# Presentation: 522642

## Human Subjects Research

- Valery M. Gordon,  Ph.D., M.P.H.
- Extramural Human Subjects Research Policy Officer
- Office of Extramural Research, OD, NIH
- (301) 435-0945
- _[vg10w@nih.gov](http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm)_

- 6th Annual SBIR/STTR Conference, June 23, 2004

## Definition of a Human Subject

- ... a living individual
- about whom an investigator... conducting research obtains
- 		(1) data through _intervention_ or _interaction_ 	with the individual, or
- 		(2) identifiable private information
_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.102**_

## Definition of Research

- ... a systematic investigation
- research development,
- testing, and
- evaluation
- designed to
- develop or to contribute to generalizable knowledge
_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.102**_

## Definition of Risk

- 	...the **probability** of
- harm
- 		or
- discomfort
- Extracted from:
_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.102**_

## OHRP Responsibilities

- Office for Human Research Protections (OHRP) is in Office of the Assistant Secretary for Health, DHHS
- 	_**http://ohrp.osophs.dhhs.gov/index.html**_
-  **OHRP is responsible for**:
-  Issuing **Assurances** to institutions “engaged” in federally-funded human research and **registering IRBs** which provide approval and oversight for human subjects research
- 	_**http://ohrp.osophs.dhhs.gov/irbasur.htm**_
-  Developing and updating policy and guidance documents
-  Education
-  Compliance with HHS Human Subjects Protections Regulations
**	****	**_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm**_

## NIH Responsibilities

- NIH is committed to the highest ethical and scientific standards for Human Subjects research
- NIH assesses proposed research for protections against research risk:
**Consistency with HHS Regulations**
_**Subpart A**_ - Federal Policy for the Protection of Human Subjects
_**Subpart B**_ – Additional Protections for Pregnant Women, Human Fetuses and Neonates
_**Subpart C**_ – Additional Protections for Prisoners
_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/prisoner.htm**_
_**Subpart D**_ – Additional Protections for Children
**Compliance with NIH Policies and Guidance**
- Data and Safety Monitoring Plans for Clinical Trials
- Required Education for Protection of Human Subjects in Research

## Slide 7

## Application (PHS 398):               Human Subjects Research

- PI should enter YES in Item 4 on application facepage;
**Exemptions** designated in Item 4a often represent the opinion of the PI because
- OHRP Guidance states Exemptions should be independently determined;
- 		_[http://](http://ohrp.osophs.dhhs.gov/humansubjects/guidance/wirbproc.pdf)__[ohrp.osophs.dhhs.gov/humansubjects/guidance/wirbproc.pdf](http://ohrp.osophs.dhhs.gov/humansubjects/guidance/wirbproc.pdf)_
- Institutions often designate IRB to make determination; and
- NIH does not require IRB approval until prior to award
- Required information must appear in the _Research Plan_ in **Section e. Human Subjects**

## Human Subjects Section: Non-exempt Research

- _Non-exempt_ Human Subjects Research
- Risks
- Adequacy of protections against risks
- Data and Safety Monitoring for Clinical Trials
- Monitoring entity
- Adverse Event Reporting
- Potential benefits
- Importance of knowledge to be gained
_**http://grants.nih.gov/grants/funding/phs398/phs398.html**_

## Human Subjects Section: Exempt Research

- _Exempt_ Human Subjects Research
- Exemption Category
- Justification for exempt status
- Population sample
- Number
- Age range
- Health status
- Sources of research materials or data

## Exemptions 1, 2*

- Research in educational settings on educational strategies
- Surveys, interviews, observations of public behavior, if participants
- cannot be identified, either directly or indirectly; OR
- may be identified, but would not be put at risk if information is disclosed
- 	*E2 only applies to research with children for observations of public behavior when the investigators do not participate in the activities being observed
_**http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101**_

## Exemption 4

- "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 subjects _cannot_ be identified,  directly or through identifiers linked to the subjects."
- 	_[http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101](http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm#46.101)_
- In order to be exempt from the requirement of IRB review and approval under exemption 4, researchers must propose the use of data or samples that are either:
- 		- _**existing**_** and publicly available**
- 		OR
- 		- _**existing**_** and unidentifiable**

## Repositories and Databases

_**Non-Research**_ Repositories & Databases
- IF samples or data collected for non-research purposes _AND_
- Samples or data submitted to the Repository without any links to identifiable private data or information; _THEN_
**NOT HUMAN SUBJECTS RESEARCH**

## Repositories and Databases

_**Research**_ Repositories & Databases
- Samples or data collected for research purposes
- Sample or data collection is a research activity
- Repository Storage/Data Management is a research activity
- Use/Disclosure of Samples/Data is a research activity
- Each research activity is Human Subjects Research
-  If archived samples/data are provided without links to individually identifiable information, then the research may meet the criteria for Exemption 4

## FAQS: Human Subjects Research?

- Research with cadaver specimens?
**NO**, Human Subjects research involves “living individuals”
- Research with tissue specimens?
**NO**, if specimens obtained from non-research repository
**YES**, if specimens obtained from research repository*
**YES**, if specimen collection is ongoing (even if samples were going to be discarded)
- Research with cell lines?
**NO**, for commercially-available cell lines
**YES**, if cell lines meet definition of *human subject*

## FAQs: Human Subjects Research?

**Research involving “Focus Groups”**
**NO**, if research will involve consultants chosen for their expertise to improve research design
**NO**, if research will involve individuals recruited to test a new product/survey instrument in order to identify problems (testing)
**YES**, if research will involve small group representing target population and individually-identifiable information will be obtained, that could result in risks (pilot testing)

## Thank you!