110530P - PROVISION OF INFORMATION TO PATIENTS AND FAMILIES ON PARTICIPATION IN CLINICAL RESEARCH

Corporate and Policy Procedure prepared by Prof. Omar Hasan Kasule, Sr. for King Fahad Medical City.

1                     STATEMENT OF PURPOSE

2                     The purpose of this policy is to explain the content and procedures of informing patients and their families about opportunities of participation in clinical research

3                     REVISION HISTORY

Date	Rev. No.	Change
29/07/1430 H / 22/07/2009	1

4                     RELATED DOCUMENTS

4.1                Institutional Review Board

4.2                Informed Consent for Research

5                     DEFINITIONS

5.1                Institutional Review Board (IRB) – is a body constituted by the institutional highest authorities but works independently to make ethical reviews and approve proposed research as well as following up the implementation of the research.

5.2                Research - is a systematic collection and analysis of empirical data to describe a phenomenon or to establish causal linkages between and among phenomena.

5.3                Clinical Research – is research carried out on patients and healthy volunteers to test new treatment modalities.

5.4                Research Subject - is an individual patient or healthy volunteer who consents to participate in research.

5.5                Informed Consent - is agreement of the research subject to participate in research after full disclosure and explanation of details pertaining to the research.

5.6                Autonomy - is a basic human right to make decisions affecting one’s body including agreeing to participate in research.

6                     POLICY

6.1                Written material in non-technical language shall be developed for distribution to patients and families consisting of the following:

6.1.1           Explanation of availability of opportunities to be research subjects in clinical research related to their medical condition or any other condition.

6.1.2           Explanation of availability

6.1.3           Explanation of potential benefits and risks of research.

6.1.4           Procedures of recruitment into research projects

6.1.5           Procedures of approval and monitoring of research.

6.1.6           Procedure of Informed Consent.

6.2                All patients will be assured that their consent or refusal to participate in research will not in any way affect the care and consideration received from KFMC.

6.3                KFMC staff shall avoid any appearance of coercion to participate in research during their interactions with patients and their families.

7                     PROCEDURES

7.1                Posters and brochures giving information about research shall be available all over the hospital.

7.2                A toll-free number shall be provided for inquiry about recruitment into research projects and for further information.

7.3                Awareness programs shall be organized for physicians, nurses, and social workers to enable them answer patient questions about participation in research.

7.4                Information about on-going research that be available and accessible to patients

8                     RESPONSIBILITIES

8.1                Research Center

8.2                Research Center

8.3                Research Center

8.4                Research Center

9                     APPENDIX

10                 REFERENCES

CPP	CORPORATE POLICY AND PROCEDURE
NUMBER:	1430-64
TITLE:	Provision of Information to Patients and Families on Participation in Clinical Research
PUBLICATION DATE:
EFFECTIVE DATE:
APPLIES TO:
PREPARED BY:	DATE:	RECOMMENDED BY:	DATE:
REVIEWED BY:		DATE:
Dr.  Kheder Al-Zahrani Director, Corporate Planning & Development Administration
APPROVED BY:                                                                                          DATE:		DATE:
Dr. Abdullah Al-Amro Chief Executive Officer