VISN 5 MIRECC Research Guide Section 3: The Ongoing Study

Research

For MIRECC Staff
Return to Conducting Research Guide
Go to Section One: New Protocol Approval
Go to Section Two: Setting Up the Research Study
Names to Know
Required Forms

Section Three: The Ongoing Study

I.   Informed Consent

1. Take two current consent forms and two HIPAA Authorization Forms to the consenting session, as well as any other documents the potential subject should read, such as a Confidentiality Certificate. After thoroughly explaining the protocol and reviewing the consent form with the patient, have her verbally confirm that she wishes to participate in the study. If the answer is yes, you will need to find another person to witness her signature before the consent forms can be signed. This person should not be connected with the study. The participant should also initial each page (excluding the signature page) of the consent at the top of the form where indicated. Only the patient signs the HIPAA Authorization Form, but if they refuse to sign, they cannot participate in the research. The patient should be given an original of the consent form and HIPAA form to take with them.
   
   
2. Medical Chart (CPRS) Enrollment Notes
   
   When a VA participant gives consent to participate in research, an Enrollment Note that contains the following elements must be entered into the Computerized Patient Record System (CPRS):
   
   
   1. Study name
      
      
   2. PI name and phone number (and a VA contact person if the PI is not located at the VA Medical Center)
      
      
   3. IRB Protocol number
      
      
   4. Validation dates of consent form
      
      
   5. Date of consent
      
      
   6. By whom consent obtained
      
      
   7. Brief timeline of study
      
      
3. Medical Records
   
   A copy of each consent form and HIPAA Authorization Form must be taken to the Baltimore VA Research Office to be scanned into the participant's computerized medical record.
   
   
   1. Print the participant's name and last four digits of their social security number in the upper right hand corner of the first page of the consent form and Authorization Form.
      
      
   2. Include a cover memo with the forms. The cover memo should state the current date, protocol name, PI name, IRB protocol number, validation dates of the consent form, a contact person's name and phone number, and the number of consents attached for that protocol. The form copies can be delivered in batches.
      
      
   3. Take all forms to the VA Research Office located in the Baltimore VAMC, Suite 3A-125. You will see a marked bin sitting on top of staff mailboxes, to your left as you enter the suite. The Research Services staff will scan the forms into the medical charts and put a note in the patients' CPRS charts that this has been accomplished.
      
      

II.   Annual IRB Reports

Federal regulations require that the IRB conduct substantive and meaningful review of all active protocols at least every 365 days. It is the responsibility of the PI to submit a request for renewal to the IRB 45 days before the anniversary date of the project. A copy of the annual report approval letter should be sent to the MIRECC Research Core Administrative Assistant.

III.   Subject Flow

1. Investigators should track:
   
   
   • number of participants enrolled (by gender and ethnicity)
     
     
   • missed appointments
     
     
   • drop-outs
     
     
   • any other subject flow information relevant to the type of study being conducted
     
     
2. All subject contact (study visits, assessments, clinically significant phone conversations) should be documented in the subject's medical record in the Computerized Medical Record System (CPRS). (See Sample CPRS Assessment Note.)
   
   
   

IV.   Audits

Audits of MIRECC protocols are performed by a member of the Research Core. Every MIRECC study will be audited at least once during the life of the study, according to the protocol set forth in the MIRECC Unit Specific Quality Management Program, Section IV. D. During the audit, VA participant files, chosen at random, as well as regulatory documents and required staff training documentation will be reviewed. The auditors and the principal investigators whose protocols are scheduled to be reviewed will be so informed a few weeks in advance in order to have the opportunity to agree upon a convenient date for the audit.

V.    MIRECC Recruiting Meeting

The MIRECC holds a semimonthly recruiting meeting to facilitate the coordination of recruitment efforts at the Baltimore and Perry Point VA Medical Centers. Any investigators who are planning to recruit VA patients should coordinate with the MIRECC about attending this meeting. Contact Dr. Dwight Dickinson at 410-605-7817 or email him at dwight.dickinson@va.gov.