Appendix for UNIMAS Research Policy

Click for full pdf documents >>

Appendix 6: Informed Consent
(Sourced from http://bms.brown.edu/fogarty/consent.htm)

[Previous] [ Table of Contents ] [ Next ]

What is Informed Consent?

The former Office for Protection from Research Risks (OPRR), now the Office for Human Research Protections (OHRP), describes informed consent this way:

"Informed consent is a process not just a form. Information must be presented to enable persons to voluntary decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act. The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand…The written presentation of information is used to document the basis for consent and for the subjects' future reference." ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm

During this process the researcher and the subject being recruited exchange information: the researcher explains -among other things- the purpose of the study, what the participant's involvement entails, the risks and benefits associated with participation; the subject shares -among other things- her reasons for possibly participating, her reservations about participating, her expectations and hopes, her questions. A participant's consent is documented before a study begins on an informed consent form, but the dialog or information exchange between the researcher and the participant continues throughout the study.

The informed consent process gives the potential research subject the opportunity to choose or not to participate in a study. In order to provide valid consent, a participant must be competent; her consent must be voluntary and informed.

All the major international research ethics code or guidelines require that researchers obtain informed consent from study participants. Even so, controversy about the precise nature and possibility of informed consent exists. A comparative analysis of international documents addressing informed consent is available at: www.georgetown.edu/research/nrcbl/nbac/pubs.html

Frequently Asked Questions

What are the procedures for obtaining consent from human research participants who do not speak English?
· ohrp.osophs.dhhs.gov/humansubjects/guidance/ic-non-e.htm

What U.S. Regulations and International Guidelines Say About Informed Consent
U.S. Regulations Title 45 (45CFR46, subpart A) "U.S. federal regulations for the protection of human subjects in federally-sponsored research."
· ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
Title 21 part 50 (21 CFR 50, subpart B)
· www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&showF R=1
FDA - A guide to informed consent
· www.fda.gov/oc/ohrt/irbs/informedconsent.html

Determining Whether or Not You Are Required to Obtain Informed Consent

Are you doing research?

The U.S. Code of Federal Regulations [45 CFR 46.102(d)] defines research this way: "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some
demonstration and service programs may include research activities."

Research with human subjects generally requires obtaining each subject's informed consent.

Are you doing research with human subjects?
- ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm
In a very few cases, for some human subjects research which must comply with 45 CFR Part 46, including that involving the study of existing data or specimens, obtaining each subject's informed consent may not be required; your IRB makes this decision.

Can the IRB/IEC waive informed consent or alter informed consent elements?
· ohrp.osophs.dhhs.gov/humansubjects/guidance/decisioncharts.htm

What consent is required for the use of human tissue specimens in research?
· www-cdp.ims.nci.nih.gov/brochure.html

Preparing an Informed Consent Document
Informed Consent Documents for Lifespan at The Miriam Hospital, Rhode Island, U.S.A.
Consent Forms, Samples. Click the link below for access to:

(i) a sample adult consent form,

(ii) a sample child assent form,

(iii) a sample parental permission form,

(iv) a sample agreement to participate in specimen banking (anonymous samples) form, and

(v) a sample agreement to participate
in specimen banking (identifiable samples) form.
· www.lifespan.org/research