Appendix 6(f) THE HONG KONG POLYTECHNIC UNIVERSITY Human Subjects Ethics Sub-committee GUIDELINES FOR ETHICS REVIEW

OF RESEARCH/TEACHING PROJECTS INVOLVING HUMAN SUBJECTS

1. Introduction It is a requirement of The Hong Kong Polytechnic University that all research/teaching projects involving human subjects must be reviewed for ethical appropriateness in accordance with the guidelines of the Human Subjects Ethics Subcommittee (HSESC). The HSESC or its delegates must determine that the benefits of the proposed research/teaching project outweigh the risks involved before permitting any experiment or study (including survey, interview, or questionnaire type of investigation) to proceed. 2. Interpretation In these guidelines, unless the context otherwise requires: (i) "Research projects" include all projects of research nature undertaken by staff, postgraduate, undergraduates and sub-degree students. "Human subjects" covers the subjects involved not only in research areas such as health or social studies or survey research but also other areas such as teaching (particularly teaching development) or other scholarly activities with elements of data collection or experimentation. "Approving authority" refers to the party with the authority delegated by the HSESC for granting ethical approval for research/teaching projects involving human subjects. In respect of applications from staff members of academic departments, the approving authority is the Departmental/School Research Committee (D/SRC) concerned. The D/SRC may refer any unresolved cases to the Faculty Research Committee (FRC)/HSESC for deliberation. FRC may further refer any problematic cases to the HSESC for action as deemed appropriate. As for applications from staff members of non-academic departments, the approving authority is the Head of Department (HoD) concerned, except when the HoD is the applicant, the approving authority rests with HSESC. If necessary, the HoD may refer any unresolved cases to the HSESC for deliberation. (iv) "Principal Investigator" (PI) or "Representative Co-Principal Investigator" (Rep. Co-PI) refers to the staff member who assumes overall responsibility for the project. Page 1 of Appendix 6(f)

(ii)

(iii)

(v)

"Chief Supervisor" refers to the staff member who assumes overall responsibility in supervising a students research project. "Student Investigator" refers to the postgraduate, undergraduate or sub-degree student who will be collecting research data for the research project supervised by the University's staff. "Co-Investigator" (Co-I) refers to any other parties involved in the project not covered by (d), (e) and (f) mentioned above.

(vi)

(vii)

(viii) "Researchers" refers collectively to the staff members and / or students who will conduct the research/teaching project. (ix) "Co-Principal Investigator" (Co-PI) refers to the staff member who will also assume responsibility in respect of the ethical approval in relation to the areas of expertise of respective co-principal investigators in accordance with the stipulations given by the approving authority if he/she has also obtained the ethical approval.

3. Procedures for Ethical Review Annex I depicts the procedures for academic departments while Annex II illustrates those for non-academic departments. 4. Responsibilities of Different Parties 4.1 The PI will be responsible for obtaining fresh approval should there be any changes in the project proposal or procedures of an approved protocol. Moreover, staff and students are reminded that for research/teaching projects involving human subjects to be carried out in the premises providing health care services, the appropriate Committee/person from the health care services must also be consulted. For studies of clinical trial, PIs are strongly advised to register the trial through the Clinical Trials Centre of the University of Hong Kong (www.hkuctc.com) or the US National Institutes of Health (NIH) (www.clinicaltrials.gov). In order to ensure that ethical approval is justifiably given for all research/teaching projects or investigations (on-going or proposed), the responsibility is devolved as follows: 4.3.1 For Academic Departments a. D/SRC (i) D/SRC to consider all on-going or proposed research/teaching projects to ensure that ethical issues involving human subjects have been appropriately addressed. (ii) DRC to inform Faculty Research Committee (FRC) of any projects (on-going or proposed) which do not meet with approval. SRC should inform the HSESC accordingly. Page 2 of Appendix 6(f)

4.2

4.3

(iii) DRC to be responsible for referring unresolved cases to FRC for further appropriate action. If the Chair of the SRC concerned is one of the team members, the application should be considered by the Dean of School (DoS) concerned. The SRC may refer unresolved cases directly to the HSESC for consideration. (iv) For the schools or departments which do not have D/SRCs, i.e. Graduate School of Business, Chinese Language Centre, English Language Centre and General Education Centre, the Heads of School/Centre concerned will assume the role of the D/SRC. b. FRC (i) FRC to ensure that the DRCs within their Faculty are satisfactorily monitoring human subjects ethics issues in research/teaching projects. (ii) FRC to be responsible for considering unresolved cases on human subjects ethical approval referred from DRC, and to grant approval as deemed appropriate. (iii) FRC to report to the Human Subjects Ethics Sub-committee for action on any cases which are not resolved. c. HSESC (i) To consider and review unresolved cases referred by F/D/SRCs. (ii) To consider and review all on-going or proposed research/teaching projects that will involve genetic work. 4.3.2 For Non-academic Departments a. HoD (i) HoD to consider all on-going or proposed research/teaching projects to ensure that ethical issues involving human subjects have been appropriately addressed. (ii) If HoD applies for ethical approval, the approving authority rests with HSESC. (iii) HoD to inform the HSESC of any on-going or proposed research/ teaching projects that are not approved. (iv) HoD to be responsible for referring unresolved cases to the HSESC for further appropriate action. b. HSESC (i) To consider and review unresolved cases referred by HoDs. (ii) To consider and review all on-going or proposed research/teaching projects that will involve genetic work. 5. Guidelines on Determining the Benefits and Risks of Research/Teaching Project The PI/Rep. Co-PI/Chief Supervisor should submit to the approving authority, an outline of any potential risks to the subjects which might arise in the course of conducting a research/teaching project. Procedures must be justified in writing, explaining why alternative approaches involving less risk cannot be used. A description of potential benefits to the subjects, the scientific community and/or society must also be included. Page 3 of Appendix 6(f)

5.1

Definition of Benefit Benefit is 'anything that is for the good of a person or thing' (Macquarie Dictionary 1985). It may be personal and direct or may be societal and indirect. It is appropriate to use both forms of benefit in making the judgement of risk/benefit ratio.

5.2

Definition of Risk Risk is defined as a situation involving exposure to harm or danger' (Oxford Dictionaries Pro 2012). It should be noted that no procedure is without risk, although the risks may be minimal.

5.3

The Declaration of Helsinki and the International Declaration on Human Genetic Data 5.3.1 The Declaration of Helsinki (2008) and the International Declaration on Human Genetic Data (UNSECO 2003) provides basic guidelines with respect to the determination of benefits and risks in the conduct of biomedical research. 5.3.2 Research involving human subjects cannot legitimately be carried out unless the importance of the objective outweighs the inherent risks and burdens to the subject. 5.3.3 Every research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interest of science and society.

5.4

Determination of Risks in Research/Teaching Project 5.4.1 Risk may arise from both non-invasive and invasive procedures. 5.4.2 Non-invasive procedures are those which do not interact directly with the body, e.g. asking patients to adopt a particular (normal) posture for measurement purpose. 5.4.3 Invasive procedures are those which interact directly with the body, e.g. asking patients to take a drug or instilling a drug into the eyes. 5.4.4 In the social/psychological sense, invasive procedures are those which impinge on the right to privacy of the individual, in his or her personal life, or his or her medical and social records. In many respects, all social procedures are invasive, since it cannot be known what impact they may have on a particular individual. 5.4.5 Collection of personal data such as opinions, attitudes or beliefs through interviews, questionnaires, participant observation, diaries and letters, may involve psychological risk. Where no record is maintained of the individual's identity in a particular research study, breach of confidentiality is not an issue. However, there may be risks in terms of provoking anxiety or other undesirable states in the interview or questionnaire situation. 5.4.6 A judgement needs to be made as to whether a particular intervention is likely to affect the well-being of the subjects. Particular caution should Page 4 of Appendix 6(f)

be taken in case vulnerable groups are used in the project and where potentially sensitive areas (such as death and bereavement, religion or sex) are the subject of the project. 5.4.7 Normal routine clinical examination may involve the use of invasive procedures with potential risks, and consent to the clinical examination implies consent to have these procedures performed. However, if such procedures are performed as part of a project, then informed consent to participate in the project will normally be necessary after the potential risks involved in such procedures are clearly explained. 6. Guidelines on the Practice of Obtaining Subjects' Consent to Participate in Research/Teaching Project 6.1 Consent should normally be obtained from all human subjects who are to be involved in a research/teaching project. Consent is informed when it is given by a subject who understands the purpose and nature of the study, what participation in the study requires the subject to do and to risk, and what benefits are intended to result from the study. The following guidelines should be observed when informed consent is obtained from any subjects involved in a research/teaching project: 6.2.1 Use of Verbal/Written Consent and Information Sheets (i) Voluntary informed consent, in writing, should be obtained from any subject who is able to give such consent. (ii) Procedures involving no physical and psychological discomfort, such as measurement of height and weight, may be carried out after a simple explanation and a verbal response. (iii) Most procedures of the project should be explained on an information sheet written in simple language that is easily comprehensible by the potential subject. (iv) The information sheet should set out the purpose of the investigation; the procedures; the risks (including psychological distress); the benefits, or absence of them, to the individual or to other or future individuals or to society; a statement that the subjects may decline to participate and also will be free to withdraw at any time without giving a reason (and without in any way impairing their care); and an invitation to ask questions. (v) The information sheet should also contain a statement informing the subjects of the existence of the HSESC and its supervisory functions and that the subjects may report to the HSESC any procedures that seem to violate their welfare. (vi) The subjects should be given plenty of time to study the information sheet, to consult their families or their general practitioners or the investigator. (vii) The information sheet is an important part of the process of seeking consent and, with the consent form, should form part of the application to the HSESC. (viii) It is the researcher's responsibility to seek ongoing consent during the course of a study.

6.2

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(ix) The key requirements as well as examples of the consent form and information sheet are set out in the Annexes III to V. 6.2.2 Undue Influence and Inducement to Participate (i) Subjects should be free from coercion of any kind and should not be pressured to participate in a study. (ii) Subjects should be informed that they may decline to participate and are free to withdraw at any time without giving a reason. (iii) The benefits of a study such as increased or new knowledge are proper inducements. (iv) Promises of compensation and care for damage, injury or loss of income should not be considered inducements. (v) Inducements, such as unreasonable services or financial payments, and the creation of inappropriate motivation should be avoided. (vi) Risks involved in participation should be acceptable to subjects, even in the absence of inducement. (vii) Reimbursement of subjects' expenses, e.g. for journeys, is not payment in the sense of reward, and can be provided. (viii) All proposed payments to subjects, particularly where there may be an element of inducement to recruit them, should be submitted to the HSESC for examination. 6.2.3 Informal Consent From Others Affected By the Research/Teaching Project (i) In situations when a third party (e.g. spouses, nurses or other health care professionals who are directly involved in the treatment and care of the potential subjects) is involved or affected by the research, consent should also be obtained from them. (ii) The consent may be informal and may involve sharing of information about the project. (iii) If the proposed research may interfere with, or is closely associated with the treatment or care being provided by the third party, it is necessary that they be fully informed and should sign a consent to participate. (iv) In certain situations, the affiliation of subjects to certain organisations or special groups such as educational institutions or hospitals, may necessitate the granting of permission to conduct the project. 6.2.4 Vulnerable Subjects Who Need Special Consideration (i) Vulnerable subjects are either unable to give informed consent, or are captive subjects who are less able to protect themselves. (ii) Children are believed to be incapable of weighing the risks and benefits of research and should not be the subjects of a project that might equally well be carried out on adults. However, if their participation is indispensable, then the consent of a parent or other legal guardian, after a full explanation of the aims of the research and of possible hazards, discomfort or inconvenience, is always necessary. To the extent that is feasible, which will vary with age, the willing consent of the child should be sought. Generally children over age of 16 may be assumed to be capable of giving Page 6 of Appendix 6(f)

(iii)

(iv)

(v)

(vi)

(vii)

(viii)

(ix) (x)

informed consent preferably also with the consent of the parent or other legal guardian. But this will vary depending on the nature of research and special guidance will need to be sought. The mentally ill or mentally retarded may be unable to comprehend the implications of research and should not be the subjects of a project that might equally well be carried out with adults in full possession of their intellectual faculties. If their participation is indispensable, informed consent may have to come from both the subject and a legal guardian or the next-of-kin, and the attending physician where appropriate. Some elderly people cannot comprehend well and in this way, resemble the case of children or the mentally handicapped people in the consideration of obtaining their informed consent to participate in a project. The quality of the consent of potential subjects who are in a potentially dependent relationship with the researcher (e.g. students, employees and patients) requires careful consideration, as willingness to volunteer may be unduly influenced by the expectation of adventitious benefits or penalties. The quality of the consent of friends and family of the researcher also requires special consideration, as the love and trust in the relation may override their concern to participate in the project. The economically disadvantaged, especially those who are dependent on certain facilities for health care, are vulnerable subjects who need special protection when giving informed consent to participate in any project. Unconscious or acutely ill persons are incapable of dealing with research issues and the best guidance for such research might be that witnessed, informed consent should be obtained from the nextof-kin or legal guardians. Sedated or anaesthetized persons should only be subjects of a project if they have given informed consent when totally conscious. Witnessed consent is required for vulnerable subjects who have intellectual or cultural difficulties in speech or understanding, but who are deemed capable of giving consent. An independent person, e.g. a senior nurse, signs a document that the witness was present when the researcher explained the project to the potential subject and that in the witness's opinion consent was given freely and with full understanding.

6.2.5 Research/Teaching Project Involving Deception' of Subjects (i) The use of one-way mirrors in any investigation must be clearly justified. (ii) Sometimes, it may be necessary to withhold certain information about the study design from the subjects. In this event, a full justification should be provided. 6.2.6 Research Project Involving Specimens or Materials to be Taken from a "Data Bank" (Including Discarded Specimens)

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Some organisations may keep records of clinical data and specimens like blood and urine taken from patients/subjects. Although the patients/subjects may not have given consent for the clinical data and specimens to be used for research purpose, the specimens may be regarded as materials from "data bank" which could be used for research purpose provided that the following conditions are met: (i) the organisation in charge of the "data bank" agrees to the use of specimens in the "data bank" as proposed by the researcher; (ii) the organisation withholds from the researcher all recorded information which allows the identification of the patients/subjects concerned; and (iii) the specimens from the "data bank" will not be used for DNA work. If the above conditions are not met, informed consent should be obtained from the patients/subjects concerned. 6.2.7 Prospective Research Project Involving Collection of Specimens If specimens are planned to be collected for a prospective research project, then informed consent should be obtained from the patients/subjects concerned and the quantity of specimens to be collected should not exceed what is required for the research work. 6.2.8 Research Involving Review of Medical or Social Records In order to ensure that the study will not impinge on the subject's right to privacy, the researcher should provide evidence of reasonable attempts to access anonymous medical or social records. 6.2.9 Research Involving DNA Work The specific nature of genetic data and the purposes for which they should be collected, treated, used and stored are to be considered on the basis of ethically acceptable procedures, in compliance with the International Declaration on Human Genetic Data (UNSECO, 2003) 6.3 Research/Teaching Project Conducted Without Consent There are some activities which the HSESC may agree to be carried out without consent of the subject, such as in the case of community research which may be so unintrusive that individual consent is not necessary, e.g. studies involving observation of public behaviour. While these guidelines are intended to be as comprehensive as possible, they may not cover all situations and the researcher should seek further advice from the HSESC. 7. Guidelines on Ensuring Confidentiality of Research Data 7.1 Research/teaching projects may involve collecting and storing data relating to individuals and groups, and such data, if disclosed to third parties, may cause harm or distress. Consequently, researchers should make arrangements for Page 8 of Appendix 6(f)

protecting the confidentiality of such data. Confidentiality is ensured by the researcher's ability to keep data sources protected and subjects involved in the project nameless. 7.2 The general principle is that at all times, the researchers and other collaborators shall deal with all data obtained through their project in such a manner as not to compromise the personal dignity of the subject and not to infringe upon the subject's right to privacy. Whatever information is obtained in the course of a project should be considered privileged information and should under no circumstances be publicly disclosed in a fashion that would identify any specific person or organisation (except if subpoenaed by a court). The researcher must outline to prospective subjects, methods which protect the identity of subjects and information obtained in the course of the project. Procedures for protecting the confidentiality of subjects and data should be outlined in the consent form and include: (i) securing individual confidentiality statements from all researchers; (ii) coding data with numbers instead of names so as not to reveal to unauthorised persons the identity of the subjects (names and code numbers are kept in different locations); (iii) maintaining data with any identifying information in a locked file to which only one or two identified investigators have access; (iv) using pseudonyms for subjects, agencies and geographical settings in the publishing of reports ( the keys to the pseudonyms are kept locked and in different locations); and (v) disposing of information that can reveal the identity of subjects or places carefully (e.g. being burned or shredded rather than thrown into wastebaskets). Under no circumstances, the identity of the subject, or any information which may identify the subject, may be revealed without the subject's adequate prior consent in writing. When personal identifiers are used in a study, researchers should explain to the approving authority why this is necessary and how confidentiality will be protected. The use of computers for processing the data collected for projects poses a special set of risks to anonymity, privacy and confidentiality. The security of the computer-stored data and project reports is of special concern. Security breaches may result in unauthorised access to data, possibly resulting in change to the data or even its loss, and use of data for purposes other than that for which informed consent of subjects allows. Substituting identification numbers for subjects' names on computer files and storing the files under lock and key are possible ways to prevent any accidental breach of confidentiality. In case where confidentiality is threatened, relevant records should be destroyed.

7.3

7.4

7.5

7.6

7.7

7.8

7.9

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7.10 It is the researcher's responsibility to ensure that all pledges of confidentiality are strictly honoured. 7.11 The steps to be followed to maintain confidentiality of data and the use to which data will be put, need to be revealed to the approving authority. 7.12 Researchers should familiarise themselves with the Personal Data (Privacy) Ordinance and copyright regulations, and ensure adherence when necessary.

February 2012

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Annex I

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Page 12 of Appendix 6(f)

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Annex III Key Requirements for Informed Consent and Information Sheet (I) Informed Consent The consent form should be written so that a lay person can understand the terminology. In order for consent to be given, the following information must be included: 1. Who is conducting the study and how to contact the researchers. It should be on a PolyU letterhead. 2. The procedures to be used. 3. Time commitment for the participant. 4. Potential risks to the participant (state if there are none). 5. Potential benefits (may be specific to the individual or to the knowledge base of the field of study). 6. Participation is voluntary. 7. Their right to withdraw without affecting related services in any way. 8. How the confidentiality/anonymity of their participation is ensured. 9. How the information will be used. (II) Information Sheet The following issues may be addressed in a separate information sheet as deemed appropriate: 1. Basic Information of the Project 1.1 Title of the study 1.2 Purpose of the study 1.3 Description of procedures, purpose and length of time required 2. Involvement of the Subject 2.1 Why the subject was selected 2.2 How will the subject be involved 2.3 Discomforts, inconveniences expected 2.4 Benefits and / or risks, if any 2.5 Standard treatment or alternative treatment that may be withheld 2.6 Compensation to be expected, if any 3. Confidentiality Issues 3.1 Classes of persons to whom the subjects personal data may be transferred to 3.2 How confidentiality, anonymity and privacy will be maintained 4. Rights of the Subject 4.1 Right to refuse to participate or withdraw at any time for any reason without penalty of any kind 4.2 Right to request access to and correction of the personal data supplied for the project 4.3 Sources for information and assurances that the researcher will provide further and ongoing information (e.g., name and contact phone no. of the researcher) Page 14 of Appendix 6(f)

Annex IV

Example CONSENT TO PARTICIPATE IN RESEARCH TITLE OF RESEARCH PROJECT I _______________________ hereby consent to participate in the captioned research conducted by __________________. I understand that information obtained from this research may be used in future research and published. However, my right to privacy will be retained, i.e. my personal details will not be revealed. The procedure as set out in the attached information sheet has been fully explained. I understand the benefit and risks involved. My participation in the project is voluntary. I acknowledge that I have the right to question any part of the procedure and can withdraw at any time without penalty of any kind. Name of participant Signature of participant Name of Parent or Guardian (if applicable) Signature of Parent or Guardian (if applicable) Name of researcher Signature of researcher Date

Hung Hom Kowloon Hong Kong Tel (852) 2766 5111 Fax (852) 2784 3374 Email polyu@polyu.edu.hk Website www.polyu.edu.hk

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_____________________________________

______________________________________ ______________________________________ () _________________________ () _________________________ _____________________________________ _____________________________________ _____________________________________________

Hung Hom Kowloon Hong Kong Tel (852) 2766 5111 Fax (852) 2784 3374 Email polyu@polyu.edu.hk Website www.polyu.edu.hk

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Annex V

Example INFORMATION SHEET TITLE OF RESEARCH PROJECT You are invited to participate on a study conducted by XXX, who is a staff member / postgraduate / undergraduate student of the Department of XXX in The Hong Kong Polytechnic University. The project has been approved by the Human Subjects Ethics Sub-committee (HSESC) (or its Delegate) of The Hong Kong Polytechnic University (HSESC Reference Number: XXX). The aim of this study is XXX (explain background). The study will involve completing a questionnaire, which will take you about half an hour. You will then be asked to take part in a procedure to investigate XXX. Measurements will be taken by XXX equipment (describe procedure). It is hoped that this information will help to understand the disease XXX in order to develop better treatments. The testing should not result in any undue discomfort, but you will need to (anything the subject is required to do ? e.g. disrobe, be photographed, videotaped, etc.). All information related to you will remain confidential, and will be identifiable by codes only known to the researcher. You have every right to withdrawn from the study before or during the measurement without penalty of any kind. The whole investigation will take about XXX hours. If you would like to get more information about this study, please contact Dr. XXX on tel. no. XXX or Dr. XXX on tel. no. XXX (mobile tel. no. XXX or pager tel. no. XXX); mailing address XXX and email address: XXX. If you have any complaints about the conduct of this research study, please do not hesitate to contact Dr Virginia Cheng, Secretary of the Human Subjects Ethics Sub-Committee of The Hong Kong Polytechnic University in writing (c/o Research Office of the University) stating clearly the responsible person and department of this study. Thank you for your interest in participating in this study.

Dr. XXX Principal Investigator/Chief Investigator

Hung Hom Kowloon Hong Kong Tel (852) 2766 5111 Fax (852) 2784 3374 Email polyu@polyu.edu.hk Website www.polyu.edu.hk

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Annex VI

Memo To From Email <Name of PI>, <Department> <Name of Approver>, Chair/Delegate/Deputy Chair, <Name of Committee> <email address of Approver> Date <Date of Approval Memo>

Application for Ethical Review for Teaching/Research Involving Human Subjects I write to inform you that approval has been given to your application for human subjects ethics review of the following project for a period from <Project Start Date> to <Project End Date>: Project Title: <Project Title> Department: <Full Name of Department> Principal Investigator: <Name of PI> Please note that you will be held responsible for the ethical approval granted for the project and the ethical conduct of the personnel involved in the project. In the case of the Co-PI, if any, has also obtained ethical approval f or the project, the Co-PI will also assume the responsibility in respect of the ethical approval (in relation to the areas of expertise of respective Co-PI in accordance with the stipulations given by the approving authority). You are responsible for informing the <Name of Committee> in advance of any changes in the proposal or procedures which may affect the validity of this ethical approval. You will receive separate email notification should you be required to obtain fresh approval.

<Name of Approver> Chair/Delegate/Deputy Chair (show one of them only as appropriate) <Name of Committee>

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