Terms of the Federalwide Assurance

Version Date 1/6/2005

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=20 THE UNITED STATES

1. Human Subjects Research Must be Guided by Ethical=20 Principles

All of the Institution=92s 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=20 Guidelines for the Protection of Human Subjects of Research of the = National=20 Commission for the Protection of Human Subjects of Biomedical and = Behavioral=20 Research, or (b) other appropriate ethical standards recognized by = federal=20 departments and agencies that have adopted the Federal Policy for the = Protection=20 of Human 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=20 whenever (a) the Institution=92s employees or agents intervene or = interact with=20 human subjects for purposes of federally-conducted or =96supported = research; (b)=20 the Institution=92s employees or agents obtain individually identifiable = private=20 information about human subjects for purposes of federally-conducted or=20 =96supported 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=20 Human Subjects and Other Applicable Federal, State, Local, or=20 Institutional Laws, 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=92s = Assurance=20 will comply with the Federal Policy for the Protection of Human = Subjects. =20

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

&nbs= p; =20 7 CFR part 1c = =20 = Department of=20 Agriculture

&nbs= p; =20 10 CFR part 745 =20 = Department of=20 Energy

&nbs= p; =20 14 CFR part1230 =20 = National=20 Aeronautics and Space Administration

&nbs= p; =20 15 CFR part 27 =20 = Department of=20 Commerce

= 16=20 CFR part 1028 =20 = Consumer=20 Product Safety Commission

&nbs= p; =20 22 CFR part 225 =20 = Agency for=20 International Development

&nbs= p; =20 24 CFR part 60 =20 = Department of=20 Housing and Urban Development

&nbs= p; =20 28 CFR part 46 =20 = Department of=20 Justice

&nbs= p; 32=20 CFR part 219 =20 = Department of=20 Defense

&nbs= p; =20 34 CFR part 97 =20 = Department of=20 Education

&nbs= p; =20 38 CFR part 16 =20 = Department of=20 Veterans Affairs

&nbs= p; =20 40 CFR part 26 =20 = Environmental=20 Protection Agency

&nbs= p; =20 45 CFR part 46 =20 = Department of=20 Health and Human Services

&nbs= p; =20 45 CFR part=20 46 = ; =20 Central Intelligence Agency

&nbs= p; =20 (by Executive Order 12333)

&nbs= p; =20 45 CFR part 690 =20 = National=20 Science Foundation

&nbs= p; =20 49 CFR part 11 =20 = Department of=20 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=20 retains final judgment as to whether a particular activity conducted or=20 supported by the respective department or agency is covered by the = Common=20 Rule. If the Institution needs guidance regarding implementation = of the=20 Common Rule and other applicable federal regulations, the Institution = should=20 contact appropriate officials at the department or agency conducting or=20 supporting the research. For federally-conducted or = =96supported =20 research covered by the FWA, the department or agency that conducts or = supports=20 the research retains final authority for determining whether the = Institution=20 complies with the Terms of Assurance. If HHS receives an = allegation or=20 indication of noncompliance related to human subjects research that is = covered=20 by the FWA and is conducted or supported solely by a Common Rule = department or=20 agency other than HHS, HHS will refer the matter to the other department = or=20 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 =96supported. =

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/irbgd702.htm.]

5. Scope of IRB(s)=92s 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=20 authority to approve, require modifications in, or disapprove the = covered human=20 subjects research. For research approved by the IRB(s), further=20 appropriate review and approval by any department or agency conducting = or=20 supporting the research or by officials of the institution holding the = FWA may=20 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 =96supported 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=20 may operate under the FWA with the approval of the department or agency=20 conducting or supporting the research and the institution holding the = FWA.

For federally-conducted or =96supported 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 =96supported 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 =96supported 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=92s 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=20 on file and provide copies upon request to OHRP and any department or = agency=20 conducting or supporting the research.

For federally-conducted or =96supported 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 ensure that each IRB designated under the FWA has = meeting space=20 and sufficient staff to support the IRB=92s 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=92s 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,=20 the Human Protections Administrator, and the IRB Chair(s) personally = complete=20 the relevant OHRP Assurance Training Modules, or comparable training = that=20 includes 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=20 staff complete relevant educational training before reviewing human = subjects=20 research; and b) research investigators complete appropriate = institutional=20 educational 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=20 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=20 INTERNATIONAL (NON-U.S.) INSTITUTIONS

1. Human Subjects Research Must Be Guided by Ethical=20 Principles

All of the Institution=92s 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=20 so engaged whenever (a) the Institution=92s employees or agents = intervene or=20 interact with human subjects for purposes of U.S. federally-conducted or = =96supported research; (b) the Institution=92s employees or agents = obtain=20 individually identifiable private information about human subjects for = purposes=20 of U.S. federally-conducted or =96supported research; or (c) the = Institution=20 receives a direct award to conduct U.S. federally-supported human = subjects=20 research, even where all activities involving human subjects are carried = out by=20 a subcontractor 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=20 Guidelines

When the Institution becomes engaged in U.S. federally-conducted or=20 =96supported human subjects research to which the FWA applies, the = Institution and=20 institutional review boards (IRBs) or independent ethics committees = (IECs)=20 designated under the FWA at a minimum will comply with one or more of = the=20 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 1993 Council for International Organizations of Medical = Sciences=20 (CIOMS) International Ethical Guidelines for Biomedical Research = Involving=20 Human Subjects;

f) The 1998 Medical Research Council of Canada Tri-Council Policy = Statement=20 on Ethical Conduct for Research Involving Humans;

g) The 2000 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=20 needs guidance regarding implementation of the Common Rule and/or other=20 applicable U.S. federal regulations, the Institution should contact = appropriate=20 officials at the U.S. federal department or agency conducting or = supporting the=20 research. For U.S. federally-conducted or =96supported research = covered by=20 the FWA, the U.S. federal department or agency that conducts or supports = the=20 research retains final authority for determining whether the Institution = complies with the Terms of Assurance. If HHS receives an = allegation or=20 indication of noncompliance related to human subjects research that is = covered=20 by the FWA and is conducted or supported solely by a Common Rule = department or=20 agency other than HHS, HHS will refer the matter to the other U.S. = federal=20 department or agency for review and action as appropriate.

4. IRB/IEC Written Procedures*

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

conducting IRB/IEC initial and continuing review (not less than = once per=20 year), of research, and reporting IRB/IEC findings to the = investigator and=20 the 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/IEC = review;=20 and
ensuring prompt reporting to the IRB/IEC of proposed changes in a = research activity, and for ensuring that such changes in approved = research,=20 during the period for which IRB/IEC approval has already been given, = may not=20 be initiated without IRB/IEC 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/irbgd702.htm.]

5. Scope of IRB(s)/IEC(s)=92s 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)/IEC(s).=20 The IRB(s)/IEC(s) shall have authority to approve, require = modifications=20 in, or disapprove the covered human subjects research. For = research=20 approved by the IRB(s)/IEC(s), further appropriate review and approval = by any=20 U.S. federal 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 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=20 subjects research, the Institution will comply with any human subject=20 regulations and/or policies of the supporting U.S. federal department or = agency=20 for these classes 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 =96supported 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. = =20

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

For U.S. federally-conducted or =96supported research covered = by the FWA,=20 the U.S. federal department or agency that conducts or supports the = research=20 retains final authority for determining which institutions are engaged = in the=20 research and need to hold an assurance for the protection of human = subjects.=20

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 =96supported 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 =96supported 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/IEC review. = OHRP=92s=20 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=20 commitment agreements on file and provide copies upon request to OHRP or = any=20 U.S. federal department or agency conducting or supporting the research. =

For U.S. federally-conducted or =96supported research covered = by the FWA,=20 the U.S. federal department or agency that conducts or supports the = research=20 retains final authority for determining which independent investigators = are=20 engaged in the research and need to be covered by a written commitment = agreement=20 with the institution holding the FWA.

10. Institutional Support for the IRB(s)/IEC(s)

The Institution will ensure that each IRB(s)/IEC(s) designated under = the FWA=20 has meeting space and sufficient staff to support the IRB=92s/IEC=92s = review and=20 recordkeeping 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)/IEC(s) designated under the FWA agree = to comply=20 with these terms, and (b) the IRB(s)/IEC(s) possess appropriate = knowledge of the=20 local research context for all research to which the FWA applies (please = refer=20 to the OHRP = Guidance on=20 IRB Knowledge of Local Research Context on the OHRP website at = http://= www.hhs.gov/ohrp/humansubjects/guidance/local.htm).=20

Any designation under the FWA of the IRB/IEC or another institution = or=20 organization should be documented by a written agreement between the = Institution=20 holding the FWA and the IRB/IEC organization outlining their = relationship and=20 include a commitment that the designated IRB/IEC will adhere to the = requirements=20 of the FWA. OHRP=92s sample IRB Authorization Agreement may be used for = such=20 purpose, or the parties involved may develop their own agreement. This = agreement=20 should be kept on file at both institutions/organizations and made = available=20 upon request to OHRP and any U.S. federal department or agency = conducting or=20 supporting research covered by the FWA.

12. 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/IEC Chair(s) that must be = fulfilled under=20 the FWA. OHRP strongly recommends that the Institutional = Signatory=20 Official, the Human Protections Administrator, and the IRB/IEC Chair(s)=20 personally complete the relevant OHRP Assurance Training Modules, or = comparable=20 training that includes the content of these Modules, prior to submitting = the=20 FWA.

13. Educational Training

OHRP strongly recommends that the Institution and the designated=20 IRB(s)/IEC(s) establish educational training and oversight mechanisms=20 (appropriate to the nature and volume of its research) to ensure that = research=20 investigators, IRB/IEC members and staff, and other appropriate = personnel=20 maintain continuing knowledge of, and comply with the following: = relevant=20 ethical principles; relevant U.S. regulations; written IRB/IEC = procedures; OHRP=20 guidance; other applicable guidance; national, state and local laws; and = institutional policies for the protection of human subjects. = Furthermore,=20 OHRP recommends that a) IRB/IEC members and staff complete relevant = educational=20 training before reviewing human subjects research; and b) research = investigators=20 complete appropriate institutional educational training before = conducting human=20 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, click=20 ohrp@osophs.dhhs.gov
If = you have=20 questions/suggestions about this web page, click Webmaster
Updated=20 [2/02/2005]

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)