Expedited Review Process

Research Eligible for Review

ERRC may use the expedited review procedure to review minor changes in a previously approved research during the period for which approval is authorized (usually, one year from the most recent approval).

The expedited review procedure may be used to review research which involves no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods):

Collection of:

1.                   hair and nail clippings, in a non-disfiguring manner;

2.                   deciduous teeth; and

3.                   permanent teeth if patient care indicates a need for extraction.

Collection of excreta and external secretions including:

1.                   Sweat

2.                   Uncannulated saliva,

3.                   Placenta removed at delivery, and

4.                   Amniotic fluid at the time of rupture of the membrane prior to or during labour.

            Recording of data from subjects aged 18 years and above using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. Includes such procedures as:

1.                   weighing,

2.                   testing sensory acuity,

3.                   electrocardiography,

4.                   electroencephalography,

5.                   thermography,

6.                   detection of naturally occurring radioactivity,

7.                   diagnostic echography, and

8.                   diagnostic electroretinography.

           This does not include exposure to electromagnetic radiation outside the visible range (e.g.., x-rays, microwaves).

           Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant. All collection of blood requires a trained and qualified practitioner.

            Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.

            Voice recordings made for research purposes such as investigations of speech defects.

            Moderate exercise by healthy volunteers.

            The study of existing data, documents, records, pathological specimens, or diagnostic specimens.

           Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate a subject's behavior and the research will not involve stress to the subjects.

           Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.

Application Instructions for Expedited Review

The applicants shall submit the proposal indicating that the above stated criteria is met.  The proposal will be submitted in duplicate.  The Secretariat/chairman will have discretion of reviewing it or giving it to one of the members to review within one week.  The secretary/chairman will communicate the decision to the applicant without the full committee sitting.

Appeals

A procedure for appeals will be followed as:

1.       Calling the researcher for questioning

2.       Sending the proposal to another ERRC  committee

3.       Sending the proposal to the National Council of Science and Technology

Complaints and Suggestions

A suggestion box will be put outside the secretariat for receiving complaints and suggestions. The box will opened by the secretary to the ERC in presence of one one member. The suggestions and complaints will be read during a meeting a responses drafted jointly. Alternatively the members of the public will be encouraged to write to the chairman indicating the nature of complaint or suggestions.

Periodically the committee will have a survey to assess its functions and shortcomimg in view of improving its services.