Hello, I'm Jaime Hernández from the HHS Office for Human Research Protection. I'm here to give you an overview of the changes to exemptions one, two, three, and five in the revised Common Rule, which was published on January 19, 2017. The first thing I would like to address about the exemptions is that the actual location of the exemptions within the regulatory text has changed. In the pre-2018 Common Rule, the exemptions could be found under section 101.101, which is titled "What does this policy apply?" In the revised Common Rule, there is a new section 104 titled "Exempt research," which includes all the exemptions. Another clarification that needs to be made is that there have been no changes in the revised Common Rule regarding who can make an exemption determination. It is still the case that institutions can implement their own policies. However, OHRP guidance provides that the institutional policies and procedures should clearly identify who is responsible for making such determinations. Additionally, it is still not recommended for investigators to make their own exemption determinations. Lastly, author P will provide decision charts which will hopefully aid in making the determinations. Now, let's talk about the exemptions themselves. This is a very general summary of the changes to the exemptions in the revised Common Rule. Exemption one, for educational practices, has some new restrictions added. Exemption two, for educational tests, surveys, interviews, and observation of public behavior, has been expanded. Exemption three, for research on public officials, has been entirely removed and replaced by a brand new exemption. Extension four, for research on existing data, has been expanded with certain changes. The same is true for exemption five, for research on public benefits. Exemption six, for taste of food evaluations, remains exactly the same. And then there's the new exemption seven, for the...
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Describe how this activity furthers your exempt purposes. Form: What You Should Know
You may wish to refer to any published literature about nonprofit organizational strategy and business development. The first part of the Form 1023 (Part IV) Narrative of Activities is to explain the core function of your organization, which in turn must address all major aspects of the mission. The following sections are more detailed explanations of the activities you'll need to take into account for an exempt purpose statement: Chapter 1– How your charity relates to the mission of your nonprofit and relates to the world. Part 2— How you will implement your planned activities to solve a problem. How will you determine which problem to address? For each activity (chapter) identified in Part 3 you need to be able to provide a description of where it will be directed, what its major goal is, who will be involved, what will be the organizational structure, and how your charity will measure its progress. What is a Problem? A problem is defined as “an urgent need or a specific, difficult problem.” You can identify any problem that is affecting the people or the community in which your organization operates (i.e., local needs or issues). Chapter 2– Specific Exempt Purposes to be Fulfilled Section 5—General Guidance What is a “general” purpose? Any nonprofit organization is authorized to promote the general welfare. An organization's general purpose must be based on an independent judgment, and can not be based on the organization's religious belief. Thus, the general purpose cannot be a religious purpose. The purpose of a nonprofit must not be the primary purpose of the organization or the function of the organization. What does this mean to you? A general purpose can be used in a more general way to support the charity's social or moral goals, but may NOT be used to promote the religious goals of the organization. How do you define special-need programs, specifically with an issue of special needs in mind? Sections 6 and 7—”Specific Exempt Purposes to be Fulfilled›” Do not refer to the general purpose or any other purpose in the statement; describe what the organization will promote that is in the area of social services. You must provide that you will provide services for the poor and for persons with special needs within the first 3 pages of the statement. This rule is part of our description of a description of “Specific Exempt Purposes to be Fulfilled›.
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