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Patient Recruitment Methods (To be included in the eIRB submission package)

Option 1. Recruitment using potential candidate list based on Clinical Data: PI will submit a signed electronic Data Request Form upon IRB approval of the study plan & HIPAA waiver to select a patient cohort that meets the inclusion and exclusion criteria and to retrieve identified patient data from the UMMS Data Lake / EPIC on the selected cohort. The UMMS Data Science & Technology Team will deliver the list of one or more individuals who meet the criteria securely to the study teams. Delivery methods could include, for example, electronic lists or mobile alerts. For example, a text message would instruct the study team member to access patient information securely from a central location.  This process may be repeated on a regular basis until the recruitment target is met.

Option 2. EHR alerts to care providers or study team about patients in clinic who meet eligibility criteria: Best Practice Advisory (BPA) is a functionality available in Epic (UMMHC's Electronic Medical Record system). BPAs can be used to assist in patient recruitment.  PI will submit a signed electronic Data Request Form upon IRB approval of the study plan & HIPAA waiver to select a patient cohort that meets the inclusion and exclusion criteria and to retrieve identified patient data from the UMMS Data Lake / EPIC on the selected cohort. The UMMS Data Science & Technology Team will deliver the list of one or more individuals who meet the criteria securely to the study teams.  Delivery methods could include, for example, electronic lists or mobile alerts. For example, a text message would instruct the study team member to access patient information securely from a central location.  Upon the verification by the study team, the UMMS Data Science & Technology Team will deliver the list securely to UMMHC EPIC builders. The patient list will then be securely uploaded to Epic.

a. BPA will be implemented to send the message/alert to the treating provider during the patient encounter to enable the provider to alert the patient about the research and provide study team contact information.  When the target recruitment is achieved, BPA will be stopped.  

b. BPA will be implemented to send the message/alert to the treating provider during the encounter to enable the provider to alert the patient about the research.  The provider passes patient contact information to the study team via the authorization to contact form provided by the study team.  When the target recruitment is achieved, BPA will be stopped. 

c. BPA will be implemented to send the message/alert to the study team. This process may be repeated on a regular basis until the recruitment target is met.

 To avoid potential distraction for the physicians (physician fatigue), 2A & 2B will be used only in very difficult to recruit studies or studies that require real-time recruitment. 

Action Items for Study Team (Option 1 & 2):

  • Please ensure that the study plan further describes:

    • The identified patient data being requested, e.g., MRN, patient name, DOB, address, upcoming appointments, treating physician
    • The extent to which the study team will use the list to work with the treating physician/provider in advance and how / when the study team will approach patients to inquire about interest in participating studies.
    • A HIPAA waiver must also detail the use of this recruitment method.

3Use of EHR patient portals to notify patients of research opportunities: MyChart is Epic's patient portal where the patient may sign up and participate in managing his/her health care.  MyChart can also be used in assisting in patient recruitment. PI will submit a signed electronic Data Request Form upon IRB approval of the study plan & HIPAA waiver to select a patient cohort that meets the inclusion and exclusion criteria and retrieve identified patient data from the UMMS Data Lake or using EPIC tools on the selected cohort.  The UMMS Data Science & Technology Team will deliver the list of one or more individuals who meet the criteria securely to the study teams.  Delivery methods could include, for example, electronic lists or mobile alerts. For example, a text message would instruct the study team member to access patient information securely from a central location.  Upon the verification by the study team, the UMMS Data Science & Technology Team will deliver the list securely to UMMHC EPIC builders.  Potential patients will see the following message in their MyChart portal:

Dear (Patient Name),

 I would like to let you know about a research study being offered at the UMASS Medical School. The purpose of this study is (Study Purpose in about 6 words- no jargon). My study team will be reaching out to (eligibility gender) who are (eligibility age range) years of age to see if they are eligible and if they choose to participate in the research study.

If you DO NOT want to be contacted about this research study please contact (Study Team Contact Name) at (Phone Number) OR (E-Mail Address) and you can decline the research invitation in MyChart.

 If you do not call or e-mail (in the timeframe or by actual date), my study team member may call you to describe the research study in more detail and answer any questions you may have. Participation in research is always voluntary, and you do not have to participate unless you want to. If you declined the research invitation in MyChart only, you may be contacted by the study team.

 If you are interested in learning more about the research study or have any questions, please e-mail or call the telephone number listed above to speak with a member of my study team.

Thanks for your consideration, (PI Signature)

 When the target recruitment is achieved, the message will be removed.


Action Items for Study Team (option 3):

  • Please ensure that the study plan further describes the identified patient data being requested, e.g., MRN, patient name, DOB, address, upcoming appointments, treating physician
  • A HIPAA waiver must also detail the use of this recruitment method
  • Exact MyChart recruitment language needs to be submitted and approved by UMMS IRB. 

Option 4. Opt-in Recruitment using Conquering Diseases Volunteer Registry: The UMMS Volunteer registry allows patients to express interest in being contacted by study teams when a study that suits the condition that they have expressed interest in opens in the future. The system facilitates automated consenting for future contacts.

If you have questions related to the institutional standards on patient recruitment, please request a consultation with us.