9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them? 

HDEC must review the methods and material that investigators propose to use to recruit participants.

Direct advertising for research participants is allowed and not considered an objectionable practice.

HDEC considers advertising clinical research studies to potential participants to be part of the informed consent process. All participant-facing recruitment material for HDEC-approved studies must be approved by HDEC prior to use.

The guidelines have been developed to help prevent potential participants from being confused, misled, or unduly influenced by advertising material.

Recruitment materials that should be submitted to HDEC include:

• Ad copy for digital platforms, including but not exclusive to Facebook, Twitter, paid search platforms, and banners.
• Website text for landing pages
• Scripts for phone recruitment
• Video advertisements
• Print advertisements, including text and images to be used. Note that the order of the text submitted should not be altered in any final advertisement.
• Text for radio advertisements
• News articles or advertorials designed to drive recruitment.

Where personal / health data is collected during the pre-screening process for a specific study or suite of studies, the following should be submitted:

1. The pre-screening questionnaire
2. Information about the management of questionnaires (access, storage, potential use including retention for other clinical trials, maximal retention timeframe). This should specifically address data collected from potential participants who do not complete the questionnaire for any reason, or who fail the pre-screening questionnaire.
3. Where a third-party clinical trial recruitment company is utilized, the company’s privacy policy should be included with the submission and made clearly available to potential participants.

HDEC will review content, as well as the font size and type, and other visual effects, in determining whether materials meet the following guidelines:

1. No explicit or implicit claims should be made that the investigational treatment is safe or effective unless this has been proven in the population and indication under study. Potential therapeutic benefits should not be overstated. Example: “Want to improve your diabetes? Enroll in our trial.” would not be approved by HDEC.
2. No explicit or implicit claims should be made that the investigational treatment is equivalent or superior to existing treatments unless this has been proven in the population and indication under study.
3. Recruitment materials should not use language such as "new treatment", "new medication", "new drug" or “new device” to describe investigational treatments, without explaining that the treatment is investigational. Such phrases may lead potential participants to believe that they will be receiving a treatment that has already been approved by Medsafe. Example: "investigational medication" or “potential new medication” would be approved, but "new medication" or “new treatment” would not be approved. If the study involves an approved product this may be indicated, and the investigational component of the research outlined.
4. For therapeutic studies where participants will receive investigational treatment or a placebo, this should be stated. Potential participants may otherwise assume they will all receive active treatment.
5. Phrases such as “Hurry”, “Call now”, “Don’t miss out”, “Places filling fast”, and “Enrolment limited” should not be used.
6. Recruitment materials should not promote "free medical treatment" or “free specialist care” to refer to study-related care participants will receive.
7. Potential study benefits should not be over-emphasized. The relative size of the type used and other visual effects (placement of information, bolding, change in color, animation, exclamation marks, etc) should not unduly promote compensation or benefits.
8. If the trial is paid, specific compensation may be mentioned, but not emphasized e.g. through prominent placement, larger or bolder type, or other devices (flashing font, exclamation marks, etc.). Specific compensation should in general not be mentioned in recruitment material aimed at pediatric populations.
9. Language, language devices or images that may be perceived as misleading, deceptive, ambiguous, or which play on fear should not be used. Example: “Asthma can be dangerous in kids” would not be approved by HDEC.
10. For commercially sponsored or funded trials, the study funder should be stated.
11. Where a third-party recruitment company is recruiting on behalf of a sponsor and/or research site, the name and address of the research site and/or Sponsor should be included.
12. A statement that the study has been approved by HDEC, together with the HDEC study reference number, should be included.
13. If stock photos of persons are used in recruitment material, efforts should be made to ensure that these are representative of the New Zealand population.
14. Though not required, advertising material may include the following information to help potential participants make the decision to take part in a study:
    1. the condition under study,
    2. the purpose of the research,
    3. a summary of eligibility criteria in lay language,
    4. a general description of the time commitment for the study,
    5. who to contact for more information.

9.2 Vulnerable Subjects

Vulnerable subjects are those "who have restricted capability to make independent decisions about their participation in the study".

The inclusion of vulnerable subjects is discussed in the National Ethical Standards for Health and Disability Research and Quality Improvement.

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

Before undertaking research with children, the investigator must ensure that legally valid consent is sought on the basis of the information provided:

1. The consent of a child of or over the age of 16 must be obtained and has the same effect as if the child were of full age, provided the child does not lack competence for reasons other than age.
2. If the child is below the age of 16 but has the competence to understand the nature, risks, and consequences of the research:
   • the consent of the child must be obtained, and
   • that consent will have the same effect as if the child were of full age.
3. If the child is below the age of 16 and lacks the necessary competence to give legally effective consent:
   • proxy consent to the child’s participation must be obtained,
   • the child’s assent must be obtained unless the child is unable to communicate,
   • the refusal of a child to participate in research must be respected unless:
     • according to the research protocol, the child would receive therapy for which there is no medically acceptable alternative, or
     • the research comes within the scope of 3.8.3(a) (see link below).
4. Consent and assent are dynamic, continuous processes and should be checked throughout the study to ensure they are maintained. If during the study the child attains competence to give legally effective consent, the child’s consent must be obtained and will replace the proxy consent.
5. Only one parent or legal guardian is required to give proxy consent. However, if there is more than one parent or guardian, and the research is not routine, then there is an expectation that the person giving proxy consent will consult all of the other parents or legal guardians. The researcher should make the person giving proxy consent aware of their duty to consult and, if practicable, the time to consult.
6. If the researcher becomes aware that the person who gave proxy consent to the child's participation has been replaced, proxy consent should be obtained from the child's new legal guardian as soon as practicable.
7. Care must be taken to ensure that no pressure is placed upon a child to consent to participate in research, especially if the procedures are not intended to be of direct benefit to the child participants.
8. The requirement for written consent should take into consideration the age and competence of the child.

Research Involving Children - https://www.hrc.govt.nz/sites/default/files/2019-06/Resource%20Library%20PDF%20-%20Research%20involving%20children.pdf

9.4 Financial Disclosures

Researchers must declare any financial matters which may represent a real or perceived conflict of interest.

https://neac.health.govt.nz/assets/Uploads/NEAC/publications/national-ethical-standards-health-disability-research-quality-improvement-2019-v3.pdf

9.5 ICF translations – Are Certificates Required? 

Not applicable.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

1. Each clinical trial sponsored by a manufacturer of a pharmaceutical or medical device and conducted in NZ public health organizations must be covered by an Indemnity and Compensation Agreement between the site and the trial sponsor.
2. The intention is that this sICA can be used by all NZ DHBs without modification to speed the process of approval of clinical trials and remove the need for a lengthy and difficult negotiation.
3. This sICA has been developed for use in all industry-sponsored clinical trials that take place in NZ DHBs.
4. This sICA does not cover clinical trials that are:
   1. sponsored by collaborative clinical trial groups;
   2. are investigator-initiated;

as compensation for injuries caused to participants as a result of their participation in these clinical trials is covered by NZ’s statutory no-fault compensation scheme (Injury Prevention, Rehabilitation, and Compensation Act 2001).

Standard Indemnity And Compensation Agreement For Clinical Trials In New Zealand Public Health Organizations: https://www.adhb.health.nz/assets/Uploads/ADHB-NZ-DHB-Standard-Indemnity-01Jul10-v2-0-incl-Guidance-Document2.doc