The Application for Approval of Research Protocol and Document Review is a prescribed form that allows for the institution to review and approve conduct of the research project at Truman Medical Centers/University Health facilities or involving patients. Appropriate department and administrative approval ensures that the institution is advised of the research project, that proper training of research staff has been completed and that formal contracts and agreements are executed according to institutional policies.
All research policies concerning the protection of human research subjects, clinical trials, research privacy, and research integrity are available for review on the TMC intranet site.
Administrative approval by Truman Medical Centers/University Health is granted when all study documents have been received and the research application is complete (all signatures obtained). This includes receipt of IRB approval.
The Research Administration Office will contact the researcher directly to notify him or her that administrative approval has been granted.
Approval to conduct your research will require designation of a principal investigator (PI) or co-PI who is a current member of the active medical staff or an employee. The PI will be the responsible for the conduct and supervision of all research-related activities concerning the project.
A new Truman Medical Centers/University Health research application form will not need to be submitted to the Research Administration Office unless the revised study protocol affects other departments (e.g. lab work added, chest x-ray added, enrolling subjects in other clinics).
The IRB will need to be notified of any changes to previously approved information including any changes to the study protocol, consent form, advertisements, investigator’s brochure, study personnel/staff changes.
The researcher will need to sign and submit a revised research application form to the Research Administration Office for review and approval along with the revised contract and/or study budget for negotiation with the study sponsor.
Joint Commission standards and Truman Medical Centers/University Health policy require that informed consent forms (ICF) are part of the patient's medical record. Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers. A signed copy shall be maintained in the patient's official medical record.
ICFs are scanned and filed in the "administrative" section of the EMR under Procedural consents. ICFs have to be attached to an encounter so if there was no encounter that day (research visit only) then the ICF is attached to the encounter with the closest date.
Affix the patient sticker to the study ICF and HIPAA authorization form to ensure the forms are maintained in the patient's medical record in HIM. Or, in addition to the patient's name on the ICF and authorization form—ensure at least two identifiers such as name, DOB or MRN are recorded on the forms. This ensures the correct ICF gets to the correct patient's medical record.
The consent form bar-code label must be affixed to the front page of signed informed consent forms and HIPAA authorization forms. This helps to ensure the signed ICFs and HIPAA authorizations are scanned into patients' EMR.
No, it is not a violation as HIPAA research authorization gives permission to do so.
Per federal regulations, a copy must be given to the study participant and a copy placed in the subject's official medical record. The researcher shall maintain the original signed version.
Keep in mind that the informed consent form must have IRB's stamp of approval.
The worksheet is a prescribed form that identifies the study expenses and revenues allocated for each funded research study that is sponsored by industry. This form should be completed and accompany the research application form for all industry sponsored clinical trials. This document may be obtained from the Research Administration Office.
As part of the submission of manuscripts, the International Committee of Medical Journal Editors (ICMJE) requires any clinical trial that prospectively collects data for a medical research intervention or health outcome research to be registered before enrollment of the first subject on an approved publicly accessible database (www.clinicaltrials.gov) in order for the study results to be published.
ICMJE Journals include: JAMA, New England Journal of Medicine and The Lancet.
More information is available at ICMJE.org
For sponsored research projects, Truman Medical Centers/University Health will request the sponsor to register the study as part of the contract process. For investigator-initiated projects, the Research Administration Office can assist you with this process before you start the study.
In addition to IRB review of all information to be shared with study participants, Truman Medical Centers/University Health has specific branding policies. Compliance with these policies ensures Public Relations reviews and approves all information, including for research, to maintain a consistent and positive image of the healthcare system. Public Relations shall review information that may be viewed or heard by study participants in the form of flyers, posters, newspaper ads, radio ads, etc. The review includes research projects conducted at Truman Medical Centers/University Health and those projects that may recruit potential participants at the healthcare system. Please contact the Research Administration Office for further details or to obtain guidance concerning these policies.
If a study participant is injured because of participation in an industry sponsor's clinical trial, Truman Medical Centers/University Health policy does not allow the institution to bill any third party insurers for the costs associated with a subject injury. TMC does not want to violate Medicare Secondary Payer Rules, which state that it is against the law to bill a claim to Medicare when another payer agrees to pay if Medicare does not pay. And private insurers' subrogation rules may place TMC at risk for filing fraudulent claims as TMC will not file false claims. In addition, the healthcare system feels it should not financially disadvantage a patient who volunteers to participate in a trial by having the patient pay copays or deductibles.
The Medicare National Coverage Decision states that Medicare will pay the costs of reasonable and necessary care arising from the diagnosis or treatment of complications in study participants for qualifying and deemed clinical trials. The terms "qualifying" and "reasonable and necessary" as well as other aspects of the Medicare National Coverage Decision are complicated and require careful analysis and review by Truman Medical Centers/University Health Finance, Compliance, Research Administration, and Legal departments before the study starts and contracts are processed. As an example, cancer clinical trials that are funded by the National Cancer Institute typically meet the criteria for a qualified clinical trial.
For all outpatient studies, the researcher and/or research staff must request a study account and contract number from the Research Administration Office prior to initiation of the study project after the study agreement is executed. After a research account number is assigned to the project, research subjects may be registered on the day of their appointment to the specific study account and contract number. Subjects shall be registered by TMC Registration staff using the prescribed form. All procedures performed at that visit will be charged to the study account and not any other payer source. Later, Truman Medical Centers/University Health Patient Billing will send an invoice to the researcher to pay for the procedures performed related to that specific study account.
For inpatient studies, the researcher must notify Patient Billing in advance of the start of the new study project and its anticipated procedures to be performed. After a subject is enrolled, the researcher must notify the Patient Billing of the procedures performed via a prescribed form to remove all study related charges from the subject’s account.
The research study account assigned to each funded research study is used to track all payments received from the study sponsor and to pay all study related expenses (e.g. study procedures, salaries) for the specific study project. Please contact the Research Administration Office for the appropriate forms at research@TMCMed.org
In accordance with Truman Medical Centers/University Health policies, to prevent and avoid undue coercion or influence of the study participant’s judgment, payments to study participants shall approximate similar costs that would be incurred for travel and related expenses to a clinic appointment. The study informed consent form must describe the specific payments to study participants and the IRB submission form requires details on payments to participants.
To comply with IRS income reporting regulations, the study participant’s name, address, and Social Security number will be provided to the Accounting Department. A 1099 form will be sent to the study participant if total stipends paid by Truman Medical Centers/University Health for the year exceed the current IRS threshold amount.
Truman Medical Centers/University Health policies also address the specific check requests or vouchers used to pay study participant stipends. The FDA has a Guidance Sheet on this subject.
Research staff may complete a Truman Medical Centers/University Health check request to utilize study account funds in accordance with the approved project expense worksheet and budget. Research participants may be compensated in accordance with their IRB approved informed consent document via the Truman Medical Centers/University Health Cash Offices at Truman Medical Center Health Sciences District and Truman Medical Center Lakewood. Prior to the start of the study, researchers may notify Research Administration of their intent to process stipends with the Cash Office. The researcher completes a form to list staff to complete the cash payment process.
The stipend form is a three-part triplicate form. The researcher must authorize payment and maintain the original copy (white). The pink and yellow copies are given to the participant and taken to the Cash Office, which verifies (e.g., photo ID and active research project account) and processes the payment to the participant. Research Administration will post the payment transaction to the appropriate study account. The researcher may view the stipend payment transaction details on the posted monthly project financial report. Researchers should review the report online to reconcile account activity.
To avoid conflicts of interest and transparency in research activities, Truman Medical Centers/University Health research policies expressly forbid any payment of finder's fees, recruitment incentives, or referral fees for any research project. This practice is in accordance with the policies of the American Medical Association and guidelines of the Association of American Medical Colleges.
Indirect costs, also called overhead or facilities and administrative costs, represent the expense of conducting research not directly identified with a specific research study, but that are shared among all programs of an organization. Infrastructure costs such as utilities, accounting, building, and equipment use, and nonstudy related personnel are examples of indirect costs. Indirect costs are real costs, but are not readily identifiable as belonging to a specific project, as direct costs are. As a result, indirect costs are generally stated in study budgets as a percentage of direct costs.
The current overhead rate at Truman Medical Centers/University Health for clinical trials is 25%.
Conflicts of interest could affect the reliability of study data, increase the potential for bias, amplify questions regarding integrity of the study data, or adversely affect the protection of study participants. A conflict of interest arises when an individual or private interest may compromise, or may have the appearance of compromising, an individual's professional judgment in conducting or reporting research. In particular, a significant financial conflict of interest may influence or lead to decisions that create personal gain for that individual or the individual’s family.
Disclosure of financial interests of amounts greater than $5,000 are required to be completed prior to study review at Truman Medical Centers/University Health and review by the IRB. All individuals directly involved (e.g. investigators, study coordinators) in conduct of the research study need to complete the Truman Medical Centers/University Health research disclosure form.
Subsequent review and management of identified conflicts of interest shall be reviewed by the director of clinical research, the department chair, and the chief medical officer of Truman Medical Centers/University Health.
Clinical trial agreements (CTAs), also called study agreements or contracts, cement the relationship between the parties (study sponsor and the institution) for the conduct of a research study. The study CTA addresses many important issues for all parties, including confidentiality, publication rights, indemnification, insurance, intellectual property, the medical care of subjects injured during the research, and the study budget.
For research conducted at Truman Medical Centers/University Health, the institution collectively refers to TMC and the physician investigator's employer. Because of the legal nature of the contracts, all study agreements need to be forwarded to the Research Administration Office for review and negotiation with the study sponsor. This includes any confidential disclosure agreement that the sponsor requires before providing you any study related materials (e.g. study protocol, investigator's drug brochure). Only the CEO of Truman Medical Centers/University Health can authorize and commit the healthcare system to any contractual agreement.
Depending on the study project and sponsor of the research study, the research records should be maintained by the researcher in compliance with applicable regulations and contractual obligations. IRB communications, approved informed consent forms and research records need to be maintained in accordance with UMKC Research Records All Departments Authorization No. 00-018. Studies conducted under an FDA New Drug Application may need to be stored even longer (required for up to 15 years by some pharmaceutical and device sponsors). The study sponsor typically designates the time period in the study contract.
The study sponsor must be notified (update the FDA 1572 Form) and the Research Administration Office in writing before any records are transferred to another location.
The Health Information Management Department coordinates long-term storage of documents with an off-site vendor.
Institutional review board
The Institutional Review Board (IRB) is an independent, academically based committee comprising medical, scientific, and nonscientific members whose goal and responsibility is to ensure the safety, well-being, and protection of the rights of human subjects who take part in research studies. The IRB reviews research in accordance with the U.S. Department of Health and Human Services (DHHS) and U.S. Food and Drug Administration (FDA) regulations.
No, it does not. Per a signed formal affiliation agreement, authority for review and approval of all human subject research at Truman Medical Centers/University Health corporate facilities shall be delegated and vested in the appropriate UMKC IRB (Adult Health Sciences IRB or Social Sciences IRB) for adult research projects or the Children's Mercy Hospital IRB for research that involves children. The IRBs comply with federal regulations for the protection of human subjects at 45 CFR part 46 (DHHS), CFR Title 21 (FDA), and the requirements of the institutions' Office of Human Research Protections approved assurances.
More information about the UMKC IRBs and the meeting times may be obtained on their website.
For proposed research projects that intend to recruit minors at Truman Medical Centers/University Health, please contact the Children's Mercy IRB for a list of requirements and meeting information.
For National Cancer Institute oncology research trials and Truman Medical Centers/University Health's participation in the Kansas City Community Oncology Program (KCCOP), the KCCOP IRB reviews and approves each study project.
Depending on the nature of the research project, the documents to accompany the submission vary. Typically, a study protocol, informed consent form, specific information about the medication or device (if applicable), and any other pertinent patient information are submitted (e.g., advertisements, data survey form, adverse event information). Refer to the IRB submission checklist to ensure all documents requiring IRB review are included.
The complete research proposal documents must be submitted to the IRB two weeks before the next scheduled meeting to be included in the review packets for the committee members. For research protocols requiring full board review, three board members are assigned to review all of the submitted materials and documents in depth, while the other board members review the research study summary and informed consent form. Principal Investigators are asked to attend the meeting to present their research protocol and answer any potential questions or clarify the project to the committee.
Research requiring access, review, use, recording, or disclosure of any patient protected health information at Truman Medical Centers/University Health also requires review to ensure compliance with HIPAA Privacy Rule requirements. The Privacy Rule requirements will be reviewed during the IRB review. All study recruitment materials are also reviewed, including advertisements, information sheets, study participant newsletters, serious or unexpected adverse events that occur during the study, protocol amendments, and informed consent form changes.
Expedited review means that full committee review at a convened meeting may not be required. Federal regulations allow the IRB to review a study project via expedited review if the project involves no more than minimal risk to participants. Certain minor changes for previously approved research may also be evaluated by expedited review.
If a research project falls within one of the six federally defined categories (45 CFR 46.101(b)) of minimal risk to participants, then the IRB may determine the project to be exempt from review, and the investigator will need to complete a Request for Exemption form. For reference see DHHS regulations 45 CFR Part 46.101.
Most of the IRBs that review research projects at Truman Medical Centers/University Health utilize a consent document template. Please check the IRB's site for more information as the consent templates include institution-required information as well as elements of the consent required by the federal research regulations.
Federal research policies require IRB approval and institutional policies require administrative approval before any research data is reviewed or collected.
Continuations must be reviewed by the IRB at a regularly convened meeting. In order to prevent unnecessary suspension of the study, the IRB must review the information before the approval expires.
If human subjects are involved, yes.
Please note: Student researchers are required to obtain a faculty sponsor for each research project. If the research project is conducted at Truman Medical Centers/University Health or will evaluate patients hear, administrative approval by Truman Medical Centers/University Health is required as well. Some projects require careful consideration for whether the activity is defined as research. These projects may not be determined to be research and thus do not require IRB committee review. The UMKC IRB office must make the determination.
Case evaluations/reports do not strictly meet the DHHS definition of "research," so IRB review is not needed. However, the author of the case report must comply with HIPAA. Authors should obtain the signed authorization of the patient (or legally authorized representative) to use or publish a patient's information in the article. The UMKC IRB has further guidance about case reports and IRB review.
Federal regulations mandate that the IRB grant approvals for a period not to exceed 365 days. However, if the protocol is reviewed, and changes have to be made (i.e. consent form revisions) before full approval is granted, IRB approval will be granted from the day the IRB receives the changes up to one year (or less, depending on the study) from the initial review.
For example, a research study protocol is submitted by a researcher and reviewed at the November 9th IRB meeting. At that meeting, the IRB decides that some minor changes should be made to the consent form before full approval of the protocol is granted. The changes are subsequently submitted by the researcher to the IRB on December 1st. The changes are then reviewed and approved by the IRB. The approval time period will be from December 1st, the day the changes were submitted, through November 8th, the date not to exceed one year from the day of the initial review.
Human subjects research
Research is a systematic investigation designed to develop or contribute to generalized knowledge.
Visit the National Institutes of Health (NIH) website to read about research clinical trials and more definitions www.ClinicalTrials.gov.
The federal policy (also known as the Common Rule) for the protection of human subjects (45 CFR Part 46) requires that each institution engaged in federally supported human subject research provide documented assurance that it will comply with the federal regulations. This agreement is known as a Federal Wide Assurance (FWA). Each institution has a number assigned to their FWA. TMC’s FWA is 00005188.
An investigator is a medical researcher in charge of conducting a research study protocol. The principal Investigator (PI) is the individual personally conducting or supervising the research study. The PI assumes day-to-day responsibility for the study conduct. To conduct a research study at Truman Medical Centers/University Health, a TMC employee or an individual on the current medical staff roster must be listed as a PI.
GCP consists of an international ethical and scientific standard by which clinical trials involving human subjects are designed, conducted, implemented, and reported. See FDA Guidance.
Links to the Common Rule (DHHS regulations), the Belmont Report (the ethical principles for the protection of human subjects of research), U.S. Food and Drug Administration (FDA) regulations and the HIPAA Privacy Rule are available for review.
Informed consent is a term which describes the communication process that enables individuals to make an informed choice about participation in a research study. The informed consent process includes the discussion that takes place between the researcher and the participant and the written document that formalizes the agreement to participate and documents the process.
Depending on the study project and sponsor of the research study, the information collected should be maintained by the researcher in the event of a sponsor audit, FDA audit, data query or other relevant need. IRB communications, approved informed consent forms and research records need to be maintained in accordance with UMKC Research Records All Departments Authorization No. 00-018. Studies related to an FDA New Drug Application may need to be stored even longer. Please contact the Research Administration Office to discuss retention requirements. The Truman Medical Centers/University Health Health Information Management Department coordinates long-term storage of documents with an off-site vendor.
Both the FDA and the DHHS have regulations that govern financial conflicts of interests of investigators and research staff. Disclosure of the potential conflict and the subsequent management of specified financial arrangements minimize the potential for bias and lessen questions regarding integrity of study data. Because financial conflicts of interest could affect the reliability of study data, disclosure of the potential conflict is required in accordance with institutional policies. (See Rules and Regulations FAQ)
The DHHS Common Rule defines a human subject as a living individual about whom a researcher obtains:
- Data through intervention or interaction with the individual.
- Identifiable private information.
The FDA regulations define a human subject as an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. For more information about federal research guidelines and regulations, see FAQs – Rules and Regulations.
Some projects require careful consideration for whether the activity is defined as research. Such activities may include: oral histories, case studies, and quality or internal process improvement projects. These projects may not be determined to be research and thus do not need a TMC Research Application Form. The IRB office should be consulted for this determination.
Truman Medical Centers/University Health and the UMKC IRBs require all researchers and staff to complete education from CITI. This training is required every three years. More information is listed on the UMKC IRB site.
At the CITI site:
- Pick the option to register for the CITI courses.
- From the list of Participating Institutions, select the University of Missouri-Kansas City.
- Choose a username and password.
- After you have logged in to CITI, click "Add a course or update your groups."
- Select Group 1 (Biomedical Investigator) to begin the training modules.