Terms of the Federalwide Assurance

FEDERALWIDE ASSURANCE (FWA) FOR THE PROTECTION OF HUMAN = SUBJECTS

U. S. Department of Health and Human Services (HHS)
Office for = Human=20 Research Protections (OHRP)

A. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR INSTITUTIONS = WITHIN THE=20 UNITED STATES

1. Human Subjects Research Must be Guided by Ethical = Principles

All of the Institution=E2=80=99s human subjects research activities, = regardless of=20 whether the research is subject to federal regulations, will be guided = by the=20 ethical principles in: (a) The Belmont Report: Ethical Principles and = Guidelines=20 for the Protection of Human Subjects of Research of the National = Commission for=20 the Protection of Human Subjects of Biomedical and Behavioral Research, = or (b)=20 other appropriate ethical standards recognized by federal departments = and=20 agencies that have adopted the Federal Policy for the Protection of = Human=20 Subjects, known as the Common Rule.

2. Applicability

These terms apply whenever the Institution becomes engaged in human = subjects=20 research conducted or supported* by any federal department or agency = that has=20 adopted the Common Rule, unless the research is otherwise exempt from = the=20 requirements of the Common Rule or a department or agency conducting or=20 supporting the research determines that the research shall be conducted = under a=20 separate assurance. In general, the Institution becomes so engaged = whenever (a)=20 the Institution=E2=80=99s employees or agents intervene or interact with = human subjects=20 for purposes of federally-conducted or =E2=80=93supported research; (b) = the=20 Institution=E2=80=99s employees or agents obtain individually = identifiable private=20 information about human subjects for purposes of federally-conducted or=20 =E2=80=93supported research; or (c) the Institution receives a direct = federal award to=20 conduct human subjects research, even where all activities involving = human=20 subjects are carried out by a subcontractor or collaborator.

[*Federally-supported is defined throughout the FWA = and the=20 Terms of Assurance as the U.S. Government providing any funding or other = support.]

3. Compliance with the Federal Policy for the Protection of Human = Subjects=20 and Other Applicable Federal, State, Local, or Institutional = Laws,=20 Regulations, and Policies

When the Institution becomes engaged in federally-conducted or = -supported=20 human subjects research to which the FWA applies, the Institution and = the=20 institutional review boards (IRBs) designated under the = Institution=E2=80=99s Assurance=20 will comply with the Federal Policy for the Protection of Human = Subjects.

The reference in the Code of Federal Regulations is shown below for = each=20 department and agency which has adopted the Common Rule:

7 CFR part 1c	Department of Agriculture
10 CFR part 745	Department of Energy
14 CFR part1230	National Aeronautics and Space Administration
15 CFR part 27	Department of Commerce
16 CFR part 1028	Consumer Product Safety Commission
22 CFR part 225	Agency for International Development
24 CFR part 60	Department of Housing and Urban Development
28 CFR part 46	Department of Justice
32 CFR part 219	Department of Defense
34 CFR part 97	Department of Education
38 CFR part 16	Department of Veterans Affairs
40 CFR part 26	Environmental Protection Agency
45 CFR part 46	Department of Health and Human Services
45 CFR part 46 (by Executive Order 12333)	Central Intelligence Agency
45 CFR part 690	National Science Foundation
49 CFR part 11	Department of Transportation

For any federally-conducted or -supported human subjects research to = which=20 the FWA applies, the Institution also will comply with any additional = human=20 subjects regulations and policies of the department or agency which = conducts or=20 supports the research and any other applicable federal, state, local, or = institutional laws, regulations, and policies. When the=20 Institution is engaged in human subjects research conducted or supported = by the=20 Department of Health and Human Services (HHS), the Institution will = comply with=20 all subparts of the HHS regulations at Title 45 Code of Federal = Regulations part=20 46 (45 CFR part 46, subparts A, B, C, and D).

Human subjects research conducted or supported by each federal = department or=20 agency listed above will be governed by the regulations as implemented = by the=20 respective department or agency. The head of the department or agency = retains=20 final judgment as to whether a particular activity conducted or = supported by the=20 respective department or agency is covered by the Common Rule. If the=20 Institution needs guidance regarding implementation of the Common Rule = and other=20 applicable federal regulations, the Institution should contact = appropriate=20 officials at the department or agency conducting or supporting the = research. For=20 federally-conducted or =E2=80=93supported research covered by the FWA, = the department or=20 agency that conducts or supports the research retains final authority = for=20 determining whether the Institution complies with the Terms of = Assurance. If HHS=20 receives an allegation or indication of noncompliance related to human = subjects=20 research that is covered by the FWA and is conducted or supported solely = by a=20 Common Rule department or agency other than HHS, HHS will refer the = matter to=20 the other department or agency for review and action as appropriate. =

Please note that if the Institution voluntarily extends the Common = Rule or=20 the Common Rule and subparts B, C, and D of the HHS regulations at 45 = CFR part=20 46 to all research regardless of support, OHRP will have the authority = to ensure=20 that the Institution complies with this commitment for all research to = which the=20 FWA applies that is not federally-conducted or =E2=80=93supported.

4. Written Procedures*

unanticipated problems involving risks to subjects or others; =
serious or continuing noncompliance with the federal regulations = or the=20 requirements or determinations of the IRB(s); and
suspension or termination of IRB approval.

Upon request, the Institution will provide a copy of these written=20 procedures to OHRP and any department or agency conducting or = supporting=20 research covered by the FWA.

b) The Institution must ensure that the IRB(s) designated under the = FWA has=20 established written procedures* for:

conducting IRB initial and continuing review (not less than once = per=20 year) of research, and reporting IRB findings to the investigator = and the=20 Institution;
determining which projects require review more often than = annually and=20 which projects need verification from sources other than the = investigator=20 that no material changes have occurred since the previous IRB = review; and=20
ensuring prompt reporting to the IRB of proposed changes in a = research=20 activity and for ensuring that such changes in approved research, = during the=20 period for which IRB approval has already been given, may not be = initiated=20 without IRB review and approval, except when necessary to eliminate = apparent=20 immediate hazards to the subjects.

Upon request, the Institution will provide a copy of these written=20 procedures to OHRP and any department or agency conducting or = supporting=20 research covered by the FWA.

[*For HHS-conducted or -supported human subjects = research,=20 see OHRP= =20 guidance on written IRB procedures on the OHRP website at http= ://www.hhs.gov/ohrp/humansubjects/guidance/irbgd107.htm.]

5. Scope of IRB(s)=E2=80=99s Responsibilities

All human subjects research to which the FWA applies, except for = research=20 exempted or waived in accordance with Sections 101(b) or 101(i) of the = Common=20 Rule, will be reviewed, prospectively approved, and subject to = continuing review=20 at least annually by the designated IRB(s). The IRB(s) will have = authority to=20 approve, require modifications in, or disapprove the covered human = subjects=20 research. For research approved by the IRB(s), further appropriate = review and=20 approval by any department or agency conducting or supporting the = research or by=20 officials of the institution holding the FWA may be required.

6. Informed Consent Requirements

Except for research exempted or waived in accordance with Sections = 101(b) or=20 101(i) of the Common Rule, informed consent for research to which the = FWA=20 applies will be:

a) sought from each prospective subject or the subject's legally = authorized=20 representative, in accordance with, and to the extent required by, = Section 116=20 of the Common Rule; and

b) appropriately documented, in accordance with, and to the extent = required=20 by, Section 117 of the Common Rule.

7. Requirement for Assurances for = Collaborating=20 Institutions

When the Institution holding the FWA is either a) the primary awardee = under a=20 federal grant, contract, or cooperative agreement supporting research to = which=20 the FWA applies, or b) the coordinating center for federally-conducted = or=20 =E2=80=93supported research to which the FWA applies, the Institution is = responsible for=20 ensuring that all collaborating institutions engaged in such research = operate=20 under an appropriate OHRP-approved or other federally-approved assurance = for the=20 protection of human subjects.

An institution holding an FWA may collaborate with another = institution that=20 does not have an FWA. In such circumstances, a collaborating institution = may=20 operate under the FWA with the approval of the department or agency = conducting=20 or supporting the research and the institution holding the FWA.

For federally-conducted or =E2=80=93supported research covered by the = FWA, the=20 department or agency that conducts or supports the research retains = final=20 authority for determining which institutions are engaged in the research = and=20 need to hold an assurance for the protection of human subjects.

8. Written Agreements with Independent Investigators Who are=20 not
Otherwise Affiliated with the Institution

When the Institution holding the FWA is either a) the primary awardee = under a=20 federal grant, contract, or cooperative agreement supporting research to = which=20 the FWA applies, or b) the coordinating center for federally-conducted = or=20 =E2=80=93supported research to which the FWA applies, the Institution is = responsible for=20 ensuring that all collaborating independent investigators engaged in = such=20 research operate under an appropriate OHRP-approved or other = federally-approved=20 assurance for the protection of human subjects.

The engagement in federally-conducted or =E2=80=93supported human = subjects research=20 activities to which the FWA applies by each independent investigator who = is not=20 otherwise an employee or agent of the Institution may be covered under = the FWA=20 only in accordance with a formal, written agreement of commitment to = relevant=20 human subject protection policies and IRB review. OHRP=E2=80=99s sample = Ind= ividual=20 Investigator Agreement (see htt= p://www.hhs.gov/ohrp/humansubjects/assurance/unaflsup.rtf)=20 may be used or adapted for this purpose, or the Institution may develop = its own=20 commitment agreement in coordination with the department or agency = conducting or=20 supporting the research. Institutions must maintain commitment = agreements on=20 file and provide copies upon request to OHRP and any department or = agency=20 conducting or supporting the research.

For federally-conducted or =E2=80=93supported research covered by the = FWA, the=20 department or agency that conducts or supports the research retains = final=20 authority for determining which independent investigators are engaged in = the=20 research and need to be covered by a written commitment agreement with = the=20 institution holding the FWA.

9. Institutional Support for the IRB(s)

The Institution = will=20 ensure that each IRB designated under the FWA has meeting space and = sufficient=20 staff to support the IRB=E2=80=99s review and recordkeeping duties.

10. Compliance with the Terms of Assurance

The Institution accepts and will follow items 1-9 above and is = responsible=20 for ensuring that (a) the IRB(s) designated under the FWA agree to = comply with=20 these terms; and (b) the IRB(s) possess appropriate knowledge of the = local=20 research context for all research to which the FWA applies (please refer = to the=20 OHRP=20 Guidance on IRB Knowledge of Local Research Context on the OHRP = website=20 at http://= www.hhs.gov/ohrp/humansubjects/guidance/local.htm).=20

Any designation under the FWA of the IRB of another institution or=20 organization must be documented by a written agreement between the = Institution=20 holding the FWA and the IRB organization outlining their relationship = and=20 include a commitment that the designated IRB will adhere to the = requirements of=20 the FWA. OHRP=E2=80=99s sample IRB Authorization Agreement may be used = for such purpose,=20 or the parties involved may develop their own agreement. This agreement = should=20 be kept on file at both institutions/organizations and made available = upon=20 request to OHRP and any department or agency conducting or supporting = research=20 covered by the FWA.

11. Assurance Training

The OHRP = Assurance=20 Training Modules (see http://137.187.1= 72.153/CBTs/Assurance/login.asp)=20 describe the major responsibilities of the Institutional Signatory = Official, the=20 Human Protection Administrator (e.g., Human Subjects Administrator or = Human=20 Subjects Contact Person), and the IRB Chair(s) that must be fulfilled = under the=20 FWA. OHRP strongly recommends that the Institutional Signatory Official, = the=20 Human Protections Administrator, and the IRB Chair(s) personally = complete the=20 relevant OHRP Assurance Training Modules, or comparable training that = includes=20 the content of these modules, prior to submitting the FWA.

12. Educational Training

OHRP strongly recommends that the Institution and the designated = IRB(s)=20 establish educational training and oversight mechanisms (appropriate to = the=20 nature and volume of its research) to ensure that research = investigators, IRB=20 members and staff, and other appropriate personnel maintain continuing = knowledge=20 of, and comply with, the following: relevant ethical principles; = relevant=20 federal regulations; written IRB procedures; OHRP guidance; other = applicable=20 guidance, state and local laws; and institutional policies for the = protection of=20 human subjects. Furthermore, OHRP recommends that a) IRB members and = staff=20 complete relevant educational training before reviewing human subjects = research;=20 and b) research investigators complete appropriate institutional = educational=20 training before conducting human subjects research.

13. Renewal of Assurance

All information provided under the FWA must be renewed or updated at = least=20 every 36 months (3 years), even if no changes have occurred, in order to = maintain an active FWA. Failure to update this information may result in = restriction, suspension, or termination of the Institution's FWA for the = protection of human subjects.

DOMESTIC INSTITUTIONS ACCEPTING THESE TERMS MAY PROCEED WITH THE = ASSURANCE=20 FILING PROCESS

[ Return = to OHRP=20 Assurance Main Page ]

B. TERMS OF THE FEDERALWIDE ASSURANCE (FWA) FOR = INTERNATIONAL (NON-U.S.) INSTITUTIONS

1. Human Subjects Research Must Be Guided by Ethical = Principles

All of the Institution=E2=80=99s human subjects research activities, = regardless of=20 whether the research is subject to U.S. federal regulations, will be = guided by=20 one of the following statements of ethical principles: (a) The World = Medical=20 Association's Declaration of Helsinki (as adopted in 1996 or 2000); (b) = The=20 Belmont Report: Ethical Principles and Guidelines for the Protection of = Human=20 Subjects of Research of the U.S. National Commission for the Protection = of Human=20 Subjects of Biomedical and Behavioral Research; or (c) other appropriate = international ethical standards recognized by U.S. federal departments = and=20 agencies that have adopted the U.S. Federal Policy for the Protection of = Human=20 Subjects, known as the Common Rule.

2. Applicability

These terms apply whenever the Institution becomes engaged in human = subjects=20 research conducted or supported* by any U.S. department or agency that = has=20 adopted the Common Rule, unless the research is otherwise exempt from = the=20 requirements of the Common Rule or a U.S. federal department or agency=20 conducting or supporting the research determines that the research shall = be=20 conducted under a separate assurance. In general, the Institution = becomes so=20 engaged whenever (a) the Institution=E2=80=99s employees or agents = intervene or interact=20 with human subjects for purposes of U.S. federally-conducted or = =E2=80=93supported=20 research; (b) the Institution=E2=80=99s employees or agents obtain = individually=20 identifiable private information about human subjects for purposes of = U.S.=20 federally-conducted or =E2=80=93supported research; or (c) the = Institution receives a=20 direct award to conduct U.S. federally-supported human subjects = research, even=20 where all activities involving human subjects are carried out by a = subcontractor=20 or collaborator.

If a U.S. federal department or agency head determines that the = procedures=20 prescribed by the institution afford protections that are at least = equivalent to=20 those provided by the U.S. Federal Policy for the Protection of Human = Subjects,=20 the department or agency head may approve the substitution of the = foreign=20 procedures in lieu of the procedural requirements provided above, = consistent=20 with the requirements of section 101(h) of the U.S. Federal Policy for = the=20 Protection of Human Subjects.

[*Federally-supported is defined throughout the = Assurance=20 document and the Terms of Assurance as the U.S. Government providing any = funding=20 or other support.]

3. Compliance with Laws, Regulations, Policies, and Guidelines =

When the Institution becomes engaged in U.S. federally-conducted or=20 =E2=80=93supported human subjects research to which the FWA applies, the = Institution and=20 institutional review boards (IRBs) designated under the FWA at a minimum = will=20 comply with one or more of the following:

a) The U.S. Federal Policy for the Protection of Human Subjects = (see=20 section 3 of the Terms of the FWA for Institutions within the United = States=20 for a list of U.S. federal departments and agencies that have adopted = the=20 Common Rule);

b) The Common Rule and subparts B, C, and D of the U.S. Department = of=20 Health and Human Services (HHS) regulations at 45 CFR part 46;

c) The U.S. Food and Drug Administration (FDA) regulations at 21 = CFR parts=20 50 and 56;

d) The May 1, 1996, International Conference on Harmonization E-6=20 Guidelines for Good Clinical Practice (ICH-GCP-E6), Sections 1 through = 4;

e) The 2002 Council for International Organizations of Medical = Sciences=20 (CIOMS) International Ethical Guidelines for Biomedical Research = Involving=20 Human Subjects;

f) The 1998 (with 2000, 2002, 2005 amendments) Medical Research = Council of=20 Canada Tri-Council Policy Statement on Ethical Conduct for Research = Involving=20 Humans;

g) The 2006 Indian Council of Medical Research Ethical Guidelines = for=20 Biomedical Research on Human Subjects; or

h) Other standard(s) for the protection of human subjects = recognized by=20 U.S. federal departments and agencies which have adopted the U.S. = Federal=20 Policy for the Protection of Human Subjects.

All U.S. federally-conducted or -supported human subjects research to = which=20 the FWA applies will also comply with any additional human subjects = regulations=20 and policies of the U.S. federal department or agency which conducts or = supports=20 the research and any other applicable U.S. federal, international, = state, local,=20 or institutional laws, regulations, and policies.

The head of the U.S. federal department or agency retains final = judgment as=20 to whether a particular activity conducted or supported by the = respective=20 department or agency is covered by the Common Rule. If the Institution = needs=20 guidance regarding implementation of the Common Rule and/or other = applicable=20 U.S. federal regulations, the Institution should contact appropriate = officials=20 at the U.S. federal department or agency conducting or supporting the = research.=20 For U.S. federally-conducted or =E2=80=93supported research covered by = the FWA, the U.S.=20 federal department or agency that conducts or supports the research = retains=20 final authority for determining whether the Institution complies with = the Terms=20 of Assurance. If HHS receives an allegation or indication of = noncompliance=20 related to human subjects research that is covered by the FWA and is = conducted=20 or supported solely by a Common Rule department or agency other than = HHS, HHS=20 will refer the matter to the other U.S. federal department or agency for = review=20 and action as appropriate.

4. IRB Written Procedures*

a) The Institution submitting the FWA has established written = procedures*=20 for ensuring prompt reporting to the IRB, appropriate institutional = officials,=20 the head of any U.S. federal department or agency conducting or = supporting the=20 research (or designee), any applicable regulatory body, and OHRP of = any:

unanticipated problems involving risks to subjects or others; =
serious or continuing noncompliance with the applicable U.S. = federal=20 regulations or the requirements or determinations of the IRB(s); and =
suspension or termination of IRB approval.

Upon request, the Institution will provide a copy of these written=20 procedures to OHRP and any department or agency conducting or = supporting=20 research covered by the FWA.

b) The Institution must ensure that the IRB(s) designated under the = FWA has=20 established written procedures* for:

conducting IRB initial and continuing review (not less than once = per=20 year), of research, and reporting IRB findings to the investigator = and the=20 Institution;=20
determining which projects require review more often than = annually and=20 which projects need verification from sources other than the = investigator=20 that no material changes have occurred since the previous IRB = review; and=20
ensuring prompt reporting to the IRB of proposed changes in a = research=20 activity, and for ensuring that such changes in approved research, = during=20 the period for which IRB approval has already been given, may not be = initiated without IRB review and approval, except when necessary to=20 eliminate apparent immediate hazards to the subjects.

Upon request, the Institution will provide a copy of these written=20 procedures to OHRP and any department or agency conducting or = supporting=20 research covered by the FWA.

[*For HHS-conducted or -supported human subjects = research,=20 see OHRP= =20 guidance on written IRB procedures on the OHRP website at http= ://www.hhs.gov/ohrp/humansubjects/guidance/irbgd107.htm.]

5. Scope of IRB(s)=E2=80=99s Responsibilities

All U.S. federally-conducted or -supported research to which the FWA = applies,=20 except for research exempted or waived in accordance with sections = 101(b) or=20 101(i) of the U.S. Common Rule, will be reviewed, prospectively = approved, and=20 subject to continuing review at least annually by the designated IRB(s). = The=20 IRB(s) shall have authority to approve, require modifications in, or = disapprove=20 the covered human subjects research. For research approved by the = IRB(s),=20 further appropriate review and approval by any U.S. federal department = or agency=20 conducting or supporting the research or by officials of the institution = holding=20 the FWA may be required.

6. Informed Consent Requirements

Except for research exempted or waived in accordance with Sections = 101(b) or=20 101(i) of the U.S. Common Rule, informed consent for research to which = the FWA=20 applies will be:

b) appropriately documented, in accordance with, and to the extent = required=20 by, Section 117 of the U.S. Common Rule.

7. Considerations for Special Class of Subjects

For HHS-conducted or supported human subjects research, the = Institution will=20 comply with the HHS regulations at 45 CFR part 46, subparts B, C, and D, = prior=20 to the involvement of pregnant women, fetuses, or neonates; prisoners; = or=20 children, respectively. For non-HHS U.S. federally-supported human = subjects=20 research, the Institution will comply with any human subject regulations = and/or=20 policies of the supporting U.S. federal department or agency for these = classes=20 of subjects.

8. Requirement for Assurances for = Collaborating=20 Institutions

When the Institution holding the FWA is either a) the primary awardee = under a=20 U.S. federal grant, contract, or cooperative agreement supporting = research to=20 which the FWA applies, or b) the coordinating center for U.S.=20 federally-conducted or =E2=80=93supported research to which the FWA = applies, the=20 Institution is responsible for ensuring that all collaborating = institutions=20 engaged in such research operate under an appropriate OHRP-approved or = other=20 U.S. federally-approved assurance for the protection of human subjects. =

An institution holding an FWA may collaborate with another = institution that=20 does not have an FWA. In such circumstances, a collaborating institution = may=20 operate under the FWA with the approval of the U.S. federal department = or agency=20 conducting or supporting the research and the institution holding the = FWA.

For U.S. federally-conducted or =E2=80=93supported research covered = by the FWA, the=20 U.S. federal department or agency that conducts or supports the research = retains=20 final authority for determining which institutions are engaged in the = research=20 and need to hold an assurance for the protection of human subjects.

9. Written Agreements with Independent Investigators Who are=20 not
Otherwise Affiliated with the Institution

When the Institution holding the FWA is either a) the primary awardee = under a=20 U.S. federal grant, contract, or cooperative agreement supporting = research to=20 which the FWA applies, or b) the coordinating center for U.S.=20 federally-conducted or =E2=80=93supported research to which the FWA = applies, the=20 Institution is responsible for ensuring that all collaborating = independent=20 investigators engaged in such research operate under an appropriate=20 OHRP-approved or other U.S. federally-approved assurance for the = protection of=20 human subjects.

The engagement in U.S. federally-conducted or =E2=80=93supported = human subjects=20 research activities to which the FWA applies by each independent = investigator=20 who is not otherwise an employee or agent of the Institution may be = covered=20 under the FWA only in accordance with a formal, written agreement of = commitment=20 to relevant human subject protection policies and IRB review. = OHRP=E2=80=99s sample Ind= ividual=20 Investigator Agreement (see htt= p://www.hhs.gov/ohrp/humansubjects/assurance/unaflsup.rtf)=20 may be used or adapted for this purpose, or the Institution may develop = its own=20 commitment agreement in coordination with the U.S. federal department or = agency=20 conducting or supporting the research. Institutions should maintain = commitment=20 agreements on file and provide copies upon request to OHRP or any U.S. = federal=20 department or agency conducting or supporting the research.

For U.S. federally-conducted or =E2=80=93supported research covered = by the FWA, the=20 U.S. federal department or agency that conducts or supports the research = retains=20 final authority for determining which independent investigators are = engaged in=20 the research and need to be covered by a written commitment agreement = with the=20 institution holding the FWA.

10. Institutional Support for the IRB(s)

The Institution will ensure that each IRB(s) designated under the FWA = has=20 meeting space and sufficient staff to support the IRB=E2=80=99s review = and recordkeeping=20 duties.

11. Compliance with the Terms of Assurance

The Institution accepts and will follow items 1-10 above and is = responsible=20 for ensuring that (a) the IRB(s) designated under the FWA agree to = comply with=20 these terms, and (b) the IRB(s) possess appropriate knowledge of the = local=20 research context for all research to which the FWA applies (please refer = to the=20 OHRP=20 Guidance on IRB Knowledge of Local Research Context on the OHRP = website=20 at http://= www.hhs.gov/ohrp/humansubjects/guidance/local.htm).=20

Any designation under the FWA of the IRB or another institution or=20 organization should be documented by a written agreement between the = Institution=20 holding the FWA and the IRB organization outlining their relationship = and=20 include a commitment that the designated IRB will adhere to the = requirements of=20 the FWA. OHRP=E2=80=99s sample IRB Authorization Agreement may be used = for such purpose,=20 or the parties involved may develop their own agreement. This agreement = should=20 be kept on file at both institutions/organizations and made available = upon=20 request to OHRP and any U.S. federal department or agency conducting or=20 supporting research covered by the FWA.

12. Assurance Training

13. Educational Training

OHRP strongly recommends that the Institution and the designated = IRB(s)=20 establish educational training and oversight mechanisms (appropriate to = the=20 nature and volume of its research) to ensure that research = investigators, IRB=20 members and staff, and other appropriate personnel maintain continuing = knowledge=20 of, and comply with the following: relevant ethical principles; relevant = U.S.=20 regulations; written IRB procedures; OHRP guidance; other applicable = guidance;=20 national, state and local laws; and institutional policies for the = protection of=20 human subjects. Furthermore, OHRP recommends that a) IRB members and = staff=20 complete relevant educational training before reviewing human subjects = research;=20 and b) research investigators complete appropriate institutional = educational=20 training before conducting human subjects research.

14. Renewal of Assurance

All information provided under the FWA should be renewed or updated = every 36=20 months (3 years), even if no changes have occurred, in order to maintain = an=20 active FWA. Failure to update this information may result in = restriction,=20 suspension, or termination of the Institution's FWA for the protection = of human=20 subjects.

INTERNATIONAL INSTITUTIONS ACCEPTING THESE TERMS MAY PROCEED WITH = THE=20 ASSURANCE FILING PROCESS

[ Return = to OHRP Assurance Main Page ]

If you have questions about human subjects = research,=20 click mailto:%20ohrp@hhs.gov
If you=20 have questions/suggestions about this web page, click Webmaster
Updated [07/09/2009]=20

FEDERALWIDE ASSURANCE (FWA) FOR THE PROTECTION OF HUMAN = SUBJECTS

U. S. Department of Health and Human Services (HHS)Office for = Human=20 Research Protections (OHRP)

U. S. Department of Health and Human Services (HHS)
Office for = Human=20 Research Protections (OHRP)