Johns Hopkins Gazette: November 28, 1994


University Policy on Human Research Subjects

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Human Subjects Review Board

     The following is the Assurance of Compliance M1091 with HHS
Regulations for the Protection of Human Research Subjects as
presented by The Johns Hopkins University Homewood Board on the
Use of Human Subjects to the Department of Health and Human
Services and approved by DHHS effective Dec. 1, 1993. This
assurance requires that all relevant communications be published
at least annually in the Gazette.
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Assurance of Compliance with HHS Regulations for the Protection
of Human Research Subjects

     The faculty and administration of the School of Arts and
Sciences, the G.W.C. Whiting School of Engineering, the School of
Continuing Studies and the School of Advanced International
Studies, of The Johns Hopkins University, are administratively
and academically separate from the School of Hygiene and Public
Health, the School of Medicine and The Johns Hopkins Hospital.
Throughout this document, "Homewood Schools" refers to the
faculty and administration of the School of Arts and Sciences,
the G.W.C. Whiting School of Engineering, the School of
Continuing Studies and the School of Advanced International
Studies of The Johns Hopkins University.
     Most projects and activities of the Homewood Schools do not
involve human subjects. Those projects that do involve subjects
entail relatively little or no risk to those subjects in
comparison to many activities centered at the Medical
Institutions. Regardless, the Homewood Schools have established
policies and have implemented procedures to ensure the protection
of human research subjects. A statement of these policies,
detailing the procedures that are followed in its implementation,
is attached to this Assurance of Compliance.
     Homewood Schools have established and will maintain a Review
Board on the Use of Human Subjects (hereafter referred to as the
board) with broad representation and with high competence to
review/projects and activities that involve human subjects. The
board is established and operated in accordance with the
requirements of 45CFR46 (revised June 18, 1991), and, except for
the categories specifically exempted by those regulations, all
human subject research conducted by the Homewood Schools will be
reviewed and approved by the board prior to the involvement of
human subjects. Additionally, all activities, procedures,
documentation and reporting regarding human subject research
will, at a minimum, meet the standards and requirements of
45CFR46.
     For each activity as planned and conducted a determination
shall be made as to whether subjects are involved and, if
involved, the degree of risk. "Risk" is defined as exposure to
the possibility of harm--whether physical, psychological,
sociological or resulting from legal action--as a consequence of
participation as a subject in any project or activity of the
Homewood Schools that departs from the application of those
established and accepted methods necessary to meet his or her
needs or that increases the risks of daily life.
     In each case where human subjects are involved, the board
shall insist that: (a) the risks to the subject are sufficiently
outweighed by the sum of the benefits to the subject and the
importance of the knowledge to be gained as to warrant a decision
to allow the subject to accept these risks, (b) the rights and
welfare of any subject will be adequately protected and (c)
legally effective informed consent will be obtained by adequate
and appropriate methods in accordance with the provisions of HHS
regulations.
     Homewood Schools will provide for board review to be
conducted at timely intervals with objectivity and in a manner to
ensure the exercise of independent judgment of the members.
     Homewood Schools administration, faculty and investigators
will report to the board at the earliest opportunity any instance
of noncompliance with board requirements, injuries to subjects,
unanticipated problems involving risks and changes proposed in
research activities and the progress of the research. Changes in
approved research resulting in revision to an approved protocol
may not be initiated without board review and approval except
where necessary to eliminate immediate hazards to the subject(s).
     Homewood Schools will provide space, personnel and equipment
sufficient for the board to carry out its tasks and will have
available, either directly or through referral, the facilities
and professional attention required for subjects who may suffer
physical, psychological or other injury as a result of
participation in a project or activity of the Homewood Schools.
Homewood Schools will maintain appropriate and informative
records of the board's review of each application and activity
that falls within the realm of HHS regulations as well as
documentation of informed consent in connection with each
pertinent activity in which a determination is made that risks to
subjects are involved. Homewood Schools also will maintain other
documentation the board or the administration considers pertinent
to the selection, participation and protection of subjects and to
the review of circumstances that might adversely affect the
rights and welfare of individual subjects. Research approved by
the board may be subject to further review and approval or
disapproval by appropriate officers of the university; however,
research that has not been approved by the board may not be
approved by any other means.
     Homewood Schools will at least annually determine, through
appropriate administrative overview, that its practices and
procedures designed for the protection of the rights and welfare
of human subjects are being effectively applied and are
consistent with the regulations and with the implementation of
this assurance as accepted by the Department of Health and Human
Services.
     The communication presented herewith and any related
communications of importance and bearing on the matter in
question are public documents which, following HHS acceptance,
will be published at least annually in a source such as The Johns
Hopkins Gazette (the official newspaper of record for all
divisions of the university) readily available to all personnel
of Homewood Schools. Furthermore, copies of these same documents
will be distributed annually to all department chairpersons for
dissemination to staff, and copies will be continually available
upon demand in the office of the sponsored projects officer,
Office of Sponsored Projects--through which all grant and
contract applications for Homewood Schools pass--as well as in
the office of the board. These policies will be called to the
attention of research sponsors and researchers when considered
pertinent by department chairpersons, by the sponsored projects
officer, by the deans, by one or more members of the board or by
any other concerned individual or organization. These measures
have proven adequate at Homewood Schools, ensuring full
consideration of each project or activity involving human
subjects.
     Finally, The Johns Hopkins University acknowledges and
accepts its institutional responsibilities for protecting the
rights and welfare of human subjects of research covered by this
assurance and will comply with the policies and requirements set
forth in 45CFR46, its subparts and such additions and revisions
as may from time to time occur.

                                        Theodore O. Poehler,
                                        Vice Provost for Research

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Policies Regarding the Use of Human Subjects in Research Projects

     The faculty and administration of the School of Arts and
Sciences, the G.W.C. Whiting School of Engineering, the School of
Continuing Studies and the School of Advanced International
Studies of The Johns Hopkins University have long had a policy of
firm adherence to the belief that the rights and the welfare of
individuals are of a paramount importance. In carrying out this
policy, The Johns Hopkins University is guided by the ethical
principles promulgated in the "Declaration of Helsinki," "Ethical
Principles in the Conduct of Research with Human Participants" of
the American Psychological Association, "Principles of
Professional Responsibility" of the American Anthropological
Association and "The Belmont Report: Ethical Principles and
Guidelines for the Protection of Human Subjects of Research"
prepared by the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research (DHEW Publication
Number (OS) 78-0012). Inherent in this policy are two premises
specifically applicable to research and related activities,
regardless of sources of funding, carried out by personnel of the
School of Arts and Sciences, the G.W.C. Whiting School of
Engineering, the School of Continuing Studies and the School of
Advanced International Studies.

     1.   Protection of individual rights and welfare is a
responsibility shared collectively by the Arts and Sciences,
Engineering, School of Continuing Studies and SAIS communities. 

     2.   Such individual rights and welfare are totally
applicable to individuals who may, through circumstances, become
subjects of research or more indirectly, become involved in
university activities.
     The preceding Assurance of Compliance with HHS Regulations
for the Protection of Human Research Subjects and the mechanisms
chosen for promulgation of that assurance as stated in the text
that follows are consonant with this policy of long standing.
They also take into consideration the equally strong commitments
of the faculty of the Homewood Schools to advanced research and
to the dissemination of knowledge.
     
Definitions

     "Human subject" is defined as any living individual about
whom an investigator (either professional or student) conducting
research obtains (a) data through intervention or interaction
with the individual or (b) identifiable private information. For
the purposes of this assurance, definitions of "research,"
"intervention," "interaction" and "private information" are
published in the OPRR Reports (NIH, PHS, HHS), "Code of Federal
Regulations, 45CFR46 and certain other related laws and
regulations on Protection of Human Subjects." Revisions and
additions to these documents may occur from time to time.


The Review Board on the Use of Human Subjects

     Homewood Schools have appointed and will maintain a Review
Board on the Use of Human Subjects (hereafter referred to as the
board) comprising at least eight members. The members of the
board are appointed by the dean of Arts and Sciences and are
selected both from within and from outside Homewood Schools.
Members are selected from different walks of life, bringing to
the review process a wide range of points of view. All members of
the board are aware of and concerned with individual civil
liberties. Since appointment is made of individuals who bear
varying perspectives and competence in different academic and
social areas, the members of the board collectively are competent
to review and to judge with considerable foresight and insight,
the major consequences of proposed and ongoing projects and
activities in order to ensure adequate protection of individual
rights and welfare of human subjects. This gives assurance that
each proposed project or activity in which human subjects are
involved will be reviewed in terms of HHS guidelines on human
protection as well as in terms of applicable law standards of
professional conduct and practice, modern ethical principles and
the consensus of contemporary community opinion.
     In their evaluations, the members of the board attempt in
all cases to assure that inherent and potential risks to subjects
are significantly offset by realistic projected benefits to the
subjects and/or to humanity. This policy stems directly from the
prime function of the Homewood Schools, namely the betterment of
the human condition through judicious advanced research and
through the dissemination of knowledge. In keeping with this
policy is the evaluation of each project by the board from the
point of view of minimizing inherent and potential risks to
subjects as much as is feasible, regardless of projected benefits
to individuals or to society.


Review Procedures


     Each program involving human subjects and referred to the
board by mechanisms outlined below is reviewed by the board upon
initial application (or upon development, in cases where funding
is not sought) and at timely intervals thereafter, at least
annually. The board is called into meeting by notice from its
chair at regular intervals to consider fully each and every
instance requiring its attention. Besides such scheduled
meetings, generally monthly, which grant some certainty of
adequate surveillance with regard to new and continuing research
and activities, the board may be called into meetings at
individual request concerning matters of advice, guidance and
instruction as occasions arise that demand extra attention or as
opportunities for enlightenment or operational consistency
present themselves. Finally, the board considers revisions in its
program of supervision when experience suggests that more
adequate or effective procedures for protection of individual
rights and welfare of human subjects might be engendered through
board discourse or intervention.
     A majority of members is required to be present at each
meeting of the board and decisions of the board are rendered by a
majority of all members present. Where any questions of
significance arise, board members absent from a meeting are
apprised and their views solicited, so that participation to the
fullest degree is possible in critical cases. Minutes of each
board meeting are circulated to the Homewood Office of Sponsored
Projects and to all board members and are on file in the office
of the chair of the board.
     No member of the board is permitted to be involved in either
the initial or the continuing review of a project or activity in
which he or she has a direct professional responsibility or some
other conflicting interest, except to provide information or
explanation requested by the board in its review proceedings. The
board is free to seek specialized consultation from outside
sources it deems appropriate. For example, such consultation
could involve additional legal counsel when the board considers
that some significant legal issue is involved or assistance from
pertinent members of the other Johns Hopkins boards (for example,
The Johns Hopkins University Medical School) in those rare
instances where matters of a medical nature may be thought to be
involved. Such advisers may not vote with the board. Each board
member is free to exercise and express independent judgment so
that reviews may be conducted in the most objective manner
possible.
     Board decisions involving projects or activities in which
human subjects are used may include: (a) determination of the
level of risk to which human subjects may be exposed, (b)
approval of the project or activity and procedures as submitted,
(c) specification of modifications in the protocol necessary to
obtain board approval, (d) disapproval of the project or activity
or (e) suspension of approval of ongoing projects. Where
modifications are necessary for board approval, the board chair
and/or appropriate board members work with project directors, the
Office of Sponsored Projects and the sponsor (if any) to effect
adequate safeguards for the subjects to be involved, and to
report, as appropriate and when required, to the NIH Office of
Protection from Research Risks.


Projects Exempt from Review

     Broad categories of research which do not use living human
subjects or which normally present little or no risk of harm to
subjects may be exempt from formal review by the board. In
general, most social, economic and educational research is exempt
if the only involvement of human subjects is in one or more of
the following categories: (a) the use of survey and interview
procedures, (b) the observation of public behavior or (c) the
study of existing data, documents, records and specimens.
     More precisely, the following categories of research are
exempt from board review:

     1.   Research undertaken without the intention of involving
living human subjects.

     2.   Research in which the only involvement of human
subjects will be in one or more of the following categories:

     a.   Research that will be conducted in established or
commonly accepted educational settings and that will involve
normal educational practices, such as (1) research on regular and
special education instructional strategies, or (2) research on
the effectiveness of or the comparison among instructional
techniques, curricula or classroom management methods.

     b.   Research that will involve the use of educational tests
(cognitive, diagnostic, aptitude, achievement), when information
to be taken from these sources will be recorded in such a manner
that subjects cannot be identified, either directly or through
identifiers linked to the subjects.

     c.   Research that will involve survey or interview
procedures if (1) responses will be recorded in such a manner
that the human subjects can be identified, either directly or
through identifiers linked to the subjects, and (2) the subject's
responses, if they became known outside the research, could not
reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject's financial standing or
employability, and (3) the research will not deal with sensitive
aspects of the subject's own behavior, such as illegal conduct,
drug use, sexual behavior or use of alcohol.

     d.   Research that will involve survey or interview
procedures in which respondents will be elected or appointed
public officials or candidates for public office.

     e.   Research that will involve the observation (including
observation by participants) of public behavior, if (1)
observations will be recorded in such a manner that the human
subjects can be identified, either directly or through
identifiers linked to the subjects, and (2) the observations to
be recorded, if they became known outside the research, could not
reasonably place the subject at risk of criminal or civil
liability or be damaging to the subject's financial standing or
employability and (3) the research will not deal with sensitive
aspects of the subject's own behavior such as illegal conduct,
drug use, sexual behavior or use of alcohol.

     f.   Research that will involve the collection or study of
existing data, documents, records, pathological specimens or
diagnostic specimens, if these sources are publicly available or
if the information will be recorded by the investigator in such a
manner that subjects cannot be identified, directly or through
identifiers linked to the subjects.

     g.   Certain research projects, which are subject to the
approval of the U.S. Department of Health and Human Services and
are designed to study, evaluate or otherwise examine public
benefit or service programs, if the projects meet the criteria
specified within part 46.101(b)(6) of 45CFR46, except to the
extent specified in 45CFR46.101 (i) which states that "If,
following review of proposed research activities that are exempt
from these regulations under paragraph (b)(6), the secretary
determines that a research or demonstration project presents a
danger to the physical, mental or emotional well-being of a
participant or subject of the research or demonstration project,
then federal funds may not be expended for such a project without
the written, informed consent of each participant or subject."
     An investigator who believes that his or her project
qualifies for exemption must write the chair of the Review Board
on the Use of Human Subjects, describing the project and
explaining why the investigator believes the proposed project
qualifies for exemption. Draft copies of appropriate forms of
letters are available from the board office. The chair of the
board will confirm whether the project does indeed qualify. If
the proposed project does not qualify for exemption, the chair of
the board will advise the investigator about the submission of an
appropriate form of request for review.


Research Qualifying for Expedited Review

     Certain categories of research may require only expedited
review by the board. Note, however, that this list of categories
is expected to change from time to time. Research activities
subject to expedited review will involve no more than minimal
risk; that is, the risks of harm anticipated in the proposed
research are not greater, considering both probability and
magnitude, than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
examinations or tests. Categories of research that typically meet
these requirements are:

     1.   The recording of data from subjects 18 years of age or
older using noninvasive procedures routinely employed in clinical
practice. This includes the use of physical sensors that are
applied either to the surface of the body or at a distance and do
not involve input of matter or significant amounts of energy into
the subject or an invasion of the subject's privacy. It also
includes such procedures as weighing, testing sensory acuity,
electroencephalography, thermography, detection of naturally
occurring radioactivity, diagnostic echography and
electroretinography. It does not include exposure to
electromagnetic radiation above the visible range (for example,
X-rays, microwaves).
     2.   Voice recordings made for research purposes such as
investigations of speech defects.
     3.   Moderate exercise by healthy volunteers.
     4.   The study of existing data, documents, records,
pathological specimens or diagnostic specimens.
     5.   Research on individual or group behavior or
characteristics of individuals, such as studies of perception,
cognition, game theory or test development, where the
investigator does not manipulate subjects' behavior and the
research will not involve stress to subjects.
     6.   Collection of hair and nail clippings, in a
nondisfiguring manner; deciduous teeth; and permanent teeth if
patient care indicates a need for extraction.
     7.   Collection of excreta and external secretions including
sweat, uncannulated saliva, placenta removed at delivery and
amniotic fluid at the time of rupture of the membrane prior to or
during labor.
     8.   Collection of blood samples by venipuncture, in amounts
not exceeding 450 milliliters in an eight-week period and no more
than two times per week, from subjects 18 years of age or older
and who are in good health and not pregnant.
     9.   Collection of both supra- and subgingival dental plaque
and calculus, provided the procedure is not more invasive than
routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques.
     10.  Research on drugs or devices for which an
investigational new drug exemption or an investigational device
exemption is not required.
     The first five categories are likely to be of most interest
to researchers at Homewood Schools.
     A project may receive expedited review if it falls in one or
more of the categories above, and if it will be carried out
through standard methods. Investigators who believe that their
projects qualify for expedited review must prepare a brief letter
of assurance that (1) describes the nature of the project and (2)
shows how the project qualifies for expedited review by meeting
the requirements above.
     The letter must then receive the approval of two members of
the board (generally the chair and one other member of the
board). Approval generally follows discussion of the project
between the investigator and the two members of the board
individually.
     After approval, the letter of assurance is signed and dated
by the members approving the project. The expedited letter of
assurance is then brought before the full board at its next
regular meeting for confirmation from the board.
     When the letter of assurance has received confirmation of
the board, a letter will be sent to the investigator confirming
final approval.


Research that Requires Formal Board Review

     All other projects are subject to formal board review. The
investigator must prepare a formal statement of assurance for the
board which shows that:

     1.   Risks to subjects are minimized (a) by using procedures
which are consistent with sound research design and which do not
unnecessarily expose subjects to risk, and (b) whenever
appropriate, by using procedures already being performed on the
subjects for diagnostic or treatment purposes.

     2.   Risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects and the importance of
the knowledge that may reasonably be expected to result.

     3.   Selection of subjects is equitable, taking into account
the purposes of the research and the setting in which the
research will be conducted.

     4.   Informed consent will be sought from each prospective
subject or from the subject's legally authorized representative.
The investigator must also show that informed consent will be
appropriately documented. In meeting this requirement, the
investigator must provide prospective subjects with:

     a.   A statement that the study involves research, an
explanation of the purposes of the research and the expected
duration of the subject's participation, a description of the
procedures to be followed and identification of any procedures
that are experimental.

     b.   A description of any reasonably foreseeable risks or
discomforts to the subject.

     c.   A description of any benefits to the subject or to
others that may reasonably be expected from the research.

     d.   A disclosure of appropriate alternative procedures or
courses of treatment, if any, that might be advantageous to the
subject.

     e.   A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained.

     f.   For research involving more than minimal risk, an
explanation as to whether any compensation or any medical
treatments are available if injury occurs and, if so, what they
consist of or where further information may be obtained.

     g.   An explanation of persons to contact for answers to
questions about the research and research subjects' rights, and
persons to contact in the event of a research-related injury to
the subject.

     h.   A statement that participation is voluntary, that
refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and that the
subject may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise entitled.
     When appropriate, the investigator must also provide
prospective subjects with one or more of the following:

     i.   A statement that the particular treatment or procedure
may involve risks to the subject (or to the embryo or fetus, if
the subject is or may become pregnant) which are currently
unforeseeable.

     j.   Anticipated circumstances under which the subject's
participation may be terminated by the investigator without
regard to the subject's consent.

     k.   Any additional costs to the subject that may result
from participation in the research.

     l.   The consequences of a subject's decision to withdraw
from the research and procedures for orderly termination of
participation by the subject.

     m.   A statement that significant new findings developed
during the course of the research which may relate to the
subject's willingness to continue participation will be provided
to the subject.

     n.   The approximate number of subjects involved in the
study.

     5.   Where appropriate, the research plan makes adequate
provision for monitoring the data collected to ensure the safety
of subjects.

     6.   Where appropriate, there are adequate provisions to
protect the privacy of subjects and to maintain the
confidentiality of data.

     7.   Where some or all of the subjects are likely to be
vulnerable to coercion or undue influence, such as persons with
acute or severe physical or mental illness, or persons who are
economically or educationally disadvantaged, appropriate
additional safeguards have been included in the study to protect
the rights and welfare of these subjects.
     The investigator must provide the board with assurance that
truly informed and free consent of subjects at risk will be
obtained by methods that are adequate and appropriate and that
carry the least possibility of omission, error or
misunderstanding. The informed consent procedure and documents
employed for this purpose should contain no exculpatory language
through which the subject is made to waive, or to appear to
waive, any of his or her legal rights, or to release the Homewood
Schools or any of its personnel from any liability for
negligence. The nature and the purpose of the project in terms of
the sought-for benefits to the subject directly, should be
disclosed to each subject at risk. Proposed procedures should be
explained, and any potential risks or discomforts attending or
potentially stemming from the subject's participation in, or
premature withdrawal from, the activities should be described. In
many cases, research may involve children, persons with
restricted educational backgrounds, persons for whom English is
not their native tongue. With regard to children, research shall
comply with the requirements set forth in 45CFR46 Subpart-D,
Additional Protections for Children Involved as Subjects in
Research. Consent is not "informed" if the person concerned
cannot understand the consent form. The language used in the
consent form must be appropriate for the age, educational or
intellectual levels of the persons who are to be the subjects.
     In most cases, the investigator should provide subjects with
a written document which incorporates appropriate parts of the
above requirements. This may be read to or read by subjects or
their legally authorized representatives and must be signed by
the subject or the representative. The person signing the form
must be given a copy of it.
     In some instances, the investigator may prepare a "short
form" written consent document which states that all elements
required above were read to the subject or a legally authorized
representative. When this method is used, there must be a witness
to the oral presentation. The board must approve a written
summary of the oral statement. The investigator must assure the
board that (a) the short form will be signed by the subject or
the representative, (b) the witness will sign the short form and
a copy of the summary, (c) the person obtaining consent will sign
a copy of the summary and (d) a copy of the short form and of the
summary will be given to the subject or the representative.
     In the case of certain anthropological or sociological
studies, the board may decide that oral consent is sufficient. If
the latter decision prevails after the board has reviewed the
nature of the project or activity and the consent procedures to
be employed, professional competence requires that all personnel
employed in the activity or project actively comply with the
agreed upon informed consent procedure in each case where a
subject is at risk.
     Copies of signed consent documents must be retained for at
least three years past completion of the research activity. In no
case shall an investigator propose, or the board approve, an
informed consent procedure in which any possible or potential
risk is knowingly or purposely minimized, misrepresented or
otherwise distorted. All approved consent procedures and
documents will be on file and available at the Office of
Sponsored Projects. All personnel associated with each project or
activity involving the use of human subjects should assure the
board, through assurance by the principal sponsor, that strict
confidentiality will be maintained with respect to individuals in
the collection, storage, security, use and ultimate destruction
of all primary data so that there is a minimal chance that the
privacy of the individual would be invaded. Measures taken to
assure compliance should be supplied to the board by the
principal sponsor in each case, regardless of risks to subjects
involved or of consent procedures used. Exceptions to strict
confidentiality of data associated with individual human subjects
are made only when disclosure is required by statutory or
judicial authority or when the subject has given prior written
approval to disclosure. More general information such as
descriptions of consent procedures and outcomes of the review
process and minutes of board meetings are public information. In
each case, the board requires that the research or activity be
performed by scientifically or otherwise qualified persons with
adequate supervision by professional personnel and that the
general procedures employed are legal and acceptable by both
national and local standards of practice.
     A copy of the research proposal itself and a copy of all
instruments (tests, questionnaires, survey forms) must accompany
the Statement of Assurance.
     Upon submission, the Statement of Assurance is first
reviewed by the chair, or one member of the board, to assess its
completeness and compliance with these regulations and policies.
After this initial review, the Statement of Assurance may be
returned to the investigator with a request for more details or
suggestions for change. Upon acceptance by the chair or one other
member of the board, the Statement of Assurance is put on the
agenda for the next scheduled meeting of the board. In certain
cases, the investigator may be requested to attend the meeting to
amplify or clarify the Statement of Assurance and to respond to
questions by the members of the board.
     If the project is approved, the original and Xerox copies of
the assurance are signed by at least a majority of board members
and by the sponsored projects officer or by a designated
representative of the sponsored projects officer. All records of
review are public information once the board has ascertained that
no data pertaining to individual subjects is present in those
records; such records shall be maintained for a minimum period of
three years after completion of the research. The full records of
the board shall be available to authorized representatives of the
U.S. Department of Health and Human Services (DHHS) for
inspection and copying at reasonable times; upon reasonable
request, specified records may be copied and forwarded to
authorized representatives of DHHS.
     The board shall report promptly to the provost, the
University Sponsored Projects Office and the NIH Office of
Protection from Research Risks: any serious or continuing
noncompliance by investigators with the requirements and
determinations of the board; any suspension or termination of
board approval for reasons of noncompliance or unexpected serious
harm to subjects; and, any unanticipated problems involving risks
to subjects or others encountered during the conduct of research.


Research in Progress

     The board and sponsors of projects or activities involving
human subjects will maintain a continuing exchange of information
and advice dealing with the annual review of projects or
activities and with any proposed changes that will or may
significantly affect human subjects. The board should be informed
of any emergent problems that may alter established relationships
with human subjects. Investigators should report immediately to
the chair of the board any injury or harm suffered by a subject
as a consequence of his or her involvement in an ongoing project
or activity of the Homewood Schools. In appropriate
circumstances, investigators may be asked to testify before the
board to clarify and discuss questions raised either by the board
or by outside sources. Similarly, the board will entertain any
complaints or questions referred to it by staff, subjects or
other sources and pertaining to the use of human subjects in
project or activities of the Homewood Schools. When necessary,
the board may require and conduct review of certain activities
more frequently than the annual review requirement for ongoing
activities.


Members of the Review Board on the Use of Human Subjects

     Frederick DeKuyper, associate general counsel, Johns Hopkins
University; Robert Gordon, Department of Sociology, Johns Hopkins
University; William Jordan, Center for Social Organization of
Schools, Johns Hopkins University; Michael McCloskey, Department
of Cognitive Science, Johns Hopkins University; Sandy Newman,
Institute for Policy Studies, Johns Hopkins University; Sharman
Rowe, Hampstead Hill Elementary School; Erica Schoenberger,
Department of Geography and Environmental Engineering, Johns
Hopkins University; Gretchen van Utt, minister, Presbyterian
Church (USA); Milton Cole, ex-officio member, sponsored projects
officer, Johns Hopkins University; and Howard E. Egeth, chair,
Department of Psychology, Johns Hopkins University.

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