ISMMS IRB to Review Beth Israel Human Research

As part of the continuing efforts of the Icahn School of Medicine at Mount Sinai (ISMMS) to streamline and unify the submission process to the Institutional Review Boards (IRBs) throughout the system, the Program for the Protection of Human Subjects (PPHS) is pleased to announce that effective May 30, 2017, all Beth Israel human research applications will now follow the ISMMS submission deadline schedule found on the Researcher page on the PPHS website.  With this integration, the ability for the IRB to review projects weekly rather than monthly will assist in improved turn-around times.

As a reminder all initial applications require an e-submission through Ideate.  If the project was originally submitted in Ideate, its continuation application, any modification submissions, and its final report will also be submitted through Ideate.

For projects that did not begin in Ideate, they will continue to be submitted to IRB@mssm.edu.

As always, the PPHS appreciates your attention to this matter and all that you do to protect the research volunteers who agree to take part in the research conducted by investigators working within the Mount Sinai Health System.

If you have any questions related to the changes above please call the PPHS/IRB office at 212-824-8200.

 

Retirement of Rebecca Balentine, GCO Associate Director and Promotion of Amanda Amescua, GCO Assistant Director Announced

Rebecca Balentine and Her Team

Rebecca Balentine and Her Team
(from left to right Mary Mbabazi, Amanda Amescua, Rebecca Balentine, Olga Carr, Michelle Yoon, Edwin Berrios)

We are both saddened and delighted (for her!) to announce the retirement of Rebecca Balentine from the position of Associate Director, Grants and Contracts Office (GCO) effective Friday, April 28, 2017. She has  been an outstanding member of the GCO family, and her three year term at Mount Sinai has been a wonderful capstone to an exciting 35-year career in research administration! Her hard work, dedication, and sense of humor have been central to the success of her team, and she will be greatly missed. Please join the GCO in thanking Rebecca for her valuable years of service and wishing her well in her future travels!

While we are sad to see Rebecca go, we are also pleased to announce Amanda Amescua will be taking over her role as Assistant Director, effective May 1, 2017.  Amanda Amescua has received a well-deserved promotion from GCO Senior Grants Specialist to Assistant Director.  Amanda has approximately 10 years of experience in sponsored project administration including positions at Columbia University Medical Center, Duke University Medical Center, and the University of Texas at Austin.  We are confident that Amanda will make a fine edition to the leadership team.  Please join us in congratulating Amanda in her new role.

Reminders for Upcoming May 25 Competitive NIH Grant Application Deadline and Beyond

The Grants and Contracts Office (GCO) offers the following reminders about guidelines, updates, and policies pertaining to National Institutes of Health (NIH) grants and their administration.

Option to Report Preprints and Other Interim Research Products Effective 5/25/17 (NOT-OD-17-050)
(excerpted from NIH Notice)
Interim Research Products are complete, public research products that are not final.  A common form is the preprint, which is a complete and public draft of a scientific document. Preprints are typically unreviewed manuscripts written in the style of a peer-reviewed journal article. Scientists issue preprints to speed dissemination, establish priority, obtain feedback, and offset publication bias. Another common type of interim product is a preregistered protocol, where a scientist publicly declares key elements of their research protocol in advance. Preregistration can help scientists enhance the rigor of their work.

For applications submitted for the May 25, 2017 due date and thereafter, awardees can claim these products on their progress report publication list.  They can also report them on their RPPR as of May 25, 2017, and link them to their award in their My Bibliography account.

For complete information, please read NOT-OD-17-050.

Appendix Policy Change for NIH/AHRQ/NIOSH Applications Submitted for Due Dates On or After 1/25/17 (NOT-OD-17-035)

Updated Font Guidelines for Applications to Due Dates On or After 1/25/17 (NOT-OD-17-030)

Coming Down the Pike – Form Changes Affecting 1/25/18 Competitive Grant Applications and Beyond (NOT-OD-17-062)
The  NIH is announcing application form changes planned for competitive applications due 1/25/18 and beyond. The form changes center on consolidating human subject and clinical trial information.   Please read NOT-OD-17-062 for more information about the move form the current FORMS-D to a FORMS-E version.

Please contact Allison Gottlieb, Director, Sponsored Programs Education, GCO, if you have any questions or need additional information.

Updated Financial Administration of Clinical Trials Services (FACTS) Website Coming Soon and Other Announcements

Please stay tuned for a new reorganized Financial Administration of Clinical Trials Services (FACTS)  website that will provide a more comprehensive and transparent approach to navigating the contract life cycle through Meditract. Meditract, which was launched last year, offers users the ability to track the status of their agreements in real time.

Reflected in this new website is the fact that the FACTs team has grown. Their addition of new Senior Contracts Specialist allows for more efficient and expedient contract management and thus an improvement on turnaround time.

In addition, a new fee schedule for FACTS services was announced on March 3, 2017 and will be implemented starting April 1, 2017.

 

GCO Helpful Hints – Travel Haiku to Ponder

Suitcase with Map_smFrom the Desk of Allison Gottlieb, Director of Sponsored Programs Education:

Traveling by way of airplane is often a time with many hours sitting around to wax pensive on the grandeur of the universe in all its complexity or the karmic force that put you next to the hyper-active hysterical child.

Keeping this in mind brings me to my next thought and that is about, yes. Haiku (plural). My first foray into the venerable language art form of haiku was in 4th grade starring my pet Gerbil Jerry, may he rest in peace.

Jerry the Gerbil
Lives in a small dirty cage
He gnaws newspaper

Post elementary school and many years of gainful employment at Mount Sinai is my next foray into haiku where a reader can plumb the depths of travel policy vis-à-vis grants.  Here are a few poetic lines to keep in mind before taking that trip by plane, boat, subway, taxi, rental car or sneakers* funded by your sponsored project.

Haiku 1. All Travel

Travel on a Grant
To get reimbursed, must have
Prior Approval


Haiku 2. International Travel on NIH Grants

Prior Approval
International Travel
GCO approves.


Haiku 3. International Travel on NIH Grants – A Point of Confusion Clarified

Part 1

Traveler on a Grant
But nowhere found on budget
GCO questions –

Part 2

The PI answers –
Traveler added in mid-year
Can we charge grant fund?

Part 3

GCO responds –
Yes, do add a comment in
Sinai Central please.


Haiku 4.  Creative Space for Reader to Add His/Her Own

[intentionally left blank]

 

 


Haiku 5, 6, 7 and 8    Reasons Travel Requests Frequently Get Rejected/Delayed

For those inspired to create travel haiku but in need of more structured topics –

  1. Not booking a Fly America Act compliant airline; more info in link in Haiku 1 above.
  1. Not an obvious or well explained relationship between the trip and the scope of work of the project; see link in Haiku 2 above.
  1. Referencing foreign collaborators in the justification for the trip, but having no foreign involvement as per the grant submission.
  1. Check Google Maps Prior to Submitting International Travel Request (and Going on Your Trip) – New Mexico, Babylon, and Toledo Might Actually Be in the USA

[intentionally left blank]

 

*list is not all inclusive

 

GCO Helpful Hints – Be a NIH Super Hero! Top 9 Ways to Avoid Potentially Fatal Foibles

Spider-Man

GCO Sponsored Programs Education Director Allison Gottlieb’s little super hero ready for action!

Have you ever thought about quitting your day job for something more exciting and meaningful like the life of a super hero where you can take down evil villains while traveling the world at supersonic speed through fire, flood, earthquake, and wind storm?

Yes, that thought has crossed my mind once or twice but I always got cold feet at the prospect of getting bogged down by a technical snafu, like the door in the telephone booth jamming as Superman completed his costume change or Spider-Man’s under the wrist web gizmo malfunctioning.  It’s always those technicalities that can bring down an operation.  Lucky for us at Mount Sinai, our PIs don’t need to quit their day job but can remain super heroes on their own turf while avoiding those seemingly petty but potentially fatal foibles.

Here is a list of GCO’s top technical and administrative errors that will stop your NIH competitive application dead in its tracks like the Bat Mobile running out of gas or stalled on the road.

By the way, that is a photo of my son ready to battle the bad guys or perhaps NIH cyber application moles? (For those into important details, you might notice the remnants of the energy boosting power snack, chocolate, on the super hero’s face.)

#1 Driving without GPS or a Road Map? Use GCO’s Application Submission Checklist and Instructions

Use GCO’s Application Submission Checklist and Instructions each and every time you submit to the GCO (i.e., think words of encouragement and not a requirement).  There are 20 steps listed that may be applicable to your application.  Miss a step like forgetting your InfoEd eForm or all the subaward documentation or  your co-investigator has an expired FCOIR education certification? Your Bat Mobile has stalled on the road and is sinking in quicksand fast.

#2 Selecting Your Destination?  Remember to Use the NIH Assignment Request Form and NOT a Cover Letter

For those super hero vehicles that must be parked in the garage of a specific study section, remember to use the new NIH Assignment Request Form and not a cover letter.  You would select this optional form in the InfoEd SetUp questions.  Please see complete Instructions for the Assignment Request Form on the NIH site.

#3 Attention PIs and Mentors – Forgot your ID?  It’s called “Sponsor Credentials”

PIs and mentors must enter their eRA Commons ID into InfoEd.  You would enter the information in “My Profile” in “Sponsor Credentials” section. Another option is for staff working on the application to  add it in “Sponsor Credentials” box right in the Personnel tab for the investigator.  Without it, it’s like being pulled over on the side of the road for driving without your ID.  In this case, you can’t even return home. You’re just stuck out there on the open road in the hot blazing sun. Need an eRA Commons ID? E-mail grants@mssm.edu, indicate your role on the project and the GCO will assign one to you.

#4 On the Wrong Road from the Get Go?  Check to Make Sure the NIH Institute / Center Will Accept your R03 or R21 Application or other non-R01 parent application

Did you know that not all NIH Institutes and Centers (IC) accept the R03 and R21 and other non-R01 applications in response to a Parent Announcement? When reading the Parent Announcement, you’ll see right at the top the “Components of Participating Organizations” section, which means the institutes/centers that will accept the application.  ICs that do not participate in the announcement will not consider applications for funding.

#5 Are these Human Subjects in My Super Hero Vehicle? What are Specimens?

Are human samples expedited, exempt, or not human subjects research?  The confusion is especially prevalent around coded or deidentified specimens. Please follow the first FAQ to help make the determination: https://humansubjects.nih.gov/human-specimens-cell-lines-data.

#6 Toll Bridge Ahead – New Enrollment Tables and Differences in Planned vs. Cumulative Enrollment

Planned means prospective enrollment; cumulative means you are using previously collected samples/specimens/data (for example, if using a biorepository). There are different instructions for completing the tables, depending on which type of enrollment is selected. For example, if you select “Planned”, but input numbers into the “Unknown” category, it generates an error, as this column is only for cumulative enrollment.  (GCO has a fill list of table validations available upon request.)  Can one select both “Planned” and “Cumulative” on the same table? No, this is not possible. It has to be either or; if using both, then two tables, one for each type of enrollment, is required.

#7 Want to Race Through the NIH Cyber Highway at Warp Speed During Rush Hour? Even Super Heroes Must Follow Traffic Rules

The warp speed button on everyone’s super hero vehicle has been disabled by Management.  It is purely ornamental and doesn’t work.  The GCO must be in receipt of the COMPLETE AND FINAL proposal, including completed and signed Conflict of Interest and Suspension and Debarment forms 5 business days prior to the NIH deadline by 11 am to guarantee an on-time delivery to NIH. In addition, please see NIH Competitive Application Due Date Information.  There always seem to be unforeseen circumstances so do plan ahead and submit on time.

  #8  Change the Radio Dial on Your Bat Mobile from the Biosketch Blues to Something More Upbeat?

GCO reminds PIs and staff in the review process that many items must be removed from the Biosketch page like pending awards, or grants completed more than 3 years ago, or completed projects that are listed as still active.  You might want to get a jump start on the process by reviewing the Biosketches prior to submission to the GCO. Please see the NIH Biosketch Instructions and Sample pages.

 #9  File Attachments: Beware of the “&” and Really Looooooooooooooooooong Attachment Titles 

Your InfoEd file PDF file attachments that get exported into the NIH forms are like little passengers in your Bat Mobile. They need to be loaded in just right.  Please follow these Dos and Don’ts adapted from:

http://grants.nih.gov/grants/how-to-apply-application-guide/format-and-write/format-attachments.htm#filenames

DO

  • Save all document attachments with descriptive filenames of 50 characters or less (including spaces).
  • Use unique filenames for all attachments in an application (or within a component of a multi-project application).
  • Use any of the following characters: A-Z, a-z, 0-9, underscore, hyphen, space, period, parenthesis, curly braces, square brackets, tilde, exclamation point, comma, semi colon, apostrophe, at sign, number sign, dollar sign, percent sign, plus sign, and equal sign.
  • Use one space (not two or more) between words or characters and do not begin the filename with a space or include a space immediately before the .pdf extension

DON’T

  • Use the ampersand (“&”) since it requires special formatting.

Questions about Sponsored Projects?  Please click here for a listing of Departmental Grants Specialists at the GCO who can assist you.

 

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.

 

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.

 

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.