Research Recruitment and Privacy

Recruitment of study participants is a key component of any research study, as it will determine the quantity of data collected and hence the power of the study to draw valid conclusions.

There are a number of methodologies that can be employed to recruit study participants and care needs to be taken to ensure that the method selected does not breach NSW or Commonwealth privacy legislation. Penalties for breaches of privacy can be very severe.

You should familiarise yourself with the following:

• Statutory Guidelines on Research under the NSW Health Records and Information Privacy Act 2002

• Statutory Guidelines on the Collection of Health Information from a Third Party under the Health Records and Information Privacy Act

• Guidelines approved under Section 95A of the Privacy Act 1988

• Guidelines under Section 95 of the Privacy Act 1988

• Statutory Guidelines on Research under section 27B of NSW Privacy and Personal Information Protection Act 1998

Methods of Recruitment

The following methods can be used when the researcher has an existing clinical relationship with the potential participant:

1. Personal (face-to-face) invitation from a researcher who is a member of a patient’s clinical team during a routine consultation.

2. Personal (letter / email / telephone call) invitation from a researcher who is a member of a patient’s clinical team.

**Methods 1 and 2 do not represent a breach of privacy. The invitation to participate in a research study is being initiated by a person who routinely deals with the patient in a clinical setting, and is therefore aware of the patient’s relationship with the hospital / clinic and the reason for it.**

The following methods can be used when the researcher does not have a clinical relationship with the potential participant who is a current patient:

3. Recruitment advertisement placed in a clinic waiting room, university noticeboard or community noticeboard inviting contact with a researcher.

4. Recruitment advertisement placed on a social media platform inviting contact with a researcher.

**Methods 3 and 4 do not represent a breach of privacy. The onus is on the person reading the advertisement to decide whether or not to contact the researcher about participating in the study.**

5. A member of the clinical team can verbally introduce the study to the patient during a consultation. Interested patients can be asked whether they would like to meet the junior researcher at the end of the consultation. If they agree, then this introduction will establish a relationship with the junior researcher.

6. A member of the clinical team can verbally introduce the study to the patient during a consultation. Interested patients can be asked whether they agree to being contacted by the junior researcher and, if so, ascertain the appropriate method of contact, eg telephone, letter, email. This verbal consent to be contacted by the junior researcher should be noted in the patient’s medical record. The junior researcher can then be given the patient’s contact details to contact the patient.

**Methods 5 and 6 do not represent a breach of privacy. The invitation to participate in the study has been initiated by a member of the patient’s clinical team (defined as a medical officer, nurse or allied health professional who routinely sees the patient as part of their clinical care). The patient has also provided verbal consent to be contacted by the researcher.**

7. A member of the clinical team can hand a package of information about the study and the junior researcher’s role in the study to a patient at the conclusion of a consultation. It could contain a letter of invitation, Information for Participants, Expression of Interest / Participant Consent Form and reply-paid envelope addressed to the junior researcher. Patients interested in learning more about the study or in participating in it can return the Expression of Interest form or Participant Consent Form, thus establishing a relationship with the junior researcher. The junior researcher can then contact the patient.

8. A letter of invitation can be mailed / emailed by a member of the clinical team introducing the study and the junior researcher’s role in the study to the patient. It can be accompanied by Information for Participants, an Expression of Interest form and/or a Participant Consent Form and, if mailed, a reply-paid envelope addressed to the junior researcher. Patients interested in learning more about the study or in participating in it can return the Expression of Interest form or Participant Consent Form, thus establishing a relationship with the junior researcher. The junior researcher can then contact the patient.

**Methods 7 and 8 do not represent a breach of privacy. The invitation to participate in the study has been initiated by a member of the patient’s clinical team (defined as a medical officer, nurse or allied health professional who routinely sees the patient as part of their clinical care). The patient has also provided written consent to be contacted by the researcher, by completing the Expression of Interest form.**

9. A letter of invitation can be mailed / emailed by a member of the clinical team introducing the study and the junior researcher’s role in the study to the patient. This could invite interested patients to ring or email the junior researcher about the study, thus establishing a relationship with the junior researcher.

**Method 9 does not represent a breach of privacy. The invitation to participate in the study has been initiated by a member of the patient’s clinical team (defined as a medical officer, nurse or allied health professional who routinely sees the patient as part of their clinical care). The patient has also provided implied consent by contacting the researcher.**

10. In the case of a study involving a medical record review and an associated survey / questionnaire, a letter of invitation can be mailed / emailed by a member of the clinical team introducing the study and the junior researcher’s role in the study to the patient. It can be accompanied by Information for Participants, a Participant Consent Form, the survey / questionnaire and, if mailed, a reply-paid envelope addressed to the junior researcher. Patients interested in participating in the study can return the Participant Consent Form and completed survey / questionnaire, thus establishing a relationship with the junior researcher. The junior researcher can then contact the patient if clarification of any issues arising from the medical record data collection is needed.

**Method 10 does not represent a breach of privacy. The invitation to participate in the study has been initiated by a member of the patient’s clinical team (defined as a medical officer, nurse or allied health professional who routinely sees the patient as part of their clinical care). The patient has also provided written consent by completing the Participant Consent form.**

11. In the case of a study involving an anonymous survey / questionnaire, a letter of invitation can be mailed / emailed by a member of the clinical team introducing the study and the junior researcher’s role in the study to the patient. It can be accompanied by Information for Participants, the survey form and a reply-paid envelope. Interested patients can complete and return the survey to the junior researcher.

**Method 11 does not represent a breach of privacy. The invitation to participate in the study has been initiated by a member of the patient’s clinical team (defined as a medical officer, nurse or allied health professional who routinely sees the patient as part of their clinical care).Also, the patient has provided de-identified information. **

It is important to note that a breach of privacy may occur if a researcher, with no prior relationship with a person, contacts the person to invite them to participate in a study. For example, a junior medical officer, medical, nursing or allied health student, new to a hospital department or clinic, wishes to undertake a project involving patients of their department / clinic, as part of their studies. This junior staff member contacts the patient, however they have no clinical relationship with the patient and have never met them before.

This contact may lie outside the patient’s reasonable expectation regarding the use and disclosure of their personal health information. This means that the patient believes that the study does not closely relate to their care and treatment and/or that it was not communicated to them during their consultation.

The following methods can be used when the researcher does not have a clinical relationship with the potential participant who is a discharged patient:

12. Where researchers are seeking contact with past patients with a particular diagnosis and with whom the hospital / clinic no longer has an ongoing relationship, written contact via the head of the relevant hospital department or clinic or via the head of the Medical Records Department to invite research participation may be acceptable. Depending on the nature of the disease and the time that has elapsed since the hospital / clinic’s last contact with the patient, researchers should consider the appropriateness of reviewing the Death Register to reduce the risk of attempting to contact a patient who is deceased.

13. Similarly, it may also be acceptable for the custodian of a cancer registry to write to patients to invite them to consider research participation. Again, steps should be taken to reduce the risk of attempting to contact a deceased patient.

Where researchers are proposing to telephone patients, the HREC will wish to review the script of the telephone call. This should cover the following contingencies:

That someone other than the patient answers the telephone. This is particularly important, as the person answering the telephone may not be aware of the patient’s diagnosis, so care must be taken to ensure that whatever is said does not breach the patient’s privacy;
That the patient answers the telephone, but it is not a convenient time for them to talk to the researcher about the study;
That the patient answers the telephone, but is no longer interested in participating in the study;
That the patient is deceased and the telephone call is answered by a family member who may be distressed by the approach.

Also, remember that such scripts should include a footer with page numbering in the format “Page X of Y”, a version number and a date.

If you have any concerns about your proposed recruitment methodology, please contact the Executive Officer of your hospital’s HREC, who will be able to advise you on whether there is potential for your proposal to breach patient privacy.

To assist researchers, a template ‘Letter of Invitation from Clinical Team’ is available here along with the templates for the Information for Participants, Participant Consent Form, and Expression of Interest form.

Updated: 22 November 2017