Remembering 50 Years In Research Administration

By SRAI JRA posted 04-04-2019 16:57

  

Volume L, Number 1

Remembering 50 Years In Research Administration

Authors
  • Ira S. Goodman
  • UC San Diego Moores Cancer Center

Introduction

2018 marks my golden anniversary in research administration. I started at New York University on July 15, 1968. Fifty years is a long time to spend in one profession. For me, it was a perfect match. I embraced academic research administration and witnessed transformative changes, a sampling of which is described below. This retrospective reflects my views on how research administration has evolved over a half century through regulations, technology and professional practice.

Over the course of my career I have held positions as a department administrator (twice), director of a grants office and administrator of NCI designated comprehensive cancer centers at two institutions—New York University and University of California, San Diego. Accordingly, I have witnessed the changes from the department, campus and research center levels.

The Regulatory Landscape

Fifty years ago research administration was in its infancy. The NIH budget was just under $1 billion as compared to the 2018 budget of $37 billion (Kaiser, 2018). There were 9 institutes; now there are 20 (not counting centers), and the flow of federal regulations was just beginning. The guiding principles I am most familiar with cover costs, property and protection of research subjects. The original OMB Circular A-21 was issued in 1958, and applied to research and development grants between the federal government and educational institutions. A-21 defined direct and indirect costs, and it set standards for accountability, documentation, and consistency. Institutions receiving less than $250,000 in awards were permitted to use a simplified method (short form) to calculate and allocate indirect costs. Over the 1960’s revisions of A-21 clarified and refined methods used in identifying, classifying, and distributing indirect costs, modification of effort-reporting requirements and in 1969 the federal funding limit was raised to $1 million for universities that wished to use the simplified method (short form). Principles and guidelines to be used in determining costs for training and educational service agreements were established. In 2015 OMB Circular A-21 was revamped in CFR Part 200 as Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. A-21 and its successor remain the ultimate source for interpreting and implementing federal regulations on research grant allowable costs relating to universities. The Public Health Service Grants Policy Statement (HHS, 2007 summarizes and categorizes the cost principles and should be a required reference resource for every research administrator.

We in the Office of Grants Administration and Institutional Studies, which was NYU Medical Center’s central grants office, were charged with the responsibility of monitoring the changes in federal cost principles and disseminating them to the accounting department and principal investigators. Regulations involving intellectual property and physical property also had a major impact on research and research administrators. The 1980 Bayh–Dole Act or Patent and Trademark Law Amendments Act changed the ownership of inventions made with federal funding. Previously, inventors had to assign inventions they made using federal funds to the federal government. Bayh–Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention independent of the government. Consequently, technology transfer offices rapidly sprung up at universities to capitalize on all inventions with commercial potential, including those made through federal funding. The Grants Office before 1980 was a clearinghouse for reporting inventions to the federal agencies; subsequently, inventors began dealing directly with the institutional technology transfer office and legal counsel to distill their inventions into patents.

In the 1990’s the federal government loosened its regulations on title to equipment purchased under grants and contracts. Equipment is defined as property having a useful life of more than a year and an acquisition cost of more than $5,000 per unit. Where previously the government retained title to equipment purchased under its funding, this change in the regulations (45 CFR Part 74.34) allowed both not-for-profit and for-profit grantees to retain title to equipment purchased with federal funds. With institutions taking ownership of grant-supported equipment, research administrators assumed greater responsibility for the management, allocation and disposition of equipment once the funding grant terminated.

Research involving human subjects was becoming regulated beginning in the 1970’s. Regulations governing the oversight functions of the FDA date back to the early 1900’s, making it one of the oldest consumer regulatory agencies in the federal government. The Food and Drug Act was created in 1906 and was replaced by the Federal Food, Drug and Cosmetic Act of 1938. The Act was revised many times; in 1976 it was amended to provide for the safety and effectiveness of medical devices intended for human use and other purposes. The FDA regulations, 21 CFR 11, have been constantly evolving, including the banning of carcinogens in food products, oversight of medical devices and implants, more stringent requirements for new drug applications and investigational new drug approvals.

The landmark National Research Act of 1974 codified in 45 CFR 46 the requirements for the establishment of IRBs and IRB approval of human subjects research supported by Public Health Service agencies. The Act created the NIH Office for Protection from Research Risks which negotiated General Assurance Agreements with institutions receiving NIH funds for research involving human subjects; institutions henceforth would create and maintain Institutional Review Boards to approve and monitor human subjects research. Over time, the regulations would be expanded to provide for extra protections for children, prisoners, pregnant women and fetuses. They would require that institutions apply the same ethical standards to all human subjects research. The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 federal departments and agencies, virtually all of the agencies supporting human subjects research. As a grants office manager, I was on the front lines of implementing and overseeing the protection of human subjects. In 1975 I had the honor of meeting with Drs. Charles McCarthy and Charles McKay, the directors of the Office for Protection from Research Risks, as they were drafting the original regulations. They were seeking institutional advice from around the country on striking a balance between fully protecting human subjects and not overly burdening institutions. The Grants Office was responsible for transcribing 45 CFR 46 into institutional policies and procedures, creating and supporting the Institutional Review Board and managing its proceedings. It was groundbreaking work, but it was also very exciting to create a new compliance system that would stand up to FDA audit. I managed and also served on the IRB (ex officio) for many years. The FDA is the responsible federal agency for overseeing institutional human subjects compliance. I also participated in a number of FDA audits of our IRB. Fortunately, no major exceptions were reported.

The Laboratory Animal Welfare Act (P.L. 89-544) was enacted in 1966. It is the only federal law that regulates the treatment of animals in research and exhibition. Other laws, policies, and guidelines may include additional species coverage or specifications for animal care and use, but all refer to the Animal Welfare Act (AWA) as the minimally acceptable standard for animal treatment and care. The AWA created the requirement for institutional surveillance of animal care through Institutional Animal Care and Use Committees (IACUC). The AWA required that federally funded research involving laboratory animals receive IACUC approval prior to award. The Grants Office also managed the IACUC with the help of the animal care program. We collected the animal protocols, distributed them to the IACUC and managed the meetings. I was a member of the IACUC and became familiar with the AWA, helping to draft institutional compliance policies. It wasn’t unusual in the early days for research administrators in the Grants Office to wear many hats and become the institutional experts in interpreting federal rules pertaining to research grants.

Institutional Biosafety Committees (IBCs) were created to review research involving gene splicing or recombinant DNA and potential cloning. The original NIH Guidelines for Recombinant DNA Research were issued in 1976. They assigned each type of recombinant DNA experiment a specific level of "physical containment" and of "biological containment". Responsibility for overseeing the application of the guidelines belongs to the NIH Recombinant DNA Advisory Committee (RAC)—composed of scientists and laymen, including non-voting representatives from many federal agencies—and local institutional biosafety committees at each university where recombinant DNA research is conducted. The NIH guidelines were subsequently adopted by other federal agencies, but congressional proposals aimed at extending the guidelines to private industry did not result in national legislation. The NIH guidelines underwent a major revision in 1978 and have been revised a number of times since then. The institutional review and regulation of biomedical research, specifically human subjects, animals and recombinant DNA, would establish a critical role for research administrators. Similar to the institutional response to the National Research Act and the Animal Welfare Act, the Grants Office managed the IBC. Looking back, it is quite startling to acknowledge the central and critical role the Grants Office and its leadership played in shaping the spectrum of research administration policies. It is also somewhat remarkable how much responsibility was concentrated in a relatively small work force.

The study of stem cells introduced another road bump in the regulation of biomedical research. Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources: embryos formed during the blastocyst phase of embryological development (embryonic stem cells) and adult tissue (adult stem cells). Stem cells have been used in medicine since the 1950’s when bone marrow transplants were first used to treat leukemia. Congressional involvement in stem cell policy started as early as 1974. Prior to 2009, federal funding was limited to non-embryonic stem cell research and embryonic stem cell research based upon embryonic stem cell lines in existence prior to August 9, 2001. A 2009 Executive Order allowed for NIH to support and conduct human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. In certain cases restrictions on federal funding for research involving new lines of human embryonic stem cells were lifted. Federal funding by the NIH continues to prohibit stem cell research for the creation of a human embryo for research purposes, or research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero. A number of states, including California, enacted their own regulations and funding mechanisms for stem cell research.

The most recent regulatory hurdle in clinical research is the change in federal reimbursement for patients on clinical trials. In 2003, National Coverage Determinations were expanded to include the reasonable and customary costs of treatment for patients participating in therapeutic clinical trials. This was a major victory for clinical trial patients and institutions providing such care. However, this has led to questionable charges and potential double billing to sponsors and carriers, which has required institutions to establish an intensive internal review system for bills to patients on clinical trials. This process, known as a coverage analysis, affects virtually all health providers treating patients on clinical trials whereby they must screen their invoices to public and private insurance carriers to avoid duplicate billing. This responsibility is shared between the health system and the clinical research administrators. The institutional response to the challenge of submitting reimbursement claims for patients participating in clinical trials was a joint responsibility of the clinical trials offices coordinating the research and the hospital’s revenue cycle office. In 2012, while at UC San Diego, I joined a team composed of hospital finance, clinical research and computer programming administrators called the Clinical Research Billing Steering Committee. The committee sought to build a network that would integrate the clinical trials management system (CTMS) with the electronic medical record (eMS) for screening and separating patient visits into billable and non-billable events. Over time this system has allowed the institution to bill with far greater confidence and accuracy, reducing the bill holds that were hindering cash flow.

In summary, I witnessed the introduction of a regulatory framework of institutional review and monitoring of biomedical research that exists with growing scrutiny to this day. This challenged the research administration community to invest resources in faculty level committees, policies, procedures and staff time to comply with federal regulations. To support this effort, research administrators began networking to facilitate the creation of an institutional structure of professional administrators, compliance offices and formal policies to implement the regulations. It was in this burgeoning regulatory environment that organizations such as SRA, NCURA, NACUBO and others had their roots.

Technology Transforms Research Administration

Imagine the workplace without high speed calculators, desktop computers, word processors, fax machines, email, and smart phones. I don’t have to imagine it—I was there. But just as we view progress of any sort over time, we saw the workplace as constantly improving, with every innovation making our jobs a little easier. Carbon paper—yes, carbon paper—was a tremendous tool in grant application assembly. Multiple copies of the application could be typed (and corrected with great effort) at once. White out™ (remember?) allowed for correcting typing errors, even in multiple colors. Thermal fax machines—although painfully slow and hot to the touch—sent messages over telephone lines to grant officials beginning in the 1960’s. Xerox™ machines were a huge step forward, making the copying of a grant application an automated rather than a carbon copy process. The word processing machine—the Wang 1200 WPS—was introduced in June 1976 and was an instant success, as was its successor, the 1977 Wang OIS (Office Information System). These products were true technological breakthroughs. I acquired one in 1980, replacing my IBM Selectric. It was much more than a replacement; it was revolutionary. IBM and Microsoft formed a partnership in 1980 to create an operating system known as OS/2 for the early IBM computer. Apple meanwhile came out with its own version of the computer in 1976. As we know, scientists gravitated to Apple products, and administrators favored PCs, led by IBM, making the proofing and editing of grant proposals by principal investigators and administrative staff quite vexing. From my perspective PCs seemed to be easier to use and had more office type features. The internet was created in the 1980’s which led to a technological transformation in communication. The telephone gave way to the internet, as did much of the postal service. Verbal communication morphed into digital contact. No longer would we place a telephone call to a principal investigator to no avail; waiting a day or longer for correspondence with a grating agency to be read. NIH applications, for the longest time submitted in 6 copies, via the US Postal Service or courier (how many times have you flown to DC and taken local transportation to NIH in Bethesda to deliver a grant application to Room 240 at the Division of Research Grants?), could be submitted via a computer terminal. All of a sudden (well, it wasn’t really all of a sudden), grant reviews and grant award notices were transmitted electronically. Eventually, internal grant and regulatory reviews were processed electronically, saving significant time and money in duplicating and staff costs. It’s breathtaking to consider the lightning speed (relatively speaking) at which research administration has been transformed by technology. I almost feel sorry for research administrators who missed the transition from print to digital, from grant application submission by postal service or courier to instantaneous computer submission, from telephone tag to email messaging.

Research Administration Hits its Stride as a Profession

When I started, research administrators per se didn’t exist. We had position titles of department administrator or coordinator, program manager, executive/administrative assistant, grant and contract specialist, fund manager, grant accountant, grant analyst and the like. Of course, many of these titles exist today. There was no Dean/VP for Research. The Grants Office was the administrative center of all things research. Over the years, to comply with increasing regulations, but also in response to significant increases in the federal budget, research administration became a highly specialized profession with on-site and multiple external sources of training and education. A college degree was not required for a management position; now certain jobs require advanced degrees. There are certificate programs and graduate degrees in research administration. Indeed, the profession of research administration has become so broad and complex that it contains subspecialties of compliance, research risks, ethics, sponsored projects pre- and post- award administration, clinical research management, and research finance, to name a few. In the past, an individual would be internally promoted into research management; today, research administration has become a sought after profession starting early in the career selection process.

Business dress has also been updated. When I started, suits and ties were the male uniform de rigueur. Today, a somewhat more casual dress is considered quite acceptable; ties are optional, as are jackets. However, jeans still are not widely accepted in the research administration office workplace (which is fine by me). Networking has been made significantly easier through the growth of professional organizations, the internet and social media. Research administration career advancement was so much more limited back then as compared to the 21st century. However, it must be noted that the Society of Research Administrators (in its globally restructured form as the Society of Research Administrators International) celebrated its 50th anniversary in 2017 and the Journal of Research Administration’s 50th anniversary is 2019. We grew up together.

So how much has research administration changed in 50 years? From my perspective, the greatest change has been in how it has matured. It now attracts and requires individuals from a wide spectrum of professional backgrounds including science, accounting, engineering, ethics, law, finance, and non-profit management. It now requires so much more knowledge and expertise. It has transformed from paper to digital communication, greatly facilitating the growth and speed of business. Research administration has developed into an essential leadership role at universities and not-for-profits. On the other hand, it has not changed in the challenges to provide specialized service to investigators and institutions alike, to respectfully respond to granting agency requirements, and to conduct our business by applying the most stringent means to meet all legal, ethical and public expectations. My deep respect to those who have flourished in this environment and my best wishes to all whose careers will further advance our profession and the products of the research we support.

References: 

Kaiser, J. (2018, March 22). Final 2018 budget bill eases biomedical researchers’ policy worries. Science Magazine. Retrieved from http://www.sciencemag.org/news/2018/03/final-2018-budget-bill-eases-biomedical-researchers-policy-worries

U.S. Department of Health and Human Services [HHS]. (2007, January 1). HHS grants policy statement. Retrieved from https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf?language=es


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