Page 39 - Ethical Guidelines for Conducting Research Studies Involving Human Subjects

appropriate authorities. However, the following important factors that are
unique to medical devices should be taken into consideration while
evaluating the related research projects:

 Previous safety data of the medical device in animals should be
obtained and likely risks posed by the device should be considered.

 Phase I trial is not necessary in medical and medicated devices
trails as they are not used in healthy volunteers.
 Comparatively medical devices used within the body may have
more risk than those used on or outside the body, for example,
orthopedic pins vs. crutches.

 Medical devices not used regularly have less risk potential than
those used regularly, for example, contact lens vs. intraocular
lenses.

 Safe procedures to introduce a medical device in the patient
should also be followed as the procedure itself may cause harm to
the patient.

 Like drug trials, informed consent procedures should be followed.
The patient information sheet should contain information on follow-
up procedures to be adopted if the patient decides to withdraw from
the trial.
 Study design of the intra body devices like implants can be very
challenging and should have adequate protective safeguards. The
study should be long enough to detect if there are any late onset
ADRs.

 If in phase III full assessment of safety is not complete, the Phase
III could extend to Phase IV.

10.4 DIAGNOSTIC AGENTS USE OF RADIO-ACTIVEMATERIALS
AND X- RAYS

X-rays, gamma rays, beta rays, radioactive and radio opaque materials are
often used for investigation and treatment of different diseases. In such
cases doses of radiation must not exceed the radiation limit set by the
regulatory authority Bangladesh Atomic Energy Commission (BAEC).

Special Concerns

 Data should be obtained using method that exposes the participant
to least radiation.
 In case of death of a participant exposed to lethal radiation or
radiological implant, necessary precaution as per radiological
guideline must be taken to protect the relatives and neighbors.

BMRC ETHICAL GUIDELINE ON HUMAN SUBJECTS Page 35