Aim

Ensuring study participants are treated properly

Description

General
Respect for individuals taking part in studies is not just limited to observing regulations or procedures. Researchers and research assistants should be open towards, and feel responsible for the needs of study participants. The researcher should approach participants with general courtesy and respect. Try to put yourself in the participant’s shoes and try to think what the participant would find unpleasant. Certain measurements can be uncomfortable or burdensome, such as physical or cognitive tests, or an interview about a sensitive topic.
The researcher needs to ensure there is a relaxed atmosphere, in which the participants are always aware they can stop participating should they wish to do so.

Information
The researcher should provide concrete information prior to/during recruitment, including what exactly is expected from participants, what they have to do, whether they can leave immediately after a test or whether they need to recover with a cup of coffee or tea, etc. These issues should be addressed in an information brochure or participants' letter. This information should also be provided just prior to the measurements.
The information provided may include timelines for responses, for instance that you will contact them after x weeks, or send a newsletter or (interim) report. The participant should be contacted if these timelines aren’t going to be achieved.

Physical examination
The level of undressing needs to be explicitly described in the information brochure. The researcher needs to ensure that the study participant’s privacy is optimally safeguarded, by ensuring, amongst other things, adequate study rooms with screens (if required). It is preferable for the physical examination to be carried out by staff that is of the same sex as the research participant. If this cannot be guaranteed in advance, it will need to be clearly stated.

Researchers may only conduct physical examinations if they are sufficiently skilled and authorised to do so.

You also need to carefully consider the order in which the physical measurements are carried out. Do not leave people standing in their underwear for long periods of time; take the measurements and allow them to get dressed again.

If a participant indicates (verbally or non-verbally) that he/she havs a problem with a specific part of the study, a researcher should respect this, and look for a solution along with the participant.

Cognitive tests
Cognitive tests can be taxing/tiring, particularly for old(er) participants. Often there are both short and full versions of tests. Present participants with the short version first; if they score well on this, then continuing with a more burdensome test will probably not be necessary. A pilot study can be very useful to test what the best approach to this is.

In-depth interviews
It is not always possible to properly estimate in advance how taxing an interview will be for a participant. An interview may, for instance, be taxing for the elderly or for sick participants, or if the interview covers a sensitive topic, such as euthanasia or screening for genetic disorders. Indicate before the interview starts that the participant does not have to answer the question if he/she doesn’t want to, and also indicate clearly in advance precisely what will happen to the interview and how confidentiality will be maintained. If the interview appears to be too intensive for someone, you can suggest that the interview is broken up across multiple time points.

Complaints
If a study participant has a complaint about the study, the researcher should pass on the complaint immediately to the project leader. The project leader should inform the relevant professor and work together with the researcher towards solving the complaint. If a solution cannot be found through this process then the Complaints Committee of the VUmc should be contacted. The Medical Affairs Office (bureau medische zaken) should be contacted for any insurance claims. Also look at the Ready to Go guideline (1.1A-01).

V1.1: 1 Jan 2010: English translation.
V1.0: 19 Oct 2006.