PRIM&R's Primer on the ANPRM

PRIM&R is proud to have hosted two webinars on the Advance Notice of Proposed Rulemaking (ANPRM) that the Department of Health and Human Services released last month.



If you were unable to participate in the PRIM&R’s Primer on the ANPRM, please download the presentation slides, or purchase the archived webinar.



PRIM&R is in the process of generating comments, which are due by September 26, 2011, and encourages all of our members and supporters to participate. More information on comments we’ve already submitted may be found in the public policy section of our website

"Science Times" synthesis

Whether it’s "Law & Order," "Criminal Minds" or "CSI," many of us have a favorite crime scene show. Suspense, drama, and intrigue offer thought-provoking entertainment and a basic understanding of forensic investigation techniques, such as fingerprinting. But what if this form of identification remained unavailable to detectives? Read this week’s Science Times to learn more about a rare gene mutation that disables the development of fingerprints and footprints.



Just for fun, can you guess whose fingerprint appears below?



Week of August 1



No Prints? Evidence Points to Mutated Gene: Take a look at some research on adermatoglyphia, a rare disease that prevents the development of handprints and footprints.



Who Falls to Addiction, and Who Is Unscathed?: New studies indicate that drug abuse may be caused by a developmental brain disorder.



Study Says Dyslexia May Have Auditory Tie: Learn how deficiencies in auditory processing play a role in dyslexia, and why researchers believe an accurate diagnosis should begin with voice recognition testing among children.



Europe: Increase in Tropical Diseases is Aided by Migration and Weak Economies: Tropical diseases more prevalent in Africa and Asia are becoming increasingly common in Europe.



New HIV Cases Steady Despite Better Treatment: The unwavering rate of 50,000 AIDS infections per year over the last decade challenges the effectiveness of government prevention policy.





Week of August 7



Groups Call for Scientists to Engage the Body Politic: As scientific issues remain at the forefront of politics, many groups are encouraging scientists to become directly involved in policy making.



Chimpanzees Clear Some Doubt After Generosity Is Questioned: Through a study, researchers show how chimpanzees participate in prosocial behavior.



A Colorful Way to Watch Evolution in Nebraska’s Sand Dunes: A Harvard research group travels to the sandhills of Nebraska to study the genetic mechanism that causes pigmentation in deer mice, and the way in which it affects the animals’ fitness.



An Economist for Nature Calculates the Need for More Protection: Read about the innovative technology and policy that is inspiring environmental conservation around the globe.



Test Can Tell Fetal Sex at 7 Weeks, Study Says: Take a moment to consider the implications of these tests, and why doctors may be reluctant to prescribe them for patients.



10 Years and a Diagnosis Later, 9/11 Demons Haunt Thousands: Learn what experts are saying about post traumatic stress disorder, and how the horrors of 9/11 have left their mark on at least 10,000 New Yorkers.

Update on PRIM&R's response to the ANPRM

by Elisa Hurley, PhD

PRIM&R Education Director

On July 26, 2011, the Department of Health and Human Services’ (DHHS) Office of Human Research Protections (OHRP) published an advance notice of proposed rulemaking (ANPRM), titled Human Subjects Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, proposing substantial changes to the federal regulations governing human subjects protections known as the 'Common Rule.’

The public comment period is scheduled to be open through September 26, 2011, and PRIM&R is acting quickly to organize a response. As part of this effort, PRIM&R has convened an ANPRM Task Force, composed of 17 members of PRIM&R’s Board of Directors, public policy committee, and staff. The Task Force’s first undertaking was to submit a letter to OHRP requesting an extension of the comment period from the scheduled 60 days to 120 days (ending on November 24, 2011). If any organization you are affiliated with would like to send a similar request, please feel free to use this letter as a template.

At the same time, the Task Force is preparing its comments. PRIM&R will not attempt to respond to all 74 questions embedded in the ANPRM, though. Instead, PRIM&R will think in terms of what it can offer that others groups cannot, namely, a broad, impressionistic, conceptual view of the major topics around which changes are being proposed (e.g. privacy and confidentiality, data protection, minimization of risk, informed consent), rather than detailed proposals of how to achieve particular standards.

PRIM&R’s comments will focus on questions such as: Do the proposed changes go in the right direction? What are the potential problems and benefits associated the proposed changes? Are there considerations that have been left out of the ANPRM?

As PRIM&R’s ANPRM Task Force sets out to answer these questions, the group will follow a specific plan of action:

• The Task Force will be divided into four sub-task forces of approximately four to five people each. Each will have a group leader and will be assigned to draft comments on one of the major substantive sections of the ANPRM by early September.

• In early September, the sections will be compiled into one document, which will be circulated, edited, and submitted for approval or revisions to PRIM&R’s Executive Committee.

• Upon approval of the Executive Committee, PRIM&R’s comments will be submitted to OHRP, by September 26, 2011 (assuming the deadline does not change).

We will update you on our progress in this space, on our Twitter feed, and on our website. In the meantime, we’d love to hear what you and your colleagues are thinking about the proposed changes in the ANPRM.

The ANPRM’s Intersection with Boston College’s Oral History Study

Josh Glickenhaus, Swarthmore College senior and PRIM&R intern

The U.S. Department of Health and Human Services recently released an Advance Notice of Proposed Rulemaking (ANPRM), which outlines major proposed changes to the ‘Common Rule’ regulations for human subjects research.

The ANPRM proposes changes across a broad range of issues, including a proposal to excuse all survey/interview-based research from IRB review. Part of its justification for this move is the ANPRM’s creation of new standards for data security that would minimize the risk of informational breaches, which compose the main source of risk to subjects in such studies.

But the document also implies that most research of this sort poses only minimal risk to subjects, and thus full IRB review to consider protections above and beyond the new data security standards would be unnecessary. The authors of the ANPRM then seek confirmation on this point, asking, “Are there survey instruments or specific types of questions that should be classified as greater than minimal risk?”

This article in the Chronicle of Higher Education suggests that the answer is a resounding “yes.” It describes an oral history study conducted at Boston College that featured interviews with former members of the Provisional Irish Republican Army (PIRA), who discussed in frank detail their time as paramilitary fighters in Northern Ireland. Because of the highly sensitive nature of the matter—broad disclosure of the facts could endanger the interviewees—Boston College gave a confidentiality pledge not to disclose any of the research materials until after the subjects’ deaths.

Now that pledge is in jeopardy, as the interview tapes have been subpoenaed by the U.S. Department of Justice on behalf of the British government.

BC is currently fighting the subpoenas, arguing that its confidentiality pledge—and the consequences of breaking it—applies even to the Department of Justice. The outcome of the fight is yet to be determined in court.

What do you think about this example of how interview-based research can present greater-than-minimal risk? How can IRBs mitigate such risks? Should future studies with high-stakes informational risks merit some degree of oversight beyond the routine data protections called for by the ANPRM? Please share your thoughts in our comments section.

Clinical Research: Getting Beyond Common Myths and Misconceptions

by Victoria Pemberton, RNC, MS, CCRC

clinical trials specialist, National Heart, Lung, and Blood Institute



“The PHS Syphilis Study, Guatemala, Willowbrook, radiation experiments…” Despite decades of work to improve the safety of research subjects, these words bring to mind images of fear and the mistreatment of potential research participants, including children.



Excellence in research is essential to our health and quality of life. While many potential participants recognize the need for clinical studies, they continue to shy away from participating. The perceptions surrounding pediatric research can be even more challenging and exist not only among parents, but among healthcare providers as well. Consider these facts:

• Ninety-five percent of adults support studying new and existing medical treatments, devices, and medications in humans, yet only a fraction actually participate in clinical studies themselves (NCI, 2005).
• One in four U.S. adults would consider allowing their children to participate in clinical research studies (Gullo, 2004).
• Seventy percent of medications used in children are never tested in children (Children and Clinical Studies, 2009).
• Pediatricians and pediatric nurses agree that research is important but report that their role, as caregivers, often makes them less willing to encourage parents to participate in research (Singhal, 2004, Caldwell, 2004).

These statements illuminate what many believe—that clinical research is necessary while participation is not.



Children and Clinical Studies, a website hosted by the National Heart, Lung, and Blood Institute, is designed to help parents understand clinical research, what clinical studies mean for children, and what happens during the course of involvement. It also prepares parents to make informed decisions as to whether they participate. Parents, experts and children share their clinical trials experiences in award-winning videos that enhance learning. Pediatric healthcare providers and researchers have found the site helpful in answering their patients’ questions about research, and as a training tool for healthcare providers, IRB and medical trainees, and new pediatric researchers.