Forms and Policies

  • Contracts and Clinical Research
  • Grants
  • Human Subjects Protection Program and Institutional Review Board
  • Post Award and Research Finance
  • Technology Commercialization
  • Key Policies and Information

Resource

Description

Clinical Trials Intake Form

A form that provides basic information about the study and approval from the division to perform the study. A completed intake form is required for all industry sponsored clinical trial/research projects.

Material Transfer Agreement (MTA)/Data Use Agreement (DUA) Intake Form

A form that provides basic information about the study and approval from the division to send or receive data or material. A completed intake form is required for material and/or data transfers.

Resource

Description

Grants Intake Form

The Grants Intake Form is an approval by the PI and Department/Division Administrator attesting to certain assurances, and provides pertinent information about the application to ensure appropriate review and submission. A completed intake form is required for all extramurally funded grant applications.

Grants Intake Form for Intramural Awards

The Grants Intake Form For Intramural Awards is an approval by the PI and Department/Division Administrator attesting to certain assurances, and provides pertinent information about the application to ensure appropriate review and submission. A completed intake form is required for all intramurally funded grant applications.

Request for Advanced Spending Form

When a delay in receiving an award is expected, or on a federal award which allows pre-award spending, Advanced Spending allows expenditures to be charged to the correct project and therefore limits cost transfers and retroactive personnel actions.

CHLA Budget Template (NIH)

To be used for NIH proposals only. *A completed budget template is required for all extramurally funded projects.

Subrecipient Commitment Form

This form is required for all proposed subrecipients at the time of proposal submission.

Cost Share/IDC Waiver Form

Cost sharing or an indirect cost (IDC) waiver may be requested by an investigator or funding agency for a specific project. Please read ADM 057.0 (Cost Sharing) or ADM 241.0 (Indirect Costs), as applicable, prior to requesting cost sharing or an IDC waiver.

Resource

Description

ADM 052.0 - Procurement

To establish policies and procedures for the procurement function at Children’s Hospital Los Angeles (CHLA), which provides appropriate accountability, controls, cost containment and flexibility in support of CHLA’s mission.

ADM 081.0 - Authorization to Use or Disclose PHI

The purpose of this policy is to implement the requirements of the applicable state and federal laws governing the use and disclosure of Protected Health Information (PHI).

ADM 084.0 – HIPAA Minimum Necessary

The purpose of this policy and procedure is to implement HIPAA provisions that require a covered entity to reasonably limit the use and disclosure of Protected Health Information (PHI) to the minimum necessary to accomplish a particular purpose.

ADM 091.0 - Research and Patient Privacy; De-identification and Limited Data Sets

The purpose of this Policy is to implement requirements of applicable state and federal privacy laws governing how the Protected Health Information (PHI) of patients and research subjects may be used or disclosed.

ADM - 094.0 Privacy Education and Training

This Policy and Procedure implements state and federal mandates for training the CHLA workforce on CHLA privacy policies and procedures.

ADM - 108.0 Informed Consent

The purpose of this policy is to describe the roles of CHLA Medical Staff, CHLA personnel and medical and surgical residents (“Residents”) in obtaining the Informed Consent of patients or their legal representatives to Complex Procedures in all areas at CHLA.

ADM - 118.0 Release of Patient Information

This statement will serve as the standard and policy in providing information to the news media. In the release of any information, full consideration is first given to the best interest of the patient and their family, to the ethics of the medical profession and to other hospital policies.

ADM - 141.0 – Record Retention

Standards for the retention of records of CHLA. Refer to ADM 141.1 for the retention schedule here.

ADM - 143.0 Communication Assistance

The purpose of this policy is to establish the Children’s Hospital Los Angeles workplace policy is to assist in facilitating communication between patients/research subjects/families and care providers/researchers, especially those with limited English Proficiency (LEP) or suspected communication vulnerability.
ADM - 143.2 Attachment B Communication Language Overview In connection to ADM 143.0, this policy explains the best communication/language resource options for a variety of needs.

ADM - 157.0 Conflicts of Interest in Research

The purpose of this policy is describe CHLA requirements for disclosing financial interests in research. Investigators and Research Personnel are responsible for identifying and disclosing all potential Conflicts of Interest covered by this policy at least annually. 
Requests for information regarding significant financial interests for key or senior research investigators on Public Health Service (PHS) or National Institutes of Health (NIH) funded projects determined to be financial conflicts of interest (fCOI) may be directed to the Office of Compliance & Privacy at compliance@chla.usc.edu.

Resource

Description

Intramural Project Setup Request Form

A form to set-up a new intramural projects which are linked to net asset accounts

List of General Ledger Expense Accounts

A list of general ledger expense accounts most often used

Reconciliation Workbook Template

A tool to reconcile extramurally funded projects' expenses and adjustments. This also facilitates in generating invoices and information required for the Federal Financial Report (FFR)

Journal Creation Procedure

Process detailing the steps in creating a journal and uploading it to PeopleSoft

Guidelines for Cost Transfers

The Cost Transfer Policy covers both wage and non-wage transfers.  To transfer expenses that were inadvertently charged to a project and has to be retroactively moved and charged to the correct project. The division has to prepare a journal to this effect and forward it to the post award analyst.

Request for Residual Funds

Residual funds are unobligated, unspent cash balances remaining in a privately funded fixed-price sponsored project cost center at the conclusion of an award.

Non-wage Expense Transfer Form

A form to capture the summary of expenses other than payroll, being transferred to and from departments, with required approvals, period of transfer and reason for such transfer

Payroll Expense Transfer Form

This is a form to process payroll expense transfers. Departments process payroll expense transfers in cases where the original payroll expense was charged to the wrong account and the department needs to correct it.

Participant Cash Fund Request Form

A form requesting TSRI approval to obtain gift cards and/or funds which are expensed to research projects, to distribute to participants who enroll in studies

Resource

Description

ADM 142.0 - Intellectual Property Policy

The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions

Record of Invention Form

A form to disclose an invention to OTC.

Record of Copyright Form

A form to disclose a copyright to OTC.

Resource

Description

ADM 021.0 - Equipment Acquisition and Maintenance

To establish policies and procedures for the for the acquisition, maintenance, and control of CHLA equipment at the hospital, which provides appropriate accountability, controls, cost containment and flexibility in support of CHLA’s mission.
ADM 35.0 - Petty Cash Governs disbursement and management of petty cash, which may be used for subject stipend or visit payments.

ADM 057.0 – Cost Sharing/Cost Matching Policy

The policy of the hospital is to make a cost sharing commitment only when required by the sponsor or by the competitive nature of the award and then to cost share only to the extent necessary to meet the specific requirements of the sponsored project.

ADM 058.0 – Cost Transfer Policy

The purpose of this policy is to prescribe the conditions under which expense transfers between cost centers and/or project numbers may be made.

ADM 059.0 - Time and Effort Certification

Children’s Hospital Los Angeles requires faculty/employees to certify the percentage of time (i.e., effort) that they devote to the federally funded grants and contracts

ADM 066.0 - Research Grant Accounts

This policy explains the need to identify clinical research patients, delineate the routine costs versus research charges, and ensure that appropriate billing occurs.

ADM 075.0 - Assuring Consistency between Investigator IACUC Approved Protocols and Proposal Submissions to Federal Agencies

Federal regulations require that federal awards granted to investigators at CHLA/TSRI that involve use of vertebrate animals be reviewed by an Institutional official to ensure that animal activity outlined in the proposal has been approved by the IACUC. This is an institutional responsibility. IACUC approval must be granted prior to award of funds.

ADM 099.0 - Protected Health Information: De-identification and Limited Data Sets

This policy implements HIPAA requirements for the de-identification of protected health information, which renders the health information not subject to HIPAA Privacy provisions.
ADM 142.0 - Intellectual Property Policy The purpose of the policy is to educate faculty, staff, students, and visitors about their rights and responsibilities regarding intellectual property and inventions

ADM 157.0 - Conflicts of Interest in Research

For faculty, staff, and students to disclose their business and financial interests to encourage transparency so as to not conflict with the highest ethical standards for their employment and research at CHLA.
Requests for information regarding significant financial interests for key or senior research investigators on Public Health Service (PHS) or National Institutes of Health (NIH) funded projects determined to be financial conflicts of interest (fCOI) may be directed to the Office of Compliance & Privacy at compliance@chla.usc.edu.

ADM 158.0 - Institutional Conflicts of Interest in Research

This policy promotes the highest ethical standards in the conduct of Research in situations where Institutional Conflicts of Interest may occur, and to determine those instances when an Institutional Conflict of Interest is unacceptable.
ADM 185.0 - Residual Funds on Sponsored Awards Describes the process for review and approval to move any project residual funds to a discretionary account for use.
ADM 201.0 - Signature Authority Describes the appropriate signature authority for contracts, and designates Research Operations as appropriate signatory for research agreements.

ADM 241.0 - Indirect Costs

Research Operations will ensure that all proposals submitted to any sponsoring agency include the appropriate indirect cost recovery rate.

ADM 242.0 - Research Agreements, Applications and Proposals for Extramural/Sponsored Project Funds

CHLA actively promotes research as one of its primary missions. The pursuit of external sources of funds to support research and other activities through sponsored projects is one of the most important efforts of the researchers and staff of the hospital.