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Peer Evaluation: Respond to each peer discussion. (#1 and #2). Do you agree or disagree with each peer? Any other ideas? Comment your thoughts. SIMULATED
Peer Evaluation: Respond to each peer discussion. (#1 and #2). Do you agree or disagree with each peer? Any other ideas? Comment your thoughts.
SIMULATED REB Read Read the following fictitious scenarios: Scenario 1: Bill is a graduate student proposing to conduct laboratory research using human blood samples. His research will examine caffeine levels in blood and evaluate whether differing levels are related to people's predisposition for type 2 diabetes. He proposes to recruit 100 students to his study and follow them for four years. During that time, he will take regular blood samples and provide yearly physicals. As well, he has identified the availability of 100 additional blood samples, analyzed for caffeine levels that were collected twenty years ago for a different study. He notes that the study that collected these samples was examining caffeine levels and their relation to student alertness but that the study also involved following the students for four years and included a yearly physical, including testing for diabetes. Scenario 2: Joe is in the first year of his Ph.D. in Social Work. His thesis work will evaluate the impact of rising living costs on street youth. As part of this work, he will approach street youth in downtown Kamloops and interview them to determine (1) how long they have been living on the street; (2) if they work, attend school, or do other activities; and, (3) what their plans are for the future. He plans to provide anonymity to his research subjects by recording only their first names. In order to recognize their participation, Joe will provide each interviewee with a $10 gift certificate to a local coffee shop. Scenario 3: Sally is a professor in Native Studies, and Kelly is a professor in the Biology department. Their proposal is to begin a new study with First Nation community members around the community's use of medicinal plants, before and after timber harvesting. Sally has worked with the partner First Nation for eight years on related projects. Their proposal notes that because many of the community's Elders did not attend formal schooling, they do not all write and read English. Sally and Kelly propose that informed consent can be obtained by having the elected Chiefs and Council sign a consent form on behalf of the entire community. DISCUSSION How would you respond to each example? Evaluate each one on its ethical merits and assign it a green light (good to go!), a yellow light (revisions required), or a red light (do not proceed). PEER'S DISCUSSION #1 Case #1 Concerns - yes, Yellow light Informed Consent Article 3.1 - Bill must ensure student participation is voluntary - not made under coercion or incentivized, and can be withdrawn any time without reason. Should the participant choose to withdraw, they can also request to withdraw their blood samples and associated data. Article 3.2 - 3.3 - Bill must provide all info presented in an understandable way, respond to all questions, and clearly explain the purpose, risks / benefits, what's collected, how info will be protected, dissemination method etc. The participants need to be aware of any updates or changes done to the research process, as well as the time commitment and blood / physical tests Concerns w Incidental Findings Article 3.4 - Researchers need to disclose to the participant any incidental findings within the limits of consent provided. Should Bill make any discoveries relating to the participants through their blood samples and physicals, he needs to disclose that information to the participants to the extent that they'd like to know (as they also have the autonomy to not know). Research based on secondary use of info TCPS Chapter 5D - Bill will need to seek out the participants of the research conducted 20 years ago to obtain consent as he is using identifiable human biological materials Privacy and Confidentiality concerns * Inaccordance with Article 5.1 and 5.2, Bill will need to safeguard the confidential information obtained from the blood samples and physical exams, and clearly define the measures to meet these obligations. Minimal risk research Bill needs to ensure that the probability and magnitude of harms are no greater than those experienced in the daily life of the students to ensure minimal risk research (TCPS 2, 2022). In this case, the possible benefit of the research (predisposition for Type II diabetes) should outweigh the risks (i.e. distress related to regularly obtaining blood samples and disclosing personal results of physicals for 4 years). Case #2 Concerns - yes, Yellow light Consent Article 3.1 emphasizes that participation is voluntary - not made under coercion or incentivized, and can be withdrawn any time without reason. A $10 gift certificate may not be considered a sizeable amount of money, but taking into account the vulnerable circumstances of the street youth, Joe should mention that receiving the gift card is not contingent on them participating in the interview and frame it as a form of encouragement, not obligation. Research-attributable risks and Minimal risk research Participants need to be informed of risks distinct from which they're normally exposed to and researchers must ensure that the probability and magnitude of harms are no greater than those experienced in the daily life of the students to ensure minimal risk research (TCPS2, 2022). Approaching homeless youth in downtown Kamloops poses certain risks to both the researcher and possibly the participant (i.e. should the interview be conducted at a high crime area in the evening). Joe could lower rescarch-attributable risks by choosing a safe setting for the interview. Privacy and Confidentiality concerns Joe is using anonymized information by collecting participants' real first name, and personal details (i.e. where they attend school). This raises privacy concerns as the interview is not completely anonymous, and the data can run the risk of re-identification of the participant if picced together (TCPS2, 2022). Use of a pseudonym may help. Case #3 Concerns - yes, Red light Informed consent Article 9.6 emphasizes the importance of diverse interests within communities, including individuals NOT involved in formal leadership. Having only the elected Chiefs and council sign the consent form on behalf of the community may undermine the autonomy of the individuals. One of TCPS 2's core principles emphasizes respect for persons, which includes recognizing the intrinsic value of humans and autonomy. This includes placement of additional measures to protect those who lack decision-making capacity. As such, the researchers need to implement strategies to help the Elders fully understand the entirety of the research process in a way that takes into account their education level and language barriers. Failure to do so indicates that consent is not informed. References Canadian Institutes of Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC), & Social Sciences and Humanities Research Council of Canada (SSHRC). (2022). Tri-council policy statement: Ethical conduct for research involving humans. Retrieved from Government of Canada, Panel on Research Ethics website: https://ethics.gc.ca/ eng/policy-politique_tops2-eptc2_2022.html TCPS 2: CORE-2022. (n.d.). https://tops2core.ca/welcome PEER'S DISCUSSION #2 Case #1 Concerns: Yes, Yellow . Informed Consent: Bill proposes to use blood samples collected for another study. According to the Tri-Council Policy Statement (CIHR, NSERC, & SSHRC, 2022), secondary use of identifiable data requires the original participants' informed consent, unless otherwise specified. Privacy and Confidentiality: Creswell & Creswell (2023) emphasize the need to protect participant confidentiality. The use of data without consent or anonymization raises significant ethical concerns. Reflection and Rationale: Bill needs to obtain new consent for the use of previously collected blood samples to align with the principle of autonomy (Porta, 2014). This aligns with the Tri-Council Policy Statement's principle of respect for persons(CIHR, NSERC, & SSHRC, 2022). Long-term studies must ensure that the participants' personal information is adequately protected and that re-consent is obtained periodically, especially when using identifiable data. Decision: Yellow Light (Revisions Required): Bill must address the ethical issues around secondary data use by obtaining new informed consent, and the study design must respect participants' ongoing rights to privacy and confidentiality.Case #2 Concerns: Yes, Yellow Vulnerability: According to the Tri-Council Policy Statement (2022), vulnerable populations, such as street youth, require special ethical considerations. Creswell & Creswell (2023) also note that participants' vulnerability must be accounted for during recruitment and data collection. Coercion: Providing compensation could be viewed as coercion, particularly when dealing with financially unstable participants (Porta, 2014). Reflection and Rationale: Street youth represent a vulnerable population, so Joe must take extra care to avoid undue coercion through compensation (Porta, 2014). Ethical guidelines suggest that compensation should not be so large that it unduly influences participation (CIHR, NSERC, & SSHRC, 2022). Creswell & Creswell (2023) also highlight the importance of justiceensuring that the benefits of research are fairly distributed and that participation is fully voluntary. Decision: * Yellow Light (Revisions Required): Joe should reconsider his compensation strategy to ensure it is ethical and non-coercive. He should also strengthen anonymity protections, possibly by using pseudonyms or participant codes instead of first names. Case #3 Concerns: Yes, Red . Informed Consent: The Tri-Council Policy Statement (2022) stresses the importance of obtaining informed consent from each individual, rather than from a collective body, such as Chiefs and Council. This scenario raises concerns about autonomy and whether the consent of individuals is adequately obtained. . Cultural Sensitivity: Creswell & Creswell (2023) note the importance of cultural sensitivity and respect when working with Indigenous communities, especially regarding traditional knowledge and beneficence (Porta, 2014). Reflection and Rationale: * While Sally and Kelly have a long-standing relationship with the community, the principle of individual autonomy(Porta, 2014) requires that informed consent be obtained from each participant. The chiefs and council cannot consent on behalf of individuals (CIHR, NSERC, & SSHRC, 2022). * Ethical conduct also demands culturally appropriate methods of obtaining informed consent, possibly involving translation or oral consent processes where necessary. Decision: Red Light (Do Not Proceed): Sally and Kelly's proposal does not meet the standards for informed consent, and the study cannot proceed without significant revisions to ensure individual autonomy is respectedStep by Step Solution
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