Steps to Conduct an EI

Print
Related Pages
Requesting an EI

Your EI request proposal should address each of the four questions and include information that

  • Describes the exposed population(s),
  • Identifies the data gap(s),
  • Explains how the EI will address the data gap(s), and
  • States how the EI results will affect public health decision making.

The EI group and ATSDR management will evaluate your proposal and decide whether to conduct an EI at your site. Note that not all sites with “Yes” answers for each question will be selected for an EI.

Planning the EI
Team, Roles, and Responsibilities
team planning meeting

If the ATSDR EI group approves the EI proposal, they will start by organizing the EI team, identifying an EI lead, and determining the various roles and responsibilities of team members. The EI team is located at ATSDR headquarters and will coordinate with the appropriate regional personnel. For instance, the EI team will define and agree upon who will do the following tasks:

  • Write the EI protocol
  • Interact with the community
  • Collect samples
  • Obtain and interpret sample results from the laboratory
  • Send individual results to participants
  • Write the EI report and present results to the community
Protocol

Once the EI roles are assigned, a protocol is completed. The protocol goes through ATSDR’s review and approval process to allow ATSDR to conduct biological and environmental sampling. The protocol will include

  • site background,
  • list of federal, state, and local partners,
  • recruitment methods and materials (e.g., fact sheets, posters),
  • methods for data collection, including a Sampling and Analysis Plan (SAP) for environmental samples,
  • consent forms and questionnaires for participants, and
  • samples of letters that will be used to provide participants with their results.
OMB package

After the protocol has been reviewed and approved, the package is submitted to the Office of Management and Budget (OMB) for approval.

The Paperwork Reduction Act (PRA) requires that federal agencies, including ATSDR, do not overly burden the public by taking up too much of their time when requesting information for a study or an exposure investigation. ATSDR is required to submit forms that will be used to interact with the public, such as a questionnaire, to OMB for approval.

The ATSDR EI group has a generic clearance package approved by OMB for conducting EIs. For each EI, however, a site-specific package is submitted that includes the full protocol along with the number of “burden” hours the EI will require for each participant. OMB needs to approve the site-specific package before data collection can begin.

The Institutional Review Board (IRB) oversees research involving human subjects. EIs are exempted from IRB because EIs are not considered to be research.

Data Management Plan
woman reading document
  • The EI team will also prepare a Data Management Plan (DMP) that outlines how the data will be collected, handled, managed, and stored.
  • The DMP describes the anticipated use and release by CDC/ATSDR of the dataset planned for collection.
  • All DMPs need to comply with CDC/ATSDR policy on releasing and sharing data.
Protecting the Confidentiality and Privacy of EI Participants

The confidentiality and privacy of EI participants need to be protected. For more information about confidentiality and privacy laws, go to the following websites:

Freedom of Information Act of 1996: https://www.justice.gov/oip/blog/foia-update-freedom-information-act-5-usc-sect-552-amended-public-law-no-104-231-110-stat

Privacy Act of 1974: https://www.justice.gov/opcl/privacy-act-1974

Common Rule of 1991: https://www.hhs.gov/ohrp/policy/ohrpregulations.pdf

Let’s Practice
The following proposal has been submitted to the ATSDR EI Group to determine if an EI should be conducted.

“A community obtains water from private wells, and residents have noticed changes in their water quality. A new factory has been built in the community that manufactures and packages various solvents, and people are concerned that the operations may be impacting water quality in the area. Monitoring wells on the facility have shown solvents and their byproducts in the groundwater. The private wells have not been sampled since the factory started production. The state has requested that ATSDR perform an EI to sample the private wells and fill a data gap at the site.”

Based on criteria needed for an EI, do you think that ATSDR will accept the proposal to perform an EI?

Answer: Based on the EI criteria outlined below, ATSDR’s EI Group will accept the proposal to conduct an EI.

The following are the four EI questions and their respective answers:

1. Can an exposed population be identified?
Yes – the community that is served by the private wells.
2. Does a data gap exist that affects the ability to determine if there is a health hazard?
Yes – private well water quality data are not available since the factory began operations, so it is not known whether contaminants may be in the private wells.
3. Can an EI be designed that will address this data gap?
Yes – the private wells in the area can be sampled.
4. Will the EI results impact the public health decisions for the site?
Yes – the results will allow ATSDR to determine whether there are contaminants in the private well water that may be a health hazard.
Back Next