Review of Submitted Protocol

All research proposals shall be subjected to full review by all the members. Primary reviewer assigned by the Member Secretary will review and present the project in the meeting.

While reviewing the research protocols, the following points should be carefully assessed for risk/benefit analysis

1. Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture (Refer AP5/V1).

2. Prospective collection of biological specimens for research purposes by noninvasive means.

For instance

a. Skin appendages like hair and nail clippings in a non-disfiguring manner.

b. Dental procedures - deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction of permanent teeth; supra and sub gingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth.

c. Excreta and external secretions (including sweat).

d. Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum or by applying a dilute citric solution to the tongue.

e. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings.

f. Sputum collected after saline mist nebulization and bronchial lavages.

g. Collection of data through noninvasive procedures routinely employed in clinical practice.

h. Where medical devices are employed, they must be cleared/ approved for marketing, for instance (Refer AP18/V1 detailed guideline for submitting project of medical devices):

i. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant’s privacy.

j. Weighing or testing sensory acuity.

k. Magnetic Resonance Imaging.

l. Electrocardiography, Echocardiography Electroencephalography, Thermograph, detection of naturally occurring radioactivity, Electroretinography, Ultrasound, Diagnostic Infrared Imaging, Doppler Blood Flow and other similar procedures.

m. Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

n. Research involving clinical materials (data, documents, records, or specimens) that will be collected solely for non-research (clinical) purposes.

o. Collection of data from voice, video, digital, or image recordings made for research purposes.

p. Research on individual or group characteristics or behavior not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

q. Research involving collection and storage of genetic materials (Refer AP9/V1)

r. Research involving gene therapy and gene transfer protocols (Refer AP10/V1)

Elements of review

The primary task of the IEC is review of research proposals and their supporting documents with special attention given to the informed consent process, documentation, and the suitability and feasibility of the protocol. IEC will take into account prior scientific review by the Research committee/department/funding agency/doctoral committee/scientific committee, and the requirements of applicable laws and regulations.

The following will be considered, as applicable

Scientific design and conduct of the study

a. The justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants and the concerned communities.

b. The justification for the use of control arms; criteria for prematurely withdrawing research participants.

c. Criteria for suspending or terminating the research as a whole.

d. The adequacy of provisions made for monitoring and auditing the conduct of the research, the adequacy of the site, including the supporting staff, available facilities, and emergency procedures.

e. The manner in which the results of the research will be reported and published.

Care and protection of research participants

a. Suitability of the investigators’ qualifications and experience for the proposed study.

b. Any plans to withdraw or withhold standard therapies for the purpose of the research, and the justification for such action.

c. Medical care to be provided to research participants during and after the course of the research.

d. Adequacy of medical supervision and psycho-social support for the research participants

e. Steps to be taken if research participants voluntarily withdraw during the course of the research.

f. Criteria for extended access to, the emergency use of, and/or the compassionate use of study products.

g. Arrangements, if appropriate, for informing the research participant’s general practitioner or family doctor, including procedures for seeking the participant’s consent to do so.

h. Description of any plans to make the study product available to the research participants following the research; a description of any financial costs to research participants (Refer AP6/V1).

i. Rewards and compensations for research participants (including money, services, and/or gifts).

j. Provisions for compensation/treatment in the case of the injury/disability/death of a research participant attributable to participation in the research (Refer AP3/V1, See Also ICMR Draft Guidelines 2006, p25 on compensation).

k. Insurance and indemnity arrangements.

Protection of research participant confidentiality

a. A description of the persons who will have access to personal data of the research participants, including medical records and biological samples.

b. The measures taken to ensure the confidentiality and security of personal information concerning research participants.

Participant information document and consent process

a. A full description of the process for obtaining consent, including the identification of those responsible for obtaining consent (Refer AP6/V1 & AP7/V1).

b. Adequacy, completeness, and comprehension of written and oral information to be given to the research participants, and, when appropriate, their Legally Acceptable Representative(s) (Refer AP7/V1).

c. Clear justification for the intention to include research participants who cannot consent, and a full account of arrangements made to obtain their consent /authorization.

d. Assurances that research participants will receive information that becomes available during the course of the research relevant to their participation including their rights, safety, and well-being.

e. Provisions made for receiving and responding to queries and complaints from research participants or their representatives during the course of a research project.

Community considerations

a. Impact and relevance of the research on the local community and on the concerned communities from which the research participants are drawn.

b. Steps taken to consult with the concerned communities during the course of designing the research.

c. Influence of the community on the consent of individuals.

d. Proposed community consultation during the course of the research.

e. Extent to which the research contributes to capacity building, such as the enhancement of local healthcare, research, and the ability to respond to public health needs.

f. A description of the availability and affordability of any successful study product to the concerned communities following the research.

g. The manner in which the results of the research will be made available to the research participants and the concerned communities.

Recruitment of research participants

a. The characteristics of the population from which the research participants will be drawn (including gender, age, literacy, culture, economic status, and ethnicity) (Refer AP1/V1).

b. The means by which initial contact and recruitment is to be conducted.

c. The means by which full information is to be conveyed to potential research participants or their representatives.

d. Inclusion criteria for research participants.

e. Exclusion criteria for research participants.

Communicating decision

The decision will be communicated in writing by the Member Secretary to the PI, preferably within a period of 10 days of the IEC meeting at which the decision was made.

The communication of the decision will include,

1. A clear statement of the decision reached.

2. Validity of approval usually will be yearly; for multiyear projects, however changing on case to case basis.

3. Any suggestions by the IEC.

4. A conditional decision (i.e. approval with recommendations or modifications, suggestions for revision and the procedure, any other requirements by the IEC), will be valid only for six months from the date of issue of letter. If the PI does not comply with the IEC suggestions during three months, a reminder will be issued. The modifications will be reviewed by Member Secretary, IEC or IEC subcommittee and /or may be referred for full board review.

5. In the case of a positive decision, the PI is notified of the following requirements through an approval letter.

6. PI requested to Communicate date of start of study to IEC.

7. Submission of progress report(s) decided on case to case basis, usually yearly.

8. The need to notify the IEC in cases of protocol amendments (other than amendments involving only logistical or administrative aspects of the study).

9. The need to notify the IEC in the case of amendments to the recruitment material like the potential research participant information, or the informed consent form.

10. The need to report serious and unexpected adverse events related to the conduct of the study

11. The need to report unforeseen circumstances, the termination of the study, or significant decisions by other IEC.

12. The information the IEC expects to receive in order to perform ongoing review.

13. The final summary or final report.

14. The schedule/plan of ongoing review of sponsored trials.

15. In the case of a negative decision, the reasons should be clearly stated in the communication to the PI.

16. The PI will also be notified of the duration of the approval, which normally will not exceed one year or duration of project whichever is later.