Human Research Ethics Protocol

Sample Questionnaire (NOT FOR OFFICIAL USE)

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The Hong Kong University of Science & Technology

Human Research Ethics Protocol Personnel Please provide the names of all personnel who will oversee or conduct work under this protocol. Notes for STUDENT PROJECTS:

• If the project is an integral part of the student’s degree (e.g. PhD Research), the supervisor should be named as PRINCIPAL INVESTIGATOR and the student listed in the RESEARCH PESONNEL (STUDENT).

• If the project is independent of the student’s degree research, and has been approved by the supervisor, the student should be named as CO-INVESTIGATOR and the supervisor listed as PRINCIPAL INVESTIGATOR below. The supervisor should contact VPRDO to add the student to the system before the student can be named as CO-INVESTIGATOR.

Principal investigator

The Principal Investigator is responsible for all work conducted under this protocol and can edit the information. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below. Last name First name

Co-lnvestigator The Co-Investigator is responsible for all assisting the PI in writing, the protocol and preparing modifications and continuation reviews. Click “Edit Selection” and select the user. If the desired user is not available, see the “Request the Addition of a New User” section below. Last name First name

If Co-Investigator who are Non-HKUST faculty, please specify the faculty and university name(s), if any.


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Research Personnel (Staff)

Other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way. Last name First name

Research Personnel (Student)

Students performing research as part of their coursework are listed here. Their faculty mentor is listed as the Principal Investigator on the protocol.

Last name First name

Signers

Individuals listed here are required to review and sign the protocol. The PI is responsible for assigning the appropriate signers below based on institutional rules. Required signers include: The PI, Co-PIs as appropriate, the PI's Department Chair (if the PI is a Department Chair then the PI's Dean needs to sign). Last name First name

Request Addition of a new User

If you are unable to locate a user by using the “Edit Selection“ button above, list that user's ITSC username, e-mail address and which personnel group they belong to in the box below.

ITSC username Email address First name, last name

Department Personnel Group (Co-I/Research Personnel/Student Research Personnel)


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General Information

Please upload the following documents in this tab by clicking the 'Attachments' button on top, if appropriate:

Mandatory: (1) Full research proposal including any questionnaire and/or interview script Mandatory if research involves children: (2) Parent/Guardian Consent Form Mandatory unless waiver has been applied for or no data collection is being taken: (3) Informed Consent Form (4) Consent script, for oral consent or email reply for consent If appropriate: (5) Deception: post debriefing form

General Information Project Title (*)

Is it a funded project? (*)

No

Yes

If yes, please specify Funding Source / Sponsor:

Internal research grants

Please specify

• Grant Title (if different from Project Title)

• Funding reference number, if applicable

Research Grants Council Please specify

• Please specify Funding Scheme

GRF

CRF

TBR

AOE

Other Funding scheme


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• Funding reference number, if applicable

Other external grant

Please specify

• Sponsor

• Funding Scheme


• Funding reference, if applicable

Contract Research

Please specify

• Sponsor


• Funding reference, if applicable

Have you submitted or intended to submit this to another HREP? (*)

No

Yes

If Yes, please specify Name of other HREPs and attach any approvals document.


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Training Principal Investigator Qualification Describe the Principal Investigator‘s Qualifications to perform or oversee the research.

Additional General Training Details For each of the Study Personnel, list their responsibilities under this protocol and describe any additional information and SOP regarding the training and qualifications of Study Personnel that may be relevant.


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Protocol/Forms Links Links to Other Protocols or Forms If this HREP is linked to another SP (Safety Protocol) or AEP (Animal Experiment Protocol) form, please select the appropriate item. If you are unable to find protocol to link, please contact the appropriate Coordinator and ask to be added to the File Access Group. (By clicking the button “Edit Selection”, a window pop up for selection of other forms. Click “+” button to choose. Click “Apply current selection”.) Edit selection Number Protocol Title Type of Protocol

Additional Details for Linked Protocols and Forms If additional details need to be discussed regarding any of the links above, describe them below


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Project Information Use lay-language, avoid acronyms or technical jargon.

Project Information

What are the objectives of your study? (*)

What are the specific study hypotheses?

What research methods will you use? Include how the data will be collected, analyzed, coded or transmitted to others, and how you would communicate to the subject. (*)

Give a bried, non-technical, step-by-step description of what the human participants will be expected to do.(*)

Describe the project and details of participation as you would do to the subjects. (*)

Will the study be carried out in specific location/facility? (*)

No

Yes

If yes, describe your facilities (the setting in which the research is going to take place) and justify that the facilities are adequate

Is this a drug study? (*)

No

Yes

If yes, answer the following questions


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What is the name of the drug? (*)

Provide a brief explanation of methods used to determine dosing. (*)

Expected maximum dosage. (*)

Duration of exposure to the drug. (*)


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Data Collection

Date Collection

Does your project use existing data? (*)

No

Yes If yes, answer the following questions Describe where you will be obtaining the data, documents, records, pathological specimens, or diagnostic specimens, i.e. medical records, existing data set, pathological specimens (waste) (*)

What is the approximate number of records or specimens that you will use? (*)

Are the data/records or specimens you are obtaining publicly available? (*) Publicly available” means that the data can be accessed without an approval process.

No

If No, please specify the approving authority for access

Yes

If Yes, please indicate where the dataset is available (e.g. web address)

Was the original dataset collected for academic research purpose? (*)

No

Yes

If Yes, answer the following question.

Do you have protocol/consent form or relevant document from the original dataset ?

If yes, please attach the consent form or relevant document.

Is the original dataset sensitive? (e.g. sexual preference, health status, criminal activity) (*)

No

Yes

If Yes, please provide full details on types of personal data to be used


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Do the original dataset contain any personal identifiers (*)?

No

Yes

If Yes, answer the following questions.

Is the personal identifier direct or indirect? (*)

Direct identifier – e.g. names, address, ID card no., etc.

Indirect identifier – e.g. assigned code that can make a subject reasonably identifiable

Will you abstract/record any subject identifiers in the data extraction process? (*)

Yes

No

N/A

New data to be collected from human participants: (*)

No

Yes If Yes, please specific sources of data to be collected:

Experimental procedures / Treatment / Intervention

Focus group

Internet survey

Observation

Personal interviews

Self-administered questionnaire

Telephone survey

Others


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Human Subjects and Recruitment Information Human Subjects Information How many participants do you expect to enrol. (*)

Describe your participant inclusion criteria. e.g. Hong Kong residents aged 18 years and above

Describe your participant exclusion criteria. e.g. people with metal implants need to be excluded from MRI

Describe your plan for voluntary and involuntary withdrawal of participants from the study. (*)

Who will perform the data collection? (*)

Where will the data collection take place, and how long will it take for each participants? (*)

Please describe the study populations by checking all that apply. (*)

Males

Females

Your own University students

Other University students

Minor – Neonates (birth to 28 days)

Minor – Infant (1 month to 6 years)


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Minor – Child (7 years to 12 years)

Minor – Teenager (13 years to 17 years)

Ma Employees les

Females

Pregnant Women

Prisoners

Minority/Minorities

Economically or Educationally Disadvantaged

Persons with Diminished Capacity

Fetuses

Recruitment How will you initially select and contact participants? (*)

Will you use any form of advertisement? (*)

All recruitment activities/materials must be reviewed and approved by the HREC prior to engaging in any recruitment activities. All advertisement must be submitted in its final form. Please attach the advertisement.

No

Yes

If yes, specify what type of advertisement? (*)

E-mail

Poster

Mailing

Telephone

Social media

Others. Please specify

Describe your screening procedures to determine if a subject qualifies for the study.


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Describe how you plan on protecting the subjects' personal privacy. (This is about the subjects'

privacy, NOT the data.) (*)

Will the subjects be compensated or given extra credit? If so describe the compensation or extra credit (*)

No

Yes

If yes, describe the compensation or extra credit.


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Investigational Drugs or devices

Investigational Drugs and Devices Are you using Investigational Drugs and Devices? (*)

No

Yes If Yes, answer the following questions. Drug and/or devices name (*)

Describe your inventory controls for storage, monitoring, and dispensing of study drugs or devices. (*)

Your submission of this application indicates that you understand that you are the only one who may use the investigational study drugs or device in the HREC approved research study. The study drugs and devices MUST be under the control and direction of the PI.

• How will you dispense the drug or device (include any other staff that has this responsibility)?

• How will you store the drug or device?

• How will you control the drug or device?

• What are the alternatives to the research interventions or treatments?


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Biological Specimens Instructions: Complete this section if you are working with a biological toxin or select agent. This will also include microorganisms which synthesize a toxic molecule lethal for vertebrates, or the biosynthesis of toxic molecules.

Biological Specimens Are biological (tissue, specimen, blood, urine) samples collected? (*)

No

Yes If yes, answer the following questions.

List biological samples to be collect (*)

Check below all that apply (*)

The research involves genetic testing.

Samples will be kept for future, unspecified use.

Samples will be made anonymous to maintain confidentiality.

Samples will be destroyed after a specified one time use.

The donor will be informed of any and all results obtained from his/her DNA.

Samples will be sold in the future.

The donor will be paid for his/her sample now or in the future.

The donor will be informed of the results of the study.

Family members will be implicated in the study. (If so, they are subjects.)

Measures have been taken to minimize the potential for psychological, social, and/or physical harm from participating in this aspect of research.

The privacy and confidentiality of the subjects will be adequately protected.

How are biological specimens stored and by whom? (*)


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Does the described use of human derived agents, tissues or cell lines have an HREP approval or exemption letter?

No

Yes

If Yes,

• Attach the HREP approval or exemption letter to this tab.

• List the IRB Protocol number and date of approval. Be sure that any referenced IBC protocol is selected on the "Protocol/Forms Links" tab.


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Risk and Benefits

Risks and Benefits What benefit to participants/society would come from this study? (*)

Check all possible risks below that apply:

No more than minimal risk

The study involves intervention, such as action research / treatment / surgical procedures of any type

The study involves deception (e.g. of the full context of the study) and/or administration of placebo

The study will involve greater than minimal privacy risks Before any attempts are made to minimize privacy risk (e.g. making the forms anonymous), the study will involve greater than minimal privacy risks to research participants, either due to collection of sensitive data, such as political behaviour, illegal conduct, drug or alcohol use and sexual conduct, or because there is some risk of re-identification using a unique identifier such as DNA

The duration of the procedures may induce greater than minimal stress, in particular, for children, given their age and capacity

The study will induce greater than minimal psychological stress/pain/discomfort

The study will expose participants to greater than minimal physical or medical risk (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.)

Major changes in diet, exercise or sleep

Use of approved/unapproved devices

Administration of physical stimuli

Administration of controlled substance(s)

Radiation/isotopes (such as x-rays, CT-scans, etc.) done for research purposes only You will need to obtain approval from Safety Panel

Recombinant DNA You will need to obtain approval from Safety Panel

Toxic, carcinogenic, mutagenic, or infectious agents You will need to obtain approval from Safety Panel

Human gene transfer You will need to obtain approval from Safety Panel

Pathogenic organisms You will need to obtain approval from Safety Panel

Others


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If you checked any of the risks above, you must describe the nature and the degree of risk or harm and how it is being minimized. (The risks and harms must be disclosed in the consent form.)

Will the study involve vulnerable participants who are unable to give informed consent, e.g. under the age of 18, mentally handicapped individuals?

No

Yes

If yes, please specify details of the age group and/or vulnerability, and attach a Parent/Guardian Consent form in the General Information Tab.

Is there any potential conflict of interest? (e.g. financial gain to the investigators, power over participants such as teacher/student relationship)

No

Yes

If yes, please state details about the conflict of interest and state how that potential conflict will be addressed.

Will this study involve matching of personal data from different data sources (e.g. multiple questionnaires)?

No

Yes

If yes, please explain what identifier will be used for matching.

Is there anything else the HREC needs to be aware of to accurately determine the risk/benefit ratio?

No

Yes

If yes, please describe.

Will medical or psychological services be needed as a consequence of the research?

No

Yes

If yes, describe how the subject will be referred to those services.


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Informed Consent When conducting research where seeking written consent is not practical or too sensitive, audio-recorded oral consent or email recorded consent might be less of a privacy risk than written consent and can be considered as an alternative.

The waiver of recorded informed consent is normally only applicable to newly collected data without personal identifiers. In this case, PIs are required to clearly specify that they are recording data without personal identifiers in their research grant proposals.

Informed Consent Will you obtain consent/assent from each participant (or their Legally Authorized Representative) ? (*)

Yes If yes, answer the following questions. How will you record informed consent? (*)

Written consent

Audio-recorded consen

Online/Email recorded consent

Explain in detail when and where subjects/parents/legally authorized representatives will be approached to obtain informed consent/assent (e.g., clinic waiting room, private room, by mail, etc.) (*)

Explain in detail how much time you will give the participants to consider participation in the study. (Potential subjects need adequate time to consider participation). (*)

Explain the steps you will take to minimize coercion and undue influence. (*)

If any of your subjects do not understand the language you speak, explain how the person obtaining consent will communicate with the participant in a language understandable to the subjects/parents/legally authorized representative.

Explain how you will determine whether subjects/parents/legally authorized representatives understand the information that was provided in the informed consent/assent document


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Will you obtain consent from each participant? (*)

Yes

No If No, answer the following questions. Following are questions to determine if a Waiver of Documentation can be used. Please note if the waiver is not granted you will have to obtain signatures from all participants. Does the proposed research, in its entirety, involve greater than minimal risk? (*)

If no, please explain.

Does the research involve procedures for which written consent is normally required outside the research context? (*) If no, please explain.

Is the informed consent the only record linking the subject to the research? (*) If yes, please explain.

If the signature would be required, is there a risk of harm to the subjects from a breach of confidentiality? (*) If yes, please state reasons.

Will each participant be asked whether he or she wants documentation linking them with the research? (*) If yes, please state how this will be done. If no, please state reasons.

No

If no, answer the following questions.

The research involves no more than minimal risk to participants. State the reasons below. (*)

The waiver or alteration will not adversely affect the rights and welfare of the participants. State the reasons below. (*)


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The research could not practicable be carried out without the waiver or alteration. State the reasons below.

Do you know the identity of respondents?

Will you provide participants with additional pertinent information after participation? (*)

Participants will be provided with additional pertinent information after participation.

Providing participants additional pertinent information after participation is not appropriate.

The research designed to study, evaluate, or otherwise examine : (*)

Please check all that apply:

Public benefit or service programs.

Procedures for obtaining benefits or services under those programs.

Possible changes in or alternatives to those programs or procedures.

Possible changes in methods or levels of payment for benefits or services under those programs.

None of the above.


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Protection of Data

Protection of Data Check all data that you will be collecting. (*)

Billing record

Medical records/chart reviews

Quality improvement records

Databases

Biological specimens

Clinical laboratory results

Images (e.g., photographs, x-rays, etc.)

Physiological measurements

Questionnaires/surveys

Interviews

Audio/video recordings

Observational

Other

Name of the location where the data is gathered. (*)

When you obtain the data, will it already be: (*)

Anonymous (without any identifiers that could link the data to a specific subject)

Unlinked (collected with identifiers, but all identifiers/codes have been removed and destroyed)

Coded (linked to a specific subject by a code-link rather than a direct identifier (e.g., name)

Identified (linked to a specific subject by personal identifiers sufficient to identify a specific subject)

Others. Please specify


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When you store the data it will be: (*)

Anonymous (without any identifiers that could link the data to a specific subject)

Unlinked (collected with identifiers, but all identifiers/codes have been removed and destroyed)

Coded (linked to a specific subject by a code-link rather than a direct identifier (e.g., name)

Identified (linked to a specific subject by personal identifiers sufficient to identify a specific subject)

Will data identifying the subjects be made available to anyone other than the PI? (*)

No

Yes.

If Yes, please specify to whom.

Who will have access to the identifiers and who will keep the link?

How long will the data containing personal identifiers be kept after publication of the first paper arising from the research project?

How long will the anonymized data be kept after publication of the first paper arising from the research project?

Describe how you plan on protecting the confidentiality of the data, where and how the research will be stored, and ultimately disposed of to ensure the confidentiality

Will you use any audio/visual recording during the study?

No

Yes.

If Yes, please answer the following questions.

• Please check all that apply.


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Photography of participants

Video-recording of participants

Audio-recording

• Please provide details and justifications for the recording and storage strategies


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PI Assurance Statement

Message to : Principal Investigators, Key Personnel, Project Directors, Study Coordinators, and Students The principal investigator undertakes the primary responsibility for protecting the rights and welfare of research participants and must be familiar with the ethical principles of human subject protection requirements of HKUST and discipline specific code of conduct.

PI Assurance Statement The principal investigator agrees to (*)

• Conduct the research according to the HREC approved protocol and in compliance with all HREC determinations.

• Disclose any conflict of interest (financial or other) that may affect the relationship with the research participant or the outcome of the research.

• Equitably recruit and select participants.

• Seek guidance from the HREC, when needed.

• Keep current on policies and procedures that affect human subject protections.

• Quickly respond to complaints or requests for information.

• Ensure each potential participant (or participant’s legally authorized representative) is informed and understands the nature of the research, voluntarily agrees to participate, signs and dates the HREC-approved informed consent, and receives a copy of the HREC-approved informed consent document.

• Maintain copies of all study records and signed consent documents for at least three (3) years beyond the study completion date.

• Promptly report to the HREC any proposed changes (e.g., protocol amendments/revised informed consents) in previously approved human subject research activities, except when necessary to eliminate apparent immediate hazards to the participant.

• Promptly report to the HREC all unanticipated problems involving risks to participants or others. Provide continuing review and closure reports to the HREC in a timely manner and in accordance with the HREC approval period.

• Ensure educational training on human research protections is completed by the investigators, key personnel, study coordinators, and students materially involved with the research study. This requires completing any courses required by HREC Policy.

I have read and agree to follow the PI Assurance statement above Checklist of attachments (*) Check the boxes as appropriate to indicate documents that have been enclosed

Full research proposal including any questionnaire and/or interview script Mandatory.


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Parent/Guardian Consent Form Mandatory if research involves children.

Informed Consent Form Mandatory unless waiver has been applied for or no data collection is being undertaken.

Consent script, for oral consent or email reply for consent Mandatory unless waiver has been applied for or no data collection is being undertaken.

Deception: post debriefing form If appropriate.

Human Research Ethics Protocol

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