IRB Guidance and Best Practice on Depositing Data Into Large Databases

Increasingly the NIH and other federal funding sources insist that data, especially genomic data, generated in research are put into large nationally accessible databases. If a repository is funded by NIH (such as dbGAP or dbSNP), there are very particular specifications that must be met before researchers can deposit data. Per the requirements of the NIH, the IRB needs to be able to certify certain things. In order to do so, researchers need to have specific information in the protocol regarding the data sharing plan and language in the consent form describing what the researcher is doing with the data, the risks unique to depositing large amounts of genetic data, and what it means to have one’s data in such a database. While this article highlights work funded by NIH and other federal sources, the IRB supports a single standard approach and regardless of funding, suggests all projects meet the criteria listed below if depositing data into repositories. Links to the NIH Policy are at the bottom of this article.

If researchers plan to deposit data into large databases, a clear statement regarding deposits must be in the consent form and best practice is to include an option for subjects to agree/not agree to this use of their research data in the consent form.

Please read this information carefully and keep the suggested language available when crafting consent forms.  It is recommended that you modify your current project and consent forms if your vision is/was to share data and you don’t currently have that process approved in your project.      

Data sharing plans include data type, data repositories to which data will be submitted, appropriate uses of the data and limitations on the future use or an exception to submission which explains why the Institutional Certification criteria cannot be met and must describe an alternative mechanism for data sharing. Please see The NIH Guidance for Investigators in Developing Genomic Data Sharing Plans for more information.

If you are planning on depositing data into a large-scale repository, NIH requires the IRB must assure certain criteria are met:

  1. The protocol for the collection of data is consistent with 45 CFR 46;
  2. Data submission and subsequent data sharing for research purposes are consistent with the informed consent of study participants from whom the data were obtained;
  3. Consideration was given to risks to individual participants and their families associated with data submitted to NIH-designated data repositories and subsequent sharing;
  4. To the extent relevant and possible, consideration was given to risks to groups or populations associated with submitting data to NIH-data repositories and subsequent sharing; and
  5. The investigator’s plan for de-identifying datasets is consistent with the standards outlined in the GDS (Genomic Data Sharing) Policy.

In order for the IRB to make the assurance, it needs to review the protocol, data sharing plan details, and informed consent document.

The protocol needs to include information about the data sharing, future use and deposits to repositories, in addition to statements about the potential privacy risks to the subjects and their families (as well as to their kin group or population, if a specific population or group is being targeted or investigated).

The informed consent document must include detailed information about future use including what data will be shared, with whom and for what purposes. In addition to detailed future use language, the following language must be used:

 

IRB Approved Language for Consent Form(s):

Under Description

To do more powerful research, it is helpful for researchers to share information they get from studying human samples. They do this by putting it into one or more scientific databases, where it is stored along with information from other studies. Researchers can then study the combined information to learn even more about health and disease. If you agree to take part in this study, some of your genetic and health information might be placed into one or more scientific databases. There are many different kinds of scientific databases; some are maintained by [institution], some are maintained by the federal government, and some are maintained by private companies. For example, the National Institutes of Health (an agency of the federal government) maintains a database called “dbGaP.” A researcher who wants to study the information must apply to the database. Different databases may have different ways of reviewing such requests. Researchers with an approved study may be able to see and use your information, along with that from many other people. Your name and other information that could directly identify you (such as address or social security number) will never be placed into a scientific database. However, because your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small, but may grow in the future. Researchers will always have a duty to protect your privacy and to keep your information confidential.


Under Risks

Group Risks
Although we will not give researchers your name, we will give them basic information such as your race, ethnic group, and sex. This information helps researchers learn whether the factors that lead to health problems are the same in different groups of people. It is possible that such findings could one day help people of the same race, ethnic group, or sex as you. However, they could also be used to support harmful stereotypes or even promote discrimination.

Privacy Risks
Your name and other information that could directly identify you (such as address or social security number) will never be placed into a scientific database. However, because your genetic information is unique to you, there is a small chance that someone could trace it back to you. The risk of this happening is very small, but may grow in the future.  Since the database includes genetic information, a break in security may also pose a potential risk to blood relatives as well as yourself. For example, it could be used to make it harder for you (or a relative) to get or keep a job or insurance.  If your private information was misused it is possible you would also experience other harms, such as stress, anxiety, stigmatization, or embarrassment from revealing information about your family relationships, ethnic heritage, or health conditions.

There is a Federal law called the Genetic Information Nondiscrimination Act (GINA). In general, this law makes it illegal for health insurance companies, group health plans, and most large employers to discriminate against you based on your genetic information.  However, it does not protect you against discrimination by companies that sell life insurance, disability insurance, or long-term care insurance.

For more information on the GDS policy, data use limitations, writing data sharing plans, and more visit  https://gds.nih.gov/06researchers1.html.

For Guidance on Future Use and Large-Scale repository considerations from the PPHS, please refer to PPHS Guidance.

 

4D CTSA Technology Development Awards Announced

With support from ConduITS, the Institutes for Translational Sciences, the 4D (Discover, Design, Develop, Deliver) Technology Development Projects promote technology-based solutions for unmet needs across the healthcare system in therapeutics, diagnostics, devices, and digital health. This program takes a mentored approach to facilitate the teams executing their plans.

Please join us in congratulating the following team leaders awarded for this cycle (Fall 2016-March 2017):

  • Jamilia Sly, PhD Instructor, Department. of Oncological Sciences

Internet-Based Patient Activation Intervention to Improve Referrals for Cancer Screening (PAIRS)

  • Ya-El Mandel-Portnoy, 5th year PhD Candidate, Emergency Medicine K12 Scholar

Developing cutting-edge technology to improve the treatment and quality of life of Atrial Fibrillation patient

  • Sander Houten, PhD, Associate Professor Genetics and Genomic Sciences

Novel Treatments for Glutaric Aciduria

  • Ilse Daehn, PhD, Assistant Professor, Department of Medicine, Division of Nephrology

Predictive Biomarkers for Diabetic Nephropathy (DN)

  • Evren Azeloglu, PhD, Assistant Professor, Department of Pharmacological Sciences

Next Generation Bandages for Improved Wound Healing

If you would like more information about this program, please contact the Louise Lammers at louise.lammers@mssm.edu.

 

Funding Opportunities from the Department of Corporate and Foundation Relations

The Department of Corporate and Foundation Relations of the Mount Sinai Development Office provides this curated list of funding opportunities to find faculty who may be interested and to offer assistance with the application process. Please see below for some of their upcoming deadlines, and contact them at CorpFoundHelp@mountsinai.org, if you would like to find out more.

Melanoma Research Alliance: http://www.curemelanoma.org/research/request-for-proposals/
The Melanoma Research Alliance (MRA) announces a Request for Proposals (RFP) soliciting high-impact translational research from scientists and clinicians around the world. The RFP calls for ideas that have the potential to lead to near-term clinical application in melanoma prevention, detection, diagnosis, staging, and treatment.

  • Proposals will be accepted for Young Investigator Awards, Established Investigator Awards, Pilot Awards, and Academic-Industry Partnership Awards (for Established Investigators).
  • Principal Investigators (PIs) must hold a full-time faculty appointment at the level of Assistant Professor (or equivalent) or above at an academic or other non-profit research institution within or outside the United States
  • Proposal deadline: October 21, 2016 at 5 PM ET

Pershing Square Sohn Cancer Research Alliance 2017 Prize: http://www.psscra.org
The Pershing Square Sohn Cancer Research Alliance (PSSCRA) will open applications for its 2017 Prize on October 3rd, 2016. At least five New York based scientists will be selected, to enable them to pursue groundbreaking research at a stage when traditional funding is lacking. As part of the program created around the Prize, winners will be introduced to a mentor in the pharmaceutical industry and will present their work to scientific and business audiences.

  • $200K/yr for up to three years
  • Applicants must have between 2 to 8 years of experience running their own laboratories and must have a PhD, MD or MD-PhD (or equivalent).
  • Letter of intent deadline: November 7, 2016

American Society of Nephrology Funding for New Investigators: https://www.asn-online.org/grants/career/
The ASN Foundation for Kidney Research awards these grants to advance the independent careers of young investigators in biomedical research.

  • Career Development Grants for New Investigators
  • Next deadline cycle will open on October 19 and close on December 14, 2016 at 2 PM
  • Please see website for additional funding opportunities and schedules

American Federation for Aging Research 2017 Grants: http://www.afar.org/research/funding/
Since 1981, AFAR has provided over $160 million to nearly 3,200 talented investigators and students. AFAR offers grants at all different levels of investigation, from student to senior investigator.

  • Deadlines and amounts are varied, please see website for details regarding specific grants

Pancreatic Action Network 2017 Research Funding Opportunities: https://www.pancan.org/research/grants-program/
Five funding mechanisms are now accepting applications from postdoctoral fellows, junior independent researchers and senior investigators. We are also announcing our two new targeted grants (in early detection and precision medicine) that will open in December.

  • Projects are normally funded for a period of four years, in the range of $750,000 over the term of the project.
  • Deadlines: Various, please see website

Sidney Kimmel Foundation Kimmel Scholar Awards: http://kimmel.org/kimmel-scholars/application-process/
The Kimmel Scholar Award is a two-year, $200,000 award given to promising young cancer researchers.  Of the 15 annual Awards, ten are typically given in the fields of basic cancer research and five for translational science.  Please review the Application FAQs for additional information regarding eligibility and selection.

  • Deadline TBD, application process has not yet opened online, but will be opening in early-mid September.

 

xTRACT Support for September 25th NIH Institutional Training Grant Deadline

If you are planning to submit an institutional training grant for the September 25th NIH deadline, you are invited to contact Allison Gottlieb at allison.gottlieb@mssm.edu, for a one-on-one training on using “xTRACT,” a software module in eRA Commons, still in pilot phase, that generates the required tables.

In addition, below are other NIH institutional training grant table resources.

Please stay tuned for emails and additional information about updates relating to the January 2017 deadline.

 

New GCO Staff Member Announced

Shelle O’Loughlin is a new Grants Coordinator whose responsibilities are processing the intake of InfoEd applications and Sinai Central forms for the academic departments listed here.  Shelle comes with many years of experience as an executive assistant in academic medical centers and has previously temped as a Grants Coordinator at the GCO.  Please join the GCO in welcoming Shelle O’Loughlin.

 

NIH Loan Repayment Program (LRP) – Paying Education Debt? Start saving $70,000

Are you a U.S. citizen, U.S. national, or permanent resident who spends and will continue to spend at least 20 hours per week on research?  Do you have a doctoral degree (M.D., or Ph.D. or equivalent)?*  Is your educational debt at least 20% of your annual salary?

If the answer is YES to all of the questions above, you are encouraged to apply to the LRP and first register for the upcoming webinar on Thurs, 9/15 from 4 to 5:30 pm.  Click on NOT-MD-16-010 for further information.

The LRP application cycle deadline starts 9/1/16 and ends 11/15/16 (8:00 pm EST).

NIH LRP Resources

  • Extramural Loan Repayment Program for Clinical Researchers (LRP-CR) (NOT-OD-16-138)
  • Extramural Loan Repayment Program for Pediatric Research (LRP-PR) (NOT-OD-16-139)
  • Extramural Loan Repayment Program for Contraception and Infertility Research (LRP-CIR) (NOT-OD-16-140)
  • Extramural Loan Repayment Program for Health Disparities Research (LRP-HDR) (NOT-OD-16-141)
  • Extramural Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds (LRP-IDB) (NOT-OD-16-142)

* All LRP recipients must have doctoral degrees with the exception of the LRP-CIR for Contraception and Infertility Research.

 

NIH Changes to Application Forms – Phase 2 Now In Effect for Apps Due 5/25/16 and Later

NIH changes for competitive applications with due dates of 5/25/16 and after, also referred to by the NIH as “Phase 2,” are now in effect.  These latest changes primarily center around new NIH forms in the application set for different application types (e.g., all applications, career development awards, institutional fellowships, and training grants).  Please refer to the NIH Notice NOT-OD-081 and the “Significant Changes” section of NIH Form D Application Guide.  For more information, please email allison.gottlieb@mssm.edu.

 

What the GCO Actually Does Need From You in Your InfoEd Application

Last month GCO issued a Helpful Hints e-column on “What the GCO Doesn’t Need From You in Your InfoEd Application,” which generated some enthusiastic feedback.  So the GCO decided to let the pendulum swing the other way by offering you the Helpful Hints companion column, “What the GCO Actually Does Need From You in Your InfoEd Application.”

Here’s a list of the Top 9 Items the GCO needs to keep your project on track, in shape, and administratively healthy.

  1. Your Research or Sponsored Project Application

This one might be obvious since the GCO is the centralized office for research and sponsored project applications, but it must be not so obvious since it’s making its way to the #1 slot on this list. The list below highlights some of the more obtuse GCO submissions.  Needless to say, it is not exhaustive.

  • New Sponsored Project Application – The actual entire application.
  • Industry Sponsored Clinical Trial  – The company written protocol; GCO doesn’t need the Investigator Brochure.
  • New Project Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – Statement of Work (SOW) and relevant parts of the application if the SOW does not provide adequate information.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • New internally funded / unfunded study – The protocol that you or a colleague wrote.  You may also use the HRP-503 Protocol Template if the project is going to the IRB.  But please, don’t give the GCO all the IRB forms.

Rule:  Whatever documentation the funding agency is asking from you, please submit that to the GCO.

  1. Your Progress Report

What is the use of a Progress Report application without a progress report?  This one is actually equally tied for the #1 slot but let’s make it # 2 to make this communication more art than science. More obtuse examples are outlined below.

  • Projects where the external funding agency requires a progress report every year- the actual entire external progress report.
  • NIH 1st No Cost Extension – Make it easy and complete this NIH 1st Time No Cost Extension and Progress Report Form.
  • Non-Competitive Continuation Where You (i.e., Mount Sinai) are the Sub-Award on Someone Else’s Project – SOW or confirmation of No Change in the SOW; and a Progress Report.  Refer to GCO’s Policy/Procedure Memo When Mount Sinai is the Subawardee for more information.
  • Internally funded study continuation or externally funded without a requirement for a progress report from the funding agency –  A progress report that you write yourself.

You may also use the HRP-212 Continuing/Final Review Progress Report if the project is going to the IRB. But please, don’t include all the other IRB forms.

Rule: When reading this column, apply the rule in #1 to # 2 too.

  1. E-Form

Forgot to click on the link at the bottom of the Internal Documents tab, choose the appropriate 1 of 2 e-forms, and complete it?  Not a problem.. The GCO will just submit your multi-million dollar InfoEd application back to after you moved major mountains to get 5 departments to sign off in 10 minutes flat and burned all your political capital to go through this routing process once again.  There’s no other workaround.  The GCO has in earnest tried.  Please remember the form and the right one at that too.  GCO takes no pride in the power of the reject button.

  1. Investigator Form (IF)  #

Think bold.  When you insert that # in your E-form, it’s like you’ve built a bridge between two cyberspace universes – InfoEd and Sinai Central, enabling your designated GCO Grants Coordinator to  transverse these parallel systems as he/she goes along methodically checking that the appropriate personnel signed off on the Sinai Central forms for your project.

Added the IF # to the box in the E-form?   Take a deep breath, internalize your achievement, and move on to the next item on the list.

Did you, by chance, insert last year’s IF #, an IF # from another project, or some other alien UFN (unidentifiable form number)?  It’s like you’ve created a volcano of confusion which can cause a meltdown of both staff as well as the actual cyberspace universes you truly seek to bridge.  New Info Ed submission = New IF #.  We’re moving on.

  1. Signed Conflict of Interest (COI) Forms and Suspension and Debarment (S&D) Form, if applicable

Now that you’ve got the IF # squared away, don’t forget the GCO can’t review your InfoEd application until all the appropriate personnel have electronically signed off on the Sinai Central COI and S&D forms (when S&D is applicable).  You don’t need to add any extra documentation in the InfoEd application.

Allison Gottlieb of the GCO reports, “If I had a nickel for every time a GCO Grants Coordinator issued an ‘Incomplete COI’ email to a PI, I’d be able to pay for private school college tuition for all my kids and that’s a lot of kids. Donations, anyone?”

Seriously, you are empowered in your spare work time to check Sinai Central to see if the investigators have signed the forms and follow up with them if you see “Status: Not started” or some other equivalent, worrisome term.   What do the statuses mean? How do you go about checking?  Go to the IF Instructions for more information and helpful tips.

  1. Up to Date Certification of COI Education Module for all Investigators

The GCO is the institutional gatekeeper for research and sponsored projects and reviews compliance with both external and internal regulations for each project under review, and that includes whether investigators are COI certified.   You don’t need to include anything extra in the InfoEd application for this requirement.

But what you can do is be proactive and check that the investigators’ education certification on your project has not expired.  It is good for four years.  How to check and what to do if it is expired?  Refer to the Sinai Central COI Education Module section of the Application Submission Checklist Instructions.  GCO must notify the COI Office of investigators who are not certified and must also remove them from NIH projects.

  1. Project with Subawards? Don’t Forget all the Subaward Documentation

This would make for a good class but until then, please do refer to GCO’s subaward policy/procedure memo.  There’s a list of what’s required. Take heed of all of the “show stopper” information in there.  Failure to include required items can result in removal of the subaward from your project.

  1. Less is Not Always More.  Include the Triple Signed Cost Sharing Memo if You Need

“Don’t worry,” your co-investigator reassures you.  “I’ve got this one covered. I’m working for free on your project.”  That might sound simple and save you the money that you need to use for something else on the project BUT you now need to jump through three administrative hurdles worth of signatures and include the signed cost sharing form in your InfoEd Application.  If you’ve put an investigator on with effort and no salary and cannot procure a triple signed cost sharing form documenting that some internal fund (i.e., not another grant fund) somewhere in the school/hospital is actually covering the cost, the GCO has no choice but to remove the investigator from your project.  Please review the cost sharing policy for more examples of cost sharing and general policy/process information.

  1. New Competitive Application to Say … the Chamber Music Society of America testing whether chamber music orchestra members are more calm and composed than heavy metal artists? Due tomorrow, but not getting funded for a year?  Wait before you submit that IRB application! GCO’s got an easier initial step.

Include a compliance waiver form signed by the PI with your InfoEd application, which explains that if the project will be funded, the PI will submit to the PPHS Office at a later time, and of course not rush the PPHS Office for immediate review if the PI forgets.  If this project were, say, with chimpanzee and zebrafish musicians, you can use the waiver form for the down the road IACUC submission too.

For additional criteria for the use of the waiver form refer to the Compliance (PPHS/IACUC) section of the Application Submission Checklist Instructions.

Got any other useful advice for your fellow investigators?  Feel free to send to allison.gottlieb@mssm.edu to include in a future GCO Helpful Hints column.

 

Are You Recruiting Healthy Subjects for Clinical Research?

The Office of Research Services periodically receives inquiries from members of the general public seeking opportunities to participate in clinical research projects. In order to serve our research community and the community at large, we are establishing an informal list of studies that are currently seeking participants. If you would like to add your study to this list, please email research.services@mssm.edu with a copy of the current IRB-approved consent and preferred contact information.