By Kevin Hogencamp
(UPDATED 7 P.M. WEDNESDAY, JUNE 15. Please check back for additional updates)
Albany State University is accused of botching a federally funded 2010 DNA study involving 21 undergraduate students by failing to obtain approval for the project beforehand and by not following privacy regulations, training requirements and other protocol, public records show.
Among the most egregious errors alleged by the university’s Institutional Review Board (IRB): The project’s planners did not make obtain parental consent or make provisions to offer assistance to participants who discovered unanticipated DNA test results, records show.
Albany State University President Everette Freeman was the project’s director. In a statement Wednesday, the university refuted the IRB’s allegations.
“Due to initial precautionary concerns voiced by the ASU Institutional Review Board (IRB), the Ancestry Project Staff submitted a request to the IRB on May 25 for approval of human subject research as a measure of extra caution,” the university said in a statement. “Later, the Ancestry Project Staff did withdraw that application because the scope of the project did not require such approval nor did the project require HIPPA training since no activities involved the student as a subject of research.
“Specifically, the project involved student participants who voluntarily collected saliva samples from their own mouths to be sent off for analysis by a commercial vendor to determine their ancestor’s geographic place of origin. There have been no HIPPA violations involving this project.”
The DNA study was among the issues cited last month in a scathing report by an ASU professors’ group alleging fraud, grade changing, mismanagement, hostile employment practices and widespread state policy violations at the university. The IRB says a significant outcome of the blunders is that due to federal protocol being sidestepped is that the study’s results cannot be widely published as planned by the project’s organizers.
The DNA project was conducted from May-July 2010 without IRB approval. In September 2010, the IRB concluded that the ASU DNA Ancestry staff displayed “research misconduct,” then-IRB Chairman Cassandra M. Smith, said in a letter to Title III Program Director Connie Leggett.
Since then, the matter has been reported to the U.S. Department of Education Office of Inspector General and Smith no longer works for the university.
Freeman is listed on a federal grant application as the project director, and in March 2010, responding to an inquiry from Freeman, Smith asked Freeman to ensure that the project participants be trained according to federal guidelines.
“…We will provide the training,” Smith wrote to Freeman on March 2, 2010. “It will protect everyone involved (students, their families, ASU, etc.). The NIH (National Institutes of Health) and NSF (National Science Foundation) are now requiring that any individual conducting research with their funds receive not only the electronic versions of human subjects, HIPPA (Health Insurance Portability and Accountability Act), animal assurance, etc., but to provide documented 8 hours face to face (training) due to a number of issues that have developed.”
Neither Freeman nor Leggett, however, arranged for the training.
An Institutional Review Board is a committee mandated by the National Research Act, to be established within each institution that conducts biomedical or behavioral research involving human participants and receives federal funding for research involving human participants. The purpose of the IRB is to review all proposals for human research before the research is conducted to determine whether the research plan has adequately included the ethical dimensions of the project.
“In layman term, as IRB members we are to ensure there will not be a reoccurrence of the Tuskegee syphilis study or public health service syphilis study,” Smith said in an interview with The Albany Journal.
The Tuskegee, Ala., project was an infamous clinical study of untreated syphilis in poor, rural black men between 1932 and 1972. The participants were never told they had syphilis, nor were they treated for it; instead, the men were given free care for other medical issues in addition to meals and free burial insurance.
Smith said that she thinks the university’s actions are a blatant breach of the University System of Georgia ethics policy, which states, “We will uphold the highest standards of intellectual honesty and integrity in the conduct of teaching, research, service and grants administration . . . Research integrity requires that principal investigators and others with a fiduciary obligation for grant funds use those funds in a manner consistent with the grantor’s terms and conditions and applicable laws, rules and regulations. Finally, research involving human subjects shall be conducted only after appropriate review and approval by institutional review boards (IRBs) and should be conducted in accordance with IRB principles.”
According to ASU records, the DNA study was part of an eight-week course during which students traced their DNA using a commercial vendor (Ancestry.com) to which they submitted a DNA cheek swab. The university purchased the kits, but the students’ DNA results were available only to the students and were protected by an online password, the university said.
The Ancestry Project covered the sciences, social sciences, history and humanities. In its statement, ASU said “the project brought interdisciplinary research and pedagogy together by having students explore the subject matter with an emphasis on their ancestry.”
“With faculty serving as instructors in subject-matter from ASU approved courses, students were guided in these subject areas, referencing their own ancestry. Based on the genetic markers in the DNA, students were able to identify the clan of their ancestors and, with faculty guidance, explored the African Diaspora and the migration of their ancestors,” the university said. “These students also created journals to document their experience and write essays on their research discoveries.”
The Ancestry Project was funded by the U.S. Department of Education under Title III Historically Black Colleges and Universities College Cost Reduction and Access Act. ASU received $5.4 million in Title III funding – which pays for many of the university’s faculty, staff and consultants — this year.
Following is the text of Dr. Smith’s Oct. 10 letter to Leggett.
“The Albany State University Institutional review Board (IRB) met Sept. 3, 2010 and discussed the DNA Ancestry Project. After detailed discussions the following conclusion was met: the board found the DNA Ancestry staff displayed research misconduct for conducting research without prior IRB approval.
Electronic documentation indicates the following:
Discussions with DNA Ancestry staff began Feb. 4, 2010.
March 1, 2010 DNA Ancestry staff was advised students must complete human subjects and HIPPA training prior to the beginning of the study.
March 2, 2010 DNA Ancestry staff was informed after students are selected the IRB will provide human subjects and HIPPA training
May 21, 2010 DNA Ancestry Project began
May 25, 2010 DNA Ancestry project was submitted to IRB for approval
Full review incomplete as of Sept. 10, 2010 – concerns of IRB not answered.
The definition of research misconduct is the following: adverse effect on the integrity of research or the safety of people, animals and property …
During the IRB meeting, there were several issues of concern, many of which would bring adverse effects on either or all (students, their families, ASU). The concerns are listed below:
Has the project participants completed the IRB online training before participating in the ancestry project?
Has the project participants completed the IRB face to face training before participating in the ancestry project?
The summary statement mentioned in the IRB full review application mention that a participant’s individual data will be confidential and will not be shared with project staff. Marketing component, mapping component and genealogy component contradict the above statement.
Marketing component – “The DNA results of the students will be analyzed to validate or invalidate the above hypothesis”; mapping component (objective 1): “Map the routes traversed by the ancestors of the students and map the location of the cemeteries where their ancestors reside”.
The genealogy component indicates that “This course will utilize the findings of Y-DNA and mitochondrial-DNA haplogrouping to identify ad study project participants’ ancestry and culture of origins”.
It is unclear whether the listed courses have been approved, if so what is their course number?
How long will the company keep the samples if a participant does not request that it is destroyed?
Some of the participants are likely underage and need a parental consent form on file.
The NIH defines a minor as age 21 or under, therefore an adult consent for minor should be on record.
The research team should consider seeking parental consent – in addition to the students’ consent – even if the students are all over 18 years old. The rationale for this suggestion is that the students’ DNA will have implications/reflections on the entire family. Should the team decide to disseminate the results in some way (even without identifiers), some parents may take offense. It is also likely that the students are all under parental guardianship.
How will you provide assistance to participants who discover unanticipated results from the DNA test results?
How will you advise participants about the risk that could be associated with keeping DNA on file at Ancestry.com.
There is no indication of benefits of this project by the company.
What is the process of collecting the swab and the disposal of the swab?
The 8-week program sessions are outlined along with the presenters. The research team may consider adding a bit more information about the timeline for the cheek swab such as: the date or time frame for the initial swab; the date/time frame that results are anticipated and how the results will be utilized throughout the project.
Faculty participants were not trained or certification had expired.
The IRB is requesting no further activities occur with this project, which includes but not limited to publication of any sort, local or national.
On Oct. 19 – four months after the eight-week course that included the DNA study concluded — Leggett withdrew the project’s application for IRB human subject approval.
“The project retracts from the course descriptions any statements that would imply that the results would be used …” Leggett wrote to Smith. “Indeed, it seems to us that we should have never done an application, given the scope of our project.”
The ASU chapter of the American Association of University Professors (AAUP) said in a report last month that a “hostile work environment” at the university is the result of “the failure of the Albany Sate University administration to act in compliance with the statutes of Albany State University and Board of Regents policies in order to mask violations of federal-grant fiscal practices and coercive personnel practices.”
The AAUP asks in the report that the Board of Regents “conduct a formal and thorough investigation of our findings regarding concerns, complaints and perceived administrative violations brought forth by members of the faculty; and to examine documents submitted – and others not made available to the chapter – in order to verify their truthfulness and their compliance with ASU statutes, BOR policies, state of Georgia law principles, and federal law governing grants and contacts …”
“Albany State University has been seriously shaken by the current administrative practices of President Everette Freeman which have been brought before us by ASU faculty, staff, students, and administrators. As concerned faculty members of the ASU chapter of the AAUP, we wish to express our confidence (in) the Board of Regents of the University System of Georgia, and we hope that its members are sufficiently concerned about the future of Albany State University, a unit of the University System of Georgia,” the professors say in the report.
“The administration violated the rights of the faculty at Albany State University to share in the governance of our university by disallowing a system of checks and balances through a top down process, particularly in its reports to the many accrediting agencies, such as Southern Association of Colleges and Schools, National Council on the Accreditation of Teacher Education, Council on Social Work Education, and National Association of Social Workers,” the professors say in the report.
The report, which includes dozens of pages of documentation, notes with documentation that “highly placed” University System administrative personnel were notified of mismanagement of federal grant funds by ASU officials, but that their concerns were either ignored or “trivialized.”
Freeman has not responded to the Albany Journal’s request for an interview about the AAUP report. The Board of Regents, meanwhile, is reviewing the matter.