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How Do I know if I need to submit my proposal under these guidelines?

The Vermont Agency of Human Services requires that research conducted by any component of the agency involving human subjects, their health related information and/or any potential risk to human subjects, be approved before the research is begun. The Agency Institutional Review Board (IRB) reviews applications concerning research on human subjects or their protected health information when the subjects are Agency clients or recipients of public services or benefits furnished by the Agency AND when the research is proposed by, affiliated with, conducted at the request of, or involves an Agency department, division, program or office. The Agency of Human services procedures related to this policy are outlined in these pages.

You need to answer the following two critical questions:

  1. Is the activity in which you will be engaged research?
  2. Will the project involve human subjects?

Answering these questions will help you determine if IRB review of the research is required.

1.  Is my project research?

Ask yourself the following questions:

A.  Is the activity designed to produce generalizable knowledge?

  • In other words, will the information derived from the activity be applicable to other individuals outside of those served by the VT Agency of Human Services?

B.  Will the information be gathered systematically?

  • In other words, will it be arranged so that conclusions can be drawn, and so that others outside of VT AHS can review those conclusions?

Note: Intent to publish results of an activity nearly always means it is research. For the purposes of this discussion, “publish” does not include our obligations to:

  • Share and distribute information to co-workers, policy makers and others responsible for oversight; program reporting obligations; program monitoring or evaluation reports; audits or quality assurance/improvement reports.
  • Comply with state and federal access pursuant to public records law

"Publish" does refer to those activities that are discretionary or of a more academic or scientific nature whereby the primary purpose of the research is to advance a general knowledge base or foster innovations in a specific area of thought.

Please consider the intent associated with pursuing your proposed study before you submit an application to the IRB. For example, if information is collected for quality assurance or improvement, state or federal monitoring or reporting, audits or other such program monitoring, then it should not be considered research reviewable by the IRB.

If you wish, please feel free to contact the Agency’s IRB chair to discuss your project.

If the answers to the questions A & B above are NO, then your proposed activity does not meet the definition of RESEARCH; and the IRB does not need to review the activity.

OR

If the answers to the questions A & B above are YES, then your proposed activity meets the criteria for research.

2.   Will your project involve human subjects?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
     A.   data through intervention or interaction with the individual, or
     B.   identifiable private information.

ADDITIONALLY, THE DEFINITION OF HUMAN SUBJECT INCLUDES:
~ research involving previously collected data or tissue specimens, or
~ research involving autopsy material.

Will your project involve HUMAN SUBJECTS?

If the answers regarding human subject involvement are NO, then your proposed activity does not meet the federal definition of HUMAN SUBJECTS and therefore the IRB does not need to review the activity.

OR

If the answers regarding human subject involvement are YES, then your proposed activity meets the criteria for including HUMAN SUBJECTS.

NOTE:  If you have answered YES to both of the previous questions and determined that:

  • the activity is research; and
  • the activity will involve human subjects,

then you must submit the protocol to the IRB for review!!

  • Please note: When research is conducted and/or reviewed by the University of Vermont or Dartmouth College it does not need to be reviewed by the Agency of Human Services IRB.

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Additional Information:

What is NOT considered research?

Quality Assurance: All actions taken to ensure that standards and procedures are adhered to and that delivered products or services meet performance requirements. Activities conducted for the intent of maintaining or improving quality of services provided by the agency are not considered research activities.

However, if the data collected are generalizable and are to be shared outside of the agency through discussion, presentation, or publication, other than to meet state and federal reporting requirements, the activity may qualify as research.

Normal Educational Practices and Settings: research conducted in established educational settings involving normal educational practices such as (i) research on regular and special educational strategies, or (ii) research on the effectiveness of, or the comparison among, instructional techniques, curricula, or classroom management methods.

Anonymous Educational Tests, Surveys, Interviews, or Observations: Research involving the use of educational test (cognitive, diagnostic, aptitude, achievement) survey procedures, interview procedures or observations of public behaviors whereby subjects cannot be identified directly or through identifiers. *Note: This exemption also applies to research involving minors when the research involves educational tests or observation of public behavior except when the investigator(s) do not participate in the activities being observed. All other research projects with minors require IRB submission.

Research Involving Survey or interview procedures and observations: (including observations by participants) of public behavior, unless:

(i) Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects: AND

(ii) any disclosure of the human subjects’ responses outside of the research could reasonably place the subjects at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation, or deals with sensitive aspects of the subject’s own behavior, such as illegal conduct, drug abuse, sexual behavior or the use of alcohol.

All research involving survey or interview procedures is exempt, without exception, when respondents are elected or appointed public officials or candidates for public office.

Collection or Study of Existing Data without Identifiers: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.

Research is exempted when it is designed to study, evaluate or otherwise examine the following: public benefit or service programs, procedures for obtaining benefits or services under the programs, possible changes to the programs or procedures, or possible changes in methods or levels of payments for benefits or services under the programs, when the research is conducted by or subject to the approval of the head of the agency, department, division or office within the agency.

Journalism - the periodical collection and publication of current news

Exercises Performed Solely Within a Classroom without intent to publish

Marketing and Assessment Surveys without intent to publish

Educational Assessments without intent to publish