Concept Implementation

Atlanta WIHS Approved Concept Sheet Implementation Process

This document is designed to guide principal investigators affiliated with Emory who have recently approved WIHS concept sheets through the WIHS study process at Emory.  There are many Atlanta WIHS resources available to Emory PIs to help them accomplish their proposed research, including data management, regulatory assistance, and biostatistical support.  In order to fully benefit from the Atlanta WIHS resources available, it is important to follow the concept sheet process outlined below.  The Atlanta WIHS team wants to facilitate completion of approved concepts and will do their best to assist PIs with their concepts.

Note that WIHS is a multi-site study and this document describes the process for principal investigators affiliated with Emory who have approved concept sheets, regardless if there are WIHS collaborators at other sites involved.  Utilizing Atlanta WIHS team is the most efficient way for PIs to quickly begin research on their concepts.  Start preparations early, as studies needing Emory IRB approval are reviewed on the rolling basis. It takes at least 3 weeks, and on average 7 weeks to get IRB approval. If the study needs full board review, it may take even longer. Their approval is required prior to a final review and approval by the Grady Research Oversight Committee, who holds their meeting once a month on a rolling basis.

As a result, all questions should be directed to the Atlanta WIHS team early upon concept submission and approval, before contacting WIHS team members at other sites.

 

Key Steps

  1. After your concept is approved by the national WIHS, please forward your letter of approval and the Concept Sheet (CS) to the Atlanta WIHS PD (Ms Antonina Foster, antonina.g.jackson@emory.edu) and DM (Dr. Anna Rubtsova, grubtso@emory.edu).
  2. Download and fill out the Concept Implementation Questionnaire that can be found here
  3. Email the completed Concept Implementation Questionnaire to Ms. Foster (antonina.g.jackson@emory.edu).
  4. Based on the information from your questionnaire, Ms. Foster will determine the next steps involved in the implementation of your CS and will schedule the necessary follow-up meetings with relevant Atlanta WIHS team members (e.g., Regulatory Coordinator, Site Coordinator, Data Manager).
  5. During your study implementation phase, please expect to provide the Atlanta WIHS team with periodic progress updates – i.e., please, fill out the annual progress report, submit conference abstracts and manuscripts for WIHS review, and notify the Atlanta WIHS team of all conference presentations, publications, and grant submissions related to WIHS data.
  6. Please, keep up with all necessary study documents and certification: e.g., study specific training logs, lab certifications, yearly study renewals, CITI certification.
  7. Be mindful of the steps involved in the study completion: e.g., make decisions about the storage of data and leftover samples; transfer your project dataset and data analysis syntax to WDMAC; remember to submit all conference abstracts and manuscripts resulting from your study for WIHS review/approval; keep notifying the Atlanta WIHS team of all conference presentations, publications, and grant submissions related to your completed WIHS project data.

The key steps involved in the CS Implementation are summarized in the Flowchart that can be found here.

IMPORTANT: Project Implementation Reports & Documents

Please, remember that WIHS requires several reports and documents connected to project implementation:

  1. National WIHS annual progress report. PIs of WIHS-approved concepts must fill out annual progress reports for each approved concept by August 30 of each year. The annual progress report form can be found here: https://statepiaps8.jhsph.edu/apollo/studies/wihs/webroot/html/  If no Annual Progress Report is received by WDMAC, one reminder will be sent before project is deactivated.
  2. Atlanta WIHS progress report. Please, expect to fill out Atlanta WIHS progress report, providing information about WIHS-related conference presentations, publications, and grant submissions. The progress report form will be emailed to investigators each year in January.
  3. Conference abstract submission. All abstracts for conference presentations in relation to WIHS-related research projects must be submitted to WIHS for approval. Please, email your completed abstract along with the information about conference name, dates, and submission deadline to (JHSPH.wdmac@jhu.edu) and CC Atlanta WIHS (grubtso@emory.edu; Antonina.g.jackson@emory.edu). Please, allow at least several weeks for WIHS approval before your conference submission deadline. Be sure to inform Atlanta WIHS team  if your abstract is accepted (grubtso@emory.edu; Antonina.g.jackson@emory.edu)
  4. Manuscript submission. Manuscripts resulting from WIHS data and/or specimens must be reviewed by WIHS collaborators who are co-authors, allowing sufficient time for revision before submission to a journal. Final versions must also be submitted to the WIHS Executive Committee (EC) (JHSPH.wdmac@jhu.edu) for review before submission to a journal. WIHS manuscript submission form can be found here: https://statepiaps8.jhsph.edu/apollo/studies/wihs/webroot/html/ Additionally, all manuscripts using WIHS data/specimens should acknowledge WIHS, using the wording stated here https://statepiaps8.jhsph.edu/apollo/studies/wihs/webroot/html/
  5. Publication submission form. After the WIHS-related manuscript is accepted for publication, the publication submission form must be submitted to WIHS. The publication submission form can be found here: https://statepiaps8.jhsph.edu/apollo/studies/wihs/webroot/html/
  6. Post-publication information. After manuscript publication/project completion, investigators must complete several steps:
    1. Email the full final citation and the PDF of the published paper to WDMAC (JHSPH.wdmac@jhu.edu) and CC Atlanta WIHS (grubtso@emory.edu; Antonina.g.jackson@emory.edu)
    2. Submit the manuscript to the NIHMS system here (https://statepiaps8.jhsph.edu/apollo/studies/wihs/webroot/html/) for assignment of PMCID. Failure to submit may result in future restrictions on the use of WIHS data/specimens.
    3. After completion of the analyses defined in the WIHS-approved CS, Investigator must destroy all copies of the limited dataset within 60 days; Investigator must send copy of all primary data to WDMAC (JHSPH.wdmac@jhu.edu), and all laboratory results must be sent to WDMAC for archival purposes (JHSPH.wdmac@jhu.edu).
  7. Atlanta WIHS updates. In addition to annual reports, Atlanta WIHS team asks investigators to update us on all your new WIHS-related abstracts, manuscripts, and grant applications that occurred since your last report. Please, expect periodic reminder emails from Atlanta WIHS team asking you for updates.

List of Abbreviations

CS: Concept Sheet
DM: Data Manager
EC: Executive Committee
GROC: Grady Research Oversight Committee
IRB: Institutional Review Board
OCR: Office of Clinical Research
OOQ: Office of Quality
PI: Principal Investigator
PD: Project Director
WIHS: Women’s Interagency HIV Study
WDMAC: WIHS Data Management and Analysis Center (Data Coordinating Center for WIHS, located at Johns Hopkins)