Minimum Consent Documentation Must Include, But Is Not Limited To, Which Of The Following? (2023)

1. [PDF] Marketplace Compliance and Agent/Broker Regulations - CMS

  • May 24, 2023 · » This presentation will cover Marketplace compliance and regulations that agents and brokers are required to adhere to before assisting.

2. Summary of CMS Guidance on New Consent Rules -- Effective 6/18

  • The documentation must contain, at a minimum, the following information: The date the information was reviewed;. The name of the consumer or their authorized ...

  • New CMS requirements make agents, brokers and web-brokers responsible for documenting consumer consent and reviewing application accuracy.

3. Informed Consent FAQs -

  • What are the requirements for assent and parental permission in research with children?

  • The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents that informed consent can be waived (45 CFR 46.116(c) or (d)); or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings. When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117. [Food and Drug Administration (FDA) regulations at 21 CFR part 50 may also apply if the research involves a clinical investigation regulated by FDA.]

4. Informed Consent - StatPearls - NCBI Bookshelf

  • Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a ...

  • Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.  Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's understanding of elements 1 through 4.

5. Obtaining and Documenting Informed Consent - UCSF IRB

  • May 22, 2023 · Obtaining consent involves explaining the research and assessing participant comprehension using a consent document, usually a written consent ...

  • Consent Discussion (ongoing) ⇒ Give Experimental Subjects Bill of Rights (if applicable) ⇒ Sign Consent Form ⇒ Sign HIPAA Authorization (if applicable) ⇒ Consent Documentation (ongoing)

6. Verbal Consent (Waiver of Documentation)

  • Jun 14, 2022 · The investigator must obtain consent following the same requirements as written consent but the subject does not sign a consent form. Waiver of ...

  • When a subject signature is not required (e.g. to obtain verbal consent).

7. FERPA - Protecting Student Privacy

  • (3) The notice must include all of the following: (i) The procedure for exercising the right to inspect and review education records. (ii) The procedure for ...

  • Below are the regulations at 34 CFR Part 99 implementing section 444 of the General Education Provision Act (GEPA), which is commonly referred to as the Family Educational Rights and Privacy Act (FERPA), and Federal Register Notices of amendments to FERPA.  They are presented here for your convenience. 

8. 11.1. Informed consent standards -

  • Sep 15, 2020 · (B) Informed consent must present information in sufficient detail relating to the research, and must be organized and presented in a way that ...

  • 340:2-39-11.1. Informed consent standards

9. [PDF] Access to/Sharing of Personal Health Information (PHI) and the Use of ...

  • Policies and procedures must include, but are not limited to the following: ... Consent must include, at a minimum, the following: • the name of the CMA, and.

10. 42 CFR Part 482 Subpart B -- Administration - eCFR

  • The emergency preparedness program must include, but not be limited to, the following elements: ... At a minimum, the policies and procedures must address the ...

  • Enhanced Content

11. 144.293 release or disclosure of health records. - MN Revisor's Office

  • A patient's health record, including, but not limited to, laboratory reports ... A consent does not expire but may be revoked by the patient at any time by ...

  • §

12. [PDF] Chapter 1 Surgery/Post-Operative Care Rule 1.1 Scope. The following ...

  • The crash cart must include, at a minimum, the following resuscitative medications, or ... Licensure may take include, but are not limited to, one or more of the ...


  • purpose and content, and shall include the following information: a description of the ... person or persons (including, but not limited to a spouse or parent) ...

14. [PDF] Informed Consent and the Research Subject Policy

  • The consent process must include a description of the following: The method ... Final communication can occur at any time and includes, but is not limited to:.

15. Part 2 - Definitions of Words and Terms | Acquisition.GOV

  • (2) Does not include computer databases or computer software documentation. ... Examples of ICT include but are not limited to the following: Computers and ...

  • (a) A word or a term, defined in this section, has the same meaning throughout this regulation (48 CFR chapter 1), unless-

16. Understanding Federally-Facilitated Marketplace Standards of Conduct

  • Jul 3, 2023 · This includes but is not limited to: Conducting a search for ... ” Any documentation of the consent must be secured and retained for a minimum of ...

  • A thorough review of the process life and health insurance brokers must follow to obtain consent from individuals, employers, and employees before providing assistance to Marketplace/ACA consumers.


  • "Unprofessional conduct" shall include, but not be limited to, the following: (1) ... minimum standards of practice include, but are not limited to the following: ...

  • The Georgia Composite Medical Board ("Board") is authorized to deny, revoke, suspend, fine, reprimand or otherwise limit the license of a physician or physician assistant for all the grounds set forth in O.C.G.A. § 43-34-8 and to deny, revoke, suspend, fine, reprimand or otherwise limit the license of a physician pursuant to O.C.G.A. § 43-34-8. In addition, the Board is authorized to terminate the approval of a physician's assistant and to revoke the license of a physician's assistant pursuant to O.C.G.A. § 43-34-107.

18. Institutional Review Boards Frequently Asked Questions - FDA

  • IRB review of informed consent documents also ensures that the institution has complied with applicable regulations. 11. Does an IRB or institution have to ...

  • IRB, institutional review board, FAQs

19. 243 CMR 3.00: The establishment of and participation in qualified patient ...

  • (d) patient communications and documentation activities including, but not limited to, informed consent policies, maintenance of medical records, and the ...

  • The establishment of and participation in qualified patient care assessment programs, pursuant to M.G.L. c. 112, § 5 , and M.G.L. c. 111, § 203

20. [PDF] Rule 360-3-.06. Pain Management. - Georgia Composite Medical Board

  • ... and chronic pain, the. Board has determined that the minimum standards of practice include, but are not limited to the following: (a) Physicians cannot ...

21. [DOC] MAPA-3 -

  • Consent documentation must, at a minimum: a. Indicate that the Member or ... Care coordination includes but is not limited to the following: Assistance ...

22. Guidelines for obtaining meaningful consent - Office of the Privacy ...

  • These choices must be explained clearly and made easily accessible. Whether each ... Such demonstrations may include – but are not limited to – showing, when ...

  • Practical and actionable guidance regarding what organizations should do to ensure that they obtain meaningful consent.

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