Friday, February 9, 2007

10:00 a.m.-12:00 Noon

4006 Fleming 

Minutes 

Present:  Carl Akerlof, Toni Antonucci, Jerald Bachman, Michael Combi, Mary Haan (chair), Josephine Kasa-Vubu, Angela Kuznia, Kazuhiro Saitou, Michelle Sargent, Qiang Zhu 

Absent: Chris Baldwin, David Blair, Cynthia Marcelo, Carol Persad, Usha Pasupuleti, Kristin Seefeldt, Elizabeth Young 

Staff:  Elizabeth Beattie (OHRCR), Lois Brako, Ron Maio (OHRCR), Judy Nowack, Marvin Parnes, Terry Vanden Bosch (OHRCR), Jackie Hoats-Shields (committee staff) 

The meeting was called to order at approximately 10:05 a.m. 

1.      Consideration of minutes from January 12, 2007

        Regarding the last paragraph of the January 12, 2007 RPC minutes, it was suggested that to clarify meaning the final sentence should read: "We are looking for ways to guarantee human subjects protections while departing from federal process standards where it is legal to do so for non-federally supported projects."

    Jerald Bachman: Motion to change the minutes as suggested above.

    Qiang Zhu: Seconded motion. 

    Vote: All in favor. 

2.      Update on the Human Research Protection Program

    Presenters: Judy Nowack, Associate Vice President for Research

     Ron Maio, Director, Office of Human Research Compliance Review 

Judy Nowack, who is the Deputy Institutional Official for the Human Research Protection Program (HRPP), gave the first presentation.  She said before describing the initiatives of the HRPP she would like to update the committee on the status of responses to RPC’s report of last year on human subjects issues.  RPC’s May 2006 report contained six recommendations (listed below) and Ms. Nowack described the responses of the HRPP to each:

    1.     Increase IRB Health/BehavSci Staff from "6-7 FTE" and provide for an educator.

            Response:  The IRB-Health/BehavSci staff is currently at 9 FTE with one position designated as an educator.  Also, an education needs analysis is part of the Institute for Social Research/OHRCR faculty survey that is being developed. 

    2.     Increase faculty compensation and service credit. 

            Response:  This recommendation is being approached through a reduction in burden on IRB members.  Plans for a new IRB/review committee will help accomplish this.  Also, a reduction in the volume of IRB activities is expected through success of the "Demonstrations and Innovations" project, described in more detail below.  In addition, increased use of central IRBs and inter-institutional agreements should alleviate some burden. 

    3.     Systematically evaluate faculty experiences. 

            Response: There have been many such evaluations ranging from an eResearch survey in spring 2006, to real-time monitoring of faculty experiences of eResearch, to the ISR/OHRCR survey currently being developed. Among still other efforts, there is the augmentation of the IRB Council, and plans for a "data dashboard" on the HRPP website.  The input of RPC would be useful about what summary indicators would be most useful for faculty.   

    4.     Address IRB "mission creep."

            Response: The HRPP Demonstrations and Innovations initiative is directly in response to this, as well as augmentation of the IRB Council with six additional faculty members. 

    5.     Promote or create a CIC committee on IRBs. 

            Response: UM was instrumental in development and approval by CIC of this committee, which was in operation prior to RPC's recommendation.  There is significant UM leadership of this group.  Areas being addressed include performance metrics, staffing benchmarking, approaches to social/behavioral research, international research, and accreditation experiences. 

    6.     Limit/reduce jurisdiction of the IRB (e.g. pre-exempt public use data sets) where practical and reasonable. 

            Response:  The policy for pre-exemption of public use data sets was in place even before RPC's recommendation. ISR's Health and Retirement Survey Data was added January 2007.  The HRPP Demonstrations and Innovations project is also addressing this recommendation.  UM is also active in encouraging new OHRP guidance toward reducing administrative burden. 

Moving on, Judy Nowack described the status of the University's application to the Association for the Accreditation of Human Research Protection (AAHRPP). The 1,500 page application has just been sent in and a site visit is tentatively scheduled for the week of June 4.  During the site visit six AAHRPP representatives will interview about 150 people with notice given six weeks ahead.  There will be an exit interview at the end of the site visit and the official report will be received from AAHRPP within 30 days.  The University will then have 30 days to respond to issues raised in the report.  If the University's responses are acceptable, an accreditation determination might be able to be made at the September 2007 meeting of the AAHRPP Accreditation Council.  In preparation for the site visit just-in-time briefings of the interviewees will be planned. Other preparations include refinement of the HRPP operations manual, and a new HRPP website front door.   

With regard to eResearch Ms. Nowack said that version 1.5 was released in December. Some problems were found with the underlying structure of the software but these have worked through with a patch from the vendor.  It is acknowledged that eResearch needs some streamlining, and six faculty at large are being added to the IRB Council to assist with this process. A committee member said she knew of problems where the identity of reviewers was revealed to applicants. 

Mary Haan said in the fall the IRB-Health itself has established an internal quality assurance step in which a certain number of expedited decisions are reviewed by the committee. . Another comment was that in reviewing renewals, the history of the study is not available on eResearch; it would be nice to have access to the earlier history electronically and not just on paper..  It was noted that this is an artifact of the conversion to eResearch and, although a headache for a transitional period of time, should not be a problem after all protocols are eventually entirely captured in eResearch. 

On the topic of education and training, Ms. Nowack reported that there is new human subjects content in PEERRS.  Furthermore, eResearch will now include enforcement of PEERRS certification for PIs, Co-Is, and faculty advisors (to begin in March).  In addition, she said the "help" capacity in eResearch is being enhanced, and the faculty survey previously mentioned will attempt to assess educational needs and preferred learning modes. 

The HRPP Policy Innovation and Demonstration Initiative was described by Ms. Nowack. The initiative is for non-federally supported projects, those that do not fall under FDA jurisdiction, and those not bound to federal process regulations by contract. It focuses especially but not exclusively on minimal risk, non-sponsored social/behavioral research, and involves a partnership with faculty to maintain performance standards while experimenting with federal process standards where allowable. OVPR is identifying existing HRPP policies and processes that are that are unnecessarily burdensome to investigators and beyond what may be reasonable considering potential risks to human subjects.  Innovations may be outright changes to policies or processes; demonstrations are temporary changes to policies or processes with the intent of demonstrating that the rights and welfare of subjects are not adversely affected by such changes.  A document was provided to the committee that includes examples of the changes being employed.  In conclusion, Ms. Nowack said this process is being overseen by the IRB Council with periodic reports to RPC, the Research Associate Deans, and the Human Research Coordinating Council. 

Ron Maio, Director of the Office of Human Research Compliance Review (OHRCR), began his presentation.  Dr. Maio, who is also a professor of emergency medicine, started as Director of OHRCR in May 2006. Prior to that he was on the IRBMED for seven years.  Dr. Maio also introduced OHRCR staff members Terry Vanden Bosch and Elizabeth Beattie, noting that both of them and he all have experiences not only from the regulatory side but also from the investigator side.  OHRCR was formed in September 2003 and it reports to the vice president for research. The mission of OHRCR is to facilitate safe, ethical, and efficient human subjects research. Their focus, conceptually, is on what happens from a compliance standpoint after a project is approved, that is, does the PI conduct the study as they say they will. They conduct reviews both for-cause and not-for-cause (preventative in nature).   

Dr. Maio explained that the unit's mission has four pillars: outreach, compliance review, leadership, and knowledge/education.  Goals of their work include contributing to the development of knowledgeable faculty, staff, and students; the conduct of timely reviews; instilling the value of best practices; contributing to the positive public perception of research and of UM as model and leader in research.  Toward those ends Dr. Maio explained that OHRCR has been doing the following: working on a strategic plan; conducting reviews; meeting with a faculty advisory committee regarding not-for-cause reviews; developing the computer-based HRPP survey on faculty satisfaction and educational needs and practices; devising a continuous quality improvement plan including outcome markers; and performing outreach activities.  Dr. Maio emphasized that OHRCR wants to work as a partner with faculty in cultivating attitudes that foster respect for subjects and ethical research practices. 

Mary Haan asked about OHRCR’s primary educational mission.  She commented that with all that faculty need to do to comply, the basic knowledge of why compliance is important is not getting through.  Dr. Maio said the question of how to approach this problem is very challenging as different people have different needs.  He said a core curriculum is needed starting with research ethics and how those principles are put into practice.  Furthermore, the PI has to internalize these values.  Once the core values have been established, Dr. Maio said then you can approach them within the areas in which PIs are interested. Case studies seem to engage people at all different levels from student to senior investigator.  He said ultimately we would like to have a core curriculum that could be applied at these different levels.  Committee member Josephine Kasa-Vubu asked whether modules could be added to PEERRS.  She suggested a tailored case study could be provided based on information collected from the person logging on.  Dr. Maio said he likes the idea of a tailored response.  Dr. Kasa-Vubu said there is a group in North Ingalls Building that designs these server-based responses for PIs. 

Mary Haan thanked Judy Nowack and Ron Maio for their presentations on HRPP initiatives, and said it looks like great progress is being made.  

3.      Data Archiving/Data Sharing  

    Guest: John King, Vice Provost for Academic Information and Professor, School of Information 

John King explained that he started his job in the Provost's office in June 2006.  He said much of his work is not solely focused on information technology but also on the academic mission of the University. Referring to recent guests at RPC meetings, he noted the committee has been talking with all the right people about the topic of data archiving.  

Professor King offered two cautionary points about the recent impetus for data archiving.  He said some of the drive behind it comes from federal requirements and that access to archived data can make it easier for certain political or economic sectors to impeach the work of scientists when the results threaten their interests. Secondly, he said more and more scholarship is based on the availability of information that is archived. As more online resources have become available one must be careful about the provenance of the archived data one is using. It is important to know in what context the measurements were taken; this metadata should be attached to the archived data.  Without the metadata, there is a question of how reliable the numbers are.  He said this has been recognized at the national policy level.  While the productivity of scholarly work will go up immensely if we do the archiving well, it needs to be done with great care.  

The committee discussed with Professor King the issue of discerning data that has been massaged depending on the researcher's or archivist's viewpoint, and how to approach archiving data in subject areas where there is a lot of theoretical input.  It was proposed that perhaps this type of data cannot be archived, or only with great care and special attention.  Professor King gave an example from the humanities where ancient texts were archived but due to their fragmentary nature some important notations were left out.  Questions about the texts resulting from this omission were subsequently answered through a committee vote.  Professor King's point was that one using the archived version wouldn’t know that some of the information presented had been determined by a committee instead of through reference back to the originals. 

Mary Haan brought up the idea to have a university-level advisory committee on data archiving, and John King agreed that it would be good idea to bring together the thought-leaders on the topic as a community of expertise.   

Professor King was asked whether the emphasis in data archiving on documenting how the data is taken is different from what would normally occur.  Professor Haan said that for example there is already the requirement of keeping one's lab notebooks.  Professor King said the documentation issue is essentially the same: how does one determine the amount of detail and metadata one puts in a lab notebook?  The question also remains of how to even choose what should be archived electronically.  In some cases keeping the lab book may be enough.  It was commented that in biomedical research the issue of data archiving has not been widely addressed beyond keeping disks and data dictionaries.   

A data archiving initiative needs to be organized from the top, it was commented.  Yet one of the big issues is where are the resources going to come from to provide for the increased costs it would entail.  Individual units often back away from this.  And how will it be organized?  Professor King said that instead of reacting to mandates which originate from outside the research community, an organized effort should ideally include providing ample input to the government before/as they write the legislation – and for that we must determine ahead of time what we need.  Researchers themselves need to be involved in this process.  He noted that any legislation will likely be an unfunded mandate.   

Professor King said he is often in contact with the UM Washington DC office on various related issues and he needs a "go-to" group on campus for this topic.  Mary Haan said RPC can work on recommendations.  Marvin Parnes said OVPR recently convened a group to do some preliminary framing on computing infrastructure issues and they touched on data archiving. He said it would be a welcome next step in the process to receive recommendations from RPC on archiving issues such as organization, access and control/stewardship.   

In conclusion, Professor King said we should be proactive by considering what is our vision of the future of science and scholarship.  He said the high cost of data archiving will be in people, in expertise.  Moreover, we are going to need to make sure we understand the data that is being archived and how to use it.  How records are kept matters a lot if those records will be used for subsequent research.  He said it is easy to merely store data; the skill is determining what should be stored and then getting it back in a useful way.  We need to create a new class of expert that can work with faculty to help determine what will be useful over time. 

4.      Matters arising

        Brian Athey has been invited to the next RPC meeting.  Review of the Regental Research Policy is another item that may be on the March agenda. 

The meeting was adjourned at 12:02 p.m.