When I was a teenager, my grandfather would invite my new boyfriends to run short, pointless errands with him, just so he could watch them drive. He said he could tell a lot about a boy’s character simply by observing his actions behind the wheel. Did he stay under the speed limit? Did he use his signal when he was switching lanes? Did he slow down when children were playing near the road? If so, it was a good sign that the boy was generally a careful and attentive fellow. If not, it was an early indication of reckless tendencies, and I would do well to be on my guard.

What does this have to do with PI oversight?



As Sponsors and CROs, you’re sometimes forced to make site selection decisions based on a limited set of criteria that you deem to be – hope to be – reflective of the site as a whole. In a short space of time, you need to assess a PI’s commitment to study oversight. On what should your pre-study “test drive” focus to help you gauge the level of care and attention a prospective PI will devote to your study?

We have some suggestions.


Assessing Attention to Detail
Any GCP-compliant site can produce a set of current CVs, job descriptions, and training records; they’re essential documents. But the most attentive sites are able to show you more than a collection of records during your pre-study visit with them. These sites keep a complete, organized set of uniform records and can describe their tight system for maintaining it. All documents for each staff member are found in dedicated tabs inside a records binder, or are equally well-organized in an electronic records system. All CVs are in a standard format so Sponsors can easily compare qualifications across individuals. Every document is current; CVs are up to date, and there’s a system in place to track which medical licenses are expiring when. Training records are comprehensive and include training on GCP regulations, site SOPs, and EMRs.

This is not sexy stuff. That’s why it’s a good indicator of PI oversight.  A site that is disciplined enough to keep such tight control over its personnel records is likely to carry that control into all aspects of trial execution.

Assessing Commitment to Protocol Compliance
During site initiation visits, Sponsor/CRO staff is on site to conduct protocol training; all study sites start off the same in this respect. But protocol amendments are inevitable, and sometimes – though nobody’s happy about it – frequent. You need assurances that a site’s response to each amendment will be swift, well-coordinated, and deliberate. Ask the prospective PI, “What procedures does your site follow for managing protocol amendments?”

The A answer:
“When a protocol amendment arrives, we convene a special team meeting to review the changes and discuss their effects. For example, if additional safety tests are required, the team discusses who shall be delegated to perform them? Do we have adequate time scheduled into the visit for any additional procedures the amendment requires? How will I be demonstrating oversight of any new test results? Once we’ve asked and answered these kinds of questions, we document attendance at the meeting, record assignments of delegated duties, and publish meeting minutes.”

The F answer:
“I email the amendment out to my team. I assume they’re all adults and know how to read.” (#TrueStory)

Just Ask
After reviewing essential documents and protocol amendment procedures, you should ask about other PI oversight mechanisms the site has in place. A good prospective site might tell you the PI holds biweekly meetings to review the items raised during monitoring visits. A PI may block out time at regular intervals to review adverse events and other study documents, and sign off on labs. A PI who values staff excellence may actively encourage and support Study Coordinator certification; some may even require it after an initial period of employment. In the past, we’ve worked with sites that have established internal Quality Control procedures, some maintain CAPA programs, and others conduct mock inspections.

There’s a wide variety of responses that can give you confidence a prospective PI is committed to running your study in a constant state of control. Whatever oversight measures are discussed, remember to ask how they will be documented, so during the study you’ll be able to verify that each activity is being consistently carried out.

Epilogue
After running an errand with a boy I met at college, my grandfather happily reported back to me, “He didn’t roll through a single stop sign coming down Green Hill Road. He’s all right, that one.”

My grandfather, a retired police detective for the city of Pittsburgh, knew how to read a person. That boy and I celebrated our 30th anniversary last month.

I was a child bride.

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In an April report that warns of the risks of fraud in mail-in voting, a conservative legal group significantly inflated a key statistic, a ProPublica analysis found. The Public Interest Legal Foundation reported that more than 1 million ballots sent out to voters in 2018 were returned as undeliverable. Taken at face value, that would represent a 91% increase over the number of undeliverable mail ballots in 2016, a sign that a vote-by-mail system would be a “catastrophe” for elections, the group argued.

However, after ProPublica provided evidence to PILF that it had in fact doubled the official government numbers, the organization corrected its figure. The number of undeliverable mail ballots dropped slightly from 2016 to 2018.

The PILF report said that one in five mail ballots issued between 2012 and 2018, a total of 28.3 million, were not returned by voters and were “missing,” which, according to the organization, creates an opportunity for fraud. In a May 1 tweet that included a link to coverage of the report, President Donald Trump wrote: “Don’t allow RIGGED ELECTIONS.”

PILF regularly sues state and local election officials to force them to purge some voters from registration rolls, including those it claims have duplicate registrations from another state or who are dead. It is headed by J. Christian Adams, a former Justice Department attorney who was a member of the Trump administration’s disbanded commission on election integrity.

The report describes as “missing” all mail ballots that were delivered to a valid address but not returned to be counted. In a statement accompanying the report, Adams said that unaccounted-for ballots “represent 28 million opportunities for someone to cheat.” In particular, the organization argues that the number of unreturned ballots would grow if more states adopt voting by mail.

Experts who study voting and use the same data PILF used in the report, which is from the Election Administration and Voting Survey produced by the federal Election Assistance Commission, say that it’s wrong to describe unreturned ballots as missing.

“Election officials ‘know’ what happened to those ballots,” said Paul Gronke, a professor at Reed College, who is the director of the Early Voting Information Center, a research group based there. “They were received by eligible citizens and not filled out. Where are they now? Most likely, in landfills,” Gronke said by email.

A recent RealClear Politics article based on the PILF report suggested that an increase in voting by mail this year could make the kind of fraud uncovered in North Carolina’s 9th Congressional District in 2018 more likely. In that case, a political consultant to a Republican candidate was indicted on charges of absentee ballot fraud for overseeing a paid ballot collection operation. “The potential to affect elections by chasing down unused mail-in ballots and make sure they get counted — using methods that may or may not be legal — is great,” the article argues.

PILF’s report was mentioned in other news outlets including the Grand Junction Sentinel in Colorado, “PBS NewsHour” and the New York Post. The Washington Times repeated the inaccurate claim of 1 million undeliverable mail ballots.

In a statement, the National Vote at Home Institute, an advocacy group, challenged the characterization of the 28.3 million ballots as missing. Of those ballots, 12 million were mailed by election officials in Colorado, Oregon and Washington, which by law send a mail-in ballot to every registered voter, roughly 30% of which are not returned for any given election. “Conflating voters choosing not to cast their ballots with ‘missing’ ballots is a fundamental flaw,” the statement reads.

In an interview, Logan Churchwell, the communications director for PILF, acknowledged the error in the number of undelivered ballots, but defended the report’s conclusions, saying that it showed potential vulnerabilities in the voting system. “Election officials send these ballots out in the mail, and for them to say ‘I have no idea what happened after that’ speaks more to the investments they haven’t made to track them,” he said in a telephone interview.

But 36 states have adopted processes where voters and local officials can track the status of mail ballots through delivery, much like they can track packages delivered to a home. Churchwell said there are other explanations why mail ballots are not returned and that state and local election officials could report more information about the status of mail ballots. “If you know a ballot got to a house, you can credibly say that ballot’s status is not unknown,” he said.

The EAVS data has been published after every general election since 2004, although not every local jurisdiction provides complete responses to its questions.

In the data, election officials are asked to provide the number of mail ballots sent to voters, the number returned to be counted and the number of ballots returned as undeliverable by the U.S. Postal Service, which provides specific ballot-tracking services. The survey also asks for the number of ballots that are turned in or invalidated by voters who chose to cast their ballots in person. It asks officials to report the number of ballots that do not fit into any of those categories, or are “otherwise unable to be tracked by your office.”

Gronke described the last category as “a placeholder for elections officials to put numbers so that the whole column adds up,” and said that there was no evidence to support calling those ballots a pathway to large-scale voter fraud.

Numerous academic studies have shown that cases of voter fraud are extremely rare, although they do occur, and that fraud in mail voting seems to occur more often than with in-person voting.

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The 2018 National Defense Strategy (NDS) is predicated on a single organizing principle: America’s military pre-eminence is rapidly eroding. This is not a new concept. For years, experts have warned that the economic and technological advancements of U.S. adversaries, coupled with the 2008 financial crisis and America’s focus on peripheral conflicts, have caused a decline in America’s military dominance. 

In this context, the advances of near-peer competitors such as China and Russia have created plausible “theories of victory” in potential conflicts across Eastern Europe and East Asia. Competitors’ unaddressed improvements in strategic innovation, economic investment, and dual-use technology increases the risk of conflict and strains the U.S. alliance system. It is urgent that the United States reestablish and maintain credible deterrents against these near-peer competitors. After decades of focusing on post-Cold War ‘shaping’ operations, the American military needs to reinvigorate for full spectrum great power competition.

This report is intended as a blueprint on how to begin that process from graduate students at the Belfer Center for Science and International Affairs at Harvard University. Contained inside are 12 memorandums. Each provides a high-level overview and specific recommendations on a key issue of American defense policy. 

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In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

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How do presidents incorporate morality into decisions involving the national interest? Moral considerations explain why Truman, who authorized the use of nuclear weapons in Japan during World War II, later refused General MacArthur's request to use them in China during the Korean War. What is contextual intelligence, and how does it explain why Bush 41 is ranked first in foreign policy, but Bush 43 is found wanting? Is it possible for a president to lie in the service of the public interest? In this episode, Professor Joseph S. Nye considers these questions as he explores the role of morality in presidential decision-making from FDR to Trump.

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How do presidents incorporate morality into decisions involving the national interest? Moral considerations explain why Truman, who authorized the use of nuclear weapons in Japan during World War II, later refused General MacArthur's request to use them in China during the Korean War. What is contextual intelligence, and how does it explain why Bush 41 is ranked first in foreign policy, but Bush 43 is found wanting? Is it possible for a president to lie in the service of the public interest? In this episode, Professor Joseph S. Nye considers these questions as he explores the role of morality in presidential decision-making from FDR to Trump.

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Stephen Walt writes that the United States' unusual historical experience, geographic isolation, large domestic market, and general ignorance have weakened its ability to make viable foreign-policy strategies.

Jan 21, 2020

Joseph Nye's new book rates the efforts of presidents from FDR to Trump.

Mar 2, 2020

How do presidents incorporate morality into decisions involving the national interest? Moral considerations explain why Truman, who authorized the use of nuclear weapons in Japan during World War II, later refused General MacArthur's request to use them in China during the Korean War. What is contextual intelligence, and how does it explain why Bush 41 is ranked first in foreign policy, but Bush 43 is found wanting? Is it possible for a president to lie in the service of the public interest? In this episode, Professor Joseph S. Nye considers these questions as he explores the role of morality in presidential decision-making from FDR to Trump.

Apr 24, 2020

In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

Apr 24, 2020

In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

Apr 24, 2020

In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

Apr 24, 2020

In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

Mar 24, 2020

The 2018 National Defense Strategy (NDS) is predicated on a single organizing principle: America’s military pre-eminence is rapidly eroding. This is not a new concept. For years, experts have warned that the economic and technological advancements of U.S. adversaries, coupled with the 2008 financial crisis and America’s focus on peripheral conflicts, have caused a decline in America’s military dominance. 

In this context, the advances of near-peer competitors such as China and Russia have created plausible “theories of victory” in potential conflicts across Eastern Europe and East Asia. Competitors’ unaddressed improvements in strategic innovation, economic investment, and dual-use technology increases the risk of conflict and strains the U.S. alliance system. It is urgent that the United States reestablish and maintain credible deterrents against these near-peer competitors. After decades of focusing on post-Cold War ‘shaping’ operations, the American military needs to reinvigorate for full spectrum great power competition.

This report is intended as a blueprint on how to begin that process from graduate students at the Belfer Center for Science and International Affairs at Harvard University. Contained inside are 12 memorandums. Each provides a high-level overview and specific recommendations on a key issue of American defense policy. 

Apr 24, 2020

In his new book, Do Morals Matter? Presidents and Foreign Policy from FDR to Trump, Joseph S. Nye developed a scorecard to determine how U.S. presidents since 1945 factored questions of ethics and morality into their foreign policy. In an interview, Henry Farrell asked him a few questions to get to the heart of his findings.

Mar 24, 2020

The 2018 National Defense Strategy (NDS) is predicated on a single organizing principle: America’s military pre-eminence is rapidly eroding. This is not a new concept. For years, experts have warned that the economic and technological advancements of U.S. adversaries, coupled with the 2008 financial crisis and America’s focus on peripheral conflicts, have caused a decline in America’s military dominance. 

In this context, the advances of near-peer competitors such as China and Russia have created plausible “theories of victory” in potential conflicts across Eastern Europe and East Asia. Competitors’ unaddressed improvements in strategic innovation, economic investment, and dual-use technology increases the risk of conflict and strains the U.S. alliance system. It is urgent that the United States reestablish and maintain credible deterrents against these near-peer competitors. After decades of focusing on post-Cold War ‘shaping’ operations, the American military needs to reinvigorate for full spectrum great power competition.

This report is intended as a blueprint on how to begin that process from graduate students at the Belfer Center for Science and International Affairs at Harvard University. Contained inside are 12 memorandums. Each provides a high-level overview and specific recommendations on a key issue of American defense policy.