TITLE: Donor Selection Criteria for Adipose, Liver &amp; Blood Procurement -- University of Minnesota Human TMC
AUTHORS: Sayeed Ikramuddin, Laura Niedernhofer

[DESCRIPTION]
This document outlines the inclusion and exclusion criteria for donors of adipose (visceral, subcutenous) and blood for the SenNet Consortium program from the University of Minnesota Human TMC (Niedernhofer). 


Excerpt from the UMN IRB for Human Adipose procurement, section 8.0
Protocol title: Profiling of Adipose Tissue Depots and Immune Correlates
Last updated: 2/10/2023 



[STEPS]
SECTION: Inclusion Criteria
1. Age 18 years old or older
SECTION: Exclusion Criteria
4. Pregnancy or nursing -- Pregnancy is routinely an exclusion for surgery. If patients are scheduled for surgery, they receive a pregnancy test per clinical care. The study team will utilize the results available in the medical record to determine eligibility related to pregnancy status. 
SECTION: Exclusion Criteria
5. Exclusion at the discretion of attending physician or Eligibility Committee.
SECTION: Inclusion Criteria
2. Undergoing abdominal surgical procedure with general anesthesia

SECTION: Inclusion Criteria
3. Written informed consent
SECTION: Screening
6. Potential participant identification will be completed by PI or delegated team members, as appropriate.Patients within the clinical practice, meeting all inclusion and none of the exclusion criteria, will be contacted by clinic staff to determine if they are possibly interested in the study. Eligible individuals that are interested in participating will be contacted by a research team member, either remotely or in-person, to review the study details and consent. Written consent will be confirmed before any further study activities are completed.
SECTION: Vulnerable Populations
7.  
     Population   / Group      Identify   whether any of the following populations will be targeted, included (not   necessarily targeted) or excluded from participation in the study.         Children       Excluded from Participation           Pregnant   women/fetuses/neonates       Excluded from Participation           Prisoners       Excluded from Participation           Adults lacking capacity to consent and/or   adults with diminished capacity to consent, including, but not limited to,   those with acute medical conditions, psychiatric disorders, neurologic   disorders, developmental disorders, and behavioral disorders       Excluded from Participation           Non-English speakers       Included/Allowed to    Participate           Those unable to read (illiterate)       Included/Allowed to    Participate           Employees of the researcher       Included/Allowed to    Participate           Students of the researcher       Included/Allowed to    Participate           Undervalued or disenfranchised social group       Included/Allowed to    Participate           Active members of the military (service   members), DoD personnel (including civilian employees)       Included/Allowed to    Participate           Individual or group that is approached for   participation in research during a stressful situation such as emergency room   setting, childbirth (labor), etc.       Included/Allowed to Participate           Individual or group that is disadvantaged in   the distribution of social goods and services such as income, housing, or   healthcare.       Included/Allowed to    Participate           Individual or group with a serious health   condition for which there are no satisfactory standard treatments.       Included/Allowed to    Participate           Individual or group with a fear of negative   consequences for not participating in the research (e.g.   institutionalization, deportation, disclosure of stigmatizing behavior).       Included/Allowed to    Participate           Any other circumstance/dynamic   that could increase vulnerability to coercion or exploitation that might   influence consent to research or decision to continue in research.       Included/Allowed to    Participate      
 
SECTION: Additional Safeguards
8. Individuals that checked in section 7.1 that fall under the definition of vulnerable populations may be included in the study in an effort to ensure that data collected is representative of the clinical population affected by this condition. These populations will not be targeted, but will be included if eligible for the study.

The following safeguards will be implemented to protect the rights and welfare of the groups listed below:
Non-English speakers: Guidance regarding the short form consent process will be followed as listed in Section 20.4 below.
Those unable to read (illiterate): The consent form will be read to these individuals and they will be asked to make their mark on the consent form. A witness will be present during the consent discussion and will also sign the consent form.
Employees of the researcher: If an employee of the researcher is eligible for the study, a member of the study team that is not the employee’s supervisor will obtain consent.
Students of the researcher: If a student of the researcher is eligible for the study, a member of the study team who does not have a student/instructor relationship with the student will obtain consent.