ML20199E991
| ML20199E991 | |
| Person / Time | |
|---|---|
| Issue date: | 11/14/1997 |
| From: | Shirley Ann Jackson, The Chairman NRC COMMISSION (OCM) |
| To: | Gibbons J PRESIDENT OF U.S. & EXECUTIVE OFFICES |
| References | |
| NUDOCS 9711240063 | |
| Download: ML20199E991 (2) | |
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UNITED STATES g
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CHAMMAN Dr. John H. Gibbons, Director Office of Science and Technology Policy y
l The White House Washington, D.C. 20502 4
Dear Dr. Gibbons:
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The purpose of this letter is to respond to a March 27,1997, meriorandum from President Clinton to agency heads on
- Strengthened Protcdions for Human Subjects of Classified Research." The Presioent requested that each agency head inform thi Director of OSTP each year of the number of classified research projects involving human subiects underway on that date, the number completed in the previous 12-month period, and the number of human subjects in each project.
In accordance with the above public disclosure requirements of the March 27 memorandum, I am reporting that the U.S. Nuclear Rvgulatory Commission (NRC) does not conduct or sponsor classified e 'ch involving human subjects, has not conducted or sponsored such research in the p-
.s 12-month period, and has no plans to do so in the future. Please be i
advised that the NRC has not adopted the Federal Policy for the Protection of Human i
Subjects (" Common Rule") (56 FR 28002-28018) for the reasons stated in the attached June 1
3,1996, letter to Senator Glenn However, the NRC modified its regulations to add section j
10 CFR 35.6 which requires NRC medical licensees to adopt the informed consent and p
Institutional Review Board provisions of the Common Rule. As an example of how we 1
conform our regulatory program to the Common Rule, the NRC mceived a puo;ic comment
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during a recent rulemaking process requesting that the NRC extend its exempt licensing approach, for the disgustic use of 1 microcurie of Carbon-14, to the researcq use of Carbon-14 on human subjects. In response, the Commission stated that the Common Rule does not provide an exemption for research involving minimal risk (including radiological consequences), and therefore, such research use is not exempt from the requirements of 10 CFR 35.6.
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In the future, should the NRC conduct or spensor c'assified research involving human subjects, the NRC will, as requested by the March 27,1997, memorandum, consider adoption of the Common Rule and annually provide the required information by the specified
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9711240063 971114 RES ONDE E PDR cw
2-date. N the scope of the NRC research otherwise changes,'the NRC will, as noted in the June 3,1996, letter to Senator Glenn, reevaluate our practices and regulations related to the Common Rule. We will be pleased to provide any additienalinformation you may need
- regarding this subject.
Sincerely, r
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Enclosure:
As stated i
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j June 3.-1996 CHARMAN '
The Honorable John'Glenn United States Senate Washington, D.C. 20510-6250
Dear Senator Glenn:
I am responding to your letter of April. 11, 1996, in which you asked: several questions regarding how the Nuclear Regulatory Commission protects human tion of research subjects consistent with tha Federal policy for the Protec also known as the Common _ Rule.
Detailed Human Sebjects-(56 FR 28012-28018),
responses to your questions, and the additional questions communicated by your staff by telephone on April 22, 1996, are enclosed.
The NRC staff communicated with Dr. Gary B. Ellis, Director, Office for Protection from Research Risks, U.S. Department of Health and Human Services, on April 3, 1995, and again on April 8, 1996, (copies enclosed) regarding our In practices and regulations related to-the protection of human subje the Federal policy and has established practices and regulations for the protection of human research subjects consistent with the Federal policy.
While the NRC endorses the goals of the Common Rule, the administrative costs associated with formal adoption of the Common Rule are not cost effective for the NRC since we sponsor such a small number of research projects subject to the Federal Policy and, of those, all research, except that conducted at the Halden Research Project in Norway, is conducted by agencies or organizations that have elemants of the Common Rule it place.
Details concerning that question three.
In.idition, any research are described in the response ttmedical use licensees that may rescit from for regulatory burden on
...s adoption of the Common Rule, would not be 'ustified beyond existing NRC Details concerning the applicability and impact tr medical requirements.
licensees, if NRC formally adopted the rule, m described in t'.e response to Nevertheless, if the scope of NRC rese ich :::i.1vities changes, question six.
we will reevaluate our practices and regulations related to the Comon Rule.
The Commission is confident that the current practices and regulations of the NRC protect the safety of human subjects participating in research projects If you have sponsored by the NRC or performed by NRC medical use licensees.
any further questions, please contact me.
Sincerely,
Enclosures:
See'next page
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Enclosures:
Ll.! Responses;toSenator-Glenn's
_ Questions.
~2..; Letter to Dr. Ellis dated.4/3/95
-3.- Letter to Dr. Ellis dated-4/8/96
- 4,.Detai's on Quer'. tons-1. and 2'-
' S... Projects Exen c from the
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. federal-Policy Based on Section 101(b)(2)-
,6.; Projects' Exempt from..the Federal Policy Based on -
- Section.- 101(b)(4)
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- Letter Responses to Specific Questions'in Senator Glenn's April-11.--1996 q
Whatiresearch has the NRC conducted or supported, -ince_1991,.using_
1 This list'should include all medical and non-medical-1.
-human subjects?
research involving _ human subjects.
d Response - The NRC: staff has reviewed the research projects that NRC has Enclosures 4, 5
)
sponsorad since 1991 and has_ listed the 40 projects-in j
and 6. _ lists the eight. projects that would be subject to the provisions of the Federal' policy, including two bilateral foreignEnclosure 5
-research projects as covered by Section 101(h).
25 projects-that are exempt from the Policy under Section 101(b)(2);_
these are interview, survey, or observational-based-research projects.
. ' lists-the seven project, that are also exempt-from the Policy under Section 101(b)(4) because they are based on review of existing data or. documents.
It should be noted that the NRC does not sponsor any research that involves the administration of radiation or radioactive material to human subjects.
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the annual budget, staff For each experiment, pleise provide:
resources', location of experiment, security classification, name of 2.
Institutional Review Board (IRB), if any, which reviewed and approved the experiment,- and any other oversight or compliance procedures designed to protect the research subjects.
Response - Enclosure 4 1 sts the research projects that would be subject to the provisions of the federal policy.
What steps has the NRC taken to ensure that' human subject research, -
funded by the NRC, is in compliance with all elements of the Common Rule 3.
(45 CFR Part 46)?
kutgpie - With regard to NRC-funded research that would be subject to the provisions of the Federal policy, the NRC relies on the organization
_These ne forming the research to protect the human subjects.
organizations are. universities, Department of Energy national 1aboratories, private firms, and an international = jointly; funded The universities, research program (the Halden Reactor Project. [HRP]).
national laboratories, and private firms have human subject research policies which include an IRB, -informed consent, and other -aspects of
-the Common Rule.
- The' HRP_ in Norway is sponsored _by organizations, including NRC, from 19 countries.
A-portion of the research performed under the joint program The HRP has uses-human-subjects in human-system-interface testing.
based its protection of human subjects on Norway's-strict worker safety requirements and the Norwegian. Psychological Association's Ethics To supplement their current practices and to ensure: alignment
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_ Policy.
with the Federal Policy, the HRP staff are currently reviewing
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Brookhaven National' Laboratory's (BNL) Human Subjects Research Policy for possible adoption for the joint program.
BNL?s: policy is consistent
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with the Department of Energy's adoption of the Cormon Rule at 10 CFR Part 745.
NRC occasionally sponsors bilateral research agreements with perform specific studies.as W6669, has been reviewed by BNL's IRB as a m compliance with previsions of the Federal policy.
Further, many of the NRC staff working on these projects, as well as the contractors' principal investigators, are members of the Human Factors and Ergonomics Society and are bound by the Society's Code of Ethics.
This code includes the practice of obtaining informed consent and ensuring the safety of research subjects.
What provisions does the NRC have for enforcement of the Common Rule requirements, and what have been the results of such enforcement?
4.
in research is either through research Response - NRC's involvement contracts or the regulatory oversight of its medical use licensees who conduct research.
For the research contrat.ts listed in Enclosure 4, except for the two HRP projects, all of the research is conducted by organizations or agencies that have elements of the Common Rule in place including use of an IRB As discussed in the response to question 3, the and informed consent.
NRC relies on the performing organization to protect human subjects by Adoption of a policy, conforming to the elements of the Common Rule.similar to BN provisions of the Common Rule.
In regard to medical use licensees, on December 2, 1994, when the NRC amended its medical use regulations (59 FR 61767), a section was added to specifically address research involving human subjects (10 CFR 35.6,T
" Provisions for Research Involving Human Subjects").
10 CFR 35.6 addresses research covered by the Federal policy (Common In either Rule) as well as research not covered by the Federal policy.
case, the regulation regi. ires NRC medical use license the research by an IRB, as the terms are defined and described in the If the research is conducted, funded, supported, or Federal policy.
regulated by a Federal agency that has adopted the Federal policy, the NRC relies on the responsible Federal agency to enforce the provisions If the research is not conducted, funded, of the Common Rule.
policy, the NRC requires a commitment from the prior informed consent from the subjects and prior-appr This commitment by NRC licensees places responsibility on the licensees to ensure that their IRB and informed consent process satisfy policy.
the criteria in the Federal policy.
The NRC does not review or approve The NRC would, however, add a IRBs or the informed consent process.
specific license condition to the license authorizing research, subjectPrior to to the requirements for an IRB and informed consent.
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3 NRC used Policy and Guidance Directives for the review and authorization of '.he use of byproduct material for human subject research at medical Based on these directives, NRC licensees committed to the facilities.
use of a Radiation Safety Committee, a Radioactive Drug Research.
These committees were expected to review and Committee, and an IRB.
approve research involving the administration of byproduct material to humans based on ethical considerations, scientific merit, and radiation Such commitments by the NRC licensees were included as safety.
conditions of the license.
N M inspectors verify that licensees are complying with the license inspections.
To date, condition described above as part of routint.
licensee violations-of NRC requirements for research involving human,
subjects have been rare, if any.
Nevertheless, if significant violations were identified, NRC could take escalated enforcement action and impose a civil penalty.
andorsed the Common Rule
-In your judgement, why has the NRC,-
requirements for human subject researtn, and do you have any plans to do 5.
so in the future?
Response - The NRC supports the goal of the Common Rule to provide for
- Further, the protection of the rights and welfare of human subjects.th At this time, the NRC does not plan to protecting research subjects.
formally adopt the Common Rule for the following reasons:
For medical use licensees, NRC has amended its regulations (35.6) to address research involving human subjects based on the Common A.
However, the NRC's regulatory focus is on the radiation Rule.
safety of the use of the material and not the nature of the research topic.
For research contracts: 1) NRC relies on the performing organization or other agencies to have elements of the Common Rule B.
place; 2) none of the NRC's research involves intrusive
'.1testing; and 3) much of NRC's human subjects related research is With regard to research exempt from the provisions of the policy.
in category 3 (see Enclosure 2), as a matter of long-standing practice, NRC human factors researchers have adhered to the intent of the Common Rule to protect human subjects, based in part on their professional society's ethics code, which includes adherence to the practice of obtaining informed content and ensuring the safety of research subjects.
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4 The.following two_ questions are paraphrasedJfrom your staff's telephone conversation of_ April 22,-1996; if the _ Agency were to adopt' the Common Rule would it apply :to medical-6._
licensees,tand if so, what would be the impact on such: licensees?
Resoonse - Research conducted by NRC medical use-licensees involving humans is_not conducted or supported by the NRC, within the meaning of-the Common Rule, nor is it clear that such research is "otherwise subject to regulation," as-that term is-defined (and examples provided)
Our best judgment is that the Common Rule-does not in the Common Rule.
apply to research conducted by NRC.nedical licensees. "Research otherwise' subject to regulation," must comply with certain provisions of the Common Rule; f.e., those relating to the IRB and informed consent process, and those describing the ruir's applicability and itsThe i definitions.
already apply to research using human subjects, performed by medical licensees, as addressed in the NRC's regulations at 10 CFR 35.6, "Provi: ions for Research involving Human Subjects," pror..ulgated in The regulation addresses research covered by the Common December 1994.
In either case, the regulation Rule as well 'as research not covered.
requires the NRC medical licensee to obtain " informed consent" from the-subjects and prior review and approval by an IRB as the terms are Therefore, as we understand the Common described in the Common Rule.
Rule, there would be no impact on medical-use licensees with regard to the need to obtain " informed consent" from subjects and prior review and approval by-an IRB as provided and described in the Common Rule over that already needed for compliance with 10 CFR 35.6, unless it were determined that research conducted by NRC medical licensees was subject In that case, it appears that medical licensees could be to regulation.
subject to the additional requirements of the Common Rule-set out in Sections 101(d) and 101(e).
Do medical licensees do experiments on human. subjects?
7.
Yes, some NRC medical licensees conduct research involving Response -
The NRC's regulations at 10 CFR 35.6 address the human subjects.
protection of-human subjects involved in research with byproduct radioactive material.
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Gary-8bEllis,Ph.D. Director, Office for Protection from Research Risks lDepartmentjof Health and Human Services-National Institutes of Health' 4100 Executive Boulevard; MSC 7507 Rockville, M 20892-7507:
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Dear Dr. Ellis:
31, 1995, to Chairman Selin?,
I-am responding to:your letter of January Specifically, your letter states regarding-research involving human subjects.
Lwould,be appropriate for the NRC to name a
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ar; for the NRC Subjects Research Subcomittee and to consider the steps necess o
j t " 56 Federal
-to adopt the Federal Policy for the Protection of Human Sub ec s,
. We have. reviewed NRC human subjects research, Reaister 28003'(June 18, 1991)for all-intents and purposes, in compliance with by thei and. conclude that the NRC is,the_ Federal-Policy for Protection b
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17, 1994, President's memorandum dated Februaryin such compliance fo L
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lead to the development of guidance to ensure the s information.
F approach, and involvement.cf human subjects a facilities.
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= National-Laboratories -(Lil23, W6152, W6290, W629,
One is also being;
- to-the Policy through the'00E adoption of the Policy. DOE and National. C
. performed through an agreement with the Two:
cies for compliance.
h S all-
.-(W6381); thus, the NRC has-relied on those agen others are being conducted by private contractors fucJed throu 1
Finally, two.
Business Innovative Research (SBIR) grants (W pursuant to international agreement (W6196, B7488).
o studies are survey / interview efforts and, thus, are exe tsubject the Policy under Section 101(b)(2)'since we< routinely prote Five of the4 E
confidentialityLin all of our' studies. projects (Lil23, W6 m
y' 88). These-1ast-
. remaining five" efforts, three are with a-W6290,.~J6012) and two are with the HRP in Norway-(W6196, two are the only efforts.that are not exempt from the PoOne of thes another agency's adoption of. the Policy.
RC has significant control over
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= performed as a bi-lateral project where the USNThe other 4
?the conduct of the' study. program along.with 14 other countrie 4
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and a technical ste'ering l group.made up of representatives of all the.
I To the:best of our_ knowledge, the HRP does not have a formal policy regarding.the protection of humar. subjects. However,ithey signatoriet.
to Norwegian worker safety requirements and the Norwegian Psycho t of Human Subjects.
This policy Association's Policy on the. Ethical Treatmen does address issues of risk,. confidentiality and' informed consent.
1).the fact that much of NRC's research involving human' ies' adoption of-
.not subject'to-the Policy,-2) NRC's reliance on other agenc Based on:
i lity the Federal Policy,;3) NRC's practice of protecting nv hi olvest
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-intrusive testing, and 5) consideration of the NRC's limite i
to the Human
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- NRC does not, at this time, pian to provide a representat veHowever,_ as brief the Subcommittee at their May meeting on the final-rule " P Subjects-Research Subcommittee.
Transfer for Commercial Distribution, and Use of Byproduct _ Mate 2, 1994); 60 federal Medical.Use," 59 Eederal Reaister 61767 (DecemberThis rule allows, among ot Reatster 322 (January 4,-1995).
j t der certain
-byproduct materials-in research involving human sub ec s un ffice of the Medical, Academic, and Commercial Use Safety Branch of our O
' conditions.
301-415-723. The contact for any 1
Chief of Nuclear Material Safety and Safeguards, at other projects' discussed in this letter is Franklin Coffman, Branc Office of the Control, Instrumentation, and Human factors Branch in the 301-415-5698.
Nuclear Regulatory Research, at Sincerely,
/s/ Eric S. Beckjord Eric S. Beckjord, Director c
Office of Nuclear Regulatory Research
Enclosures:
As stated v
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.ill23 Risk ltoact of New Technologies Project:-
00E Laboratory - Idaho National-Engineering Laboratory Contractor:
To determine tne feasibility of assessing how digital
-technology in instrumentation and control systems in nuclear
Purpose:
power plants affects human actions.and error rates, as we
.as system unavailability and, ultimately, core-damage This frequency for Probablistic Risk Analyses (PRA).
project is primarily intended to improve Human Reliability:
Analyses (HRA) for the assessment of new technologies when they are proposed for nuclear power pl.nt control rooms.
Apply PRA and HRA ;ecta' ques to plant / system designs for hybrid control rooms and.for proposed evolutionary Approach:
passive reactors, plants which have installed digital interface there facilities. Review incident data.
techniques as appropriate.
A sample of operators from a small set of nuclear power plants will be surveyed / interviewed to determine their.
Human Subjects:
experience with digital systems.
Human Subjects Exempt per Sect. 101(b)(2) - Survey / Interview.
Policy Applicability:
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W6297. Performance Fac crs Droject:
00E Laboratory - Brockhaven National t>$ oratory Contractor:
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- !) quantify-nuclear power plant-Develop a method to
organizational performance based upon inform
Purpose:
diagnostic evaluations, accident precursi" snalysis, and i
Systematic _ Assessments of Licensee Perfo r
tools based upon this research to enhance diagnostic evaluation and inspection with respect to organizational safety performance.
The method to develop t..tmates of nuclear power plant organizational performance will be validated by collecting Approach:
data at two nuclear power plants. At each plant, a structured interview format will be used to ask questions behaviorally anchored rating scales for ea be self-administered to approximately 30 employees from operations, maintenance and technical support units.
Supervisors and managers will be included in the data collection. The anonymity of each individual will be preserved.
A sample of nuclear power plant personnel from two plants will be observed performing their normal duties and Human Subjects:
surveyed / interviewed regarding organizational dimensions.
Human Subjects Exempt per Sect. 101(b)(2) - Survey / Interview.
Policy Applicability:
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l W6152 - NPP Shift Staffing Levels l
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00E Laboratcry - Brookhaven National Laboratory I
Contractor:
1 Establish a technical basis for criteria for minimum shD staffing levels of licensed and non-licensed operators at
Purpose:
nuclear power plants, i.e., confirm the adequacy of the requirements of 10 CFR 50.54 (m) c' establish a basis fct modification.
Review documents regarding workload / function allecation for licensed and non-licensed operators; collect data on Approach:
outside-centrol-room tasks through. site visits, workload design and conduct simulator analysis and modeling;l room data collection; experiments for controverify/ validate results from workload a control room and non-control room efforts.
Interviews with managers and licensed and non-licensed sta during the site data collection to determine how functions Human Subjects:
and workload are distributed among plant personnel during In addition to hypothesized of f-normal scenarios.
structured interviews, observe licensed and non-licensed personnel who would normally be involved in event mitiga simulate actions that would be taken if an event w subject licensed and non-licensed personnel to simulated take place.
These activities events on a plant reference simulator.
would be similar to their normal training activities. The data to be collected include time, errors, worxload a event mitigation will be validated against computerized situation awareness.
workload analysis models for the same events.
Human Subjects Policy Reliance on 00E Policy.
Applicability:
Reactars "6195 - Staffing for Advance:
Project:
Halden Reactor Project -
Institutt for Energiteknik(
Contract.r:
Norway ~- Bilateral International Agreement Frovide technical basis for establishing the appropriate staf fing level requirements for advanced control rooms and
Purpose:
reactors, focusing on criteria for evaluating minimum control room crew size, c.ew functions, and effects of instrumentation and control changes for passive reactor designs.
Review vendor submittals for advanced reactors; assimilate composite of advanced ccntrol room into HA Approach:
demands; develop task network simulations; scope simulator and HAMNLAB; analyze em with observed operator performance.
Licensed control room operators from the Loviisa Nuclear Power Plant in Loviisa, Finland, will be the subjects in an Human Subjects:
experimental design that entails simulatin the HAMMLAB/NORS simulator at the Institutt fo Energiteknikk. Halden, Norway.
serve as the test bed for current, conventional emulate proposed advanced control rooms for passive reac rooms.
Data will include time, error rate, workload and Operator performance during event designs.
mitigation across the two simulators wi situation awareness.
the same events.
Human Subjects Reliance en Norwegian worker safety regulations and Policy Applicability:
Norwegian Psychological Association ethics policy, s
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Cndericad in Mocern Nuclear Power P' ant f.on'.ri Projecti W6369 - Wort Rooms-Contractor:
UES,:Inc.
(581R)
To develop a. scoring system-(including software,-instruction manual and intervention manual)' capable of identifying work
Purpose:
underload conditions in advance of occurrence and making intervention suggestions to alleviate problems that might occur; evaluate the system for validity and usability; make necessary changes and refinements to the system in order to make it ready for use in the nuclear power industry.
Develop specifications and prototype interfaces for scoring (1) identify system software that has the capability to:
Approach:
work underload conditions in advance, and (2) make suggestions for interventions to alleviate problees that At a occur as a consequence of such conditions. pa to test the prototype software, Volunteer control room personnel and managers will act as subject matter experts to determine the alertin Htean Subjects:
Th's will be performed through use of a paper and pencti test that lists activities and solicits control rooms.
operators' ratings of the activities' alerting effects.
Those activities that are determined to have face validity promote alertness on sht(t), will be inco The workload for an upcoming shift will The volunteer operators scoring system.
then be predicted from the system.actually working t f
workload at predetermined intervals throughout the shi t.
Results from the workload scoring system will be compared operators' ratings from the actual shif t to determine the predictive validity of the scoring system.
Human Subject Policy Exempt - Survey / interview Applicability:
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Operators n-W63)) - Enhanced Simulator Training'. Program _ for
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. CORE'CORPORAT!0N (SBIR):
- Contractor:
To establish whether or-not links exist between operator d by effectiveness and the simulator training receive
Purpose:
i l tor
-operators;at multi-unit _ stations as compared to s mu a training received at; single-unit _ stations.
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Gather, archiva' data generally indicative of.licensedfrom a sam operator contrc; rocs cperator effectiveness Approach:
- Also, of multi-unit and: single unit _ nuclear; power plants.
gather technical information on the spec
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as well as the number of initial license and a Survey _and interview.
. simulator multi-unit and single-unit sites.
plant personnel on training experience and effectiveness.
h_ licensed Conduct a survey and follow-up interviews Human Subjects:
nd simulator.
.recualification. training program instruc_ tors, a supervisor at the facilities to_ determine their views on simulate,r-training at their facility.
-Human Subjects
' Policy--
Exempt - Survey / Interview Applicability:-
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i W6290 - Advanced Alarm System Review Criteria project:
00E t.aboratory - Brookhaven. National-Laboratorf Contractor:-
-This research is to evaluate the impact of-alarm system design characteristics on plant / system and operator
Purpose:
performance to contribute to the understa j
of design review guidance in these areas.
Three simulator _ experiments are planned:
Approach:
Olsplay Types - This experiment will evaluate' the effects i
-display type on performance Alarm Reduction and Availability - This experiment will which evaluate the effects of alarm processing tech alarm processing results (and their interaction) on performance.
Alarm Generation - This experiment will evaluate the effects of alarm generation on performance.
participants will be volunteer nuclear power plant operators obtained from a pool of available participants at aData Human Subjects:
error, workload, and situation awareness. Test trials will simulator test site.
be similar_to those the crews experience as part of their Operators will remain anonymous, and i-routine training.
only summary statistics will be reported.
Human Subjects Policy Reliance on 00E Policy.
' Applicability:
J601
. Human factors !stae: Associated with Hybrid Human Project:
System Interfaces 00ELaborato,'y-BrookhavenNationalLaporatory Contractor:
To_ develop an understanding of the human fac
Purpose:
human system interfaces and to develop review guidance for such hybrid systems to ensure that the safety of NPP operations is not adversely affected.
Experiments will test various features of nuclear power plant control room human-System interfaces Approach:
A A sample simulator facility will be used as the test bed.
of scenarios will be developed that wculd allow the operators to interact with all aspects of the interfacer in different configurations. Data regarding plant and operator performance will be collected.
Participants will be volunteer nuclear power plant operators obtained from a pool-of available participants at aData to Human Subjects:
simulator test site. error, workload, and situation aw4reness as part of their be similar to those the crews exparienc(Operators will rema routine training.
summary statistics will be reported.
Human Subject Policy Reliance on DOE Policy.
Applicability:
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4 B7483 -_Halden Reac'.or Project:
Project:
OECO International Agreemen; Contractor:'
Institutt for Energ teknikk -
Support an international research program in coopera
Purpose:
with 14 other countries.
behavior of nuclear fuels to the effects of man-machine interfaces on operator performance. The goal-is to enhance the performance and safety _of nuclear power plants.
Various' approaches arr used to test new operator supp Approach:
systems including sime1 testing of prototypes at nucle'ar facilities.
Depending on-the approach selected, nuclear power plant operators in the employ of the institutt or' op Human Subjects:
Data collected include performance evaluation studies. time, errors, workload, situation awareness Operators are working in either simulated or actual environment similar to their normal job situation.
ratings.
Human Subjects Exempt - International Agreement with joint control by Policy representatives of 15 different countries, with both a Applicability:
- Also, policy review board and a technical review c standards of the Norwegian Psychological Association.
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W6381 - Epidemiologic Studies of Radiatton Induceo infrai:
_ Project:-
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-ContPactori 00E 1
1To provide' financial assistance to the 00E'to dev. lop and-e implement a long-term epidemiological study 1to assess the
Purpose:
risk of thyroid disease among persons, particularly
-children, who were exposed to lodine radioisotcpes duringThe N and following the Chernobyl accident. Institute (NCl)
Implement a research prntocol, approved by DOE and the Ministry of Health of **1arus,-to obtain the necessary data.
Approachi NCI will-serve as the principal for the V.S..for theThe NRC's' implementation of the prctocol.
financial.
Epidemiologic data will be coll?cted and analyzed.in accordance with the approved protocol.
Human Subjects:
Human Subjects Policy Reliance on 00E and NCI.
Applicability:
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-April-8./1996-
- Gary 8.;Ellis, Ph.0L Otrector Office for Protection-from Research Risks National Institutes of Health-6100 Executive Boulevard _MSC 7507
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-. Rockville, MD 20092-75M'
Dear Dr.- Ellis:
Thank you for your letter of December 6,1995, regarding Executi and the~ rubmission of a report to the National Bloethics Advisory C The NRCisupports the goal of the Executive Order to provide for the of the rights and welfare of. human subjects. practices and NRC's involvement in research is either through research contracts or regulatory oversight 'of its medical use licensees who conduct.res In regard to NRC research contracts, as a matter of long-standing
'NRC human factors researchers have adhered to the in The human _ factors psychologists who perform i
of obtaining informed consent and assuring the Order to' protect human subjects.
The NRC staff identified ten active research projects: involving hu in Mr.. Beckjord's April 3.1995, letter to you. Six of these projects are Two covered by the Department of Energy's adoption of the Federal Policy.
projects are being performed under international agreement and subject to the performing country's worker safety requirements _and f
d consent, The two
_ professional association policy, which includes in orme Lother projects are notisubject to the Federal Policy because the 4
as survey / interview efforts.
In regard to medical use licensees, on Decem address research. involving human subjects (10 CFR 35.6. ' Prov Research involving Human tubjects").However, the NRC's regulatory focus is on research using_bypicdect material.
the radiation safety of the use of the material, not.the nature cf the The regulation in 10 CFR 35.6 addresses research cove In the Federal Policy;as well as research not covered by the Federal P research topic.
either case,-the regulation requires NRC medica
.research by an "lastitutional Review Board" (IRB) as
.describedtin_the Federal = Policy.
c e
m 2
G. Ellis If the research is ccnducted, funded, supportet, or regulated by a Fede agency that has adopted the Federal Policy,lf are of research sabjects.
Federal agency to protect the rights and we If the research is not conducted, funded, supported, or regulated
/
from agency that has adopted the Federal Policy, the NRC requires a co the medical use Itcensee for prior infomed consent from the subjects described prior approval of-the research activities by an IR8, as defined or Acceptance of this coenitaent by MC licensees places t
responsibility on licensees to ensure th!,t their IRS and infomed consen in the Federal PoltQ.
process satisfy the criteria in the Federal policy because tha NRC Therefore,-
does not review or approve IR8s:or the informed consent process.
if the research is not covered by the Fedetal policy, the NRC would a h
specific license condition to the license authorizing research, s requirements for an IRS and infomed consent.
f is not bound by the Even though the NRC, as an independent regulatory agency, RC firmly believes Executive Order and will not be subeltting a report, the N Further, the in the protection of the rights and welfare of human subjects.
ide NRC believes that its aforementioned practices and regulations prov I
protection to human subjects.
or believe it is necessary for the NRC to take a s
t f f who to protect human subjects, please contact me or the aesbers of my s licensees.
are responsible for the aforementioned contracts and medical use t
Mr. Frank Coffman has responsibilities regarding the aforementio Mr. L.arry Casper has responsibilities 301-415-5698.
301-415-7231.
and can be reached atregarding medical use licensees and can be reached
}
Sincerely, 1
asast&
James M. Taylor Executive Director for Operations
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Y Details sn Questions.1 and 2 Tale' Centractor Term of S uurity Total Staff 14caanseser Nesne of Contract.
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$ I 14 ent o i ril.3r Imenute for Cr.aJun ICr lascentsemat Resac=
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Ph>wlogy June 1992 R.4aten.
I 19N An i saluaison os a Computerued North Carolma state hme 1991 -
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Wurm Cw adia:. I eghtmg for the NRC Shittacrk Systesm. In.
Center June 1995 lleadquarter Operstiom Cen er s
liakien Reastor Projest Januars 1994 -
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$ 195'#Mr
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A% atum I the Resguercin.:st Prevest ItalJcn Resstor Project May 1996 l'alasufkJ
. $ 454.tunt a2511E r Itah Man.Mahme '
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IN DL and Natamal Casser -
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and Natamal Cancer Segdember 1996 Induud ~1hwul Ihacase
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Projects Exemptz from the Federal Policy BasedonSection_101(b)(2)f
-Research in'volving.the use of educational tests (cognitive, diagnostic,
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-aptitude,; achievement),-survey-procodures, interview procedures or observation Lof public behavior:
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_ f.lB TITLE Supervisory / Management factors in performance indicators.
A3956.
-A3972 Control room instrumentation ---Annunciators Control room-team-performance B2933-LStaffing composition at nuclear power plants
!85696-Human performance investigation protocol
~B5876' Organizational factors in risk assessment (UCLA)
- B5878 s Organizational factors in risk assessment (APG)
B5984" Gll26 Risk assessment anchor values-1 J6012
' Hybrid control stations Human factors evaluation of remote af terloadina brachytherapy
'Lill6-Risk impact of new technology Lll23 Non-nuclear performance indicators for nuclear safety Lil84 Training effectiveness evaluatten workshop L1232 Advanced control room design review guidelines-L1317-Organizational factors in risk assessment (PSU)
L1322.
Cognitive modeling L1505 Human factors evaluation of industrial radiography L153)
Human factors evaluation of teletherapy L1532 a
Work underload in control rooms W6126 Nuclear power plant shift staffing levels W6152 W6297 Organizational performance factors Enhanced simulator training W6311'
~ Work underload in' modern.nucleai power plants
~W6369
' Advanced-digital man-machine interface analysis
-W6471 Improvements-to' root cause investigation methods W6528 o
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T Projects Exempt from-the Federal Policy Based on Section 101(b)(4)
Research involving the collection or study of existing' data, documents, records, pathological-specimens, or_ diagnostic specimens, if these data 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 sut;ects:
i EIN TITLE Procedures violations B2866 Shift scheduling and overtime at nuclear power plants B2926 B5808 Critical safety related operator actions Technical basis for communications review guidelines
' J6020 Use of requalification data for risk assessment Lil20 Lil85 Organization and Management performance indicators Ll653 Severe accident management training l
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