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Steve Joffe

@stevejoffe.bsky.social

196 followers 88 following 146 posts

Research ethics, pediatric ethics, cancer ethics, genomethics, science policy @ UPenn. Grateful immigrant. Speak only for myself. He/him.

Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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Terrific @statnews.bsky.social piece from @pennmehp.bsky.social's @annawexler.bsky.social on Neuralink's pathbreaking work and the challenges it poses for how we do science. www.statnews.com/2024/07/08/n...

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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15/ Importantly, we do not argue that consultation should be a mandate or regulatory requirement in such trials. Rather, we think it is something that investigators, sponsors, and IRBs should consider to enhance the ethical quality of trials involving waivers of informed consent.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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14/ Finally, feedback from people similar to those who might be enrolled in the trial might help investigators identify ways to reduce risk and burden.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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13/ Third, consultation might enhance public trust (through transparency) and investigator accountability (by ensuring that investigators only propose to do things that are palatable to participant communities).

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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12/ Second, when individual consent is impracticable, consultation is an alternative way of demonstrating respect for participants by seeking the perspectives of people like them.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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11/ First, consultation responds to patient and public preferences for consent. While not equivalent to consent, it fulfills at least some of the functions that consent would otherwise perform when actually seeking consent is impossible. siren.network/sites/defaul...

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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10/ Community consultation for such trials has at least 4 ethical virtues to recommend it:

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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9/ While the people with whom investigators consult might not be the same people who join the trial, they are likely to share the concerns and perspectives of those who do and to be able to represent them.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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8/ It’s generally much easier to identify members of the relevant community in minimal risk than in EFIC trials. You can identify individuals with the relevant conditions, often who receive treatment in the health systems where the trial will be conducted, & invite them to the consultation.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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7/ In our new paper, we argue that community consultation can enhance the ethics of minimal-risk trials conducted with waivers of informed consent, and that many of the challenges with consultation in EFIC trials are less in minimal-risk trials conducted under waivers of informed consent.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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6/ These are often pragmatic or comparative effectiveness trials, and often involve randomizing clusters rather than individual patients, making seeking individual consent much more difficult or even impossible.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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5/ The second setting in which regulations allow waivers of informed consent is trials that present no more than minimal risk for participants, assuming several other conditions are also met. www.hhs.gov/ohrp/sites/d...

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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4/ One requirement for EFIC trials is community consultation, which aims to assess acceptability of the trial to communities most likely to be eligible and to incorporate feedback into design. But community consultation has proved challenging in practice. onlinelibrary.wiley.com/doi/10.1111/...

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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2/ Federal regs allow informed consent waivers in 2 settings. The 1st is “investigations involv[ing] human subjects who have a life-threatening medical condition that necessitates urgent intervention …, and who, because of their condition…cannot provide informed consent.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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1/ Pleased to share a new Open Access paper in Clinical Trials, led by Emily Largent, on the value of community consultation in clinical trials that request waivers of the requirement for informed consent (threadlet). journals.sagepub.com/doi/10.1177/...

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Kristian G. Andersen's avatar Kristian G. Andersen @kgandersen.bsky.social
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I urge you to read Dr. Fauci's transcribed interview where he goes into more detail about the threats to him and his family, including how the extreme rhetoric from politicians and other academics fuel this. This needs much more focus. Below, page one more clearly displayed. The rest follows 👇.

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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Hanging with my cousin who works in AI for one of the big tech companies--who says something similar.

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Tom Pepinsky's avatar Tom Pepinsky @tompepinsky.bsky.social
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Not even close. This is straight antisemitism

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Holly Fernandez Lynch's avatar Holly Fernandez Lynch @hollylynchez.bsky.social
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Don't forget to remind your grad students about ASLME's writing competition. Deadline is July 1 to give them time to account for your comments on their seminar papers!

aslme.org/aslme-inside...

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Jacob T. Levy's avatar Jacob T. Levy @jacobtlevy.bsky.social
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This is advocacy of genocide— from one of the highest-ranking members of Israel's cabinet.

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Brendan Nyhan's avatar Brendan Nyhan @brendannyhan.bsky.social
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One of the most nuanced takes you will see - it is possible to abhor what is happening in Gaza AND have qualms about some of the groups organizing protests AND recognize that that most people participating do not share the views of those groups twitter.com/DovWaxman/st...

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Reposted by Steve Joffe

hilzoy's avatar hilzoy @hilzoy.bsky.social
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One of my favorite bits from Dennett is the second para. of this quote (the first is just there to indicate what he's talking about.)

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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Have to post this hilarious Daniel Dennett quote from The Other Site.

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Govind Persad's avatar Govind Persad @govindpersad.bsky.social
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"Fair Allocation of GLP-1 and Dual GLP-1–GIP Receptor Agonists" is now out in NEJM (w/Zeke Emanuel, Johan Dellgren, Matt McCoy).

We propose a #bioethics framework to guide gov'ts, professional societies, & docs in allocation choices about drugs like semaglutide (Ozempic/Wegovy) when demand > supply

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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Just saw one in Seattle. It really does look like something designed by SimpleHuman (the company that makes fancy trash cans).

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Steve Joffe's avatar Steve Joffe @stevejoffe.bsky.social
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These allegations, if true, are simply bizarre.

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