Institutional Ethics Committee Annexures – 2

Institutional Ethics Committee Annexures – 2

Disclosure of Financial Interests & Management of Conflicts of Interests

Purpose

Principal investigator, Staff & Ethics Committee members must disclose financial interests in private sponsors of their research and conflict of interests must be assessed, managed and, if necessary, eliminated.

Definitions

Equity (Ownership) or Investment Interest

Financial Interest

For the purposes of this policy, a financial interest in the sponsor of the research means:

  1. An equity (ownership) or investment interest;
  2. A position as director, officer, partner, trustee, employee of or any other management position;
  3. Income from the sponsor, including consulting income, received by or promised to the principal investigator within 12 months prior to the time the award is made.
  4. A gift of (fair market value), or multiple gifts promised (fair market value) or more.

Gift

For purposes of this policy, gift includes compensation, payment or other things of value received by a faculty member, student or staff of the Bhagwan Mahaveer Cancer Hospital and Research Center, Jawahar Lal Nehru Marg Jaipur, when functioning within the research project and scope of Ethics Committee roles and responsibilities.

For purposes of this policy, examples of “gifts” include the following:

  1. Free food and meals
  2. Pens, notepads, tour bags, etc.
  3. Free or discounted items where the individual receiving the item is not providing a service of similar or greater value
  4. Samples that are not a part of a formal evaluation process and/or a University contract
  5. Payment to attend meetings and travel or other activities, when the individual or unit

Receiving the payment is not providing a service of equal or greater value. For purposes of this policy “gift” does not include reasonable honoraria, prizes or awards, payment of expenses to speakers who participate in an accredited educational meeting consistent with standards for commercial support developed by the relevant Pharmaceutical/ Sponsor or honoraria and other payments allowed for those faculty and staff eligible to receive these payments as compensation for specific services.

Income

A payment received, including but not limited to any salary, wage, honorarium, reimbursement, dividend, or advance.

Private Sponsor

Non-governmental sponsor of research includes private and/or publically held companies, foundations, professional associations and voluntary health organizations.

Travel Payments

As defined under, include advances and reimbursements for travel and related expenses, including lodging and meals.

  1. Travel payments may not be classified as gifts or as income, depending on the circumstances.
  2. Travel payments are gifts if you did not provided services which were equal to or greater in value than the payments received.
  3. Travel payments are income if the principal investigator provided services which were equal to or greater in value than the payments received. When reporting travel payments as income, the principal investigator must describe the services he or she provided in exchange for the payment.

Policy

  1. Disclosure
    1. All persons employed or empanelled for BHCHRC, Jaipur, who have principal responsibility for a research project funded or supported, in whole or in part, by a contract or grant from a nongovernmental entity, must disclose any Financial Interest in the sponsor of research.
    2. Disclosure statements must be filed:
      1. Before final acceptance of such a contract, grant, or gift
      2. When funding is renewed.
  2. Review of Disclosures
    1. In the case of a disclosed Financial Interest, the disclosure statement and the research project must be reviewed by the Institutional Ethics Committee, BMCHRC, Jaipur. The committee makes a recommendation to the Executive Director of BMCHRC, Jaipur and Provide a course of action.
  3. Public Access to Information
    1. Disclosure statements are subject to public inspection, Under RTI of Gov. of India.
  4. Chairman Ethics Committee
    1. Chairman must disqualify research proposals for projects which are funded in whole or in part by a private sponsor in which Principal Investigator Staff & Ethics Committee members have a Financial Interest.

Bio-Medical Waste (Management & Handling) in Clinical Trial


Serious adverse event or reaction/experience

A SAE (experience) or reaction is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in-subject hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability/incapacity
  • Is a congenital anomaly/birth defect or
  • Is an important medical event

NOTE: The term “life-threatening” in the definition of “serious” refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.

Medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in cases of important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definition above. These events should be considered serious.

Examples of such events require intensive treatment in an emergency room, or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization; or development of drug dependency or drug abuse, or malignant tumors when they are histologically different from the primary tumor.

Other events to be treated as SAEs

Exposure to drug during pregnancy/lactation.
In the event of a pregnancy occurring during the course of a study, the subject must be withdrawn from study drug immediately. The sponsor must be notified without delay and the subject followed during the entire course of the pregnancy and postpartum period. Prenatal and neonatal outcomes must be recorded even if they are completely normal and without AEs.

The “Alert Report on SAE” (ARF) form should be used, even though pregnancy is not considered a SAE. On the AE CRF page the box seriousness “no” should be ticked. In the case summary of the ARF it has to be mentioned that pregnancy is not a SAE but requires reporting via ARF. The ARF is solely used to ensure expedited reporting.

Events not to be treated as SAEs

  • Progression of disease is not to be regarded as a SAE.
  • Death per se is an outcome and is not regarded as an SAE. The primary cause of death (the leading event resulting in death) should be recorded and reported as an SAE.
  • “Died/fatal” will be reported as the outcome of the respective event. If no cause of death can be reported (e.g. unexplained death) the death per se might be reported as an SAE.
  • Due to the seriousness of the disease in this study, certain conditions defined as SAEs will be excluded from expedited reporting on an CRF, i.e.: Elective hospitalization and surgery for treatment of disease Elective hospitalization to simplify treatment or study procedures
  • However, the events have to be entered in the AE section of the CRF.

SAEs Reporting Timeline SOP in Clinical Trial for Regulatory Compliance