For The Record:
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.
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
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.
"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.
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:
b. Research that will involve the use of educa-tional 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
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:
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) that 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.
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; Rev. Joseph Giles, pastor emeritus, University Baptist Church; Robert Gordon, Department of Sociology, Johns Hopkins University; Niloofar Haeri, Department of Anthropology, Johns Hopkins University; William Jordan, Center for Social Organization of Schools, Johns Hopkins University; Sharon Kingsland, Department of History of Science, Medicine and Technology, Johns Hopkins University; Michael McCloskey, Department of Cognitive Science, Johns Hopkins University; Sandy Newman, Institute for Policy Studies, Johns Hopkins University; Erica Schoenberger, Department of Geography and Environmental Engineering, Johns Hopkins University; 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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