autonomous person is an individual capable of making a voluntary decision as to whether or not to participate in a study or withdraw from a study, at any stage, for any reason, and without penalty. Coercion is one way in which the right to self determination could be violated. People can be coerced when they believe that their care will suffer if they refuse to participate in a study. For instance, a cancer patient without insurance may join a chemotherapy study to receive care that would otherwise be unavailable. • Right to anonymity and confidentiality-incorporates...
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...Professor Rachel Olvera Lifespan Development PSYC2314 10 March 2014 1. What is informed consent? Based on the theories from module 1.1, at what age might a child have the capacity to consent to research participation? Why? What measures that should be taken when the child’s parent/guardian consents on their behalf? What are the limits of confidentiality? Informed consent is the practice of getting permission before doing a healthcare study on a person. Sutcliffe and others believed some children as young as four could give informed consent. Children of that age have an increasingly understanding of the research being conducted. The child and guardian should be evaluated to check their understanding of the research. The child’s confidentiality can be compromised if a parent needs to consent. 2. An instructor decides to conduct a study of teacher-student interaction in a fourth grade classroom. From whom should she seek informed consent for research participation? The instructor would have to get informed consent from the parent and child for research participation. 3. A researcher wants to recruit preschoolers from low-income families for a study of cognitive development and will offer $50 to each mother who permits her child to participate. Does this violate research rights or not? Offering compensation can violate research rights if the parent persuades the child to participate. 4. An investigator wants to assess the effectiveness of an intervention designed to...
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...(Sarantakos 2013, p. 15). This correlates to 5.5.2.2: Respect, consent, privacy and review in research, (c) social workers will ensure care has been taken to protect the confidentiality of participants. To ensure confidentiality, it is crucial any identifying information of participants is not disclosed in evaluation reports or related documents. As there is only 100 staff members in this staff training program, care must be taken to ensure that there is no possibility for staff member’s identities to be revealed. To resolve the ethical issue of confidentiality, any documents containing identifying information will be secured, only to be accessed by authorised persons (Sarantakos 2013, p. 15). Furthermore, when in the process of writing the evaluation report, it will go under several proof readings to ensure no identifiable information was...
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