September 2018 – Update #1

Institutional Review Board news

  1. AAHRPP reaccreditation site visit August 20–21, 2018
    The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) reaccreditation site visit occurred on August 20–21, 2018. Thank you to all who participated and made the site visit a success. It is anticipated that the Human Research Protection Program at Main Line Health will receive reaccreditation by the end of 2018! The Main Line Health response to the draft site visit report was submitted 09/28/18.
  2. Changes to the Common Rule regulations for Human Subjects Research (45 CFR 46) – further delay until January 21, 2019
    Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.

    OHRP announced on June 19, 2018, a final rule which delays by an additional six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). The effective date is now January 21, 2019. The final rule can be found at gpo.gov/fdsys/pkg/FR-2018-06-19/pdf/2018-13187.pdf.

    Please check back frequently for additional updates. More information coming soon!

Institutional Animal Care and Use Committee news

  1. IACUC – Updated IACUC Policy and Procedure Manual
    The IACUC Policy and Procedure Manual has been updated. A detailed summary of changes will be provided via email to all principal investigators. Please review the revised policies and begin adopting the changes immediately. Contact the Office of Research Protections if you do not have the password to access the manual. The manual is located at mainlinehealth.org/research/office-of-research-protections/iacuc/forms-and-manuals.

August 2018 – Update #1

Institutional Review Board news

  1. AAHRPP reaccreditation site visit August 20–21, 2018
    The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) reaccreditation site visit occurred on August 20-21, 2018. Thank you to all who participated and made the site visit a success. It is anticipated that the Human Research Protection Program at Main Line Health will receive reaccreditation by the end of 2018!
  2. Changes to the Common Rule regulations for Human Subjects Research (45 CFR 46) – further delay until January 21, 2019
    Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.

    OHRP announced on June 19, 2018, a final rule which delays by an additional six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). The effective date is now January 21, 2019. The final rule can be found at gpo.gov/fdsys/pkg/FR-2018-06-19/pdf/2018-13187.pdf.

    Please check back frequently for additional updates. More information coming soon!

Institutional Animal Care and Use Committee news

  1. IACUC – Updated IACUC Policy and Procedure Manual
    The IACUC Policy and Procedure Manual has been updated. A detailed summary of changes will be provided via email to all principal investigators. Please review the revised policies and begin adopting the changes immediately. Contact the Office of Research Protections if you do not have the password to access the manual. The manual is located at mainlinehealth.org/research/office-of-research-protections/iacuc/forms-and-manuals.

June 2018 – Update #1

Institutional Review Board news

  1. AAHRPP reaccreditation site visit scheduled for August 20–21, 2018

    The Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) reaccreditation site visit is scheduled for August 20-21, 2018. All individuals involved with human subjects research are potential interviewees during the AAHRPP site visit. Two AAHRPP site reviewers will conduct individual interviews with Main Line Health leadership, researchers, staff and IRB members.

    The site visit is a major component in AAHRPP’s accreditation decision. The interviews are used to assess knowledge and commitment to human subjects protection, and are conducted in a professional and serious manner. This site visit is extremely important for Main Line Health, and it is critical everyone involved is fully engaged to successfully complete the accreditation evaluation. We will know who has been selected for an interview by approximately July 9, 2018. More information to come!

  2. Office of Research Protections website has moved!

    The Office of Research Protections website has been moved to the Main Line Health website and can be located at the link below. Please visit the site for new information and to access the most current forms and instructions!

    mainlinehealth.org/research/office-of-research-protections

  3. Changes to the Common Rule regulations for human subjects research (45 CFR 46) – further delay anticipated until January 21, 209

    Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.

    OHRP announced on April 20, 2018, a proposed rule that delays by an additional six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). If the proposed rule is finalized, the effective date would be January 21, 2019.

    Additional information can be found in the Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period available at: gpo.gov/fdsys/pkg/FR-2018-04-20/pdf/2018-08231.pdf. Please check back frequently for additional updates.

Institutional Animal Care and Use Committee news

  1. Office of Research Protections website has moved!

    The Office of Research Protections website has been moved to the Main Line Health website and can be located at the link below. Please visit the site for new information and to access the most current forms and instructions!

    mainlinehealth.org/research/office-of-research-protections

  2. August IACUC Meeting has been moved to August 13, 2018

    The IACUC meeting has been moved to August 13, 2018 (previously scheduled for August 20). The meeting deadline has been changed to August 1 and the pre-review deadline is now July 24.


January 2018 – Update #2

OHRP announced on 01/17/18, a new interim rule that delays by six months the effective date and general compliance date of the revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). The final rule does not delay the compliance date for the cooperative research provision of the revised Common Rule which remains January 20, 2020. The implementation date is now scheduled for July 19, 2018. Please check back frequently for additional updates. View the complete complete interim rule is located on federalregister.gov.


January 2018 – Update #1

Institutional Review Board Committee news

  1. Changes to the Common Rule Regulations for Human Subjects Research (45 CFR 46) effective on January 19, 2018

    Changes to the Common Rule, the primary rule regulating human subjects research, go into effect on January 19, 2018. Common Rule regulations are separate from FDA regulations. The FDA regulations have NOT changed.

    Policies and procedures will continue to be updated to reflect the new changes. Please review the following documents:

    1. Policy for Implementation of Changes to the Common Rule Regulations for Human Subjects Research (45 CFR 46), Effective on January 19, 2018.
    2. Revised Informed Consent Form Preparation Guide which contains additional elements of informed consent which are now required in certain types of research.
    3. Updated MLH IRB Policy V, Research Determinations and Activities Requiring IRB Review which expands the definition of human subjects research.
  2. Final NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research effective on January 25, 2018

    The NIH policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program. Refer to the MLH Policy.

    Visit grants.nih.gov for the final NIH final policy


December 2017 – Update #1

Institutional Review Board news

  1. AAHRPP Application for Reaccreditation submitted December 14, 2017

    The Reaccreditation application for the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) was submitted on December 14, 2017.

    It is anticipated that a site visit will take place in 04Q2018. The site visit is a major component in AAHRPP’s accreditation decision. The interviews are used to assess knowledge and commitment to human subjects protection, and are conducted in a professional and serious manner. All individuals involved with Human Subjects Research are potential interviewees during the AAHRPP site visit.

  2. IRB – Updated IRB forms and requirements for submission
    1. The following IRB forms and information sheet have been revised and are currently available for use:
      • MLH IRB Form 001- Protocol Submission Form
      • MLH IRB Form 002- Initial Submission Form
      • MLH IRB Form 003 - Continuing Review and Final Report Form
      • MLH IRB Form 005 – Grant Application Information Form
      • MLH Bew Research Proposal Transmittal Form
      • Transmittal Form Information Sheet

      Forms are available here

      Please begin using the new versions with all submissions effective immediately.

    2. The following IRB guides have been revised and are currently available for use:
      • Informed Consent form Preparation Guide
      • Short Form Consent Template
      • Short Form Consent Guide

      Guides are available here


September 2017 – Update #1

Institutional Review Board news

  1. IRB – Informed Consent Changes for Biomedical Research, The Pennsylvania Supreme Court's recent decision in the Shinal v. Toms

    As reported in the Main Line Health Clinician on 09/01/17 and via email to the Main Line Health Medical Staff on 08/23/17. Please review and revise informed consent form signature line as necessary based on the information below and submit for IRB approval.

    The Pennsylvania Supreme Court's recent decision in the Shinal v. Toms case significantly impacts the informed consent process in Pennsylvania. The case involved an allegation that the operating surgeon failed to obtain informed consent for a neurosurgical procedure. As part of his defense, the surgeon presented testimony that his physician assistant also provided information about the procedure to the patient during the informed consent process.

    The Supreme Court ruled that the duty to obtain a patient's informed consent is a nondelegable duty owed by the physician conducting the surgery or treatment. In addition, the Court held that a physician may not delegate to others his or her obligation to provide sufficient information in order to obtain a patient's informed consent. The physician must personally disclose to the patient the risks, benefits, likelihood of success, and alternatives to the proposed procedure or treatment in order to obtain the patient's informed consent.

    In reaching its decision, the Court relied on the language contained in the Pennsylvania MCARE statute provisions related to informed consent. The statute provides that except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient's authorized representative prior to conducting the following procedures:

    1. Performing surgery, including the related administration of anesthesia
    2. Administering radiation or chemotherapy
    3. Administering a blood transfusion
    4. Inserting a surgical device or appliance
    5. Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner

    The requirements imposed by the Court in the Shinal decision are effective immediately. Information provided to a patient by qualified providers other than the physician who is performing the procedure or conducting the treatment will not be admissible in a lawsuit to establish that informed consent was obtained.

    Practice Implications for Providers. (Note: The following guidance is based on currently available information. This situation is fluid and this guidance may be updated if additional information becomes available.)

    • The provider performing the procedure must personally obtain the patient's informed consent.
    • The attending surgeon/proceduralist performing the surgery must obtain informed consent. Obtaining informed consent for the surgery cannot be delegated to a fellow, resident, nurse practitioner or physician assistant.
    • The attending anesthesiologist must obtain informed consent for anesthesia and obtaining informed consent cannot be delegated to a fellow, resident or nurse anesthetist.
    • The fellow, resident, nurse practitioner or physician assistant who is personally performing a procedure (such as insertion of a chest tube or central line) may obtain the patient's informed consent for that procedure.
    • The fellow, resident, nurse practitioner or physician assistant who orders the administration of a blood transfusion to a patient may obtain the patient's informed consent for the blood transfusion.
    • The attending physician ordering a PICC line to be inserted by a member of the PICC team must have the informed consent discussion with the patient and document consent via the CPOE order (this is currently embedded in the Siemens CPOE PICC order). The PICC team RN may finalize the consent document. Obtaining informed consent for PICC line placement in procedural areas (non PICC team insertions) such as Interventional Radiology, is the responsibility of the practitioner inserting the PICC line.
    • The informed consent process must include a description of the procedure, disclosure of the risks and benefits of the procedure or treatment, the likelihood of success, and alternatives. The provider performing the procedure or treatment must personally answer any questions the patient requires in order to feel informed and willing to consent. There must be direct communication between the provider performing the procedure and the patient during the informed consent process, with a face-to-face exchange of information except in circumstances where the individual providing consent on behalf of the patient is not available for a face-to-face discussion.
    • With respect to informed consent forms, the best practice is for the provider performing the procedure to sign the form and have the patient sign the form at the time informed consent is obtained (i.e., at the time of the direct communication between the provider and the patient). The provider should also document a contemporaneous note in the medical record describing the information provided and the discussion between the provider and the patient. If the patient is at particular risk for a complication based on his/her/their condition or circumstances, this should be discussed with the patient and documented in the medical record.

    If you have any questions about the informed consent process, please feel free to contact your facility’s Patient Safety Specialist or the Main Line Health legal department.

    Effective immediately