U.S. Department of Health and Human Services
ACD Virtual Meeting has concluded.

HeLa ACD Virtual Public Meeting

Advisory Committee to the Director Virtual Meeting

Welcome to the first virtual public meeting of the Advisory Committee to the Director (ACD). The meeting will be open for eight hours, with the first four hours reserved for ACD member discussion and the second four hours reserved for ACD member voting and discussion.

HeLa Working Group Findings

The purpose of today’s meeting is for the ACD to vote on the findings of the HeLa Genome Data Access Working Group on the nine pending data access requests. The Working Group has found eight of the nine requests consistent with the HeLa Data Use Agreement. Click on any request to see the full summary and working group finding.

Data Access Requests Workgroup Findings:
Consistent with
Data Use Agreement?
ACD Vote on Data
Access Request
Mining Exome Sequencing and Array Based Genome Wide Association Studies for Disease Target and Biomarker Discovery
No Reject
TargetInfectX-Multi-Pronged Perturbation of Pathogen Infection in Human Cells
Yes Accept
Identifying Allele-Specific Biases in Hela Transcript Processing
Yes Accept
Genomic Engineering in Alzheimer’s Disease
Yes Accept
Allele-specific Analyses in the HeLa Genome
Yes Accept
Allele‐specific Gene Regulation
Yes Accept
Use of HeLa Cells to Study Assembly of HIV-1
Yes Accept
Compare HeLa Genome with SH-SY5Y Neuroblastoma Cell Line
Yes Accept
Genome Editing of HeLa Cells to Study Endocytosis
Yes Accept
 View Detailed
Results

Meeting Discussion

38 Meeting Comments
New Comments. Reload
  1. Dr. Dina Paltoo NIH Staff / Moderator
    March 28, 2014, 5:58 pm

    The voting period will close in a few minutes.

  2. Dr. Reed Tuckson ACD Member
    March 28, 2014, 5:55 pm

    I just voted but I am not sure that it was clear that I am voting to accept the working group recommendations…that is what I am voting for.

    reed

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 5:56 pm

      Yes, that is what your vote indicates.

  3. Dr. Moncef M. Slaoui ACD Member (Ad Hoc)
    March 28, 2014, 5:15 pm

    I also vote per the working group recommendations.  Regards, Moncef

  4. Dr. Christopher B. Wilson ACD Member
    March 28, 2014, 5:14 pm

    My understaning is that a reject does not preclude reconsideration, but that in order to do so, the applicant must be provided a succinct critique or set of questions to inform possible resubmission and reconsideration.

    It is my impression that the exome mining proposal did not provide a clear rationale for why HeLa cells, as opposed to any number of other possible ‘control’ cell lines, should be employed and that such a rationale was required to be consistent with the agreement. Thus, I think they need to provide such rationale if there is one.

    As regards, data sharing, the summary slides state that ‘future whole genomoe sequencing data will be deposited in dbGAP.’ I would take this to be a requirement, but that the other data derived from the project is encouraged but not required, as per Bob Horvitz remarks.

    Also based on the slides, it seems to me that this should be rejected but that this application would remain in the ‘Pending’ category until further information is provided and a re-review by the committee takes place.

  5. Dr. Russ B. Altman HeLa Working Group / ACD Member (Ad Hoc)
    March 28, 2014, 5:09 pm

    Do I vote here?  I don’t see a special voting area?  I vote per the working group recommendations.  Thanks, Russ.

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 5:17 pm

      We appreciate your comments.  You are an ad hoc ACD member and will not see a ballot.

  6. Dr. Russ B. Altman HeLa Working Group / ACD Member (Ad Hoc)
    March 28, 2014, 4:05 pm

    The questions about “Mining…” are very useful to me as a member of the subcommittee.  I think I will still vote against it for concerns about in what way HeLa is a “control” (just doesn’t sound plausible without a bit more detail) and the related issue of specifying how HeLa is valuable for this study in any particular way (e.g. is it really needed?).

    The issue of mandatory dissemination raised by colleagues is a good one, and we should determine if dissemination is mandatory–it probably can’t be because sometimes your analyses just fail and there is nothing to report.   So I guess the question becomes:  do we allow people to use the HeLa genome to do exploratory stuff with no intention of dissemination, even if they find something useful/interesting?

  7. Dr. H. Robert Horvitz ACD Member
    March 28, 2014, 3:08 pm

    Given the choices of approve, reject and abstain, what vote indicates “reconsideration”?  Does “reject” mean “reject for now, but reconsideration is possible”?

    • Dr. Kathy Hudson NIH Staff / HeLa Working Group
      March 28, 2014, 3:15 pm

      A vote of “reject” would be a vote for “reject for now” as the applicant can revise and re-submit the application.

  8. Dr. Francis Collins NIH Director
    March 28, 2014, 2:52 pm

    Hello all, I’ve been tracking your interesting discussions, and it’s clear that ACD members are approaching these decisions very thoughtfully.  That’s just what we had hoped for — and it gives us confidence that this new format can be quite effective for this kind of deliberation.  We look forward to your votes.  Many thanks!

  9. Dr. Renee R. Jenkins HeLa Working Group / ACD Member
    March 28, 2014, 2:50 pm

    Based on the lively posting discussion it may be a reasonable strategy to reconsider the “Mining” project rather than outright reject it.  The current language of the agreement expresses what appears to be the family’s intent for the use of Hela cells to advance science.  The wording is short of being explicit.  Comments from ACD members have been very helpful to the process.

  10. Dr. Eric P Goosby ACD Member (Ad Hoc)
    March 28, 2014, 2:14 pm

    Vote:

    Yes on 2-9 requests

    For #1  would clarify dissemination concern and specific utility of dbGaP access for biomarker and gene manipulation affect on gene activity discovery efforts.  If the group decides to have them resubmit I am fine with this.  I will check back in a few hours.  EG

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 2:19 pm

      Thank you for you comment.  As a reminder, ACD members with voting rights are to submit their votes on the homepage.  Ad hoc ACD members do not have voting rights and will not see a ballot.

  11. Dr. Dina Paltoo NIH Staff / Moderator
    March 28, 2014, 2:08 pm

    We have now switched over to the ACD member voting period.  ACD members, please remember that you are voting to recommend approval or rejection of each data access request.

    The final ACD vote will be posted at the end of the meeting.

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 2:11 pm

      Also, discussion can continue during the voting period.

  12. Dr. Kathy Hudson NIH Staff / HeLa Working Group
    March 28, 2014, 2:00 pm

    Bob, I agree that the working group needs to consider modifying the language to make it explicit that there is an expectation that resulting data will be dessiminated.

  13. Dr. Eric P Goosby ACD Member (Ad Hoc)
    March 28, 2014, 1:56 pm

    thanks Kathy, sounds good to me.  EG

  14. Dr. H. Robert Horvitz ACD Member
    March 28, 2014, 1:56 pm

    My sense is that if we want to REQUIRE dissemination we should say so explicitly.

  15. Dr. Kathy Hudson NIH Staff / HeLa Working Group
    March 28, 2014, 1:46 pm

    Thank you all for your comments. This is a great discussion. This was a tricky request for the working group and it spurred a very robust discussion. We had two concerns – the requestor proposes to use HeLa genomic data as a control for the experiment and we couldn’t understand how genomic data from HeLa – knowing what we know about it – would make a good control. The requestors are required to describe how HeLa data is specifically valuable for the question they’re asking so we would need to understand that aspect better.

    Regarding the dissemination of findings, we had extensive discussion on this issue and read (and re-read) the language in the data use agreement. It’s true that there is a strong encouragement to publish and the working group gauged that reading of the agreement against the principle that there is responsibility from the community to report findings that come from use of these data.

    An important aspect of our discussions with the Lacks family was their commitment to the use of the HeLa sequence to advance science and the broad dissemination of that knowledge. In addition there was a concern about private gain. If this application is not accepted, we can ask the requestor to come back with an explanation of how HeLa data will be valuable to the experiment design and how they plan to share their findings.

    • Dr. Elba E. Serrano ACD Member (Ad Hoc)
      March 28, 2014, 2:17 pm

      I had similar concerns about the proposed use of HeLa cells as “controls”.

  16. Dr. Richard P. Lifton ACD Member (Ad Hoc)
    March 28, 2014, 1:30 pm Mining Exome Sequencing and Array Based Genome Wide Association Studies for Disease Target and Biomarker Discovery

    Like two other Commenters, I am unclear as to why the “Mining” application would be deemed inconsistent with the data use agreement  based on the lack of intent of disseminating results of their analyses. This is not a stated requirement and I’m not clear how the ‘inconsistent with data use agreement’ conclusion is justified.

    • Dr. Richard P. Lifton ACD Member (Ad Hoc)
      March 28, 2014, 1:35 pm

      I see that Dr. Akil’s comments, with mine, bring the total to four commenters questioning the propriety of rejecting the Mining project.

  17. Dr. Eric P Goosby ACD Member (Ad Hoc)
    March 28, 2014, 1:21 pm

    To NIH Team:

    In that the “science” proposed by the requester for the “Mining Exone Sequence” request seems like comparable science, could the secretariat inquire as to publication/dissemination of findings in a peer reviewed journal or any concerns around IP.  It seems that the other recess all had these issues and made statements that seemed to imply they would not pursue IP and manufacturing agendas without coming back to the Working Group for approval.  Is it possible to go back to the requester and clarify this point before we vote?   If the pursuit of actionable knowledge (new science) is the goal would it not be smart to clarify before denial?

    Enough!   EG

  18. Dr. Huda Akil ACD Member (Ad Hoc)
    March 28, 2014, 1:20 pm

    Like Bob, I had a question about the requirement vs. encouragement for dissemination (while maintaining security of all derivative information as stipulated in the agreement). Is this a primary reason for rejecting Exome Mining request, or is the main reason the lack of clarity of the scientific intent of the project? Given the importance of biomarker development and the need for the pharmaceutical industry to be actively engaged in this process, I wonder whether the applicant could be encouraged to clarify some issues and return for re-consideration?

    I agree with others that this is a very interesting and flexible way to conduct the meeting.

  19. Dr. Elba E. Serrano ACD Member (Ad Hoc)
    March 28, 2014, 12:46 pm

    Good afternoon! I found it noteworthy that data requests are for projects that will implement HeLa cells for highly technical genetics research with the goal of developing treatments for a spectrum of intractable medical disorders (Parkinson’s, cancer, Alzheimer). With one exception (Mining Exome ….), all data requests are for projects where investigators state that research outcomes will be disseminated in an open format. No data requests are for projects where the investigators intend to commercialize findings or develop intellectual property applications at this time.

  20. Dr. H. Robert Horvitz ACD Member
    March 28, 2014, 12:39 pm Mining Exome Sequencing and Array Based Genome Wide Association Studies for Disease Target and Biomarker Discovery

    For the “Mining Exome …  ” request, the Working Group states that the request is inconsistent with the Hela Genome Data Use Agreement in part because the requester  has no intention to disseminate findings.  The statement in the Agreement is “Approved Users are strongly encouraged to publish … and present … research findings … .”  This statement is not a categoric, only an “encouragement.”  Given that, is it appropriate to use this criterion as a basis for disapproval?  What has been the precedent, and why?

     
    Inconsistent with the HeLa Genome Data Use Agreement.

    Requestor has no intention to disseminate findings

  21. Dr. Harlan M. Krumholz ACD Member (Ad Hoc)
    March 28, 2014, 12:37 pm

    Thank you for the opportunity to participate. This is an interesting way to conduct a meeting – and I can see the advantages. I am new to this issue but it seems that the guidelines for use are fairly clear and adherence to the policy is not something that involves a lot of judgment – am I missing something? And if they do not comply I assume it is possible for them to improve the proposal and reapply. Is that right? As I looked through the proposals I felt that the Workgroup findings were consistent with the policy.

  22. Dr. Dina Paltoo NIH Staff / Moderator
    March 28, 2014, 11:49 am

    For any ACD members that are logged on, we encourage you to comment on any of the Data Access Requests.

  23. Dr. Eric P Goosby ACD Member (Ad Hoc)
    March 28, 2014, 11:49 am

    Good Morning Colleagues:

    Impressive display of technology.  I hope it helps you  help Dr. Collins in what is a difficult set of considerations.  I have read through the proposals and largely agree with the conclusion to allow access to the dbGaP.  In the Mining Exome  Sequencing request it would seem the request to understand how HeLa genome manipulation may impact gene activity is a legitimate line of inquiry that would/could result in discovery of new biomarkers.

    I would think clarifying any question you may have on relevancy to research and the question of dissemination could be answered with a back and forth with the “requestor.”  Is this something that could be done before a flat denial?

  24. Dr. Cori Bargmann ACD Member
    March 28, 2014, 11:48 am

    I was pleased to see a number of applications from research institutions outside the US. This HeLa request program has the added benefit of raising international awareness of the costs and benefits of “identifiable” genomes. I also thought that most of the requests were scientifically coherent and clear.

  25. Dr. H. Robert Horvitz ACD Member
    March 28, 2014, 11:29 am

    Given that the public is invited to this virtual meeting, is it best if we state that we are involved via a comment, even though NIH staff know this to be the case?

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 11:35 am

      If the ACD members provide a comment, their names will be displayed in the discussion.

  26. Dr. Reed Tuckson ACD Member
    March 28, 2014, 10:03 am

    Hello! I am not sure if you want to be notified that we are tracking the discussion…I apologize if we are not supposed to check in.

    reed

    • Dr. Dina Paltoo NIH Staff / Moderator
      March 28, 2014, 10:07 am

      We are able to track who is logging in, so we know who is on.  Thanks!

  27. Dr. Francis Collins NIH Director
    March 28, 2014, 10:03 am

    Welcome everyone to the first virtual meeting of the ACD. This is a big change to how we normally hold ACD meetings. And while this will not replace the incredibly valuable in-person meetings, I’m very excited about the prospect of having a new way of working with you all and doing it in a way that allows the public to easily follow along. I’m hoping that this flexible meeting platform will ensure that researchers waiting to access HeLa genomic data can hear back from NIH swiftly. Thank you for your participation today!

  28. Dr. Renee Jenkins HeLa Working Group / ACD Member
    March 28, 2014, 10:02 am

    To date, the Working Group has assessed 18 data access requests which were forwarded to the Advisory Committee to the Director (ACD). The ACD recommended eight for approval to Dr. Collins and one request was incomplete. Nine requests are pending ACD review and will be discussed by the ACD today. The Working Group found 8 of these 9 requests to be consistent with the HeLa Data Use Agreement. A listing of these requests and the Working Group’s findings can be seen above, and a complete summary of each request may be found in the Data Access Requests tab.

    I know that some of the working group members will be logging on today and we will be happy to be part of the discussion.

  29. Dr. Dina Paltoo NIH Staff / Moderator
    March 28, 2014, 10:01 am

    This virtual meeting is open to the public and is eight hours in duration. The first 4 hours (10 am – 2 pm EDT) is reserved for ACD member discussion of the working group findings, and the second 4 hours (2 pm – 6 pm EDT) is reserved for ACD member voting on the nine data access requests. The final vote will be published after the voting period has closed at 6pm (EDT).

    We look forward to today’s meeting.

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