Human Research Protection Program (HRPP) & Institutional Review Board (IRB)

Baptist Memorial Health Care Corporation Human Research Protection Program and Institutional Review Board

The Baptist Memorial Health Care Corporation (BMHCC) Human Research Protection Program (HRPP) fosters a research environment that promotes the respect for the rights and welfare of individuals recruited for, or participating in, research conducted by or under the auspices of BMHCC. In the review and conduct of research, actions by BMHCC will be guided by the principles (i.e., respect for persons, beneficence, and justice) set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report). The actions of BMHCC also conform to all applicable federal, state, and local laws and regulations.

The HRPP consists of various individuals, committees and entities that are responsible for maintaining the overall HRPP mission. Components of the HRPP include, but are not limited to, the Institutional Official, the Assistant Director of the HRPP, the Corporate Compliance Officer, the Privacy Officer, the IRB staff, the IRB, Conflict of Interest Committee, Legal Counsel, Sponsored Program Administrators, investigators, research staff, education and training and research pharmacy.

The mission of the HRPP is to:

• Safeguard and promote the health and welfare of human research subjects by ensuring that their rights, safety, and well-being are protected.
• Provide guidance and support to the research community in the conduct of research with human subjects.
• Assist the research community in ensuring compliance with relevant regulations.
• To provide timely and high-quality education, review, and oversight of human research projects; and
• To facilitate best practices in the conduct of human subjects research.

The Baptist Institutional Review Board (IRB) is a committee composed of physicians, researchers, non-scientists, community advocates and others that ensures that research involving human subjects is ethical and the rights and welfare of study participants are protected.

By federal regulation, all human subject research (HSR) conducted in BMHCC facilities or under the auspices of BMHCC must be approved by an IRB (Baptist IRB or an approved external IRB) before they begin. Requests to rely on an external IRB require a reliance agreement and can be made in IRB Manager by completing and submitting the “Request to Use and External IRB” form. Requests to rely on an external must be approved prior to submitting to the external IRB.

All proposals to conduct HSR using the Baptist IRB must be submitted to the Baptist IRB two (2) weeks prior to the next scheduled meeting (check meeting and submission schedule below). Submission for continuing review should occur four (4) weeks prior to study expiration date to assure uninterrupted continuation of research activities. Please complete the appropriate documents for your submission. The IRB submission and management electronic platform is “IRB Manager” and can be accessed by clicking the hotlink below.

• Log Into IRB Manager

If you are not currently registered in IRB Manager, please contact Baptist.IRB@bmhcc.org.

Human Research Protection Program (HRPP)

Education and Training: All individuals conducting HSR at BMHCC must complete a Collaborative Institutional Training Initiative (CITI) education and training course related to the type of the research role they will be filling (e.g., social-behavioral researcher, biomedical researcher, etc.). Please refer to the document in the following hotlink to determine your specific training requirements and obtain the CITI Program login hotlink.

• Baptist HRPP/IRB Training Requirements and CITI Login

Conflict of Interest and Commitment: Federal regulations also require training in financial conflict of interest (FCOI) training every four years and submission of an FCOI disclosure prior to conducting HSR. Click the appropriate link below to access the NIH FCOI training and the FCOI disclosure form. After completion of the NIH training, print the completion certificate and include with you IRB initial submission application. The certificate will be saved in your IRB Manager Profile.

• NIH FCOI Training Certification
• Baptist FCOI Disclosure Form

HRPP/IRB Standard Operating Procedures: The BMHCC HRPP/IRB has comprehensive Standard Operating Procedures (SOPs) that describe applicable regulations, institutional policies and procedures and guidelines for when and how to submit applicable applications and reports. The SOPs are located at:

• HRPP/IRB Standard Operating Procedures

IRB Submission and Meeting Dates: Click here to see upcoming IRB submission and meeting dates.

Other Reviews May Also Be Required

Researchers who submit an IRB Initial Submission and receive a Non-Human Subject Determination and are accessing, using, generating or disclosing Protected Health Information (PHI) are responsible for contacting Corporate Privacy & Security corporateprivacysecurity@bmhcc.org to obtain a Privacy review. Additionally, a Feasibility Review may also be required and can be obtained by contacting Regulatory Compliance at BCRIQualityAssurance@bmhcc.org, 901-226-1366; Option #4 for Research Compliance.

IRB Initial Submissions for exempt, expedited or full board studies will be forwarded, when applicable, by the IRB for Privacy Review. However, it is always the researcher's responsibility to contact Regulatory Compliance to obtain a Feasibility Review or an exemption from the review.

Consent Form and Protocol Sample Templates

Template Consent Forms

• Consent to Participate in a Data and/or Biospecimen Repository for Research
• Children’s Assent Form for Participation in Research
• Expanded Access Consent Form
• Focus Group Consent Form
• General Research Consent Form
• HUD Consent Form
• Internet Research Consent Form
• Parental Permission form for Children’s Participation in Research
• Telephone Survey Consent Form

Sample/Template Research Protocols

• Sample Biomedical Research Protocol
• Sample Social-Behavioral, Educational Research (SBER) Protocol

Guidance for Standard Operating Procedures for Data and/or Biospecimen Repositories

• Repository SOP Guidance

Related References

• DHHS Regulations on Protection of Human Subjects (45 CFR 46)
• DHHS/OHRP Guidance
• FDA - Protection of Human Subjects Regulations (21 CFR Part 50)
• FDA - Institutional Review Boards (21 CFR Part 56)
• FDA - Financial Conflict of Interest Disclosure by Clinical Investigators (21 CFR Part 54)
• FDA Regulations (21 CFR)
• HIPAA Regulations
• Family Educational Rights and Privacy Act (FERPA) (for research use / access / disclosure of student records) FERPA Regulations
• Protection of Pupil Rights Amendment (PPRA)
• The Belmont Report

Baptist Institutional Review Board
2026 Submission Deadline & Meeting Dates
Full Board Review Only

Baptist HRPP/IRB Announcements

Upcoming IRB Manager changes – In order to make the IRB processes more efficient, several submissions forms have been revised or created and the procedures for submitting applications will be changing.

New Initial Submission Form

The new Initial Submission Application is an all-in-one form, i.e., investigators will be able to apply for a human subject determination, exempt or expedited review or submit for a convened IRB review (full board) using the same application. The questions have been designed with logic that routes the submitter to appropriate questions for their research procedures and the applicable level of review.

New procedures for amending protocols

• Currently ongoing research. To request an amendment to a currently ongoing research protocol, PIs/Submitters should use the amendment form currently in IRB Manager.
• For amendments to approved protocols that used the new initial submission application, when published, a separate amendment form will no longer be used. Instead, submitters will use the “Copy to Amend” function. When “Copy to Amend” is selected, the submitter will be prompted to select the type of amendment(s) they wish to make and then routed to the applicable application pages to make their proposed revisions in the application. When completed, select “Submit”. The revised application will be routed through the appropriate review stages and may be approved or returned for more information. Once approved the PI and submitter will receive a copy of the approval letter and can implement the changes.

New/Revised Submission Forms

• HUD Non-Research Initial Application
  This new submission form was added because use of a Humanitarian Use Device is not considered by FDA to be research but does require IRB review. Since use of an HUD is not research, questions on the initial submission application (research oriented) are generally not applicable.
• Request to Establish a Data and/or Biospecimen Repository
  Research repositories are required to have IRB oversight. A “Request to Establish a Data and/or Biospecimen Repository” form (when implemented) must be submitted in IRB Manager along with Standard Operating Procedures for the repository (See Repository SOP Guidance above). This application will be used to apply to establish Data and/or Biospecimen repository to be used for future research.
• Emergency Use Report
  FDA requires that after emergency use of an investigational product (not FDA approved or cleared), the use must be reported to the IRB within 5 working days. Emergency use of an investigational drug or device must meet several criteria. Refer to the Baptist HRP/IRB Standard Operating Procedures, Section 16.10 for further information.

Contact the Baptist Memorial Health Care Institutional Review Board

For information regarding possible trials, please contact the Baptist Institutional Review Board:

6025 Walnut Grove Road
Suite 210 A/B
Memphis, TN 38120
Tel: 901-226-1678, 901-226-1658
Fax: 901-226-1680
Email: Baptist.IRB@bmhcc.org