Step by Step: Mission Hospital/HCA data and/or Survey of Mission inpatients

Use this page for:

All studies using Mission/HCA data and/or survey of Mission patients/residents.

Online training in protection of human subjects.

CITI Program

Create an account with IRBNet and download a protocol template.

How to use IRB net

Submit research protocol to CARRIE to screen for exemption or IRB review.

A. If you are using Mission Data and have a GME researcher (i.e. Resident/Fellow), you will submit to CARRIE Screening via IRB Manager

B. If you are a researcher in the MAHEC Dental department OR using Mission Data but do not have a GME researcher, you will submit to the Mission IRB via IRBNet.

After IRB exemption or approval, data collection may begin.

A. If you are using Mission Data and have a GME researcher (i.e. Resident/Fellow), you will submit to DataClear to request data.

B. If you are a researcher in the MAHEC Dental department OR using Mission Data but do not have a GME researcher, you will collect/request data with HIPAA protections in mind.

All research done with Mission Data requires clearance before dissemination of results.

This requirement applies to abstracts, posters, presentations, manuscripts, and all other dissemination of research results outside of MAHEC and/or Mission hospital.

A. If you are using Mission Data and have a GME researcher (i.e. Resident/Fellow), you will submit to PubClear for review.

B. If you are a researcher in the MAHEC Dental department OR using Mission Data but do not have a GME researcher, you will submit to External Data Release for review.

GME Research Step-by-Step

This page is for research involving MAHEC residents/fellows (a.k.a GME Research)

Follow these steps when you have a resident or a fellow as member of your MAHEC research team. This process is required before you begin any research.

1. Online training in protection of human subjects via CITI Program.

2. Create an account with IRBNet and download a protocol template.

PLEASE NOTE: LINKS ONLY WORK WHEN CONNECTED TO THE MAHEC NETWORK EITHER ON-SITE OR CONNECTED VIA VPN (Global Protect)! THIS ENSURES THE PRIVACY OF THE LINKED DOCUMENTS.

How to use IRB net

  • Much GME research will be retrospective chart review. Use the Study Protocol– Medical Records Research form
  • Surveys or other benign interactions should use the Study Protocol– Minimal Risk Research form
  • If your GME research involves an intervention or interaction with subjects, you will want to use IRB Manger resources, specifically, “IRB Manager Initial Submission” This document details submission of your research protocol. Includes all questions that will be asked.

3. Once your protocol is completed, it needs IRB review.

If you are using Mission Data and have a GME researcher, you will submit to CARRIE for IRB screening for exemption.

If you are using MAHEC Data only and have a GME researcher, you will submit to the Mission IRB through IRBNet.

  • Regardless of route (CARRIE or Mission IRB) you will need to attach your research protocol, surveys, data collection sheets, etc. to the submission.
  • Please send all research protocols using Mission Data to the HCA NC Division Director of Research – Tokesha Warner.
  • Questions about the Mission IRB request for Exemption may be directed to Elizabeth Hamilton.

4. After IRB exemption or approval, data collection may begin.

If you are using Mission Data and have a GME researcher, you will submit to DataClear to request data.

  • Once approved, an HCA GME data analyst will set up an Initial Statement of Work (SOW) conference call with the Principal Investigator and team to discuss.
  • HCA GME does not conduct data analysis at this time. Please contact MAHEC Research for assistance with data analysis and statistical support.

If you are using MAHEC Data only, proceed to data collection, keeping HIPAA protections in mind.

  • Keep data sets on secure MAHEC servers and encrypt/protect with a password.
  • Create a de-identified data set for analysis with a crosswalk to patient identifiers kept separately.

5. All research done with Mission Data requires clearance before dissemination of results.

If you are using Mission Data and have a GME researcher, you will submit to PubClear for review.

  • When your research has been analyzed, you will likely want to present and/or publish your results. Any and all dissemination requires clearance prior to presentation via PubClear.
    • This requirement applies to abstracts, posters, presentations, manuscripts, and all other dissemination of research results outside of MAHEC and/or Mission hospital.

If you are using Mission data but does not include GME researchers or is Dental research, you will submit to External Data Release for review. (page under construction)

Mission GME Research process

IRB Net

IRB Net is for two main needs:

Downloading IRB Forms

IRBNet gives access to all research protocol forms. Step-by-step instructions to create an IRBNet account.

Note: When logged in, forms can be accessed from the Forms and Templates button on the left sidebar (underlined in yellow in the image below). Be sure to use the pull down menu to select the correct library of forms (Select a Library).

  • If you plan to do retrospective chart review, use the Study Protocol– Medical Records Research form
  • Surveys or other benign interactions should use the Study Protocol– Minimal Risk Research form
  • If your research involves an intervention or interaction with subjects, you likely need an Expedited or Full protocol form

Uploading IRB protocol and documents for the Mission Hospital IRB

Create a project package and submit to Mission Hospital IRB. Step-by-step instructions to create a research project package.

IRB Manager:

When IRB Oversight IS required, use IRB Manager to submit your research protocol

IRB Manager is the home of the screening tool CARRIE. After CARRIE screening, your GME research protocol may require IRB oversight. When this is the case, submit your research protocol for full or expedited IRB review with IRB Manager.

IRB Manager Website

IRB Manager (portal to login to IRB Manager)

Links for IRB Manager

PLEASE NOTE: LINKS ONLY WORK WHEN CONNECTED TO THE MAHEC NETWORK EITHER ON-SITE OR CONNECTED VIA VPN (Global Protect)! THIS ENSURES THE PRIVACY OF THE LINKED DOCUMENTS.

IRB Manager Initial Submission Detailed instructions for submission of your research protocol. Includes all questions that will be asked.

IRB Manager Guide User manual for IRB Manager.

Frequently Asked Questions (FAQ) for IRB Manager protocol submission

  • You must have an HCA 3-4 ID to submit your protocol to IRB Manager.
  • IRB Manager is intended for the Principal Investigator (PI) to complete, as there are a number of attestations that are most appropriate for the research team leader (e.g. oversight of entire project).
  • For GME related scholarly activity, your Local Institution Approver is your Division Director of GME Research (DRD).

DataClear

DataClear is for requesting Mission or HCA data for MAHEC GME Research.

If your research uses Mission Hospital data but is not GME Research, please use the External Data Release (EDR) process.

What is DataClear?

DataClear is and HCA GME system used to request data sets from Mission Hospital for GME Research. You can request data from Mission Hospital, the NC Division, or all HCA Hospitals. There is an associated Data Dictionary with details. All data requested via DataClear will be de-identified before delivery. Data will only be viewed via the Virtual Desktop Interface (VDI). The VDI includes statistical packages from R or SPSS (not SAS).

Scholarly Commons/DataClear Website

HCA Healthcare Scholarly Commons (website for DataClear). You will need to make an account on Scholarly Commons and have an HCA 3-4 ID to use DataClear.

Links for DataClear

PLEASE NOTE: LINKS ONLY WORK WHEN CONNECTED TO THE MAHEC NETWORK EITHER ON-SITE OR CONNECTED VIA VPN (Global Protect)! THIS ENSURES THE PRIVACY OF THE LINKED DOCUMENTS.

Using DataClear for MAHEC Research (step-by-step instructions for MAHEC)

DataClear Example (all questions in DataClear)

HCA DataClear Data Dictionary (Excel file, describes available data elements, limitations, etc.)

Frequently Asked Questions (FAQ) for DataClear

  • You must have an HCA 3-4 ID to submit to DataClear. You also need an account on HCA Scholarly Commons.
  • All DataClear requests must include your Division Director of GME Research (DRD).
  • Once approved, an HCA GME data analyst will set up an Initial Statement of Work (SOW) conference call with the Principal Investigator and team to discuss.
  • HCA GME does not conduct data analysis at this time. Please contact MAHEC Research for assistance with data analysis and statistical support.

CARRIE

CARRIE is the first IRB step for MAHEC GME Research using Mission data

If your research does NOT have a resident/fellow on the research team, OR if your GME research does NOT use Mission data, please use the Mission Health IRB process via IRB Net.

What is CARRIE? Centralized Algorithm for Research Rules on IRB Exemptions

CARRIE is the first step of the IRB process for MAHEC GME researchers at MAHEC. You will be asked questions to determine whether your project is exempted from further IRB Review.

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is an ethics committee tasked with protecting the rights and well-being of humans involved in research. You learned about this when you completed your required CITI training in protection of human subjects.

CARRIE Website

CARRIE and IRB Manager (portal to login to CARRIE)

Instructions for CARRIE

PLEASE NOTE: LINKS ONLY WORK WHEN CONNECTED TO THE MAHEC NETWORK EITHER ON-SITE OR CONNECTED VIA VPN (Global Protect)! THIS ENSURES THE PRIVACY OF THE LINKED DOCUMENTS.

Using IRB Manager CARRIE for MAHEC Research (step-by-step instructions for MAHEC)

IRB Manager CARRIE guide (HCA how-to instructions)

Frequently Asked Questions (FAQ) for CARRIE

  • You must have an HCA 3-4 ID to submit to CARRIE.
  • CARRIE is intended for the Principal Investigator (PI) to complete, as there are a number of attestations that are most appropriate for the research team leader (e.g. oversight of entire project).
  • You will need to attach your research protocol, surveys, data collection sheets, etc. to the CARRIE submission.
  • For GME related scholarly activity, your Local Institution Approver is your Division Director of GME Research (DRD). See Using IRB Manager CARRIE for MAHEC Research for details.
  • Please send all research protocols using Mission Data or surveying Mission inpatients to the HCA NC Division Director of Research – Tokesha Warner.

Potential CARRIE Outcomes:

  • Does NOT Require IRB oversight because:
    • not engaging in research with human subjects as defined by federal regulations
    • engaging in research with human subjects deemed excluded from IRB oversight per 45CFR46.102(l)
    • engaging in research with sufficient human subject protections in the design to meet one or more IRB exemption criteria set forth in 45CFR46.104
  • DOES Require IRB Oversight – GO TO IRB Manager

PubClear

PubClear is for researchers using Mission Hospital data AND with GME researchers.

All research done with Mission Data requires clearance before dissemination of results.

  • If your research does not use Mission Hospital data, you don’t need PubClear.
  • If your research does use Mission data but does not include GME researchers, please see External Data Release (page under construction).

What PubClear is…

PubClear (Publication Clearance) is an HCA process to review Mission Hospital/HCA Healthcare publications before external dissemination. PubClear looks for legal issues (e.g. PHI, copyright, etc.), privacy issues (e.g. HIPAA), and publications that may impact service line policies and practices.
You must receive PubCLEAR approval before releasing any information outside of Mission Hospital/HCA Healthcare, including but not limited to:

  • research abstracts
  • submissions to peer-reviewed journals, professional society journals and/or blogs
  • poster presentations
  • live or recorded presentations, and
  • any public dissemination of Mission Hospital/HCA Healthcare data.

What PubCLEAR isn’t….

  • Permission to do research
  • Peer review of your product
  • An endorsement of your product’s results
  • A retroactive approval of products already released

How long does clearance take?

Initial review can take up to 30 days. Time to final approval is not guaranteed.

PubClear on Scholarly Commons website

Scholarly Commons (portal to submit PubClear submissions)

Links for PubClear

PLEASE NOTE: LINKS ONLY WORK WHEN CONNECTED TO THE MAHEC NETWORK EITHER ON-SITE OR CONNECTED VIA VPN (Global Protect)! THIS ENSURES THE PRIVACY OF THE LINKED DOCUMENTS.

Using PubClear for MAHEC Research (step-by-step instructions for MAHEC)

Scholarly Commons PubClear Guide (HCA how-to instructions, including guide to expediting PubClear process.

Frequently Asked Questions (FAQ) for PubClear

IMPORTANT! You must add your HCA GME Division Research Director (DRD) as last author for communication purposes. Reference Using PubClear for MAHEC Research for more details

  • SUBMISSIONS WITHOUT A DRD AS AN AUTHOR WILL BE SENT BACK WITHOUT REVIEW.
  • This is NOT for true authorship purposes.
  • Research Directors need to stay in the loop about products in their divisions.

ALL submissions should include the following disclaimer VERBATIM:

This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.

You can and should use MAHEC GME Presentation templates (posters or slide presentations).

You need to include the following comment in your PubClear submission:

The non-standard poster template is for Dr. Awesome’s GME program through Mountain Area Health Education Center (MAHEC).

You must have an account on HCA Scholarly Commons to submit to PubClear. You do not need an HCA 3-4 ID to submit to PubClear.

Training in protection of Human Subjects

Training for Investigators and Key Personnel Conducting Human Subjects Research

The Department of Research at UNC Health Sciences at MAHEC requires that any MAHEC or UNC Health Sciences at MAHEC faculty, providers, employees, learners, and affiliates seeking to engage in research and evaluation activities maintain current training credentials in the protection of Human Subjects and Conflicts of Interest.

Instructions, links, and form to enter completion certificates. Information on CITI Training

 For Mission IRB, Choose the Human Research course based on your research project.

  • Conflict of Interest mini-course – Conflict of Interest (ID 60486)
  • AND
  • Human Research – Group 1. Biomedical Research Investigators and Key Personnel (ID 885)
    • For clinical outcomes research, using data from clinical encounters with patients, e.g. retrospective chart review.
  • OR
  • Human Research – Group 2. Social / Behavioral Research Investigators and Key Personnel (ID 886)
    • Social and behavioral research explores how and why people behave the way they do in certain situations; e.g. surveying a group of residents about their simulation training.

NEW Users:

  1. Go to Citiprogram.org
  2. Register as a new user
  3. Select Organization Affiliation = Mission Health System. Agree to terms of service
  4. Steps 1-6: Personal information, password creation, role, etc.
  5. Step 7
    1. Would you like to take the Conflict of Interest mini-course? Yes.
    2. Select the group appropriate to your research activities. 
    3. Select the group for which you have previously completed an institutionally approved Basic Course in the Protection of Human Research Subjects. I have not previously completed an approved Basic Course.
    4. There is no Question 4.
    5. Would you like to take the Good Clinical Practice (GCP) Course? NO.
      1. You may choose to take the GCP, but it is not required. This module is OPTIONAL unless you are conducting a clinical trial. Required for NIH funded research.

EXISTING CITI Users:

  1. Log In to an existing CITI account at Citiprogram.org
  2. Add an Institutional Affiliation – Mission Health System.
    1. Adding the Affiliation will harmonize your previous training records.
  3. Steps 1-6: Personal information, etc.
  4. Step 7:
    1. Would you like to take the Conflict of Interest mini-course? Answer Yes.
      1. If you have taken the course previously, answering “Yes” will only bring up the module if your training has expired.
    2. Select the group appropriate to your research activities. 
    3. Select the group for which you have previously completed an institutionally approved Basic Course in the Protection of Human Subjects. Pick whichever, but *BE SURE TO PICK ONE* or it will assume you haven’t taken one and erase any record that may exist.
    4. There is no Question 4.
    5. Would you like to take the Good Clinical Practice (GCP) Course? NO.
      1. You may choose to take the GCP, but it is not required. This module is OPTIONAL unless you are conducting a clinical trial. Required for NIH funded research.
  5. You may take a refresher course to renew your certification, if necessary.

Frequently Asked Questions (FAQ) for CITI Training

  • You can complete the quizzes as many times as necessary to achieve a passing score.
  • How do I find my completion certificate?
    • Login to Citiprogram.org
    • Go to the Records page to see your course completions
    • Show records for:
      • Select appropriate institution
    • For each course, under Completion Record, Click View-Print-Share
    • On the next screen, View/Print the Completion Certificate (Report not necessary)
    • Download a copy of the certificate with the training expiration date.
  • Note for NIH Researchers: Researchers associated with the NIH may have completed NIH training in Protecting Human Research Participants (PHRP). While the PHRP training is no longer offered by the NIH, certificates previously obtained do not expire. Mission IRB will accept the NIH training module in lieu of the CITI Basic Biomedical Training.

Video Instructions for CITI Training