Category: Human Subjects Research

New Data Reports on Learning “Research Integrity”

lstark Leave a comment

When it comes to research with human subjects, about 60 percent of faculty members and 50 percent of graduate students learned about ethics through online or print resources according to a recent survey. These data could be seen as good or bad news—depending on how you feel about getting your ethics through online training modules, such as CITI. These stats—and many more measures of ethics—are included in a remarkable new data set collected and made publicly available by the Council on Graduate Schools.

The data set is a great resource. Anyone with a browser can build custom tables that include different variables and topics related to “research integrity.” Users can slice data by fields of training (life sciences, social sciences, etc.) and by rank of researcher (faculty members, postdocs and graduate students).

Here is the punch line on human-subjects training—and a few questions about the data (the CGS has covered questions about methodology covered):

Read More

Upcoming Event – The Guatemala STD Inoculation Studies: What Should We Do Now?

kparas Leave a comment

Tuesday, November 13, 2012
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.

 

Reminder, TODAY – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

kparas Leave a comment

TODAY!
12-1:30pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Pharmacy Compounding: Federal Law in Brief

Jonathan Darrow Leave a comment

by Jonathan J. Darrow

Until recently, most ordinary people had never heard of “pharmacy compounding.”  Then, a number of deaths and illnesses caused by a drug that was compounded in a Framingham, Massachusetts pharmacy propelled drug compounding to the national spotlight (see, e.g., Denise Grady et al., Scant Oversight of Drug Maker in Fatal Meningitis Outbreak, N.Y. Times, Oct. 6, 2012).

Compounding is the practice of preparing a drug for an individual patient’s needs, and is used when those needs cannot be met by a mass-produced drug.  See Thompson v. Western States Medical Center, 535 U.S. 357, 360 (2002).  For example, if a patient is allergic to a particular excipient (inactive ingredient) in an FDA-approved medicine, a doctor may order a special compounding pharmacy to prepare the medicine without that excipient. Because of the very small scale of compounding, Congress in 1997 attempted to exempt (via 21 U.S.C. § 353a) the industry from a number of provisions of the Food Drug and Cosmetic Act, including the requirement to submit a new drug application prior to interstate sale (21 U.S.C. § 355), the requirement that the drug labeling bear “adequate directions for use” (21 U.S.C. § 352(f)(1)), and the need to strictly follow good manufacturing practices, or GMP (see 21 U.S.C. § 351(a)(2)(B)).  A number of controls on compounding were included, however, such as the requirement that there be a valid prescription from a licensed practitioner (21 U.S.C. § 353a(a)(1)), that the drug be compounded by a licensed pharmacist (or physician) (21 U.S.C. § 353a(a)(1)), and that the drug be compounded from ingredients that meet certain quality standards (21 U.S.C. § 353a(b)(1)(A)–(B)).

However, § 353a—and with it, all of the provisions and exemptions just mentioned—was held unconstitutional in its entirety in Western States Medical Center v. Shalala, 238 F.3d 1090 (9th Cir. 2001), aff’d 535 U.S. 357 (2002), on the basis of certain restrictions on free speech that were also contained within the statute and which, according to the Ninth Circuit, could not be severed from the remaining provisions because “Congress intended to exempt compounding from the FDCA’s requirements only in return for a prohibition on promotion of specific compounded drugs.” See 535 U.S. at 366. Thereafter, the FDA promulgated a policy by which it would primarily “defer to state authorities regarding less significant violations” but would enforce a number of provisions relating to ingredient standards, unapproved substances, commercial scale production, adulteration, and promotion.  The FDA made clear that its enforcement activities “need not be limited to” these or any particular areas, however, thus negating any expectations that Congress’ now-invalidated exemptions might nevertheless provide a safe harbor through the weight of influence, if not law. Since then, the FDA has in fact exercised oversight of compounding pharmacies, as is evident from the handfuls of warning letters that it sends to non-compliant facilities each year.  These letters have addressed, for example, promotion that made unsubstantiated efficacy claims, contamination, and the large-scale manufacture of what were essentially copies of FDA-approved drugs.

Read More

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

kparas Leave a comment
Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

Bleg: IRBs & Health Disparities Research

mmeyer 4 Comments

By Michelle Meyer

As most readers of this blog well know, health disparities of various kinds are rampant in the U.S. — in obesity, infant mortality and morbidity, cardiovascular health, and many other areas. In most cases, however, we seem to know more about the extent of health disparities than we do about what causes and what is most likely to ameliorate them.

To rectify this situation, we need to conduct research — and lots of it. Typically, however, health disparities research will have to occur with the same populations who are most likely to be considered vulnerable and in need of extra protections from research. Often, moreover, health disparities research will need to occur in the clinical setting (as opposed to the lab), where patients normally rightly expect that everything done there is designed to serve their individual best interests, rather than to produce generalizable knowledge. Health disparities research might involve research methodologies that are relatively unfamiliar to IRBs, such as community-based participatory research (CBPR), which blurs the traditional distinction between investigator and subject on which the regulations are built. To the extent that disparities are thought to derive from provider discrimination or bias, researchers may face difficulties from a research review system that is designed to protect all “subjects,” including professionals who are incompetent or worse. Eventually, health disparities research scales up to multiple research sites, which usually requires approval from multiple, often conflicting, IRBs. Many interventions to address health disparities, finally, will take the form of public policy rather than clinical treatment. If we want such policies to be evidence-based (and we should), they will have to be tested, perhaps in ways that raise legal or ethical issues (say, randomizing a state’s Medicaid recipients to receive or not receive particular benefits, or randomizing the businesses in a jurisdiction to be required to display nutrition information on the food they sell — or not).

I’m delighted to have received so many comments, both on- and offline, on my last IRB post from those with experience in the research trenches. As I begin a new project along these lines, I would be very interested in hearing again from both researchers and research reviewers with experience in health disparities research, whether you have struggled with these or similar issues (or have abandoned research plans at least partly out of fear of such problems), or have experienced smooth sailing. Feel free to leave comments here, anonymously if you wish, or contact me directly at mmeyer at law dot harvard dot edu. Many thanks in advance.

Physician-Assisted Suicide in MA

Holly Fernandez Lynch 1 Comment

Next Tuesday, those of us registered in Massachusetts will have the opportunity to vote on “Question 2” – prescribing medication to end life, otherwise known as physician-assisted suicide.  As described by the state secretary, “This proposed law would allow a physician licensed in Massachusetts to prescribe medication, at a terminally ill patient’s request, to end that patient’s life. To qualify, a patient would have to be an adult resident who (1) is medically determined to be mentally capable of making and communicating health care decisions; (2) has been diagnosed by attending and consulting physicians as having an incurable, irreversible disease that will, within reasonable medical judgment, cause death within six months; and (3) voluntarily expresses a wish to die and has made an informed decision.”  There are, of course, a number of other safeguards built in, such as the need to make the request twice, separated by 15 days, in the presence of witnesses.  However, there could probably be stronger safeguards to protect individuals who are experiencing depression and anxiety, and might have preferable alternatives to physician-assisted death.

The proposed law is similar to measures already in place in Oregon and Washington state, where statistics show relatively low uptake and certainly not the sort of slippery slope that critics seem to be worried about.  In today’s NY Times, however, Zeke Emanuel describes 4 myths about physician-assisted suicide that might give some pause to people like me who plan to vote “Yes” on Question 2.  In the end, though, it strikes me that preserving room for maximal choice in these difficult end-of-life situations is for the best.

Without delving into the merits, which has been done very well elsewhere, let me just make a quick note about something else that struck me re: Question 2, which was the pamphlet of materials I received at home about the ballot measure.  It came from the state secretary, had an excellent, understandable summary of the law and what it would do, and included brief statements for and against written by selected advocates.  I thought this was an incredible mechanism to promote informed voting and deliberative democracy – and because I always have human subjects research ethics on the brain, it made me think of the possible ways this approach could be adapted to improve informed consent.  Perhaps traditional consent forms could be accompanied by a brief neutral statement about a study from the IRB, followed by short statements pro and con about the decision to participate. Just a thought.

And finally, one more note: we’re having a bioethics-heavy election day in Massachusetts this year.  Question 3 is about whether we should eliminate state criminal and civil penalties for the medical use of marijuana by qualifying patients.

 

Conflicting Interests in Research: Don’t Assume a Few Bad Apples Are Spoiling the Bunch

srivera Leave a comment

by Suzanne M. Rivera, Ph.D.

In August of 2011, the Public Health Service updated its rules to address the kind of financial conflicts of interests that can undermine (or appear to undermine) integrity in research.  The new rules, issued under the ungainly title, “Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors,” were issued with a one-year implementation period to give universities and academic medical centers sufficient time to update their local policies and procedures for disclosure, review, and management (to the extent possible) of any conflicts their researchers might have between their significant personal financial interests and their academic and scholarly activities.

The rules were made significantly more strict because a few scoundrels (for examples, click here, and here) have behaved in ways that undermined the public’s trust in scientists and physicians. By accepting hundreds of thousands, even millions, of dollars from private pharmaceutical companies and other for-profit entities while performing studies on drugs and devices manufactured by the same companies, a few bad apples have called into question the integrity of the whole research enterprise.  This is a tremendous shame.

Having more than one interest is not bad or wrong; it’s normal.  Everyone has an attachment to the things they value, and most people value more than one thing.  Professors value their research, but they also want accolades, promotion, academic freedom, good parking spots, and food on their tables.  Having multiple interests only becomes a problem when the potential for personal enrichment or glory causes someone (consciously or unconsciously) to behave without integrity and compromise the design, conduct, or reporting of their research. Read More

Fear of a Digital Planet

srivera 2 Comments

by Suzanne M. Rivera

Federal regulations and ethical principles require that Institutional Review Boards (IRBs) consider the anticipated risks of a proposed human research study in light of any potential benefits (for subjects or others) before granting authorization for its performance.  This is required because, prior to the oversight required by regulation, unethical researchers exposed subjects to high degrees of risk without sufficient scientific and ethical justification.

Although the physical risks posed by clinical research are fairly well understood, so-called “informational risks”—risks of privacy breaches or violations of confidentiality— are the source of great confusion and controversy.  How do you quantify the harm that comes from a stolen, but encrypted, laptop full of study data?  Or the potential for embarrassment caused by observations of texted conversations held in a virtual chat room?

IRBs have for years considered the potential magnitude and likelihood of research risks in comparison to those activities and behaviors normally undertaken in regular, everyday life.  But everyday life in today’s digital world is very different from everyday life in 1981 when the regulations were implemented.  People share sonogram images on Facebook, replete with the kinds of information that would, in a research context, constitute a reportable breach under the Office of Civil Rights’ HIPAA Privacy Rule.  They also routinely allow their identities, locations, and other private information to be tracked, stored, and shared in exchange for “free” computer applications downloaded to smart phones, GPS devices, and tablet computers. Read More

Exempt Research & Expedited IRB Review: Curb Your Enthusiasm

mmeyer 16 Comments

By Michelle Meyer

A while back, over at PrawfsBlawg, Martin Pritikin had a useful post collecting advice for legal academics looking to break into increasingly popular empirical legal studies (ELS). As Jeremy Blumenthal notes in the comments, Step 1 is to be sure to get IRB approval. This post addresses what I’ll call, with a nod to Cass Sunstein’s work on Chevron deference, IRB Step Zero: Determine whether your research needs IRB approval at all.

Don’t worry, it’s an easy step: As Jeremy’s plenary admonition to all wannabe ELS scholars implies, the answer is almost certainly Yes. Although the regulations in theory establish three risk-based tiers of review — human subjects research (HSR) otherwise subject to IRB review that the regulations nevertheless exempt; HSR that is eligible for expedited review; and HSR that requires review by a fully convened IRB (everything else) — in practice, the first two tiers tend to collapse into the third. In this sense, and now I borrow from Matthew Stephenson and Adrian Vermeule, IRB review has only one step.

A quick note of clarification: As I’ve noted before (here and here), several projects I have in the works, beginning with Regulating the Production of Knowledge: Research Risk-Benefit Analysis and the Heterogeneity Problem, forthcoming next June in the Administrative Law Review, argue that we suboptimally regulate knowledge production. Just to be clear, my argument in that article doesn’t depend on my argument here about the broad scope of the regulations and their failed attempt to achieve risk-based levels of review.* Consider this post a public service for ELS types. That said, I draw here on The Heterogeneity Problem‘s background section, where interested readers will find the relevant citations.

Read More