"RED BOOK": HMS Nominations for 2006 Faculty Fellowship Awards. Info available online Mon. Feb. 13
Tosteson Postdoctoral Fellowship Awards:  $50K for work related to research in Bldg 149.  Due April 6
New IRB Forms Required July 15, 2005
The National Postdoctoral Association has Announced Three New Publications
Easy To Use Template for NIH Biosketches! - No More Formatting Nightmares!
Find Out About New NIH Funding - Subscribe To The NIH Guide for Grants & Contracts NOW!
E-Buy is Here!
The NIH ListServe!
Manage your Research Funds with NIH eRA Commons and Partners InSight!
Registration of Clinical Trials - Mandatory for Publication!






"RED BOOK": HMS Nominations for 2006 Faculty Fellowship Awards. Info available online Mon. Feb. 13

Each year Harvard is invited to nominate candidates for over 50 Postdoctoral and Faculty Fellowships/Grants.  To choose candidates to represent the Harvard Medical Community in the national competitions, the HMS Faculty Fellowship Committee conducts an internal selection process. On February 13th, HMS will publish information online about the awards and application process. (This information was formerly circulated in a “Red Book.”). Although the Foundations’ application deadlines span the entire year, the HMS selection process occurs only once during the spring, and preliminary applications must be submitted to HMS in early April to be considered.

While most award opportunities are directed toward junior faculty members, a small number are unrestricted as to rank. In addition, a few are targeted specifically toward postdoctoral fellows. Since these are invitational awards, the HMS Faculty Fellowship Committee invites Department Heads to submit nominations for eligible fellows/faculty members whose research they feel would be competitive for one or more of the funding opportunities described below. The Committee encourages postdoctoral fellows and junior faculty members to discuss their eligibility for these awards with their Faculty Sponsors/Mentors who, with the sign off of their Division Chiefs and Department Heads, make the nominations to the Faculty Fellowship Committee. Information on the next cycle of invitational awards will be available online beginning Monday, February 13th (website)



Tosteson Postdoctoral Fellowship Awards:  $50K for work related to research in Bldg 149.  Due April 6

Young investigators pursuing training in basic and clinical research are invited to apply for Tosteson Postdoctoral Fellowship Awards of $50,000. Candidates who are at the postdoctoral training level, who do not currently have an award providing a stipend, and whose work is related to research being carried out at Building 149 are eligible.  Four awards are funded by the Massachusetts Biomedical Research Corporation (MBRC).  Applications are due on April 6.  (Download .doc)






New IRB Forms Required July 15, 2005

NEW IRB FORMS (new full application, protocol summary, special populations forms, consent forms) must be used for any new protocols submitted after July 15, 2005.  New forms are available at the IRB website; see the "red updates."  Submissions received after July 15 on the older forms will be returned to investigators. These forms were revised in response to an external review by the Association for Accreditation of  Human Research Protection Programs (AAHRPP). MGH and BWH are fully accredited. The consent form template is our new "Plain Language" version in a new user friendly format.

Comments on the new forms may be submitted to Daniel Connor.

See also our Partners Human Research Newsletter.



The National Postdoctoral Association has Announced Three New Publications

The National Postdoctoral Association has announced three new publications developed for use by postdocs and others wishing to support postdoctoral research:

1) Recommendations for Postdoctoral Policies and Practices - a resource for institutional leaders, postdoc office administrators, principal investigators and postdoc association leaders, these recommendations reflect the NPAs "best current thinking on those policies and practices that every institution should consider for enhancing the postdoctoral training experience." (Download .pdf)
 
2) Postdoc Association Toolkit - a resource guide to assist postdocs and their allies in starting and sustaining an effective PDA. The PDA Toolkit is a member benefit of the NPA. To access the Table of Contents, please visit the National Postdoctoral Association website.

3) International Postdoc Survival Guide -  intended to help international postdocs navigate life and work in the United States. (See Table of Contents)




Easy To Use Template for NIH Biosketches! - No More Formatting Nightmares!

Biosketch Template Form (Download word document)

BIOSKETCHES TEMPLATE - INSTRUCTIONS -

Mary Ann Ladd, Systems Manager for the MGH Institute for Technology Assessment has made creating new NIH biosketches a piece of cake!  No more worries about formatting when cutting and pasting from your CV!  She has upgraded the 398 Biosketch format that NIH has on their "Forms" page in the following ways:

  • Everything is locked except for the available grey fields. This means, no freaky fonts, font sizes, too many pages, discombobulated margins, incongruous details, etc!!!

  • All the text fields are in tables.  This also simplifies filling out the form, especially for those who NEED to switch to the new 09/04 form.

  • The locked in fields mean that the document is password protected.  Under "Tools" --> "Unprotect Document" you are given a "Enter Password" field where you may unlock the document.  The password is "NIH" in all capitals.  Please Note: Once you unprotect the document it means that formatting is compromised.  It is then VERY IMPORTANT to ensure that whatever changes you make conform with the NIH formatting regulations.  Once the document is unprotected, you can reduce or increase the number of rows for permitted fields and change (eek!) anything you do not like.  This makes changing things a conscious choice and not an accident waiting to happen! 

  • The "PI" section on the first page is a field that can be repeated through the Header on the remaining pages.  No longer worry about having one PI name on the first page, and a different PI name leftover from past Biosketch requests on the other pages.  This is a locked section so it will require you to unprotect the document to enter into this field.  Once you have entered the PI name on all pages, we suggest re-protecting the document and saving it so that you ensure no other accident changes happen while you are cutting and pasting other content. 

  • There are notes!  Highlighted fields have a little note with instructions when you scroll your mouse over it - amazing!


Find Out About New NIH Funding - Subscribe To The NIH Guide for Grants & Contracts NOW!

The NIH Guide for Grants and Contracts is the official publication for NIH medical and behavioral research grant policies, guidelines and funding opportunities. The Guide is published on a weekly basis and users may Subscribe/Unsubscribe to the weekly e-mail LISTSERV Table of Contents (TOC). It is also used by NIH Contracting offices and other HHS agencies, to announce their funding opportunities. The NIH Guide serves in lieu of the Federal Register, in compliance with the Administrative Procedures Act. Occasionally, unofficial notices of interest to the scientific research community are published. The NIH considers applications for the support of basic or clinical biomedical, behavioral, and bioengineering research. New extramural grant programs and priorities are implemented by publication of a Program Announcement (PA), Request for Applications (RFA) or a Request for Proposals (RFP).  Notices relevant to each of these types of announcements are also published each week and may include important deadline changes, formatting requirements or funding updates.

For more information:  http://grants.nih.gov/grants/guide/description.htm



E-Buy is Here!
(Download pdf)



The NIH ListServe!
The NIH has a listserve that sends out weekly emails with updates on forms, new PAs and RFAs, as well as other useful NIH information. To join the listserve, send an email to listserv@list.nih.gov with the following text in the message body (not the "Subject" line): subscribe NIHTOC-L your name (Example: subscribe NIHTOC-L Joe Smith) Your e-mail address will be automatically obtained from the e-mail message and add you to the LISTSERV.



Manage your Research Funds with NIH eRA Commons and Partners InSight!
The NIH eRA Commons is an on-line connection to NIH for information on pending applications and awarded grants as well as a gateway for the electronic facilitation of many routine business processes.  To join the NIH eRA Commons, you must first contact Barbara Steele at MGH.

Insight is a program at MGH that allows a PI to view all of her/his grant information (incl.: deadline, grant submission info., IRB comments, award notification, as well as the content of the application & grant).  Subcontractors have a separate fund number that gives you access to the fund.  PI's can also designate access to other people by contacting Scott McNeal, the InSight Manager (email him your name, the fund code, and the chief code).  (Insight login website)



Registration of Clinical Trials - Mandatory for Publication!

To: Partners Research Community

From: P. Pearl O'Rourke, MD - Director, Human Research Affairs

Date: April 4, 2005

Re: Registration of Clinical Trials

In September 2004, the International Committee of Medical Journal Editors (ICMJE) published a statement saying that they would only publish clinical trials that were registered on a publicly accessible registry. The ICMJE statement in concert with numerous registry initiatives from the World Health Organization, state and federal legislatures and industry has led to a situation of confusion and bewilderment.

Currently it is difficult to know how to respond to the numerous requests for registration. Unfortunately there is no standard agreement regarding what clinical trials should be registered; what information should be included in a registry, and what registry should be used.

Until there is more clarity - the following FAQs will hopefully provide some information. For those who simply want the "bottom line" - go to the last two FAQs.

Why have clinical trial registries developed?

Allegations of selective publication and biased reporting of clinical trials have led to the demand for full disclosure and transparency. Clinical trial registries are one way to provide this transparency.

Is there a single registry?

No. Not only are many registries being developed - three different types of registries are being promoted:
1. Registry of the results from clinical trials (databases)
2. Registry of all clinical trials that are enrolling subjects
3. Registry that includes both of the above.

What is a registry of clinical trial results?

Also called a clinical trial results database, this is a listing of completed studies with a description of the protocol and aggregate results. Currently there are several databases developed and maintained by industry. You may want to peruse the PhRMA site at: http://www.clinicalstudyresults.org/.

What is a registry of ongoing clinical trials?

This is a registry of ongoing trials that are still enrolling subjects. The information posted includes:
· The protocol with description of trial procedures
· Inclusion and exclusion criteria
· Where the trial is being conducted and whom to contact for information regarding enrollment

This type of registration is being championed by a number of organizations such as the AMA, the World Health Organization, and the International Council of Medical Journal Editors (ICMJE).

The registry developed and maintained by the National Library of Medicine at NIH is the most commonly used such registry and can be accessed at www.clinicaltrials.gov

Do you have to register your clinical trials?

Yes, if one of the following is true
  • If your research is funded by a pharmaceutical industry sponsor: Individual pharmaceutical companies have their own policies regarding registration - you should contact your sponsor for information.
    - In most cases, this is registration of trial results

  • If you plan to submit a manuscript of your clinical trial to a journal that has adopted the registration requirements of the International Committee of Medical Journal Editors (ICMJE)* you should be aware of the following conditions that must be met before a manuscript will be considered for publication:
    - Any clinical trial that is starting enrollment after July 1, 2005 must be registered before or at the onset of enrollment.
    - Any clinical trial that began enrollment before July 1, 2005, must be registered by September 13, 2005.
    - The ICMJE defines a clinical trial as:
    "any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. Studies designed for other purposes, such as to study pharmacokinetics or major toxicity (e.g., phase 1 trials), would be exempt."
    - The ICMJE does not advocate a specific registry - but - the only existing registry that meets the ICMJE requirements is www.clinicaltrials.gov that is sponsored by the National Library of Medicine.

    *ICMJE signatories:
    New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croation Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association.

Who is responsible for completing the registration?

The principle investigator is responsible for completing registration.

  • For industry-sponsored trials: contact the sponsor to determine registration responsibilities.
  • For clinical trials that that may be submitted to an ICMJE journal - register with www.clinicaltrials.gov Instructions on how to submit information can be found at: http://prsinfo.clinicaltrials.gov.