ML20199E991

Responds to 970327 Memo from President Clinton to Agency Heads on, Strengthened Protections for Human Subjs of Classified Research

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)

Text

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. g UNITED STATES NUCt. EAR REGULATORY COMMISSION f g WAsHlh0 ton, D.C kJ888-4001 g g

% Novenber 14, 1997 I

CHAMMAN Dr. John H. Gibbons, Director y

Office of Science and Technology Policy -

The White House l 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 1

Subjects (" Common Rule") (56 FR 28002-28018) for the reasons stated in the attached June 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.

In the future, should the NRC conduct or spensor c'assified research involving human

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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 , , ,

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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

.s.

bfh Shirley Ann Jackson

Enclosure:

As stated i

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- UNITED STATFS--

NUCLEAR RE2ULATORY COMMISSION

._ [ j WASHmoToN, o.C. 20 % 0001 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 protectstion human of research subjects consistent with tha Federal policy for the Protec Detailed Human Sebjects-(56 FR 28012-28018), also known as the Common _ Rule.

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) regardingInour 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 Details or organizations concerning that that have elemants of the Common Rule it place. In .idition, any question three.

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 requirements. Details concerning the applicability and impact tr medical m described in t'.e response to licensees, if NRC formally adopted the rule, question six. Nevertheless, if the scope of NRC rese ich :::i.1vities changes, 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,

& :s Shirley Ann Jackson

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

. federal-Policy Based on ', 'I 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

1. Whatiresearch has the NRC conducted or supported, -ince_1991,.using_ 1

-human subjects? This list'should include all medical and non-medical- l research involving _ human subjects. d l

Response - The NRC: staff has reviewed the research projects Enclosures that NRC4, 5has )

sponsorad since 1991 and has_ listed the 40 projects-in j and 6. Enclosure 4_ lists the eight. projects that would be subject to l 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.

Enclosure 6' 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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For each experiment, pleise provide: the annual budget, staff 2.

resources', location of experiment, security classification, name of 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.

3. 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 (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 ne forming the research to protect the human subjects. _These organizations are. universities, Department of Energy national 1aboratories, private firms, and an international = jointly; Thefunded 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

_ Policy. To supplement their current practices and to ensure: alignment

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with the Federal Policy, the HRP staff are currently reviewing Brookhaven National' Laboratory's (BNL) Human Subjects Research Policy BNL?s: policy is consistent for possible adoption for the joint program.

Enclosure-1

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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.

4. What provisions does the NRC have for enforcement of the Common Rule requirements, and what have been the results of such enforcement?

Response - NRC's involvement in research is either through research 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 Adoptionhuman subjects by 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 In(Common either Rule) as well as research not covered by the Federal policy.

case, the regulation regi. ires NRC medical use licensee the research by an IRB, as the terms are defined and described in the Federal policy. If the research is conducted, funded, supported, or 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 policy. This commitment by NRC licensees places responsibility on the licensees to ensure that their IRB and informed consent process satisfy The NRC does not review or approve the criteria in the Federal policy. 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 facilities. Based on these directives, NRC licensees committed to the use of a Radiation Safety Committee, a Radioactive Drug Research.

Committee, and an IRB. These committees were expected to review and approve research involving the administration of byproduct material to humans based on ethical considerations, scientific merit, and radiation safety. Such commitments by the NRC licensees were included as conditions of the license.

N M inspectors verify that licensees are complying with theTo license date, condition described above as part of routint. inspections.

licensee violations- of NRC requirements for research involving human ,

Nevertheless, if significant subjects have been rare, if any.

violations were identified, NRC could take escalated enforcement action and impose a civil penalty.

-In your judgement, why has the NRC ,- andorsed the Common Rule 5.

requirements for human subject researtn, and do you have any plans to do so in the future?

Response - The NRC supports the goal of the Common Rule Further, to provide for 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:

A.

For medical use licensees, NRC has amended its regulations (35.6) to address research involving human subjects based on the Common Rule. However, the NRC's regulatory focus is on the radiation safety of the use of the material and not the nature of the research topic.

B.

For research contracts: 1) NRC relies on the performing organization or other agencies to have elements of the Common Rule

' .1 place; 2) none of the NRC's research involves intrusive testing; and 3) much of NRC's human subjects With related regardresearch is 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; 6 ._

if the _ Agency were to adopt' the Common Rule would it apply :to medical-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, definitions.

and those describing the ruir's applicability and itsThe i 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 December 1994.

The regulation addresses research covered by the Common 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 to regulation. In that case, it appears that medical licensees could be subject to the additional requirements of the Common Rule-set out in Sections 101(d) and 101(e).

7. Do medical licensees do experiments on human. subjects?

Response - Yes, some NRC medical licensees conduct research involving human subjects. The NRC's regulations at 10 CFR 35.6 address the protection of-human subjects involved in research with byproduct radioactive material.

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UNITED STATES

[:i c  ; NUCLEAR REGULATORY COMMISSION - d y*1 jL

• " moto";oci m o*C j .

..... 6 1 k 1995- f

^fC g 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:

?,.

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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o ar; for the NRC Subjects Research Subcomittee and to consider the steps necess j t " 56 Federal

-to adopt the Federal Policy . We have.for the Protection reviewed NRC human of Human subjects Subresearch, ec s, b Reaister 28003'(June 18, 1991)for all-intents and purposes, in compliance with by thei i and. conclude that the NRC17,is,the_ 1994, Federal-Policy for iProtection L

, President's memorandum dated Februaryin suchi compliance from fo^

H i We are currently funding 10 projects that involv 7

F lead to the development of guidance toinformation. ensure the s facilities. E) approach, and involvement.cf One human subjects ar 7

= National- Laboratories -(Lil23, W6152, W6290, W629 ,

is also being;

to-the Policy through the'00E adoption of the Policy. DOETwo: and National. C

. performed through an agreement with the cies for compliance.h S all-

.-(W6381); thus, the NRC has-relied on those agen Finally, two.fucJed throu 1 others are being conducted by private contractors pursuant o

Business Innovative Research (SBIR) grants (W to international agreement (W6196, B7488).

% studies are survey / interview efforts and, thus, are exe tsubject E Five of the4 ,

m the Policy under Section 101(b)(2)'since we< routinely prote y'

confidentialityLin all of our' studies. projects 88). These-1ast-(Lil23, W6 '

. 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

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F another agency's adoption of. the Policy. RC has significant control over 4

= performed as a bi-lateral project where the USNThe other 4 + ?the conduct of the' study. program along.with 14 other countrie g

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and a technical ste'ering l group.made up of representatives of all the. _

To the:best of our_ knowledge, the HRP does not have a formal signatoriet. -

policy regarding .the protection of humar. subjects. However,ithey to Norwegian worker safety requirements and the Norwegian Psycho This policy t of Human Subjects.

Association's Policy on the . Ethical Treatmen does address issues of risk,. confidentiality and' informed consent. -

Based on:

1).the fact that much of NRC's research ies' adoptioninvolving i lity of- human'

.not subject'to-the Policy,-2) NRC's reliance on other agenc hi olvest nv the Federal Policy,;3) NRC's practice ofthe.protecting

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d resources,

-intrusive testing, and 5) consideration of the NRC's i limite to the Human )

NRC does not, at this time, pian to provide a representat veHowever,_ as

• Subjects-Research Subcommittee.

brief the Subcommittee at their May meeting on the final- rule " P Transfer for Commercial Distribution,2,and 1994); Use of Byproduct _ Mate 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 ffice of sub ec s un

' the conditions.

Medical, Academic, and Commercial 301-415-723 1Use

. TheSafety contact for Branch any of our O Nuclear Material Safety and Safeguards, at Chief of other projects' discussed in this letter is Franklin OfficeCoffman, of Branc

" the Control, Instrumentation, and Human factors Branch in the 301-415-5698.

Nuclear Regulatory Research, at Sincerely,

/s/ Eric S. Beckjord c Eric S. Beckjord, Director Office of Nuclear Regulatory Research

Enclosures:

As stated v .

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Risk ltoact of New Technologies Project:- .ill23 00E Laboratory - Idaho National- Engineering Laboratory Contractor:

To determine tne feasibility of assessing how digital

Purpose:

-technology in instrumentation and control systems in nuclear 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.

Approach:

Apply PRA and HRA ;ecta' ques to plant / system designs for hybrid control rooms and.for proposed evolutionary passive reactors, plants which have installed digital interface there facilities. Review incident data.

techniques as appropriate.

Human Subjects:

A sample of operators from a small set of nuclear power plants will be surveyed / interviewed to determine their.

experience with digital systems.

Human Subjects Policy Exempt per Sect. 101(b)(2) - Survey / Interview.

Applicability:

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Droject: W6297 . Performance Fac crs 00E Laboratory - Brockhaven National t>$ oratory Contractor:

Develop a method to: ;!) quantify-nuclear power plant-

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Purpose:

organizational performance i based upon inform diagnostic evaluations, accident precursi" r snalysis, and Systematic _ Assessments of Licensee Perfo 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 Approach: organizational performance will be validated by collecting data at two nuclear power plants. At each plant, a structured interview format will be used to ask questions behaviorally anchored rating scales for eac 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 Human Subjects: will be observed performing their normal duties and surveyed / interviewed regarding organizational dimensions.

Human Subjects Policy Exempt per Sect. 101(b)(2) - Survey / Interview.

Applicability:

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l l W6152 - NPP Shift Staffing Levels l Project: l 00E Laboratcry - Brookhaven National Laboratory ,

I Contractor: 1

Purpose:

Establish a technical basis for criteria for minimum shD staffing levels of licensed and non-licensed operators at 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 Approach: licensed and non-licensed operators; collect data on 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.

Human Subjects:

Interviews with managers and licensed and non-licensed sta during the site data collection to determine how functions and workload are distributed among plant personnel In addition to during hypothesized of f-normal scenarios.

structured interviews, observe licensed and non-licensed personnel who would normally be involved in event mitiga simulate take place.

actions that would be taken if an event w subject licensed and non-licensed personnel These activitiesto simulated events on a plant reference simulator.

would be similar to their normal training activities. The data to be collected include time, errors, worxload a situation awareness.

event mitigation will be validated against computerized workload analysis models for the same events.

Human Subjects Policy Reliance on 00E Policy.

Applicability:

"6195 - Staffing for Advance: Reactars Project:

Halden Reactor Project -

Institutt for Energiteknik(

Contract.r: Norway ~- Bilateral International Agreement Frovide technical basis for establishing the appropriate

Purpose:

staf fing level requirements for advanced control rooms and 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 Approach:

composite of advanced ccntrol room into HA demands; develop task network simulations; scope simulator and HAMNLAB; analyze em with observed operator performance.

Licensed control room operators from the Loviisa Nuclear Human Subjects: Power Plant in Loviisa, Finland, will be the subjects in an experimental design that entails simulatin the HAMMLAB/NORS simulator at the Institutt fo Energiteknikk. Halden, Norway.

serve rooms.

as the test bed for current, conventional emulate proposed advanced control rooms for passive reac designs.

Data will include time, error rate, workload and Operator performance during event situation awareness.

mitigation across the two simulators wil the same events.

Human Subjects Policy Reliance en Norwegian worker safety regulations and Applicability: Norwegian Psychological Association ethics policy, s

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Projecti W6369 - Wort Cndericad in Mocern Nuclear Power P' ant f.on'.ri Rooms-Contractor: UES,:Inc. (581R)

To develop a. scoring system-(including software,-instruction

Purpose:

manual and intervention manual)' capable of identifying work 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 Approach:

system software that has the capability to:

work underload conditions in advance, and (2) make suggestions for interventions to alleviate At aproblees that occur as a consequence of such conditions. pa to test the prototype software, Volunteer control room personnel and managers will act as Htean Subjects:

subject matter experts to determine the alertin Th's will be performed through use of a control rooms.

paper and pencti test that lists activities and solicits operators' ratings of the activities' alerting effects.

Those activities that are determined to have face validity promote alertness on sht(t), will be incor The workload for an upcoming shift will scoring system. The volunteer operators then be predicted from the system.actually f working th 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 _

Projecti

-l M Multi-Unit 3 1 ants '

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- Contractor: . CORE'CORPORAT!0N (SBIR):

To establish whether or- not links exist between d by operator

Purpose:

. effectiveness and the simulator training receive 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 Approach: operator contrc; rocs cperator effectiveness Also, of multi-unit and: single unit _ nuclear; power plants.

gather technical information on the spec ~

as well as the numberSurvey

. simulator of initial

_and interview.

license and an multi-unit and single-unit sites.

plant personnel on training experience and effectiveness.

h_ licensed Human Subjects: Conduct a survey and follow-up nd simulator. interviews .

.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:

l 00E t.aboratory - Brookhaven. National-Laboratorf  !

Contractor:-

-This research is to evaluate the impact of-alarm system

Purpose:

design characteristics on plant / system and operator performance to contribute to the understal .

j of design review guidance in these areas.

l 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 which will evaluate the effects of alarm processing techn 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 Human Subjects:

obtained from a pool of available participants at aData simulator test site. and situation awareness. Test trials will error, workload, i- be similar_to those the crews experience as part of their routine training. Operators will remain anonymous, and 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:

Purpose:

To_ develop an understanding of the human fac human system interfaces and to develop review guidance for such hybrid systems to ensure that the safety of NPP operations is not adversely affected.

Approach:

Experiments will test various features of nuclear power plant control room human-System A sampleinterfaces A

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 Human Subjects:

obtained from a pool- of available participants at aData to simulator test site. error, workload,asand partsituation of their aw4reness 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 -

Purpose:

Support an international research program in coopera 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.

Approach: Various' approaches arr used to test new operator supp systems including sime1 testing of prototypes at nucle'ar facilities.

Human Subjects: Depending on-the approach selected, nuclear power plant operators in the employ of the institutt or' op Data collected include performance evaluation studies. time, errors, workload, situation awareness ratings. Operators are working in either simulated or actual environment similar to their normal job situation.

Human Subjects Policy Exempt - International Agreement with joint control by Applicability: representatives of 15 different countries, with both Also, a

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:- j Oisease !

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-ContPactori 00E 1 e

Purpose:

1To provide' financial assistance to the 00E'to dev. lop and-implement a long-term epidemiological study 1to assess the risk of thyroid disease among persons, particularly

-children, who were exposed to lodine radioisotcpes duringThe N and following the Chernobyl accident. Institute (NCl)

Approachi Implement a research prntocol, approved by DOE and the ,

Ministry of Health of **1arus,-to obtain the necessary data.

NCI will- serve as the principal for the V.S. .for theThe NRC's' r implementation of the prctocol.

financial.

Human Subjects:

Epidemiologic data will be coll?cted and analyzed.in accordance with the approved protocol.

Human Subjects Policy Applicability: Reliance on 00E and NCI.

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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

. 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 Co 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 Order to' protect human subjects.

The human _ factors have psychologists adhered i to the in who perform of obtaining informed consent and assuring the The NRC staff identified ten active research projects: involving hu in Mr.. Beckjord's April 3.1995, letter to you. Six of these Twoprojects are 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 f dsafety consent, requirements The two _and

_ professional association policy, which includes in orme 4

Lother projects are notisubject to the Federal Policy because the

' 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 The of the use regulation in of 10 the CFR material, 35.6 not.the nature addresses research In cf the cover research topic.

the Federal Policy;as well as research not covered by the Federal P either case,-the regulation requires NRC medica _

.research by an "lastitutional Review Board" (IRB) as

.describedtin_the Federal = Policy.

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Enclosure 3 .

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, from or regulated '

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 Acceptance activities of this by an coenitaent IR8,licensees by MC ast defined or places in the Federal PoltQ responsibility on. licensees to ensure th!,t their IRS and infomed consen process satisfy the criteria in the Federal policyTherefore,- because tha NRC does not review or approve IR8s:or the informed consent process.  :

if the research is not covered by the Fedetal policy, the h NRC would a>

specific license condition to the license authorizing research, s ,

requirements for an IRS and infomed consent. is not bound by the f Even though the NRC, as an independent regulatory agency, RC Further, thefirmly believes Executive Order and will not be subeltting a report, theideN in the protection of the rights and welfare of human subjects.

NRC believes that its aforementioned practices and regulations prov I protection to human subjects.

s or believe it is necessary for thelicensees. tNRC to take a f f who to protect human subjects, please contact me or the aesbers of my s are responsible for the aforementioned contracts and medical t use Mr. Frank Coffman has responsibilities Mr. L.arry Casper has regarding responsibilities the aforementio  ;

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 -

Staff 14caanseser Nesne of Term of S uurity Total - - - - -

• Tale' Centractor IIN Contract . Oassdiatum IbJgd ' Racerces E v eunen:

I

Peview Board 4'ne.cruey of Ilhnen and ~ I herary 4 Ilknem -'

April 1990. Jurv i nela*utkJ S 216.orm o

• iTI'at -

Cniserury of frimon, at tiraml=eoJ Nuskar Poma - n-tauemmat Renew Iberd j 582%7 A Pertorman.e Indmator of the . 199_t Cthana-Clumpaigsi Trammg f~assim I statsveness of Iluman-Machee i

interta.c. for Nnlear Power fianta ICr lascentsemat Resac=

t *mlasutkJ $ I 14 ent o i ril.3r Imenute for Cr.aJun imista't for CreaJe Aprit l'no . lbard -

I. i 449 A1.-rtn< - .m it u 12 liest Stutt June 1992 l b w W .Ik=t. 1 R.4aten. Ph>wlogy .

o a rttar North Carotui. state 1 nn auts NCst t Censa.m.c c die :

hme 1991 - 1 miautkJ 5 179inne Prosestam vi the Rights of An i saluaison os a Computerued North Carolma state I 19N %Ticmher 1995 I'rm eruty liuman sul.pw twedure ss-tem Arg.a.;a Nau. mal I ab..re.n . t SC lmtenemmal Res-iew Cn veruty or southern september 1991 - t 'nsis,*itkJ 5 inwimwt eto$ fit 3r 1 Intentate..n og Wwkstatum. Joh. and EBR2 Rewarsh Reat.. ' Ik.ard .

• Qat2 Aangust 1994 team strwture un the Control Room Cat finna t.. I nhan e Rehab ists sh.ttw ek sa=

0 2 IW4r NRC licra r--tas e spa w Shittacrk Systesm. In . %Ticmber lY93 - t mia-uskJ $ M9 0cws lmtreatmetal Reucw Ileard - .

. Wurm Cw adia:. I eghtmg for the NRC Center June 1995 lleadquarter Operstiom Cen ser f ema Traming Centa. Nec. I enmJi and Januars 1994 - I mie efi-J $ 195'#Mr #3 1 II yr liakien Reastor Projest Fmfand and llah Stan. Na<gsan brLer W r.1% sealting f.w Aharwed Rea i.ws thember 1996 Mashme i Awas n. Neway Free two Iaus anJ.-

N rmegnan 1%lm lossa! -

A% atum I the Resguercin.:st Prevest Itah Man.Mahme ' ' Innw.LhaEen Naammet May 1996 l'alasufkJ . $ 454.tunt a2511E3r l atwed. es. Norwegun ItalJcn Resstor Project I ahoraten. %wmas f f WN49 Alsm sutems Resear.h I Ma) 1997 w,t, rremt r-

f and %.rwegian -

I%yJ ologkat Amutam 1 the Regenements

$1Jan> Jap) 0 3 ITEyr Hetarus and t'Liaine. IN DL and Natamal Casser -

September 1994 - 4'n ta uf eed Department of Encegy Imtdute . -

%Mxt . IpedemioL4 studies of Radiatum Segdember 1996 and Natamal Cancer '9 Induud ~1hwul Ihacase Institute filClosurV 41

J

+ g Projects Exemptz ,

from the Federal Policy BasedonSection_101(b)(2)f

-Research in'volving.the use of educational tests (cognitive, diagnostic,

~

-aptitude,; achievement),-survey-procodures, interview procedures or observation ,

g Lof public behavior:

_ f.lB TITLE A3956. Supervisory / Management factors in performance indicators.

-A3972 Control room instrumentation ---Annunciators B2933- Control room-team-performance -'

!85696- LStaffing composition at nuclear power plants

~B5876' Human performance investigation protocol

B5878 s Organizational factors in risk assessment (UCLA)

B5984" Organizational factors in risk assessment (APG)

Gll26 Risk assessment anchor values- 1 J6012 ' Hybrid control stations

'Lill6- Human factors evaluation of remote af terloadina brachytherapy Lll23 Risk impact of new technology Lil84 Non-nuclear performance indicators for nuclear safety L1232 Training effectiveness evaluatten workshop L1317-Advanced control room design review guidelines-L1322. Organizational factors in risk assessment (PSU)

L1505 Cognitive modeling -

L153) >

Human factors evaluation of industrial radiography L1532 Human factors evaluation of teletherapy a

'- W6126 Work underload in control rooms W6152 Nuclear power plant shift staffing levels W6297 Organizational performance factors W6311' Enhanced simulator training _ _

~W6369

~ Work underload in' modern .nucleai power plants

-W6471

' Advanced-digital man-machine interface analysis W6528 Improvements-to' root cause investigation methods o

9 Enclosure 5

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 B2866 Procedures violations B2926 Shift scheduling and overtime at nuclear power plants B5808 Critical safety related operator actions

' J6020 Technical basis for communications review guidelines Lil20 Use of requalification data for risk assessment Lil85 Organization and Management performance indicators Ll653 Severe accident management training l

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. Enclosure 6

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