Henrietta Lacks and the Great Healthdata Giveaway

Part Seven of Seven-Part Blog Series by Guest Blogger Patrick Taylor

A suggestion runs through the debate on the NPRM to amend the Common Rule that the proposed changes are a tribute to Henrietta Lacks, a necessity so her story is not repeated.

That story was told in a the national bestseller  The Immortal Life of Henrietta Lacks, a moving biography of the young woman whose  aggressive tumor was the source of the ubiquitous HeLa cells (probably without her consent, certainly without her awareness of what followed); her family;  the  cells’  (and her) dehumanization into a research tool to be exploited unthinkingly; and the poverty, disconnection, racism,  lack of health care and lack of concern for her family. Society and scientists received a bonanza, and did nothing for her family in return.  The book criticizes phony consent, and advocates sharing  cell line proceeds with donors and their families. It rekindled discussion of consent and racist legacies, while urging that injustice required social change.

Continue reading

NPRM Symposium: Consent, Causality, and Castles in the Air

Part Six of Seven-Part Blog Series by Guest Blogger Patrick Taylor

Reading the NPRM and its government commentary, one is subtly, slowly led to a sense of inevitability.  Arguments from abstract principles emerge, leave a footprint and then, in the wake of another tide of interests and arguments, another principal supplants them.  But we are to believe that each previous  footprint endures intact.  There’s “autonomy,” said to require expanding opportunity to consent to honor individual preferences, overtrodden by scientific convenience, which demands just one-time consent, and suggests that world-changing choices to be privacy-bare may be irrevocable.  There’s privacy demanding that information meet HIPAA deidentification standards at least some of the time; but there is some undisclosed vector requiring that there is no limit on who government may share your medical information with.  Surrender to the illusion that these are not inconsistent,  and the proposal is the best of all possible worlds, in which every inconsistent good is maximized and every tradeoff ignored.  Surrender the illusion itself and one sees a mix of juxtaposed  partial-prints going different directions, each incomplete.

Continue reading

NPRM Symposium: “I prefer to be asked”

Part Five of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The preamble to the NPRM justifies requiring consent for data and specimen research by contending  that studies indicate that people want to be asked for permission.  However, the literature on this topic is relatively thin.  Available evidence suggests that many people, upon being informed that their heath data and tissues could or would be used in research without their consent (and nothing further is said to prompt the idea that research might delve into controversial matters) are generally fine with such use.  But when also queried whether they would prefer to have been asked, people say they would.  What the literature does not show is that people say: “I object to any use without my consent,” let alone “and I choose that over all the advantages of minimal risk research involving analysis by a computer of digitized files not humanly readable limited to disease-gene associations of thousands of medical records where consent would not be possible but the results will be essential or important to my health, the health of others, and the national health.”  Pluralistic discussion of tradeoffs over time, or an extended, candid national dialogue about the reasons for the present rules, were not in the mix.   Yet still, people said the opposite of “This must not occur without my consent!”

We have already seen one way in which the claim to be respecting the preference to be asked is untrue – it applies to only some research by some organizations.   Now here is another. The commentaries to the NPRM celebrate as fact that a patient need be asked only once, for all time, and then the only acceptable “yes” answer grants permission for any research by anybody.    It seems doubtful that a one-time consent to any future scientific research by any researcher for any purpose, without ever going back to inform or re-query,  without any regulatory provisions ensuring it was revocable, was what  participants meant by  “being asked.” Rationally, that option is far worse than no consent, for reasons we shall come to. Continue reading

NPRM Symposium: So many left behind…

Part Four of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The development of research benefits depends on research participation.  Research participation, in turn, depends on being asked to participate, and how people evaluate what is being asked of them.  This post focuses on a few, not all, of those disproportionately excluded from research through one mechanism or another.  It illustrates some of what the proposed amendments to the Common Rule governing human subjects research will likely mean in practice absent some special vector that changes the outcome.  We will discuss what such a social vector might look like at the end.

We will start with those people who, understanding the real impact and meaning of providing their “blanket consent” to research, and uncomfortable with the sweeping right to invade and permit others to invade their privacy, refuse to sign it.   Who are they? Continue reading

NRPM Symposium: “We are holding health care for ransom, just get naked already!” or “Consent neutrality is non-neutral in effect”

Part Three of Seven-Part Blog Series by Guest Blogger Patrick Taylor

In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data.  The answer is a big “No,” based on their scope.  If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies.   Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.

The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data.  “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing.   Such an approach will eliminate most or any choice about what one is consenting to.  It will require consent to any research by anybody using any technique, with any goal in mind.  The options will be to consent to that or not consent at all. Continue reading

NPRM Symposium: Privacy and Promises, Promises, Promises

Part Two of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The first blog post in this series probably provided a few surprises, but the surprises are just beginning. Can the NPRM to amend the Common Rule keep its promises?

The NPRM promises that patients will be able to consent to use of their clinical data in research, which is actually two promises, not one. The first is that the consent will be given effect. The second is that the refusal will be given effect.  As to refusal, the NPRM absolutely does not keep its promise.

The NPRM is filled with page after page of exceptions where your consent is not required. These include examples like trailing you and spying on you in public, some tests done on how to affect children’s behavior, and more. Continue reading

NPRM Symposium: Your Privacy or Your Life – Human Research Subjects and the Great Healthdata Giveaway

Part One of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The recent Apple-FBI controversy has highlighted the fact that our government, obligated to protect our privacy in some contexts, actively undermines it in others. The same internal conflict of interest is responsible, at least in part, for the U.S. government’s recent proposal to revise longstanding regulations to protect people who participate in research.

The proposals emerged last September, 2015, and were hailed as the first major reworking of the regulations in several decades, four years after an Advance Notice of Proposed Rulemaking buried somewhat different approaches to the same desired adverse privacy effects in a tome of hundreds of pages. It’s a safe bet that few if any members of the public not professionally involved ever read them. The feds gave themselves four years to consider and devise the current proposal, but they gave the public about four months to consider it and with no evident structured interaction with public opinion. Continue reading

The Common Rule NPRM Blog Series: Posting of Consent Forms

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent form (absent any signatures) for each clinical trial conducted or supported by a Common Rule department or agency to be posted (within 60 days after the trial is closed for recruitment) on a publically available federal website that would be established for such purpose.

In Part 3 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM, we address the rationale behind this proposal and its potential benefits, downsides, and missed opportunities. Continue reading

Some Commentary on How to Think About Secondary Research with Biospecimens

The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when.  One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers.  This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens.  How should we feel about this status quo, and the proposed change?  My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement.  There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out.  But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.

Rebecca Skloot feels otherwise.  She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa  – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission.  Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity.  Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem?  And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists.  Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.

Continue reading

NPRM Symposium: How Should We Think About Whether To Donate Our Leftover, Non-Identified Tissue to Research?

Proposed changes to the federal Common Rule would ask patients for the first time to decide whether to allow their non-identified, leftover tissue to be used for research or thrown away. For that choice to be meaningful, the public needs to be aware of the nature, risks, and benefits of biospecimens research, and of what the proposed changes will—and will not—do. In my latest Forbes essay, “No, Donating Your Leftover Tissue To Research Is Not Like Letting Someone Rifle Through Your Phone,” I consider the power of analogies and other reflections on Rebecca Skloot’s recent New York Times op-ed on the NPRM.

NPRM Symposium: When will regs be revised again? & Marcia Angell in NYRB

There is plenty to say about the proposed changes to the Common Rule that the Office of Human Research Protections announced in September. But it’s striking to consider what is left unsaid—that the regulations will need to be revised again in the near future.

When the final revisions are published (in late 2016, so they say), the rules should include a plan to revise again in ten years. This plan is already in place in for a few areas covered in the proposed revisions, but it is imperative that OHRP extend this requirement to the entire new rule.

Continue reading

Blog Series on NPRM at PRIM&R’s “Ampersand”

Our colleagues at PRIM&R are hosting a series on “Unpacking the NPRM.” Check it out at their blog Ampersand, or by clicking on the links below!

The Common Rule NPRM: Single IRB Review

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question in the U.S. Part 2 of our Academic and Clinical Research Group (“ACRG”) blog series on the Common Rule NPRM addresses the NPRM’s proposal to require U.S. institutions engaged in domestic cooperative research to rely on a “single IRB” to provide review of the research on their behalf in most circumstances. This proposal remains a constant from the Advanced Notice of Proposed Rulemaking (“ANPRM”) that was published in 2011, despite comments from the regulated community suggesting that HHS take steps to encourage various types of IRB reliance arrangements but stop short of a mandate. We expect that many institutions may be planning to comment again on whether single IRB review should become a mandate and on the associated relative burdens and benefits of such review (whether it is mandatory or permissive). This blog post does not comment on logistical implementation issues or on the cost assumptions provided by HHS in support of the proposal. Rather, we outline below some additional questions and issues that organizations may wish to consider or address in submitting comments on the proposal.

Thanks to a just-granted 30-day extension of the public comment period for the NPRM, comments on the NPRM are now due to HHS by January 6, 2016. The ACRG has prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed changes.

ACRG Rapid Rundown: Six Things You Need to Know

Continue reading

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Continue reading

Introducing NPRM Symposium Blogger Govind Persad

GPersad 8-23-12Govind Persad will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.

Govind is a postdoctoral fellow at Georgetown University and will be an Assistant Professor (beginning 2016) in the Department of Health Policy and Management and Berman Center for Bioethics at Johns Hopkins University. His research is at the intersection of political philosophy, applied ethics, and health law.

Govind has been a visiting scholar at the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds a JD/PhD from Stanford, where he was a student fellow at Stanford’s Center on Law and Biosciences; he was a pre-doctoral fellow at the Department of Bioethics, National Institutes of Health.

Representative publications:

The Common Rule NPRM: Biospecimens

By: Academic and Clinical Research Group at Verrill Dana LLP

[Crossposted from the The Common Rule NPRM Blog Series on the Endpoints Blog]

As we previously announced, sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”).  The Common Rule NPRM is the latest development since the Advanced Notice of Proposed Rulemaking (“ANPRM”) was published on July 26, 2011.  The Academic and Clinical Research Group (“ACRG”) will be publishing a series of topic-specific blogs in the coming weeks to assist institutions in digesting various aspects of the proposed regulations, preparing to submit any comments by the December 7, 2015 deadline, and grappling with implementation changes once the final rule issues.  We have also prepared an unofficial redline of the proposed changes against the existing regulations and a set of decision charts to assist with navigating the proposed revisions.

In this installment, we discuss the NPRM’s proposed changes to biospecimens research.  The NPRM did not back down from one of the more controversial aspects of the ANPRM, proposing a fundamental shift in the applicability of the human subjects protection framework to non-identified biospecimens research.  However, once the shock of the new definition of “human subject” wears off, the reality is that most of the changes codify how the research community has tried to apply the existing Common Rule to the challenging arena of biobanking, secondary research, and genomic and other “omics” research.  That said, many of the carve-outs (i.e., exclusions and exemptions) intended to balance this shift are more restrictive than at first they seem.

ACRG Rapid Rundown:  Six Things You Need to Know Continue reading

NPRM Symposium: More Resources, Now from OHRP

The Office for Human Research Protections (HHS) has released a series of 6 webinars to help the public better understand the goals and impact of the NPRM.  Happy viewing:

  1. Overview of the NPRM (approx. 34 mins.), Jerry Menikoff, Director, OHRP
  2. Exclusions and Exemptions (approx. 30 mins.), Jerry Menikoff, Director, OHRP
  3. Informed Consent (approx. 28 mins.), Jerry Menikoff, Director, OHRP
  4. IRB Review and Operations (approx. 18 mins.), Julia Gorey, Policy Analyst, Division of Policy and Assurances, OHRP
  5. Research with Biospecimens (approx. 22 mins.), Julie Kaneshiro, Deputy Director, OHRP
  6. Secondary Research Use of Data (approx. 21 mins.), Ivor Pritchard, Senior Advisor to the Director, OHRP

NPRM Symposium: Resources from PRIM&R

Our colleagues at PRIM&R (Public Responsibility in Medicine & Research) have compiled several resources to help those interested in the proposed changes to the Federal Policy for the Protection of Human Subjects, or the Common Rule.  These include an NPRM Resources page, with a chart comparing the current Common Rule with the proposed changes by section, and other materials.  PRIM&R has also recently released a freely available (till December 11, when it becomes available only to members) annotated version of the current Common Rule, which provides the regulatory text, hyperlinked to further information in the form of guidance, frequently asked questions, and regulatory resources from the Office for Human Research Protections.

PRIM&R will be blogging about the NPRM in the coming weeks, and we will cross-post here.  Stay tuned.

NPRM Symposium: Helpful Resources to Understand What the NPRM Proposes to Change

For those trying to make sense of the NPRM, the Academic and Clinical Research Group at Verrill Dana has issued two very helpful resources: 

  1. A redline of HHS’s current Common Rule regulations at 45 C.F.R Part 46, Subpart A against the proposed regulations in the NPRM.
  2. Several decision charts walking through the following issues: 
  • the scope of covered human subject research and clinical trials,
  • the key definitions of “human subject” and “research,”
  • the exclusions (and conditions for exclusion) from the proposed regulations, and
  • the exemptions (and associated requirements) from the proposed regulations.

For those interested, the firm’s full client advisories on the NPRM are available here

[Posted with Verrill Dana’s permission]

NPRM Symposium: Escape for Many, Scant Relief for Those Left Behind

While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.

[Cross-posted from Institutional Review Blog]

Continue reading