Page 6 - Standard Operating Procedures (SOPs)

Circle the appropriate answer to each of the following

(If not Applicable write NA)

1. Source of Population: 4.Are subjects clearly informed about?
(a) Nature and Yes No
(a) ILL Participant Yes No purposes of study
(b) Non ILL Participant Yes No (b) Procedures to be Yes No
(c) Minors or persons Yes No followed including
under guardianship alternatives used
(c) Physical risks Yes No
2. Does the study involve? (d) Private questions Yes No
(e) Invasion of the Yes No
(a) Physical risks Yes No Body
To the subjects (f) Benefits to be Yes No
(b) Social Risks Yes No Derived
(c) Psychological Yes No (g) Right to refuse Yes No
Risks to subjects to participate or
(d) Discomfort to Yes No to withdraw from study
Subjects (h) Confidential Yes No
(e) Invasion of the body Yes No handling of data
(f) Invasion of Privacy Yes No (i) Compensation Yes No
(g) Disclosure of Yes No where there are risks or
Information damaging to loss of working time or
Subject or others privacy is involved in
3. Does the study involve? any particular procedure
(a) Use of records, Yes No 5.Will signed consent form/verbal
(Hospital, medical, Death, birth or other) consent be required?
(a) From Subjects Yes No
(b) Use of fetal tissue Yes No (b) From parent or Yes No
Or abortus guardian (if subjects are minors)
(c) Use of organs or Yes No 6. Will precautions be Yes No
Body fluids taken to protect
anonymity of subjects

SOP OF BMRC ETHICAL GUIDELINE Page 5