Category

Description

Protocols involving children or adolescents

Any research involving a patient under 17 requires the following:

Permission from natural or adoptive parents

Assent of the patient

Retrospective medical record review

This research may require only the review of existing medical
records without any personal contact with the research subject provided that HIPPA guidelines are met.

For example, the information that the researcher obtains may be used for:

Describing attributes of a particular diagnostic type

Preparing clinical case reports

Appraising the utility of laboratory or diagnostic procedure

Surveys and samples

This research involves the following:

Obtaining verbal information from the patient or his/her relatives by ways such as:

Questionnaires

Extended histories

Psychological tests

Rating scales

Collecting biological samples such as blood and urine

Psychobiological research

The goal of this research is to define the psychobiological aspects of a disorder in order to do the following:

Increase diagnostic sensitivity

Improve prognosis

Invasive tests such as the following may be required to define the psychobiological aspects:

PET scan

Dexamethasone suppression tests

Specimens of cerebrospinal fluids

Non- pharmacologic research

The goal of this research is to study non-pharmacological, primarily psychosocial, techniques of treatment.

It is necessary that the protocol and consent form describe the nature of the treatment

Example:

Similarities between the research treatment and accepted treatments

The schedule and length of interventions

Any impact on the length of stay

New drug research

New drugs can be tested as the following:

Studied alone Example: Dose-ranging new drugs in open studies

Compared with other treatments Example: Placebo or comparison drugs in blind

Psycho- pharmacological research on new aspects of use of accepted drugs

This research studies the following:

Improving available drugs

Assessing the treatment's impact on the patient

Such studies involve the following:

The systematic study of drug combination

Potential new indications

The value of monitoring plasma drug concentrations

The effect of drugs on biological systems

The treatment of drug side effects