Special Protections for Children as Research Subjects 2025

Get Form
Special Protections for Children as Research Subjects Preview on Page 1

Here's how it works

01. Edit your form online
Type text, add images, blackout confidential details, add comments, highlights and more.
02. Sign it in a few clicks
Draw your signature, type it, upload its image, or use your mobile device as a signature pad.
03. Share your form with others
Send it via email, link, or fax. You can also download it, export it or print it out.

How to use or fill out Special Protections for Children as Research Subjects

Form edit decoration
9.5
Ease of Setup
DocHub User Ratings on G2
9.0
Ease of Use
DocHub User Ratings on G2
  1. Click ‘Get Form’ to open it in the editor.
  2. Begin with SECTION I: General Information. Fill in the Study Title, ensuring it reflects the study's purpose accurately. Provide a concise Study Objective summarizing your research.
  3. Complete the Principal Investigator Information section by entering your name, department, contact details, and any Co-Investigator(s) or Student/Resident Researcher(s) information as necessary.
  4. Move to SECTION II: Funding. Specify your funding source and provide additional comments if needed. Ensure you include any relevant grant applications if applicable.
  5. In SECTION III: Conflict of Interest, review the ECHN Conflict of Interest Policy and complete the attached Questionnaire as required.
  6. Proceed through each subsequent section (Background, Hypotheses, Study Design, etc.), providing detailed descriptions and justifications for your research methods and objectives.

Start using our platform today to streamline your document editing and form completion process for free!

See more Special Protections for Children as Research Subjects versions

We've got more versions of the Special Protections for Children as Research Subjects form. Select the right Special Protections for Children as Research Subjects version from the list and start editing it straight away!
Versions Form popularity Fillable & printable
2018 4.8 Satisfied (172 Votes)
be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.
Contact us
The following are examples of groups that are often considered vulnerable populations or in need of additional protections or considerations in research: Pregnant women Human fetuses Neonates Prisoners Children Individuals with physical disabilities Individuals with mental disabilities or cognitive impairments
Parental Permission Because children are not legally able to provide consent in their own right, the federal regulations generally require that parents or guardians provide permission before children can be enrolled in research.
Protections for Vulnerable Populations (1) Children - see Research with Children and Youth and Research in K-12 Educational Settings. (2) Prisoners. (3) Pregnant Women. (4) Fetuses. (5) Persons with Cognitive Impairment. (6) Economically or Educationally Disadvantaged Persons - see Compensation of Participants.
Does research involving children include special requirements? Yes, subpart D of the HHS regulations at 45 CFR part 46 provides additional protections for children participating in human subjects research.
These populations include: Fetuses, neonates and children; Individuals with impaired decision-making capacity (cognitively impaired, traumatized, sedated, intoxicated, etc.);

People also ask

Some types of research are considered exempt even when children are subjects. However, some types of research considered exempt when subjects are competent adults are not exempt when children are subjects. Research involving survey or interview procedures is not exempt when children are subjects.
Pregnant women, prisoners, and minors have specific sections in the federal regulations that provide additional rules for studying these participants.

Related links