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This document provides a comprehensive FAQ regarding the Human Subjects Electronic Research Application (HS-ERA), including guidance on logging in, accessing submissions, entering data, submitting

How to fill out human subjects electronic research

How to fill out Human Subjects Electronic Research Application

1. Access the Human Subjects Electronic Research Application portal online.
2. Create an account or log in if you already have one.
3. Begin a new application by selecting the appropriate project type.
4. Fill out the basic information section, including project title, study type, and principal investigator's details.
5. Provide a detailed description of the research, outlining its purpose and objectives.
6. Include information on the study design and methodology, explaining how human subjects will be involved.
7. Detail the recruitment process for participants, including inclusion and exclusion criteria.
8. Address potential risks to participants and outline plans for risk mitigation.
9. Include any informed consent materials that will be used in the study.
10. Review and edit your application for clarity and completeness.
11. Submit the application and await feedback or approval from the review board.

Who needs Human Subjects Electronic Research Application?

1. Researchers conducting studies that involve human subjects.
2. Institutional review boards (IRBs) requiring formal documentation of the research involved.
3. Graduate students preparing for thesis or dissertation research involving human subjects.
4. Organizations seeking funding for projects that require ethical approval for research involving human participants.

People Also Ask about

What is an example of research with human subjects?

Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.

What is a research study using human subjects?

If identity is knowable, the study is considered to be human subjects research. Private information. Information for which a person can expect that observations or recordings are not taking place, and the information will not be made public.

What is considered human subjects research?

When conducting human subjects research, it is essential that researchers are familiar with the ethical principles delineated in the Belmont Report. These principles are: respect for persons, beneficence, and justice.

What is conducting research with human subjects?

Types of Human Subjects Research Analysis of Existing Data or Specimens. Observational Studies. Interventional Studies.

What are examples of human subjects in research?

Examples of projects that are considered “human participant research” include: Participants in physical activities (e.g., physical exertion, ingestion of any substance, any medical procedure) Psychological, educational and opinion studies (e.g., surveys, questionnaires, tests)

What is considered a human subject in research?

A human subject is the person that the information is about, not necessarily the person providing the information. In the case of biospecimens, the human subject is the person from whom the specimen was taken. An investigator gathers information about newborns by asking mothers questions only about the babies.

What is IRB approval for human subjects?

The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.

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What is Human Subjects Electronic Research Application?

The Human Subjects Electronic Research Application is a digital form used by researchers to submit proposals for studies involving human subjects to an Institutional Review Board (IRB) for ethical review and approval.

Who is required to file Human Subjects Electronic Research Application?

Any researcher or institution conducting research that involves human subjects is required to file the Human Subjects Electronic Research Application to ensure compliance with ethical standards and regulations.

How to fill out Human Subjects Electronic Research Application?

To fill out the application, researchers must provide detailed information about the study's purpose, methodology, participant selection, informed consent process, and how data will be collected and protected, among other necessary details.

What is the purpose of Human Subjects Electronic Research Application?

The purpose of the application is to protect the rights and welfare of human research participants by ensuring that the proposed research complies with ethical guidelines and has been thoroughly reviewed by an IRB.

What information must be reported on Human Subjects Electronic Research Application?

Researchers must report information such as study objectives, research design, participant demographics, risks to participants, recruitment methods, informed consent procedures, and data management plans.