# Presentation: 531259

## Slide 1

## What/Who is the Human Subjects Research Review Official?

- HSRRO established under EPA Order 1000.17 Change A1
- 	http://intranet.epa.gov/rmpolicy/ads/orders/1000_17a.pdf
- “All human subject research studies supported by EPA must either be approved or be determined to be exempt research by the EPA Human Subjects Research Review Official ... before any contract, grant, cooperative agreement, cooperative research and development agreement [CRADA], interagency agreement, or any formal agreement involving EPA support of such studies is awarded or entered into.  All human subjects studies conducted by EPA also must be approved or determined to be exempt by the Review Official before work can start.  Approval will be given only to research which complies with [the Common Rule].”
- I am the current HSRRO

## Current Functions of the HSRRO

- Additional EPA oversight to assure compliance with the Common Rule (i.e., IRB approval, informed consent, etc.) and ethics standards
- Approval/disapproval of _all_ EPA HSR, whether in house or extramural
- Authority to suspend or terminate HSR studies if non-compliance
- Issue single/multi-project assurances for institutions conducting research (EPA now relies on DHHS-OHRP FWAs)
- Consultative role in EPA HSR ethics considerations

## Increased Role of the HSRRO

- The HSRRO is to be moved to the Office of the Science Advisor in the Administrator’s Office, in response to the NAS recommendation
- The HSRRO position competitively advertised
- Support staff anticipated
- The HSRRO role under the draft HSR rule is to:
- Continue existing HSRRO responsibilities
- Oversee the review of intentional dosing human study proposals by EPA and covered 3rd Parties (pesticides)
- Conduct ethics screening of completed studies
- Liaise with the Human Studies Review Board
- Develop additional policies, training, and guidance

## Regional Relationship to the HSRRO

- Regional responsibilities (1000.17 A1 6.b.):
- “The EPA program or regional office that conducts or supports research covered by this Order is responsible for compliance with it.  In the first instance the office will decide whether the project involves “human subjects” and is “research” as per [this order], and hence is a covered project.”
- The region “is responsible for notifying the EPA Award Official/Contracting Officer that human subjects are involved.”
- “The Award Official/Contracting Officer is responsible for ensuring that the written approval or exemption determination from the ‘HSRRO” is submitted as part of the funding package ...”
- De facto: The Region is responsible for obtaining HSRRO approval

## Human Subjects Approval Process

*Laboratory/Program/ Region *
*Project Officer*

*GAD/Contracts*
*Award/Contract Official*

*Lab/Region/Program Human Subjects Officer*

*Senior Science Advisor*
*Dr. Roger Cortesi*

*HSRRO *
*Dr. Peter Preuss*

- Is this
- HSR?
- questions

*Grant/Contract Award Process*

- Documentation
- Questions

- HSR Decision

- Documentation

## Human Subjects Officers

- ORD laboratories, programs and regions may nominate “human subjects officers” to assist in the implementation of HSR policies and procedures to:
- Work with project officers to make determinations on what is HSR
- Assist project officers in preparing adequate HSR documentation for submission to the HSRRO
- Coordinate with the HSRRO and Senior Science Advisor on questions and process for HSR approval
- Human subjects officers should be senior staff experienced with decision-making on HSR
- Not a substitute HSRRO.  There is only one HSRRO to maintain consistency across the Agency
- This process may be modified by the new HSRRO

## Human SubjectsTraining

- All EPA project officers undergo training on the EPA human subjects approval process
- EPA staff conducting human subjects research are required to annually complete CITI ethics training https://www.citiprogram.org/default.asp
- General HSR information is available at OHRP http://www.hhs.gov/ohrp/
- Additional training for EPA human subjects officers can be arranged regionally or at a central location
- Recognize that human subjects training needs can vary depending on the activity being considered, i.e:
- Approval process for EPA supported HSR
- Protection of subjects during the conduct of HSR
- Ethics reviews of existing literature

## Additional Responses to HSR Questions

- Is an IPA employee to a state covered?
- See Rule on “any formal agreement involving EPA support for such studies.”
- Most institutions are covered by the Common Rule, so the impact is generally limited to obtaining HSRRO approval
- Do we have a list of human subjects officers?
- Yes, Dr. Cortesi maintains list of ORD and Program officers
- No, it is not maintained on a web site
- Ultimate responsibility?
- Spelled out in Rule 1000.17 (Change 1)
- Region/program supporting HSR is responsible for compliance with the Rule and to notify Grants/Contracts of HSR
- Grants/Contracts is responsible to not award without HSRRO approval
- HSRRO is responsible to ascertain Common Rule compliance
- The institution conducting the research is responsible for the conduct of the research.