User:Carmela055/sandbox

Article Evaluation (2.2.2019) - Youth Studies
youth studies = holistic study of multiple factors of the youth in relation to their personal growth and their societal impact

what's the purpose of "youth studies" as a topic?


 * exploring this topic with a goal to have a better understanding about the youth's experience in relation to social norms, political climates, international issues, and cultural differences and how those have an impact on their upbringing and how they see the world

content isn't in paragraph form; topics are links to other wiki pages, which don't seem to be the most effective way to share information; would personally prefer a short explanation at least of each topic and then have the external link cited.

tone of the intro paragraph of the article is neutral, gives a concise and brief explanation of what's in it. the purpose of the article existing is clearly stated.

sources are cited at the bottom, not as many as I was expecting. most were books so I couldn't go to the reference on the spot but the intro paragraph was littered with several citations which was encouraging. as said above, the topics were external links to other wiki articles. I read through one or two.

the talk page has not been active recently, the last thread was about the topic of "youth study" being "underrepresented." the original author asked for clarification on that but there was no response. I agreed with the user who said that the intro paragraph wasn't fleshed out as much as it could be compared to the amount of topics and sources there are on this topic, as it is a broad topic that would be addressed from many different angles.

Choosing an Article Topic (started on 2.11.2019)
Topic: human subject research

Potential Resources/Things to Add


 * ethical issues in stem cell research: link
 * list of human clinical trials to further research: link
 * annotation: patients having to pay for their procedures = huge red flag for study not approved by the government
 * Henrietta Lacks (HeLa cells)?

Clinical trials with negative outcomes


 * University of Minnesota Seroquel Experiment (2004)
 * clinical trial named the CAFÉ Study
 * Dr. Stephen Olsen = associate professor in Dept. of Psych at the university and overseer of the study
 * study funded by AstraZeneca (drug company)
 * Dan Markingson
 * committed suicide during clinical trial
 * mother sued the university
 * French Biotrial Tragedy
 * The Thalidomide Trials
 * Leukemia CAR-T Trial
 * New York Lidocaine Disaster
 * John Hopkins Asthma Trial
 * The Elephant Man Trial (Theralizumab)

Editing an Existing Article (exercise due 2.20.2019)
Article: human subject research: Clinical Trials section"'For example, a clinical drug trial case at the University of Minnesota that was under investigation in 2015 for the Death of Dan Markingson was funded by AstraZeneca, a pharmaceutical company headquartered in the United Kingdom.'"

Notes/prep for the article:
The idea of re-consenting


 * source 6
 * “to ensure that informed consent is ethically and legally valid, it is sometimes necessary to ask human subjects to re-consent, reaffirm their willingness to participate, or re-sign a consent form.”
 * “an action in which subject (or representative) makes the decision to participate in research once again. [Re-consent] is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decisions, whereas in in reaffirmation one simply expresses a willingness to abide by a decision one has already made.”
 * “similar to renewing one’s wedding vows”
 * “resigning a document is not the same as re-consenting, because a person can sign a document once agin without ever reconsidering their decision”
 * examples of when re-consent might be a thing:
 * “failing to inform subject when important risks related to the study”
 * “using an improper representative for a subject who is not capable of making an informed choice”
 * “significant changes in the research procedures, risks, potential benefits, or alternatives”
 * “the subject’s medical condition worsens or does not respond to treatment”
 * maybe in pediatric patients once the patient turns 18
 * how to get re-consent
 * contact them again by email, mail, phone, or in person
 * must have explanation for why they need re-consent and should give subjects a chance to ask questions
 * it may be important to re-consent to respect the subject’s autonomy and protect from future risk
 * BUT: must balance with other concerns
 * “need to avoid harming research subjects and implementation issues”
 * “can produce anxiety or confusion in some subjects and may make some feel that their privacy has been violated, i they did not give permission to be re-contacted.”
 * COMMON RULE FOR RE-CONSENT
 * “re-signing a consent form may be appropriate when re-consent is required” or “when re-consent is not necessary but there was a legal problem with the documentation of the original consent”
 * common rule “require that informed consent be legally effective and properly documented”
 * ex. of improperly documented consent:
 * no signed consent form
 * inappropriate legal representative signed on the subject’s behalf
 * consent form was not translated into the subject’s or representative’s language
 * study’s approval expired during the time when the subject consented
 * consent document contained some legally invalid language, such as a waiver of the subject’s legal rights
 * failure to obtain consent properly can render the collected data unusable
 * could be considered as obtained illegally
 * subject will also have to withdraw from the study until proper paperwork of consent is signed

ethical issues in pharma trials


 * source 1
 * (to put in the “Ethical Guidelines” section in wikipedia): FDA moved to strengthen requirements - made a list of specific terms of what is required of clinical investigators who are working with new drugs
 * amendment to 1962 Drug Act to include new requirement:
 * “Physicians investigating new drugs in human subjects obtain their written consent except where they deem it not feasible, or, in their professional judgment, contrary to the best interests of such human beings.”
 * new Drug Act:
 * “requires that patients who participate as research subjects must have the legal capacity and freedom of choice to give consent.”
 * psychopharmacological trials
 * split into 2 broad categories:
 * clinical investigations
 * main concerns are health oriented—will a drug be better than another type of treatment that already exists/is in use (i.e. will it be a better treatment for a particular mental illness)? will certain patients respond differently/better than others?
 * field of basic research

Prepping to move into the article:
Nagging or challenging issues

Respondents more often pointed out practical or logistical issues with the overall process rather than ethical issues. There was a general consensus that the whole practice of conducting research studies was more focused on the business aspects. A physician commented that “[industry] relationships are very important because of cash flow.” (CITE) Instead of focusing on ethical issues, there is more /PICKUPHERE181

Typical ethical issues that arise during research trial periods in a rural community setting include but are not limited to enrollment, coercion, and misconception.*** Patients are more likely to enroll in a trial if their primary care physician or a provider that they trust recommends the study. Most respondents seem to agree that patients consent to participate because they believe that through this study, they would be receiving “more attention than my regular patients” (CITE) and that “there are an awful lot of additional opportunities for interaction.” (CITE)

(consider using this quote for this section?) “...the way that we’re required to actually recruit patients, which is to have their providers be the point of contact, some ways is--I mean, I don’t want to use the word ‘coercion’, but it’s kind of leaning in that direction because basically here’s this person that they entrust themselves to, who they’re very dependent on for, you know, getting their healthcare”

Added to the article:
Of note currently in the research field is the manner in which researchers direct their conversations with potential human subjects. Recently there has been a shift from conducting research studies at research institution facilities or academic centers to rural communities. There is some concern surrounding the topics addressed during the discussions with this specific demographic of participants, particularly having to do with funding and overall efficacy of the treatment being studied.

Cook and Hoas conducted a study to gain more understanding about what influences potential candidates to consent to participation in any given clinical trial. This study is also particularly interesting because Cook and Hoas asked for the perspective of the researcher and whether they would consent to being a subject in a clinical trial. To assess the shift to rural communities, they surveyed 34 physicians or researchers and 46 research coordinators from states that have “large rural populations and have historically demonstrated limited participation in clinical research.” Proper consent forms were provided and signed at the start of the study. Of the physicians and research coordinators that participated in this study, 90% were from hospital centers or worked in a hospital-clinic setting. Of all the participants, only 66% of research coordinators and 53% of physicians received training in research methods, while 59% of the coordinators received any ethics training. Only 17% of the physicians had ethics research training prior to this study.

Hoas and Cook categorized their findings into four main topics:


 * source of funding
 * disclosure of researcher compensation
 * morally nagging and challenging issues
 * willingness to join a research study

The role of funding

Cook and Hoas found that funding played a significant role in participant selection. One of Hoas's and Cook's participants commented that "in his practice, the income from conducting pharmaceutical trials sometimes [is] used to offset the losses of conducting scientifically interesting but poorly funded federal studies," and most other participants administered trials because "reimbursements generated from such trials made it possible to maintain a financially viable, as well as profitable, practice." Interestingly, Cook and Hoas found that most of the physicians and coordinators could not explain directly if they actually told their patients or subjects about any financial compensation they received. Respondents worry that discussing funding or compensation would affect enrollment, effectively swaying participants from joining a research study. In most respondents’ experience, most patients do not even ask for that information, so they assume that they do not have to discuss it with them and not jeopardize enrollment. When asked if information about funding or compensation would be important to provide to patients, one physician replied “...certainly it may influence or bring up in their mind questions whether or not, you know, we want them to participate because we’re gonna get paid for this, you know, budget dollar amount. But, you know, when you talk about full disclosure, is that something that we should be doing? That’s an interesting question.”