HSRB Letter

Revised 06/21/2012

NIOSH Research/Non-Research Determination Form
This form can be used by the Division, Laboratory, or Office leadership (Director, Deputy Director, and Associate
Director for Science) or the NIOSH IRB Office. Conduct of Human subjects research requires IRB review as defined in
HHS 45-CFR-46. Conduct of Human Subjects Non-Research does not require IRB review.
Include with this form a description or protocol and, if necessary, a brief justification for the proposed categories.
Project Title: World
Project Officer(s):

Trade Center Health Program Enrollment, Appeals & Reimbursement

Laurie Breyer

Proposed Project Dates: Start:

11/20/2014

End:

Activity NEW:

OR Existing:

Signatory Should Check Appropriate Categories (D/L/O or NIOSH IRB)

I Activity is RESEARCH if both the following apply:
A Activity is a systematic investigation, including systematic collection of data, and
B Activity is designed to develop or contribute to generalizable knowledge.

II. Activity is NON-RESEARCH that does not contribute to generalizable knowledge because the primary intent is either:
A
B
C
D
E

Emergency Response to identify, characterize, and solve an imminent health issue; or
Surveillance that is a routine ongoing collection of data for disease or injury control; or policy purposes; or
Public Health Program that serves to educate, monitor, support, market, register, demonstrate, manage; or
Program Evaluation for measuring or monitoring the efficacy, implementation, or utility of an established activity; or
Laboratory proficiency testing.

III. Activity INVOLVES HUMAN SUBJECTS if information collected about a living individual is either:
A Identifiable private information; or
B Is collected through intervention or interaction with the individual.

IV. Activity DOES NOT INVOLVE HUMAN SUBJECTS if activity is either:
A
B
C
D

Collection or analysis of data about groups or organizations, not about persons; or
Data or specimens from deceased (only) persons; or
Anonymous (no links) data or specimens collected for another purpose; nothing collected for present purpose; or
Data collected for another purpose is not anonymous but personal identifiable information is protected through a data use agreement
(CDC 0.1375B) prohibiting the release of the key to CDC investigators under any circumstances.

V. Activity is Human Subjects Research but CDC/NIOSH is not ENGAGED (not requiring IRB review) if all the following apply:
A
B
C
D

NIOSH/CDC employees (FTE/Contractor) will not have contact (interact or intervene) with human subjects; and
NIOSH/CDC employees will not obtain or access personal identifiable information (no links or CDC 0.1375B); and
NIOSH/CDC employee involvement is limited to technical assistance or manuscript writing and no current CDC funding.
Collaborative Institutions must have IRB Review documentation and a valid Federalwide Assurance (FWA);
Institution name
, FWA#

RECOMMENDATION/DETERMINATION:
Activity DOES require IRB Review.
OR

Activity DOES NOT require IRB Review.

APPROVING OFFICIAL TITLE: NIOSH IRB (HSRB) Chair

NIOSH IRB No. HSRB 14-OD-NR03

NAME: Mark A. Toraason, Ph.D., NIOSH IRB Chair
DATE11/20/2014

If IRB (HSRB) Review is required, suggested review is:

Full Board Review

Expedited Review

Exempt Review

Comments/Rationale for Determination (attach additional comments):

Program to support health monitoring and treatment for emergency responders; recovery and cleanup workers in
New York City, the Pentagon and Shanksville, PA; and residents, building occupants, and area workers in New
York City who were directly impacted and adversely affected by the terrorist attacks of September 11, 2001

CDC/NIOSH IRB Registration #: 00000186

CDC FWA#: 00001413

1

Revised 06/21/2012
NOTE: IF THIS ACTIVITY IS DETERMINED THAT CDC NIOSH IRB (HSRB) IS NOT REQUIRED.
Although CDC IRB review is not required for projects approved under this determination, CDC investigators and project officers are expected to adhere to the
highest ethical standards of conduct and to respect and protect to the extent possible the privacy, confidentiality, and autonomy of participants. All applicable
Country, State, and Federal privacy laws must be followed.
Although this project may not constitute “research” involving human subjects, informed consent may be appropriate. Information conveyed in an informed
consent process should address all applicable required elements of informed consent.

ADDITIONAL INFORMATION:
1. Activities may be research or non-research depending on the circumstances. Please see “CDC Guidelines for Distinguishing Public
Health Research and Public Health Non-Research” http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-healthresearch-nonresearch.pdf.
2. Laboratory proficiency testing; Information gathering activity involving human subjects that does not meet the HHS definition of research
(which is a systematic investigation designed to develop or contribute to generalizable knowledge). Information gathered must not be about
persons; risks must be minimal; informed consent and supervisory approval are required.
3. DHHS regulations allow for "expedited" review of certain types of research which involves minimal risk and meets certain criteria. See:

http://inside.niosh.cdc.gov/hsrb/ExpeditedReview.html
4. Research seeking “exempted” status requires submission of appropriate forms and protocol for review by NIOSH IRB and CDC HRPO.
See: http://inside.niosh.cdc.gov/hsrb/ExemptReview.html
Definitions/Links
HHS OHRP defines research as a systematic investigation, including research development, testing and evaluation, designed to develop
or contribute to generalizable knowledge. Activities which meet this definition constitute research, whether or not these activities are
conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service
programs may include research activities. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102(e)
OHRP defines a human subject as a living individual about whom an investigator (whether professional or student) conducting research
obtains:
(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture), and manipulations of the subject
or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact
between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by
an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information
must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the
information) in order for obtaining the information to constitute research involving human subjects. HHS OHRP human subjects regulations
link: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html
HHS OHRP considers that an institution becomes "engaged" in human subjects research when its employees or agents intervene or
interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes. An
institution is automatically considered to be "engaged" in human subjects research whenever it receives a direct HHS award to support
such research. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.
http://www.hhs.gov/ohrp/policy/engage08.html. Agents include all individuals performing institutionally designated activities or exercising
institutionally delegated authority or responsibility, e.g., contractors.
CDC defines surveillance as “the ongoing, systematic collection, analysis, and interpretation of health data essential to the planning,
implementation, and evaluation of public health practice, closely integrated with the timely dissemination of these data to those who need to
know. The final link of the surveillance chain is the application of these data to prevention and control. A surveillance system includes a
functional capacity for data collection, analysis, and dissemination linked to public health programs.” (CDC 1986)
Program evaluation is the systematic collection of information about the activities, characteristics, and outcomes of programs to make
judgments about the program, improve program effectiveness, and/or inform decisions about future program development. Program
evaluation should not be confused with treatment efficacy which measures how well a treatment achieves its goals which can be
considered as research. CDC guidance on research/non-research: http://www.cdc.gov/od/science/integrity/docs/cdc-policydistinguishing-public-health-research-nonresearch.pdf

CDC/NIOSH IRB Registration #: 00000186

CDC FWA#: 00001413

2