Institutional Ethics Committee Annexures

Vulnerable Populations and Informed Consent:

Persons who may not be able to make free and informed decisions about their participation in research or medical care are considered vulnerable Vulnerable populations may be easily coerced or have limited freedom to choose. Persons identified as vulnerable have additional safeguards in the research informed consent process

Vulnerable Populations protected in regulation are:

1. Children and wards of the state
2. Prisoners
3. Pregnant Women and fetuses
4. Cognitively Impaired

Other accepted vulnerable populations are:

1. Non-English speaking persons
2. Illiterate persons
3. Financially impaired
4. Terminally Ill

Informed Consent & Prisoners:

Prisoners, due to the lack of control of their circumstances are considered vulnerable DO NOT enroll prisoners unless you check with the IRB first. There MUST be a prisoner representative on the IRB if a prisoner is enrolled. If a person becomes a prisoner during a trial, notify the IRB immediately. Informed consent for a prisoner would state that participation will not be considered in parole consideration. Must state that risks for prisoner in this study same as for a non-prisoner. If a prisoner is treated in a research study and the IRB is not aware or does not have a prisoner advocate on the committee, federal regulatory bodies must be notified.

Informed Consent & Pregnant Women:

Researchers should obtain informed consent from both the pregnant woman and the father.

Consent of the father is not necessary if:

1. The purpose of the study is to meet the health needs of the mother.
2. The identity or whereabouts of the father cannot be reasonably ascertained.
3. The father is not reasonably available.
4. The pregnancy is the result of rape.

NOTE: Research targeting pregnant women as subjects does not qualify for an exempt status.

Informed Consent in Fetal Research:

Ex Utero Research Study: personnel may play no part in determination of fetal viability Many regulatory restrictions based upon viability of fetus. Mother and father must be legally competent and have given their informed consent. (Consent of Father may not be required). If anticipating this type of research, contact IRB or ORC during planning phases.

Informed Consent & Cognitively Impaired:

Persons with diagnosed cognitive impairment such as mental retardation, dementia, and coma, can participate in research. This type of research must specifically address how an individual’s capacity to give informed consent will be determined. The signature of a legally authorized representative will be required Research with Cognitively Impaired subjects cannot be considered exempt by the IRB. Document carefully the enrollment of persons whose cognitive status is not outwardly obvious e.g. stroke patients, psychiatric patients or persons with speech or language disorders. If a person is enrolled in a study during a period of cognitive impairment and regains his ability to give consent – he must be re-consented.

Informed Consent & Illiterate Persons:

An investigator may enroll individuals, who can speak and understand English, but cannot read or write. The potential subject must be able to place a written mark on the consent form. The subject must also be able to Comprehend the concepts of the study and understand the risks and benefits of the study as it is explained verbally, and Be able to indicate approval or disapproval for study enrollment. Additional items to document:

1. What method was used to communicate the information about the study
2. Who was present during the Informed Consent Interview
3. The specific ways that the subject communicated agreement to study participation

ANNEXURE -12

‘SOP’ document describing the responsibilities and the procedures, including audit, necessary to safely and accountably manage any set of processes, in handling and management of controlled substance i.e. narcotic drugs and psychotropic substance.

Purpose:

Controlled drugs (CDs) are subject to special legislative controls because there is a potential for them to be abused or diverted, causing possible harm. Therefore the purpose of this document is to promote the safe, secure management and effective use and arrangement of all controlled drugs. Provisions are made for, the appointment of an Accountable Office within pharmacy under the supervision of medical authority. Document shall ensure safe systems are in place for the management and usage of CDs, monitoring and auditing. It provides declarations and self-assessments for CDs are undertaken in accordance with the regulations.

Procedure

1. Storage of controlled drugs
   1. CDs must be stored in a double locked cupboard within the designated licensed premises issued by regulatory authority under drug and cosmetic rules 1945.
   2. This may be separate from or within another medicines cupboard used to store internal medicines but should meet the minimum requirements of the drug and cosmetic rules 1945.
   3. Only controlled drugs or suspected illicit substances should be stored within the locked internal cupboard
   4. The Controlled Drugs cupboard must be kept locked at all times when not in use, and the keys accessible to registered staff only.
2. Access to controlled drugs
   1. The one key to the CD cupboard must be kept on the person of a “registered Pharmacist” {registered Pharmacist” means a person who is a registered Pharmacist as defined in clause (i) of section (2) of the Pharmacy Act, 1948 (Act No. 8 of 1948)} and separate from all other keys. The Registered Pharmacist in charge is responsible for controlling access to the CD cupboard.
   2. The Second key to the CD cupboard must be kept on the person of a Investigator (medical authority) of the study responsible to conduct the Ethics Committee approved clinical trial in this institution.
   3. Access to the CDs in a double locked cupboard can be made by opening the lock with these two simultaneously operating keys.
   4. Maintain time- logs for records of both signatories.
3. Missing CD keys
   1. If the CD keys cannot be found then urgent efforts should be made to retrieve the keys as speedily as possible e.g. by contacting the pharmacist or Investigator. Depending on the circumstances, it may also be appropriate to contact the police.
4. Ordering controlled drugs
   1. Before ordering any CDs check carefully the amount required as CDs cannot be returned. Registered Pharmacist who is the employees of the hospital pharmacy may order CDs.
   2. Any delegated person who is authorised to order CDs shall provide a specimen of their signature to the pharmacy.
   3. The specimen signature must be countersigned by Investigator or designee. The supply of drugs specified in Schedule X shall be recorded at the time of supply in a register (bound and serially page numbered) specially maintained for the purpose and separate pages shall be allotted for each drug. The following particulars shall be entered in the said register, namely:–
      1. Date of transaction
      2. Quantity received, if any, the name and address of the supplier and the number of the relevant license held by the supplier
      3. Name of the drug
      4. Quantity supplied;
      5. Manufacturer’s name;
      6. Batch No. or Lot No;
      7. Name and address of the patient/purchaser;
      8. Reference Number of the prescription against which supplies were made;
      9. Bill No and date in respect of purchases and supplies made by him;
      10. Signature of the person under whose supervision the drugs have been supplied
   4. No drug shall be dispended or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper.
5. Prescribing CDs
   1. Substances specified in Schedule H or Schedule X shall not be dispensed / administered except on and in accordance with the prescription of a Investigator (Registered Medical Practitioner) and in the case of substances specified in Schedule X, the prescriptions shall be in triplicate, one copy of which shall be retained by the licensee for a period of five years and other for the purpose of maintaining participating patient’s log for a period of five years.
6. Record keeping
   1. The CD Record Book shall be accessible to registered nurses and pharmacy staff Entries must be made on the correctly numbered page legibly in chronological order using black ink. For CDs dispensed / administered the following details shall be recorded in the CD Register:
      1. Date and time when dose dispensed / administered
      2. Name of patient
      3. Drug Name, Strength, Form and Quantity dispensed / administered
      4. Name/signature of pharmacist /authorised person who administered the dose
      5. Name/signature of witness
      6. Balance remaining in stock
   2. If a mistake is made in an entry, the mistake should be bracketed but without obscuring the original entry. The mistake and the correct entry should be signed and dated by the person making those entries
7. Incident Reporting:
   1. The stock balance must be checked, witnessed and recorded each time a dose of a CD is administered
   2. Any discrepancies should be investigated immediately and reported to the ward manger
8. Recording Breakage and Wastage
   1. When these occur a brief explanation shall be stated e.g. if a 2.5mg dose is given from a 5mg ampoule, write 2.5mg given, 2.5mg wasted in the amount given column. If patient refusal results in wastage of the dose, write ‘dose refused’. There must be two signatures.
9. Types of CD checks/audits to be completed and frequency
   1. A check of the actual stock against the stock balance recorded in the CD Record Book must be carried out at least daily.
   2. When checking Controlled Drugs, a package closed by the manufacturer’s unbroken seal may be assumed to contain drugs of the quantity and description on the label. If the seal is broken the contents must be examined individually.
   3. A record must be kept of the date, time and signatures of the staff undertaking the checks in a designated book.
10. Separation and storage of controlled drug stock awaiting destruction
    1. Expired or unwanted controlled drugs should be separated from the current stock and clearly labeled as ‘expired, unwanted stock/excess stock or suspected illicit substance awaiting destruction in order to minimize the risk of error and inadvertent supply to patients.
    2. Do not delete items from the CD register until it is actually destroyed
11. Disposal of controlled drug stock in the presence of and authorized witness
    1. The CDs quarantined for destruction should be added and labeled
    2. The manufacturer’s instructions should be followed carefully
    3. Use hospital drug destruction policy and keep records.
12. Review:
    1. The policy for controlled drugs shall be reviewed every 3 years and or following a change in national or local guidance or legislation or following analysis of a local incident. All staff involved in management, storage, shipment, receipt, prescription, record maintenance and disposal of controlled drugs shall be trained on this policy and must be updated whenever the SOP is revised or new systems are introduced. All staff are responsible for maintaining their competence in managing CDs.